ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.
Phase: NA
Conditions: Obstetric Complication, Obstetric Labor Complications, Newborn Morbidity
Sponsor: Jhpiego

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
JHSPH IRB Research Plan for New Data Collection  
 
PI Name:  
 
Harshad Sanghvi, Medical Director and Vice President, Innovations Jhpiego/Baltimore 
 
Co-Investigators:  
Patricia Gomez, Anthony Gichangi, Eva Bazant, Lindsay Litwin, Lynn Kanyuuru, Dicken 
Onyango 
 
Study Title:  
 
ePartogram Effectiveness Study in Kenya 
 
IRB No.: 
 
6958 
 
PI Version No./Date:   July 14, 2017, v4 
 
 
I. 
Aims of the Study: Describe the aims/objectives of the research and/or the project’s research questions or 
hypotheses.  
 
The study aim is to measure the effectiveness of use of the electronic partogram vs. the standard-of-care paper partograph 
on labor management outcomes and labor outcomes in maternity wards in Kenya. 
 
Research Questions 
 
Primary 
Comparing facilities in which birth attendant/providers are using the ePartogram and facilities in which providers are 
using the paper partograph, are the following improved?: (partograph review) 
P1) compliance with globally-recommended, labor monitoring practices and recording on the partograph of the 
practices performed 
P2) decision-making and actions taken to maintain normal labor 
P3) detection, decision-making and action to address deviations from normal labor and complications arising 
during labor 
 
Complications of interest are: prolonged labor (labors over 12 hours or labor that crosses the action line, may 
not be over 12 hours), arrest of descent/dilation that precedes obstructed labor; obstructed labor including 
arrest of descent/dilation, fetal distress and maternal distress; maternal infection; severe pre-eclampsia or 
eclampsia; fetal distress; and maternal distress with shock-like symptoms. 
 
Secondary  
In intervention and control sites: 
S1) Is facility use of ePartogam (vs. paper-partograph) associated with lower rate of (neonatal death <24 hours and 
intrapartum death (fresh stillbirth rate)? (register review) 
 
S2) What facility conditions and practices enable or hinder implementation of best practices in labor monitoring and 
decision-making? What makes the partograph/ePartogram easy-to-use? Efficient? (qualitative inquiry, facility assessment) 
 
S3) What is the availability, accessibility, acceptability, and quality of supervision/support provided with eSupervision 
connectivity and referral functions of the partogram? (qualitative inquiry) 
 
This study will inform the Ministry of Health on the effectiveness of the ePartogram and whether to use it more widely in 
Kenya. 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
II. 
Background and Rationale: Explain why this study is being done.  Summarize briefly what is already known 
about the issue and reference previously published research, if relevant.  
 
Background 
Public Health Problem 
Globally, in 2015, the World Health Organization estimated that 303,000 maternal deaths occurred.1  A global burden of 
disease study estimated that 18,789 (95% UI 16,281–21,747) women died due to obstructed labor annually out of estimated 
292,982 maternal deaths (95% UI 261 017–327 792) or 6.4% in 2013 (2014 estimate).2 Despite the majority of births 
occurring in health facilities currently, 1.3 million intrapartum stillbirths occurred, devastating families.3 In addition, 
904,000 newborns die from hypoxia.4 Many of these deaths, stillbirths and disability could be prevented with timely 
identification and management of intrapartum complications.3,4 
 
Existing Solution 
The partograph is pre-printed, paper-based medical record and early warning system to assist skilled birth attendants (SBA) in 
monitoring fetal well-being, maternal well-being, progress of labor, and identification of obstetric and fetal complications. 
WHO recommends partograph use to improve decision-making in labor and decrease perinatal mortality by reducing 
prolonged or obstructed labor (which results in maternal and fetal deaths, ruptured uterus and fistula), sepsis, fetal distress, 
and unnecessary operative interventions.5  A 2013 Cochrane review of partograph use in high- and low-resource settings 
found no difference comparing partograph and no partograph groups in rates of caesarean section, instrumental vaginal 
delivery or Apgar score less than seven at five minutes. However, the Cochrane review conceded in its conclusion, 
‘partograms may be useful in settings with poorer access to healthcare resources, as studies in Mexico and Africa also 
showed some reduction in caesarean section rates with partogram use and early intervention for delayed progress in 
labour.6 
 
Routine use of paper partograph in low- and middle-income countries is low and inconsistent.7, 88 In many settings, partographs 
are completed retrospectively for record-keeping purposes only. The MCHIP Quality of Care Study in Kenya in 20109 found 
that “the partograph was widely used during labor (in 88% of 442 cases), and when used, its use was initiated at the 
correct time in more than 90% of the cases. Providers were less consistent in filling in details on the partograph during 
labor and delivery, with all components completed in only 58% of cases.” In cases where the partograph action line was 
reached (in 19% or 78 cases), the appropriate action was taken 78% of the time. 
 
Innovation 
The ePartogram, developed by Jhpiego and partners, is an Android tablet-based application based on the modified WHO 
paper-based partograph for use by SBAs to monitor labor.  As when using the paper partograph in labor and delivery settings, 
SBAs using the ePartogram obtain clinical measurements from the woman and fetus according to the current standard of care. 
The measurements are entered into the ePartogram, which will then plot the data in the familiar modified WHO partograph 
format (see Appendix A and Appendix B).  The ePartogram is designed to increase timely utilization of the partograph (and 
thus improve labor management outcomes) by addressing key challenges in paper partograph use and interpretation. These 
challenges include data entry not being straight-forward, and lack of real-time data collection, detection of complications, and 
awareness on when to take clinical action. The ePartogram electronically captures data and triggers warnings to reinforce 
clinical expertise and action by providers; it never touches the woman and will only be used by SBAs for recording 
measurements and interpretation.   
 

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The ePartogram provides reminders1 for obtaining further routine measurements and alarms2 for abnormal measurements. 
Abnormal measurements and associated alarms are defined by “clinical rules”3 based on global guidelines published in WHO’s 
Managing Complications In Pregnancy And Childbirth: A Guide For midwives And doctors, 200310), augmented where 
necessary by opinion from Jhpiego clinicians who are experts in labor management.  The clinical rules are the basis for the 
alarm algorithm of the application. The clinical rules have undergone a validation process by expert SBAs from a variety of 
geographic and clinical settings not affiliated with Jhpiego. The ePartogram is not considered a medical device.   
 
The ePartogram has a supervision support component. The eSupervision component of the ePartogram enables real-time 
transmission of partograph data, enabling on-site supervisors, off-site supervisors, and SBAs at referral facilities to view patient 
information and provide consultation as needed.  Supervisors can view daily, weekly, and monthly labor and delivery statistics 
in the ePartogram and through the associated online dashboard. Should a laboring client need to be referred, the partograph 
record is electronically shared with the referral facility for prompt care. 
 
The ePartogram has been developed by Jhpiego over the last 4.5 years, and in collaboration with D-Tree International, a non-
profit software development company, for the past 2 years.  The usability and functionality of the ePartogram has been tested on 
the benchtop in the United States, during field validation exercises in Tanzania and Kenya, and in the “Feasibility of ePartogram 
Use in Zanzibar” study (JHPSH IRB# 6146).   The ePartogram comprises 78 clinical rules that are programmed in the software 
to trigger clinical reminders for taking measurements and alerts.  Over the past 6 months Jhpiego has simulated 125 scenarios, 
to validate that every clinical rule triggers the correct alert in ePartogram.  Jhpiego, D-tree, and Sonjara, Inc., a software testing 
and quality assurance company, have developed a comprehensive end-to-end quality assurance testing plan to verify the 
functionality, performance, and clinical support of the ePartogram.  The software testing aims to ensure the quality of the 
accuracy, stability, usability, and clinical algorithms in the ePartogram, and is further described in Appendix C.  
 
The ePartogram intervention includes features to benefit SBAs, as well as supervisors and health officials: 
 
SBAs: 
 
Automated plotting of clinical data 
 
Reminders for when to take measurements (beeps) 
 
Alarms for abnormal clinical measurements (red colored tabs or cells) 
 
Facilitates recording of medications administered and notes on client condition 
 
Data sharing between tablets actively used by SBAs for coordinated care on laboring woman 
 
Referral form and data sharing between facilities  
 
Ability to print paper record to remain at the facility 
 
Supervisors and Health Officials: 
 
Supervisor function allows for viewing partograph data in real-time, facilitating supervision and 
communication on care 
 
Completed client records available for review and audits 
 
Online database with monthly reports and raw data for analysis 
 
Online dashboard with monthly summary reports and visual representations of key data 
 
Prior ePartogram Study 
                                                            
1 A reminder is an auditory and visual alert automatically triggered within the ePartogram.  The reminder indicates when a specific 
measurement should be taken and recorded in the ePartogram. 
2 An alarm is a visual alert automatically triggered within the ePartogram to indicate when a clinical measurement is outside of the 
normal range, as defined by WHO guidelines and augmented by Jhpiego clinicians.  Alarms can be “low-level” which is indicated as 
pink in the ePartogram and alerts providers to pay attention to the clinical measurement or “high-level” which is indicated in red in 
the application and alerts providers that clinical action may be needed. (see Appendix B for more detail) 
3 “Clinical rules” refers to a document the defines the reminders and alarms “low-level” and “high-level” that are programmed into 
the ePartogram 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Jhpiego conducted the “Feasibility of ePartogram Use in Zanzibar” research study (JHSPH IRB number 6146) in April  and 
May 2015 in three health facilities: Makunduchi Health Center, Chukwani Primary Health Care Unit, and Mwembeladu 
Maternity Home. Thirty-nine skilled birth attendants (SBAs) were trained to use the ePartogram and monitored 103 laboring 
women using the application.  Trained clinical observers hired by the study assessed the providers’ comfort and confidence in 
labor management using the ePartogram. In addition, there were 84 short interviews conducted with providers after the providers’ 
first five uses of the ePartogram to gain insight on initial interactions with the application in an actual labor and delivery setting.  
At the conclusion of data collection, 15 in-depth interviews were conducted with SBAs to get feedback on the application and its 
use overall, including the possibility of scale-up. The ePartogram was used as intended by SBAs in the research setting, meaning 
that providers entered data into the ePartogram and mentioned in qualitative interviews that they responded to the clinical 
reminders and alarms.   
 
The overall study objective was to determine the feasibility of ePartogram use in low-resource clinical settings. Jhpiego 
sought to achieve this through qualitative means to achieve the following specific study objectives:  
1. To assess acceptability by SBAs and ease of use when managing multiple clients;  
2. To describe how SBAs care for tablets, keep them charged and handover during shift change;  
3. And to confirm some aspects of field refinement including time for data entry, screen flow, brightness of 
screen in different times of day, ability to enter data.    
  
Results for Objective 1: Based on observations, SBAs quickly learned how to use the ePartogram: 86% accomplished all tasks 
with ease after five shifts, and 82% demonstrated confidence in using the application within five uses.  The vast majority of SBAs 
observed (92%) responded to the ePartogram alerts and reminders by taking required measurements in a timely manner.  
Interviews revealed that SBAs felt that the ePartogram reinforced their clinical knowledge, prompting them to take measurements 
and closely monitor their clients.  SBAs also stated that the ePartogram improved the timeliness of care, simplified work, and was 
easier to interpret than the paper partograph.  They felt that it could conveniently integrate into labor and delivery settings in 
Zanzibar with a low volume of clients, but the application has not been evaluated in high-volume settings. The study also aimed 
to better understand how easy or difficult it is for SBAs to use the ePartogram to monitor multiple clients. Since SBAs 
monitored multiple clients in only one-third of the observed shifts, this was observed infrequently but no SBAs had difficulty 
in performing ePartogram tasks while managing multiple clients. The majority of SBAs interviewed felt that they would be 
able to manage 1-2 clients at a time using the ePartogram, with one stating she felt that she would be able to monitor up to 
5 clients. 
 
Results for Objective 2: SBAs consistently cleaned the ePartogram according to protocol, with more than 80% of SBAs 
correctly cleaning the tablet and tablet cover during their first shift and 100% adhered to the protocols by their fifth shift.  
The tablet battery lasted throughout 92% (77/84) of the shifts but it died during seven shifts.  However, by the third shift no 
tablets ran out of battery, and only one tablet died while being used during an SBA’s fourth or fifth shift. During this study, 
the SBA used the ePartogram and clinical observers documented measurements in real-time on the paper partograph for 
back up.  
 
Results for Objective 3: Study staff documented any issues with the application or feedback provided during the qualitative 
interviews in order to work with D-tree to optimize the ePartogram application.  The study team identified the need to 
include PMTCT information on the client intake form, update the software-refresh mechanism on the client list, and change 
display of the maternal graphs; these changes have been made.   
 
While study results demonstrated many benefits of ePartogram use, additional needed software refinements were identified, and 
further research is needed to assess its use in a greater variety of clinical settings.  The proposed ePartogram effectiveness aims 
to further test the ePartogram software and use of ePartogram on clinical decision-making and care. 
 
 
III. Study Design 
A. Provide an overview of your study design and methods.   
 
Study Design 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
The study design is a quasi-experimental design evaluation with labor management outcomes compared for the study 
period between two study groups, intervention and control. The study will involve mixed methods – quantitative and 
qualitative data. The study is depicted below. 
 
Figure 1. Study Design and Phases 
 
 
Methods 
 
The study will be conducted in the following phases. 
Phases 
1) An initial group of facilities selected for participation will be confirmed in Kisumu County and Meru County.  
A rapid formative assessment of possible facilities collected data on: 
a. training needs on the paper partograph and  
b. supplies, drugs and equipment available in stock for monitoring of normal labor, management of 
complications and referrals (facility assessment tool; this will be repeated every 3 months) (?).  
c. percent of births recorded in the register at the facility in past 3 months that had a partograph started and 
used.   
d. this activity received a non-HSR determination. 
 
2) In each region, we expect approximately 6 facilities to participate. Within each region, equal numbers of facilities 
that will be purposively assigned to the study groups.  Each study group will have facilities that have a similar 
birth volume, staffing levels, and BEmONC/CEmONC status, as much as possible so the two group are similar  
 
a. Kisumu District Hospital and Meru Teaching and Referral Hospital must be intervention sites and will not 
be randomly allocated to the study group. 
 
3) We will seek approvals: 
a. 2 IRB approvals (JHSPH and KEMRI in Kenya) (see section X.E of this document). 
b. Ministry of Health Approval to work in their sites 
c. County Approvals (Kisumu and Meru) 
d. Facility in-charge agreement will be sought at time of provider enrollment. 
 
4) A similar three-day whole-site training will be carried out in each participating health facility in both study 
groups on labor management and partograph use by providers following Kenyan and WHO guidelines. 
a. The training will be on routine labor monitoring and using the partograph as a decision-making tool. 
Facilities will receive stocks of any supplies and drugs that are needed for monitoring or normal labor and 
management of complications and referrals.  
b. This training will cover how to fill out the Ministry of Health register on each woman/newborn. 
c. ePartogram sites will also receive two days of training on using the Android-based ePartogram tablet 
‘app’, maintaining the tablet computer, and standard operating procedures for tablet use and storage to 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
ensure data confidentiality. SBAs passing the ePartogram post-training test will be asked use the 
ePartogram during clinical care. 
 
5) In both ePartogram and paper-partograph sites, facility readiness will be ensured. Enough copies of standard-of-
care paper partographs will be available on site at facilities in both study groups, and supplies/equipment (i.e. 
blood pressure apparatus).  
 
6) In ePartogram facilities: 
a. Software support procedures if needed will be set up. 
b. Standard Operating Procedures (SOPs) will be created for ownership of tablets, maintenance, and what to 
in case of tablet malfunction or loss and Jhpiego’s ongoing support. 
c. Data coordinator will be on call to troubleshoot eP software questions 
 
7) In ePartogram facilities, each participating provider will use the ePartogram tablet and application on women in 
labor.  
a.) At ePartogram sites, all data entered into the ePartogram will automatically synch to the server when 
connected to the internet and saved to a secure, cloud-based, password-protected website.  The partograph and 
outcome data will be accessed at least two times per week by the study coordinator. 
b.) A designated onsite records-management staff or, in the absence of such staff, the nurse in-charge will take 
photographs of the Ministry of Health register book, weekly--where aspects of the care to a woman/newborn(s) 
are written in one row. This has info on the health outcomes. 
c). If paper partographs are used at ePartogam sites, this data will still be included in the ePartogram group. 
 
8) In the control sites, the paper partograph will be used for labor monitoring/management. Providers will have 
available paper partographs, which is the standard of care for use during service delivery. 
a. In paper-partograph sites, every day onsite records-management staff or, in the absernce of such staff, the 
nurse in-charge will take scans of the partographs. These will be scanned to password-protected study 
laptops and the files will be saved directly to a secure Dropbox to which only study staff will have access.  
b. At paper-partograph sites, each week onsite records-management staff or, in the absence of such staff, the 
nurse in-charge will take photographs the Ministry of Health approved register. 
 
9) At the office, the study coordinator and data clerks will monitor ePartogram and partograph data in the 
ePartogram website and paper partograph Dropbox.  
a. For paper partographs, the photos or scans of partographs will be uploaded to a computer.  
b. When visiting facilities, the study coordinator will orient providers on how to record in the MOH register 
book, if this is not occurring to standard.  
c. The study training covers how to enter record in the partograph or ePartogram app. A Jhpiego clinical 
study manager will provide a one-on-one orientation to the ePartogram for any new staff . On site visits, 
the study coordinator will help validate the most recent register book info by comparing to the medical 
record if one exists and discussing any discrepancies with staff during weekly calls.  
d. Register data photographed from both study groups will be saved to the office computer. At office, a data 
entry clerk will follow the ‘abstraction tool’ to enter register data to a database. 
 
10) Partograph reviewers who are student interns from Johns Hopkins School of Public Health and Johns Hopkins 
Univeristy will be hired to review each partograph and enter data from the partograph and ePartogram records to  
the study’s Partograph Extraction Tool  (Revised) (see Study Implementation section). 
 
11) The study coordination and analysis team will conduct an analysis of data after 20 partographs and 20 
ePartograms for each site and thereafter after every 200-400 partographs. This will be to assess for completeness 
of data to know whether we on track to answer the research questions. 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
12) To answer the secondary research questions, starting in the second month after implementation, study manager 
will carry out in-depth interviews (or small focus group discussions) with providers at sites in both study groups. 
We will interview providers who use the paper partograph or the ePartogram to discuss barriers and facilitators to 
usage, including facility conditions. The supervision for providers around the ePartogram and paper-partograph 
use will also be explored. The interviews will be audio-recorded to capture all contributions from 
participants. Participants will be informed about this during consenting. The digital recorders 
erased/audio tapes will be destroyed after transcription and the recordings will not be used for any other 
purposes. 
 
 
B. Provide a sample size and a justification as to how you arrived at that number.  If you use screening procedures 
to arrive at a final sample a table may be helpful.    
 
The third study objective deals with clinical actions for complications and requires the largest sample size due to 
the rarity of complications. We describe inputs to sample size as shown in Table 1. 
 
 
Inputs to the sample size calculation are as follows: 
 
Number of sites: The available 12 sites (6 in each study arm) have 1342 births per month, , on average. 
So 6 facilities have 671 births per month. We believe 80% of these  will have a partograph 
completed  during the study. 
 
Prevalence: Kenya QoC report9 stated that “19% of labors  crossed the partograph ‘action line’”. While 
this appears high, we also will look for labors with more than one abnormal measurement signaling an 
early complication. (A study by Orji et al in Nigeria in 2008 also found 18.5% of labors crossed 
the action line.) For our study, we use the 19% to indicate that up to 19% of labor may cross the action 
line OR may have 1+ abnormal measurement that signal need for provider action. 
 
Average cluster size: is calculated to be 17.6  
 
Intraclass correlation: ICC is expected to be high as the facilities are a heterogeneous mix of district 
hospitals, health centers and some private facilities, so we assume ICC of 0.15.  
 
Coefficient of variation: COV is assumed to be 90%, after calculating the standard deviation of the 
average monthly births in these sites. Therefore,  the design effect is high at 5.3, calculated as follows: 1+ 
((average cluster size 16.4-1)*(1+(COV 0.80^2))* ICC 0.15). 
 
Outcome indicator: The value for the outcome, ‘appropriate clinical actions for complications’, is 
unknown and thus 50% gives the most conservative estimate for the facilities in the control group using 
the paper partographs.  
 
Effect size: We expect a 30% point improvement on this indicator  in facilities using ePartogram, the 
intervention sites, to 80%.  
 
Adjusted for design effect, the total number of partographs or ePartograms needed are 1004 per study group, 
or 2009 in both groups. Due to the fact that there may be additional changes to facility selection, this number 
of partographs to review may increase somewhat based on the formulas. So we request the number of 
partographs to review to be up to 2,200 in total. . 
 
Table 1. Sample Size Calculation Parameters 

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Sample size for qualitative interviewing 
In the exercise of completing the Health Worker Line Listing at each facility, we will document the numbers of 
cadres (Kenya Enrolled Community Health Nurses; Kenya Registered Community Health Nurses; Kenya 
Registered Nurses; Kenya Registered Nurse Midwives and Bachelor of Science in Nursing Nurses) and doctors 
(ObGyn and medical officers). A purposive sample of all cadres using the ePartogram or partograph will be 
selected. At high-volume sites, a sample of half of the providers on duty in a month and half of the supervisors 
will be interviewed. At lower-volume sites: all providers and supervisors will be interviewed. We will also 
interview each facility in-charge and district authority. So there are 4 respondent types: providers, supervisors, 
facility-in-charge and district authority. 
 
The study staff will carry out the interviews when visiting the facility starting in second month. Each facility will 
have qualitative data collected at one point in time. 
For the qualitative data, we will select 8 busy facilities: assume 2 to 8 providers per site (average 4 providers), 
8*4 = 32. One supervisor from each site: 8. Up to 4 in-charges and 4 district authorities. Total 48 participants. 
Note these qualitative participants will be part of the larger group of participants who consent to be part of the in 
the overall study. 
 
IV. Participants 
Describe the study participants and the population from which they will be drawn.  Specify the inclusion and 
exclusion criteria.  If you plan to include children, note their ages and whether you will include children in foster 
care. Note if the participants are particularly vulnerable in terms of cognitive limitations, education, legal migration 
status, incarceration, poverty, or some combination of factors.  
 
Facilities 
The facilities will include the higher referral-level hospitals in Kisumu and Meru, as well as lower level hospitals. 
The facilities will include both BEmONC and CEmONC sites.  
 
Facility Inclusion Criteria: 

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 
In Kisumu or Meru 
 
BEmONC or CEmONC sites 
 
At least one SBA on duty in labor ward 24 hours per day 
 
Facility in-charge or in-charge of L&D ward available physically or remotely 24 hours per day  
 
Use WHO modified paper partograph 
 
Adequate supply of paper partographs and maternity registers 
 
Availability of reliable transportation for referrals (e.g. functional ambulance or other) 24 hours per day 
 
Facility Exclusion Criteria: 
 
Facility not registered with MOH 
 
No SBA on duty in labor ward at any time during a 24 hour period 
 
No in-charge available at any time during a 24 hour period 
 
Dispensary health facilities that do not practice BEmONC 
 
 
Facility in-charges 
Following MOH letter approval and County approval, we will seek approval from the facility in-charge and 
maternity in-charge. The in-charges may serve as qualitative interviewees. 
 
Providers – for ePartograph and paper partograph data review 
Providers will give individual written consent to the study and each can voluntarily decline or opt out. All 
providers in a selected facility will be consented to the same study arm (ePartogram or paper partograph). The 
intervention will start with the training on labor management, partograph (and for intervention group, the 
ePartogram tablet use). Providers may be invited to participate in qualitative interviews. 
 
Inclusion:  
1) Providers meeting the WHO definition of Skilled Birth Attendant (SBA)4 clinical provider working in care for 
laboring women who will be working at the facility during the study. 
2) Providers completing the three-day labor management training comprised of training on partograph use and 
management of normal labors and labor complications, according to WHO and Kenya MOH guidelines 
3) Intervention sites only: Providers passing the ePartogram post-training test will be asked to use the 
ePartogram during clinical care.  
 
Exclusion:  
1) Providers not meeting the WHO definition of SBA  
2) Providers not completing the labor management training or (intervention sites only) not passing the 
ePartogram post-training test 
 
 
We plan to obtain written consent from all providers prior to the training. Any provider that joins the study 
during the study period who is in the ePartogram group B would need to receive one-on-one orientation without study 
coordinator or onsite trained providers and pass the ePartogram post-training skills test, prior to being consented to 
join the study. We will enroll no more than 200 providers. 
 
Providers who join the study at paper partograph sites, after the training, will be asked to consent when the study 
coordinator visits the sites. 
 
                                                            
4 SBA: According to the WHO, a skilled birth attendant is a doctor, nurse or midwife “trained to proficiency in the skills needed 
to manage normal (uncomplicated) pregnancies, childbirth and the immediate postnatal period, and in the identification, 
management and referral of complications in women and newborns”. (“Making pregnancy safe: the critical role of the skilled 
birth attendant” – joint statement by WHO, ICM, FIGO http://apps.who.int/iris/bitstream/10665/42955/1/9241591692.pdf() 

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We are including providers regardless of number of years in maternity ward because seasoned providers could have 
practices that are not consistent with labor management standards and newly trained providers may be practicing 
exactly according to labor management standards after their pre-service training. 
 
At each site, we will collect the register data (via photograph or scan). Analysis of this data and data capture will be 
mentioned in the information sheet and agreement with the facility in-charge. 
 
We plan to capture data from on all partographs in both study groups and analyze all partographs that are started or 
filled out on clients in both study groups. 
 
Women/Clients 
Women in labor will receive the recommended care according to the standard-of-care guidelines in both study groups. 
Women’s interactions with providers will follow normal guidelines. The difference is that the intervention group 
facility providers will use the ePartogram instead of the paper partograph to document measurements. The ePartogram 
is operating as expected. Back-up paper partographs will be available at each site. Additionally, data that we analyze 
will not have women’s names or identifiers. As such, we will not consent women clients to our study. 
 
 
Qualitative interviews with in-charges and district authorities. 
Inclusion criteria: supervise providers (or in-charges) who used the ePartogram or paper partograph to record 
care to at least 3 clients OR who supervise providers who have done this. OR facility administrators who 
supervise the in-charges or department heads 
 
Providers – for qualitative data. 
Qualitative Interviews will begin in the second month after the providers have had time to use the ePartogram or 
partograph following the training at the beginning. 
 
Inclusion criteria: used the ePartogram or paper partograph to record care to at least 3 clients. 
 
 
V. Study Procedures   
In this section, provide details of your procedures, particularly as they relate to human subjects. If this is a multi-
center study, make the role of JHSPH clear.   
 
A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants about your study.  Include 
details about who will perform these activities and what their qualifications are. 
2. Address any privacy issues associated with recruitment.  If recruitment itself may put potential participants 
at risk (if study topic is sensitive, or study population may be stigmatized), explain how you will minimize 
these risks. 
 
Once all approvals are obtained, study staff will notify facility in-charges in ePartogram sites that the training 
workshop will occur and that providers’ participation is voluntary. Jhpiego staff will be on hand to explain 
and answer questions. The cooperation of in-charges will be assured before approaching any providers. 
At the start of the training, for recruitment, providers will be approached individually by the Jhpiego clinical 
trainer or Jhpiego study coordinator (who will have a bachelor’s degree in a health or relevant topic), in a 
space allowing for audio and visual privacy 
 
 
For qualitative exercise, the study coordinator will recruit individual providers in the facility about qualitative 
interview. Purposive sampling will be used. We will ascertain eligibility through screening questions and 
recruit participants who show interest. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
B. Consent Process:   
1. Describe the following details about obtaining informed consent from study participants.  If a screening 
process precedes study enrollment, also describe the consent for screening. 
 
Who will obtain informed consent, and their qualifications. 
 
How, where, and when the consent discussion(s) will occur 
 
The process you will use to determine whether a potential participant meets eligibility criteria 
 
Providers in both study arms will be asked to give written consent to be in the study at the beginning of the 
ePartogram training workshop, by the clinical trainers (midwives or doctors employed by Jhpiego), in a space 
allowing for visual and auditory privacy. Facility in-charges will not influence consent discussions and will be 
informed that the provider can offer voluntary consent. Providers hired during the study period may consent to be 
the study.  The study staff will consent any new providers when visiting the facility biweekly, arrange for a the 
training on labor management and the partograph equivalent to the training conducted at the beginning of the 
study and  if the site has ePartogram, give ePartogram use training and post-training test. 
 
The provider consent form to be used in ePartogram sites will have information about the ePartogram intervention 
and the possibility of being selected for a qualitative interview at some point during the study period. 
 
 
Whether you will obtain a signature from the participant or will use an oral consent process 
 
Please see above. 
 
 
Whether you will obtain a legally authorized representative’s signature for adults lacking capacity. N/A 
 
If children are included in the study, if and how you will obtain assent from them. If children are 
included in the study, how you will obtain permission for them to participate from their parent, legal 
guardian, or other legal authority (if child is in foster care or under government supervision.) N/A 
 
 
If you are seeking a waiver of informed consent or assent, the justification for this request 
 
Data captured on labor management 
Data on labor management that women receive that is recorded in either the ePartogram or on paper partograph 
will be captured and analyzed by our project.  The woman’s name will be recorded on the ePartogram and paper 
partograph during routine care of the woman.  The woman’s name will be concealed on the paper partograph and 
covered up with a study ID number sticker prior to the designated and trained clinic staff scanning the partograph 
for data entry. the woman’s name will not end up in the database at all. Actual partographs will stay at the facility 
since they will be scanned. Also the ePartogram tablet will be connected to a printer so partograms can be printed 
(study coordinator will check on this when visiting each facility). The study coordinator and facility in-charges 
will have access to the ePartogram via the online portal and can print remotely. 
The woman will receive the standard of care in both study arms. 
Ministry of Health register data on the woman and newborn outcomes will be captured by our study (without 
woman’s names). We are seeking a waiver of informed consent for women since our interest is in the data 
recorded by the provider and not the woman.  
 
In the event of a complication arises, providers will give care per existing facility standards. Providers will 
provide care as per Kenyan guidelines. Providers’ clinical judgment should prevail will all cases. 
 
 
Whether you will include a witness to the consent process and why. N/A 
 
If the language is unwritten, explain how you will communicate accurate information to potential 
participants and whether you will use props or audio materials. N/A 
 

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2. Identify the countries where the research will take place, and the languages that will be used for the consent 
process.   
Table 2. 
Country 
Consent Document(s) 
(adult consent, parental permission,  youth assent, 
etc.) 
Languages 
Kenya 
Group A: Providers (SBAs) in the labor ward in paper 
partograph (control) study arm 
English (language will be 
English for all providers in 
Kenya) 
 
Group B: Providers (SBAs) in the labor ward in 
ePartogram study arm 
English 
 
 
C. Study Implementation: 
      
 Answer the following: 
1. Describe the procedures that participants will undergo.  If complex, insert a table below to help the reviewer 
navigate.   
 
a) In both study arms, providers will receive training on labor management and partograph usage per 
national and international WHO guidelines. Providers will be encouraged to consult their supervisor 
available when complications arise during labor, as per the standard-of-care. In the ePartogram study 
group only, a two-day training on ePartogram tablet  use and maintenance will be given. 
b) All providers in both study arms will be consented prior to the training. 
c) ePartogram facilities will have the data transmitted over a cloud database accessible only to study staff. 
d) An onsite facility staff will cover client identifiers and scan partographs and photograph registers for 
sending to a secure cloud folder. Client identifiers will be covered up prior to transmitting information. 
e) Jhpiego study clinicians will access the scanned partographs and registers or ePartogram database online, 
and abstract the relevant data into the Partograph ExtrationTool 4 Revised and also the Register Review Tool 
6. This data will be analyzed further by Jhpiego data analysts. 
f) A study coordinator will be on call for any technical or software issues with the ePartogram, and backup 
tablets will be stored on site. 
g) Note: if any clients in the ePartogram facility group are  followed with a paper partograph, we will 
capture this info and consider this data to belong to the ePartogram group. We believe these providers would 
have been influenced by the use of the ePartogram in the facility. 
h) Starting in second month, the study staff will collect qualitative interviews with SBAs, audio record, and 
transcribe for further analysis 
Table 3 
Study Timeline 
Mar 
Apr 
May 
June 
July 
Aug 
Sept 
Oct 
Nov 
Activity 
 
 
 
 
 
 
 
 
 
Ethical review by JHSPH and 
KEMRI 
X 
X 
X 
 
 
 
 
 
 
Finalize training materials 
 
X 
X 
 
 
 
 
 
 
Facility and stakeholder orientation 
visits 
 
X 
X 
 
 
 
 
 
 
Facility stockup on supplies 
 
X 
X 
 
 
 
 
 
 
Data collector training 
 
X 
X 
 
 
 
 
 
 
Provider trainings 
 
 
X 
X 
 
 
 
 
 
Data collection 
 
 
X 
X 
X 
 
 
 
 
Partograph Review and Data analysis 
 
 
X 
X 
X 
X 
X 
 
 
Dissemination Meeting 
 
 
 
 
 
 
 
X 
 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Table 4. Tools  
The following are data collection or abstraction tools to be used in this study. 
 
(a) Exiting tool already in use 
 
 
2. Describe the number and type of study visits and/or contacts between the study team and the participant, 
how long they will last, and where/how they will take place. 
Tool 
No. 
Tool Name 
Description 
1 
Health Worker Line 
Listing 
Study team will use this to assign a  unique provider id to  skilled birth attendants working in 
each facility who consented to the study and were trained by study staff. This provider study id 
will then be written on paper partographs,  in ePartograms and on registers, when names are 
obscured (to account for clustering of data in the provider). We will record cadre, , years of 
experience, and date passed labor management and ePartogram compentency test. 
2 
Partograph or 
ePartogram file on each 
laboring woman (a) 
 
The top portion of the partogram is completed on admission with information  about: woman’s 
name, gravida, parity, hospital id number, date and time of admission, and whether membranes 
are ruptured. At regular intervals, the following measurements are obtained by the provider: 
fetal heart rate, condition of amniotic fluid, moulding, descent of head,  cervical dilation, 
contractions,  oxytocin,  drugs and IV fluids given, pulse, blood pressure, temperature, urine 
protein, acetone and volume.  
3 
Stamp on the paper 
partograph or 
programmed into the app 
(for ePartogram). 
In this study, the paper partograph and ePartogram will include additional fields related to 
maintaining normal labor and management of abnormal conditions. The stamp will be placed 
on the paper partograph or programmed into the app (for ePartogram). Standard provider 
actions will be recorded (e.g. ambulation, nutrition, fluid intake, presence of a birth 
companion, oxygen administration,  changing the mother’s position for choice or due to fetal 
heart rate, presence of bleeding). Providers will also indicate if a consultation with another 
provider was made for the client and if the client was transferred (reason for referral), fresh 
stillbirth, or early newborn death. 
4 
Partograph Extraction  
tool (revised July 2017) 
There are sections where the data extractors will enter the information on the woman and 
newborn conditions and outcomes that appears a) at the top of the partograph, b) at the bottom 
of the partograph and c) provider actions recorded on the Jhpiego stamp tool. There are 
repeatable sections that also allow for data entry on the actual values of the  the measurements 
are recorded for 13 parameters (fetal heart rate, cervical dilation, systolic and diastolic blood 
pressure, amniotic fluid, moulding, head descent, contractions, pulse, temperature, urine 
protein, acetone and volume These data will be recorded for each 30 minute interval for the 
duration of the active stage of labor (4cm dilation to 10cm dilation).   
 
 
5 
Register review tool 
This tool will contain the abstracter id, date and facility id, month number of deliveries, Live 
births (spontaneous, assisted, cesarean, breech), fresh stillbirths, macerated stillbirths, number 
of twins, early neonatal deaths, number referred, number of maternal deaths 
 
6 
Qualitative discussion 
field guide for 
ePartogram sites (in-
depth interviews or small 
focus groups) 
 
Qualitative interviews will be conducted with providers in each study arm.  In the ePartogram 
group, qualitative interviews will be administered to  to better understand the benefits and 
challenges of ePartogram..  Providers will be asked about their experience in using the 
ePartogram, opinions on various features of the application, and implementation 
considerations for ePartogram. 
7 
Qualitative discussion 
field guide for paper 
partograph sites (in-
depth interviews or small 
focus groups) 
 
Qualitative interviews will be conducted with providers in the paper partograph group to better 
understand how providers use the paper partograph in a variety of labor and delivery settings, 
perceived benefits and challenges in using paper partograph, and the facility conditions that 
enable or hinder adoption of best practices in labor management 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
At the start of the study, the study trainers will offer a training workshop in each study group. s Thereafter, 
the study coordinator will visit each site monthly to collect ePartogram case information. Local staff who 
work in records management or the nurse in-charge will be asked to scan partographs daily and registers 
weekly and send the data on the study-loaned laptop to a secure cloud database.  Direct interaction with  study 
team members may occur only once per month  since we will mainly  collect  data on paper. If a provider is 
having trouble with the ePartogram, then more than one interaction with study staff is possible. 
 
A subset of providers will be asked to participate once in an in-depth interview lasting 45 minutes. These 
providers will have 2 contacts. 
 
3. Describe the expected duration of the study from the perspective of the individual participant and duration 
overall. 
 
The number of months of the use of the ePartogram at intervention sites and data collection (capture of labor 
information on clients) at sites in both study arms will take up to 9 months. We expect to collect all 
partograph information over 2 or 3 months, depending on volume of births and the percent covered by 
partographs during the actual period of study implementation. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
4. Provide a brief data analysis plan and a description of variables to be derived.  
 
We will compare study groups (facilities in which providers are using the ePartogram and facilities in which providers are using the paper 
partograph): 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Table 5: Data Analysis Plan (updated July 2016; updated July 2017) 
 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Research question 
Outcome  
Cases 
Analysis 
P1. Compliance with 
globally-recommended 
labor monitoring 
practices and recording 
on the partograph of the 
information obtained  – 
complete on admission 
       
(Tool 4) 
We will examine each parameter and enter 
to the database. 
 
Overall, this will be marked ‘yes’ if 11 of the 
12 items  (all except urine volume) are 
measured at admission (fetal heart rate, 
cervical dilation, systolic and diastolic blood 
pressure, amniotic fluid, moulding, head 
descent, contractions, pulse, temperature, 
urine protein, acetone and volume); and 
otherwise ‘no’. Binary variable. 
All labors with 
partograph or 
ePartogram 
 
Unit of analysis is 
each case 
(partograph).  
 
First, we will examine the 
frequency/prevalence of each 
measurement recorded on 
admission and compare 
between the two study groups 
 
Second, We will examine the 
percent of cases marked ‘yes’ 
(defined at left). Independent 
variable is study group. Bivariate 
analysis will be an unadjusted 
logistic regression accounting for 
clustering in the facility or in the 
provider. In multivariable 
analysis, other control factors 
added may be facility type, 
client volume, region or provider 
variables.  
- 
Complete over 
entire labor 
(Tool 4) 
We will examine each parameter and enter 
to the database. Then we will see how many 
hours was the labor for the appropriate 
frequency, per the Jhpiego Clinical Rules 
and determine whether this was done to a 
large extent on time. 
 
Overall, this will be marked ‘yes’ if 11 of the 
12 items  (all except urine volume) are 
measured in first 4-hour period at the 
specified intervals (reviewer will determine 
for each item if occurred within the interval): 
fetal heart rate every 30 min, cervical 
All labors with 
partograph or 
ePartogram 
Same as above – except it will be 
for the first four hour period 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
dilation every 4 hours, systolic and diastolic 
blood pressure  every 4 hours, amniotic fluid 
if membranes rupture, moulding when 
present  head descent every 2 hours, 
contractions every 30 min, pulse every 30 
min, temperature every 2 hours, urine 
protein, acetone and volume, all at every 4 
hours. ; and otherwise ‘no’. Binary variable. 
- 
Complete overl 
entire labor for a 
subset of women 
who arrived at 4 or 
5 cm 
 
 
 
P2. Decision-making 
and actions taken to 
maintain normal labor 
 
(Tool 4) 
Data on each partograph parameter will be 
entered for each time period, as well as 
actions taken in labor. Jhpiego clinical rules 
will be applied to the data in the extraction 
database to determine appropriate clinical 
actions for a labor without any complication. 
This is a binary variable.  
Labors in which 
Section 3 marked as 
“Normal Labor” 
First, we will examine the 
frequency/prevalence of each 
clinical action taken in normal 
labor and compare between the 
two study groups. 
Second, we will carry out same 
analysis as for Objective P1. 
P3. Detection, decision-
making and action to 
address deviations from 
normal labor and 
complications arising 
during labor—for 
‘slow’ labor, prolonged 
labor, obstructed labor 
and cephalo-pelvic 
disproportion 
Data on each partograph parameter will be 
entered for each time period, as well as 
actions taken in labor. Jhpiego clinical rules 
will be applied to the data in the extraction 
database to determine appropriate clinical 
actions for a labor with a specific 
complication. This is a binary variable. 
Labors in which 
Section 3 marked 
“Slow labor, 
prolonged labor, 
obstructed labor or 
cephalo-pelvic 
disproportion” 
First, we will examine the 
frequency/prevalence of each 
clinical action taken in selected 
complications and compare 
between the two study groups. 
Second, we will carry out same 
analysis as for Objective P1. 
 -- for all complications 
 
(Tool 4) 
Same as above. A composite variable will be 
created for all complications. This is a binary 
variable. 
Labors in which 
Section 3 marked as 
ANY complication  
First, we will examine the 
frequency/prevalence of each 
clinical action taken in all 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
complications and compare 
between the two study groups. 
Second, we will carry out same 
analysis as for Objective P1. 
S1. Is facility use of 
ePartogram (vs. paper-
partograph) associated 
with lower rate of…? 
 
 
 
From the Register 
Analysis 
 
 
 
Neonatal deaths <24 
hours and 
(Tool 5) 
Number of early neonatal deaths. This is a 
count variable. 
All live births 
We will compare means using t-
tests across 2 groups. Next, we 
will use unadjusted regression 
models that account for 
clustering (correlation) of data 
within the facility. Poisson  
regression with offset term (or 
another appropriate model to be 
explored) will be used for 
bivariate and multivariable 
analysis. 
Intrapartum death (fresh 
stillbirth rate) (Tool 5) 
Number of fresh stillbirths. This is a count 
variable. 
All live births  
Same as above. 
Adverse perinatal 
events (Neonatal deaths 
<24 hours+ intrapartum 
death (fresh stillbirth 
rate)) 
Number of neonatal deaths and fresh 
stillbirths 
All live births  
Same as above. 
 
Statistical analysis plan 
 
Outcomes will be dichotomous, yes/no for each measure.  
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
In the main statistical analysis of our primary outcomes, we will focus on program effect (intervention (ePartogram) group of facilities versus 
comparison (paper program) group of facilities) as the main predictor of interest. The analysis will be performed at the level of the individual case 
(partograph). In preliminary analyses we will conduct univariable and bivariable analyses to assess the distribution of key variables and joint 
distributions and unadjusted relationships. 
In final analyses addressing study aims, we will fit multi-level, multivariable regressions models for the outcomes with adjustment for possible 
confounders and account for clustering by provider and/or study clinic  by the use of GEE.  
 
While we have selected clinics roughly matched between the intervention and comparison regions, we will still evaluate confounding to attain the 
least biased estimate of our intervention effect. Facility level possible confounders are: monthly case load of laboring women, number of 
providers, key equipment availability etc.  Provider-level possible confounders that may be adjusted for are years of work experience since 
graduation and cadre. Woman-level possible confounders are age and parity. 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
5. Describe whether you are collecting or storing personal identifiers, and if yes, why you need them, and 
when and how you plan to dispose of them.  Signatures on consent forms are considered to be identifiers. 
 
Identifiers of Providers 
Our study will assign each facility and each provider a study id number of the Health Worker Line 
Listing form to be updated monthly. This will be kept separately from partograph data. 
 
partograph review analysis: the paper partograph has a place for a provider to sign it. When we 
scan/photocopy paper partographs, we will obscure the provider name (cover with lose paper) but will 
we add/write on it the provider study id number.  
 
ePartogram will enter the provider’s study id number. There will be a drop-down menu in which the 
provider name and study id appears, but only provider study id will end up in the back-end database.  
There will be no names kept in the database of ePartogram information. 
 
Each time the study staff visits the facility, the health worker line listing forms and database will be updated 
with names of new providers added to the study and for intervention sites only, who pass the post-training test 
for ePartogram 
 
Written consent forms will be kept for 3 years after the study date of closing with IRB. 
 
 
a. register review analysis: The register has a field for provider name. Prior to our taking scan/photo of 
registers, we will obscure the provider name and replace the provider name with the provider study id 
from the Health Worker Line Listing.  
 
Identifiers of Women 
a. partograph review analysis:  The name of the client/woman is on the partograph. Prior to photographing 
partographs, we will make sure the partograph has the woman’s ‘hospital admission number’. We will 
verify that this is the same as recorded in the register. Once the admission number is verified, then we will 
scan/photocopy the partograph and obscure the woman’s name by covering with a small piece of paper 
prior to scanning the partograph.  
b. When a new client sheet is started in the ePartogram, the software will automatically  assign a study-
generated ID number to each laboring woman’s eParotgram record. This record will also have the 
woman’s name during the care process, for printing the ePartogram record to leave at the facility. The 
study ID will be the facility number (i.e. MER01 for the first facility in Meru) + date + 01 for the first 
woman admitted in labor.  
 
 
c. register review analysis: The register has a field for woman’s name. When we scan/photocopy the 
register, we can obscure women’s names.  
 
 
Identifiers of Providers - for Qualitative Interviews. 
We may temporarily keep track of provider and supervisors names only for the purpose of setting up an 
interview at a convenient time. However, no names or identifiers will be collected or recorded on qualitative 
participants. 
 
The names of providers receiving any payment or reimbursement as described in the consent form will be 
retained for financial purposes only in secure financial database at Jhpiego. 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
 
 
6. Answer the following if they are relevant to your study design: 
 
a.  If the study has different arms, explain the process for assigning participants (intervention/control, 
case/control), including the sequence and timing of the assignment. 
 
This will be a cluster-randomized trial. See section on randomization under Section III Methods. 
 
 
b. If human biospecimens (blood, urine, saliva, etc.) will be collected, provide details about who will collect 
the specimen, the volume (ml) and frequency of collection, how the specimen will be used, stored, 
identified, and disposed of when the study is over.  If specimens will be collected for use in future 
research (beyond this study), complete the Biospecimen Repository section below. N/A 
c. If genetic/genomic analyses are planned, address whether the data will be contributed to a GWAS or 
other large dataset.  Address returning unanticipated incidental genetic findings to study participants. 
N/A 
d.  If clinical or laboratory work will be performed at JHU/JHH, provide the JH Biosafety Registration 
Number. N/A 
e. If you will perform investigational or standard diagnostic laboratory tests using human samples or data, 
clarify whether the tests are validated and/or the lab is certified (for example is CLIA certified in the 
U.S.).  Explain the failure rate and under what circumstances you will repeat a test.  For all human 
testing (biomedical, psychological, educational, etc.), clarify your plans for reporting test results to 
participants and/or to their families or clinicians.  Address returning unanticipated incidental findings to 
study participants. N/A 
 
f. 
If your study involves medical, pharmaceutical or other therapeutic intervention, provide the following 
information: 
 
Will the study staff be blind to participant intervention status? 
The in-charge and the providers at selected ePartorgam sites will know that their site has been selected to use this 
innovation, so they will not be blinded. 
The in-charge and providers at the paper-partograph control sites will not be told officially about the ePartogram being 
used in other sites, just that their site is part of a partograph training and monitoring intervention. These individuals may 
find out about the ePartogram being used elsewhere, from contamination/spillover from providers in other sites or from 
communications with county health officials. 
 
 
 
Will participants receive standard care or have current therapy stopped? 
Providers in control sites will monitor women in labor using the standard-of-care partograph. In the intervention arm, 
providers will use the ePartogram, an electronic version of the partograph. 
 
 
Will you use a placebo or non-treatment group, and is that justifiable? 
Please see prior question. We plan to study the effectiveness of the ePartogram in improving labor management outcomes, 
which currently is unknown. 
 
 
Explain when you may remove a participant from the study.  
All birth attendants at selected sites who meet eligibility requirements will be included and not removed unless they are 
transferred away from these sites. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
A provider in the ePartogram facility may choose not to use the tablet and instead use the paper partograph to monitor 
clients, this is a voluntary choice. Or, if an ePartogram tablet is temporarily not working, the provider will use a paper 
partograph for labor monitoring. Paper partographs will be available at all study sites. Paper partographs used at 
ePartogram sites will nonetheless contribute to the data from the Intervention sites, for ‘intention to treat’ analysis. We 
will monitor this situation if this arises.  
 
 
What happens to participants on study intervention when the study ends? 
After the study, the ePartogram facilities will return to having providers use the standard-of-care paper partograph for 
labor management. 
 
 
Describe the process for referring participants to care outside the study, if needed. 
The regular referral processes currently in place at each facility will be described at the start of the study and the same 
procedures will apply during our study.  
 
 
 VI. Data Custody, Security, and Confidentiality Protections 
The sections below describe types of data sources and how they will be protected. For the type(s) of data, put an “X” 
in the appropriate box to the left of the section that best describes how you will minimize the risk of a breach of 
confidentiality for your study.  Note, as appropriate, how you will record/store data.  These descriptions represent 
MINIMAL measures; you may add more stringent protections and other relevant information in B.  
Confidentiality: The LOSS OR THEFT of 1) original/duplicate version of physical data collection instruments (forms, 
tapes, etc.) or 2) physical devices containing electronic data (i.e. laptop/mobile device, external flash drive(s), is a 
threat to subject confidentiality.  Risk of such a loss/theft is increased during movement/transport of data (in any 
format), such as in a vehicle or other move.  Be sure to train anyone (co-investigators, staff, students, etc.) who might 
be engaged in the oversight of data handling/storage about this problem.  Some typical risk-mitigation strategies 
would include: 
 
minimizing the physical movement of data and/or devices containing data 
 
encrypting electronic data (especially when stored on any mobile device, including flash memory tools, 
phones, tablets, etc, or when transferring across networks) 
 
making use of reliable courier services (FedEx, DHL, etc) when physical transport of bulk data forms is 
necessary 
 
minimizing the transfer of identifiable data in physical or electronic form (i.e. removing/separating/destroying 
identifiable data, when physical transfer of data is necessary) 
table 6 
A. Data Storage  
1.  Hard Copies of Data Collection Forms.   
X 
This activity will not involve receiving and/or accessing hard copies of data 
Hard copies of the partographs and ePartogram-printed partographs will remain at the facility for 
purposes of care. Registers are MOH documents and will remain onsite. 
We will not collect printed/hard copies of patient partographs or registers. 
 
Qualitative data –Paper tracking forms which temporarily have names of providers in order to schedule 
interviews will be kept secure and destroyed/shredded when qualitative data collection is complete. 
 
 
Data collection forms RECORD NO PERSONAL IDENTIFIERS connecting study participants, and there are 
no codes providing a link.  Data are anonymous. 
 
Data collection forms INCLUDE IDENTIFIERS.  The forms are locked in a secure cabinet or room with 
limited access by authorized individuals.  Forms will be kept in study team’s possession during 
transport and will not be left unattended in a vehicle.  When possible, de-identified copies will be used 
for coding and analysis. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
Data collection forms ARE CODED with study participants’ random study ID numbers.  Codes/links 
between study IDs and identifiers are stored securely in a separate place (locked storage cabinet or 
secure electronic database.)   
 
 
Other:  
2.   Electronic Data 
 
The data do not contain personally identifiable information 
 
 
These data are stored on a secure server protected by limited access and strong password systems.  
Data are coded when possible.  Portable electronic devices will not contain identifiable information 
unless encrypted. 
X 
Other:  Providers will be given a study id. The Health Worker Line Listing will have provider name and 
study id only for each facility, and this will be kept secure in electronic files with password protection of 
laptop computers. Partograph scans and ePartogram data will not have provider names, only study ids. 
 
ePartograms will have woman’s name during use at the facility and for printing the record to leave at the 
facility for care purposes but the names will be removed from the database prior to analysis. 
ePartograms will have a study-generated ID for the woman. 
 
ePartograms data will be sent from the password protected ePartogram devices to the secure cloud 
server or obtained by the study coordinator on a flash drive and the devices will have passwords for 
study personnel only.  
 
The study coordinator or onsite nurses or records staff will have a smartphone  with which will take 
photos of partogaphs and registers, or a portable scanner on which to load scans to the study 
coordinator’s laptop – these will have passwords. The tablets will be kept as secure as possible while 
study coordinator visits facilities. Scanned and photographed partograms and registers will not show any 
names of clients or providers, only study ids. 
 
Qualitative data – no identifiers will be kept in electronic form.  
3.   Other Identifiable Data Storage, Retention, and Destruction (Audiotapes, videotapes, photographs, etc.) 
will be retained and stored securely (locked in cabinet or room) until: 
 
Transcription is complete, then will be destroyed. 
 
Analysis is complete, then will be destroyed. 
X 
Study is complete and file is closed.  
Audio files will be deleted once transcription is completed. Transcripts will be kept indefinitely in 
electronic form, without identifiers. 
 
Indefinitely.  Provide justification for indefinite retention: 
 
4.  Existing Biospecimens to be used in this study: n/a 
 
B. Certificate of Confidentiality N/A 
Will the study data stored in the United States be protected by a Certificate of Confidentiality?  If yes, explain 
who will apply for and maintain the Certificate. (http://grants.nih.gov/grants/policy/coc/appl_extramural.htm) 
 
C. Data Security and Sharing 
PIs have the responsibility for responsible stewardship of data and protecting data confidentiality. This 
responsibility includes protecting physical custody of the data, storage and sharing with appropriate data use 
agreements that contain the appropriate security provisions.  Describe any additional plans beyond those 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
identified in the table that you have for storing and sharing the study data and/or materials, and how 
responsibility for the data will be managed.  Include the following details: 
 
1. Where will the study data be stored? 
Study data will be kept on computers at the Jhpiego Kenya office and HQ office and/or in a secure, cloud-based database. 
We will keep these indefinitely. If another organization requests the data once the study is complete, we will do a data 
sharing agreement. 
2. Who controls access to the data? Jhpiego, under leadership of Dr. Harshad Sanghvi 
3. Will data be shared only if de-identified? Yes 
4. What additional (if any) security controls will be in place? N/A 
 
VII.  Risks of the Study 
A. Describe the risks, discomforts, and inconveniences associated with the study and its procedures, including 
physical, psychological, emotional, social, legal, or economic risks, and the risk of a breach of confidentiality.  
These risks should be described in the consent documents. 
Table 7 
Risk 
Description 
Mitigation 
Anticipated 
frequency 
Physical 
Patient care decisions will 
be made based on data 
recorded on the 
ePartogram. Therefore, if 
the battery dies, screen 
freezes or any other tablet 
or software failure occurs, 
there is a potential impact 
on care  
Each study site will have at least 2 back up tablets.  
Since ePartogram data automatically syncs, a provider 
can continue to care for the client using another tablet.  
Providers will be trained in ePartogram use and 
maintenance, and a selected provider will check the 
battery level of tablets each day.  The study 
coordinator will be on-call 24 hours/day to 
troubleshoot issues.  D-tree, the software development 
company, and Jhpiego have tested all aspects of the 
ePartogram software. 
 
Blank paper partographs will also be available at 
ePartogram sites in case they are needed, and this will 
be checked by the study coordinator at each visit. 
<5% of 
cases 
Physical 
Providers may consider 
the ePartogram reminders 
and alerts when making 
clinical decisions during 
labor and delivery.  The 
ePartogram could trigger a 
“false positive” alert that 
may cause a provider to 
consider taking an action 
when it is not warranted.   
 
Conversely, the 
ePartogram could trigger a 
“false negative” alert that 
may indicate that a clinical 
measurement is normal 
when in fact a provider 
may need to take action. 
The providers will be instructed to use their own 
clinical knowledge should they disagree with any 
reminders or alerts in ePartogram. The provider 
consent form states that a provider will use his/her 
clinical judgement in interpreting the reminders and 
alerts in the ePartogram and provide care per Kenya 
clinical guidelines.  ePartogram providers receive a 
labor management training on the Kenya and global 
standards for partograph use, managing normal labor 
and managing complicated labors and in use of and 
maintenance of the ePartogram.   
 
ePartogram sites will have a facility in-charge or labor 
and delivery in-charge available 24 hours per day to 
consult on any labor and delivery complications.  The 
study coordinator will be available or reachable by 
phone to provide support on ePartogram use. 
 
<1% of 
cases 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
The 78 clinical rules in the ePartogram have been 
validated with Jhpiego clinicians and external experts.  
The ePartogram algorithms comprised of these rules that 
are programmed in the software to trigger clinical 
reminders for taking measurements and alerts have been 
tested in the software.  Over the past 6 months Jhpiego 
has simulated 125 scenarios, to validate that every clinical 
rule triggers the correct alert in ePartogram. These tests 
have been repeated numerous times. 
 
Psychological 
or emotional 
Providers may not be 
comfortable using the 
ePartogram in a clinical 
setting, or when 
monitoring multiple clients 
Providers in the ePartogram group will be trained at 
the start of the study on ePartogram use and 
maintenance to ensure their comfort. Also each 
provider to use the ePartogram in care will pass the 
post-training test 
 
Providers can freely choose to use the paper partograph 
instead of the ePartogram.  The data from the paper 
partograph will be analyzed.  
 
 
<1% of 
providers; 
this did not 
occur in 
previous 
study 
Psychological 
or emotional 
Providers may view the 
study with suspicion if 
they do not understand the 
study purpose and 
procedures, and may be 
concerned that their 
decision to participate or 
their participation in the 
study will affect their job. 
Providers in the ePartogram sites will be consented to 
the study and this will include an explanation of study 
aims. Participants can withdraw from the study at any 
time. Data will be aggregated by facility, not by 
provider, so performance will not be assessed. 
 
We do not believe the qualitative interviews will result 
in any psychological or emotional risk; there are no 
sensitive topics. The interviews will be conducted in 
private. Participants will be reminded of their right 
to not respond to any question they are 
uncomfortable with. 
<1% of 
providers, 
did not 
occur in 
previous 
study 
 
Providers may not be 
comfortable with audio 
recording of the 
interviews. 
We will remind participants that the interview will 
be conducted in a private space and the data kept 
confidential. There will be no identifiers on the 
audio files or electronic files. We will destroy the 
audio files once the transcripts are confirmed. 
 
<1% of 
providers, 
did not 
occur in 
previous 
study 
Social / Legal 
/ Economic 
Breach of confidentiality 
of the data 
Study ID numbers will be assigned to each provider.  
Any client information will be de-identified. In the 
case of breach of confidentiality however, there are no 
anticipated social, legal or economic consequences for 
either clients or SBAs.   
 
We will ensure that in-charges, through discussion and 
the information sheet, know that the partograph 
assessment data is for study personnel only and study 
information will not be shared with the provider’s 
supervisor or anyone outside the study. 
<1% of 
cases, did 
not occur 
in previous 
study 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
 
Before transcription, audio recorded data will be 
kept under lock and key and accessed by 
authorized staff only. 
 
 
 
B.  Describe the anticipated frequency and severity of the harms associated with the risks identified above; for 
example, if you are performing “x” test/assessment, or dispensing “y” drug, how often do you expect an 
“anticipated” adverse reaction to occur in a study participant, and how severe do you expect that reaction to 
be?  See table 
C. Describe steps to be taken to minimize risks.  Include a description of your efforts to arrange for care or referral 
for participants who may need it. See table 
D. Describe the research burden for participants, including time, inconvenience, out-of pocket costs, etc.  
 
Consenting providers in each study arm will attend a training workshop on labor management.  Providers from 
ePartogram sites will attend an additional training on use of ePartogram.  The trainings will be held on-site, where 
possible, or near the facility.  Throughout study implementation, providers will administer care per the current 
standard-of-care, using either the paper partograph or ePartogram.  Providers may opt in to participate in 
qualitative interviews when not attending to a laboring client. These will take a maximum of 45 minutes. 
 
E. Describe how participant privacy will be protected during data collection if sensitive questions are included in 
interviews. 
We do not plan to ask any sensitive questions. Interviews will be done in a space allowing for visual and audio 
privacy. 
 
 
VIII. Direct Personal and Social Benefits 
A. Describe any potential direct benefits the study offers to participants (“payment” for participation is not a direct 
personal benefit). 
 
There is no direct benefit to participants for participating in the study, but providers’ actions during labor may be 
improved by use of the ePartogam—this is what the study is designed to assess. 
Providers may be satisfied to know that the Ministry of Health and Jhpiego are concerned about improving the 
usefulness of the partograph for improved clinical decision-making and labor management in diverse health 
facility settings, intrapartum maternal health care delivery, and ultimately, birth outcomes. 
Providers will benefit from the training, which will include a refresher on the use of the standard paper partograph 
and will gain a better appreciation and competency for this tool. Providers will gain competency with the 
ePartogram, and could be considered early adopters of the innovation if it is introduced in Kenya. Providers will 
also be provided tea breaks and lunch during the training days and during interviews, and will receive a certificate 
of completion.  
Clients may feel satisfied that the Ministry of Health and Jhpiego are concerned about improving the usefulness of 
the partograph by using it in an electronic form to monitor labor. 
 
B. Describe potential societal benefits likely to derive from the research, including value of knowledge learned. 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
The ePartogram has the potential to improve appropriate use of the partograph and ultimately to improve intrapartum 
maternal and fetal outcomes. If this study demonstrates ePartogram effectiveness in a clinical setting, it could contribute 
to efforts to make the ePartogram available widely in resource-challenged settings. 
 
 
IX.  Payment:   
A. Describe the form, amount, and schedule of payment to participants. Reimbursement for travel or other 
expenses is not “payment,” and if the study will reimburse, explain. 
 
       We tell providers in consent script: “As a SBA, you will receive a per diem of 1750 Kenyan Shillings for each 
day that you take part in the training workshop.  You will also receive 2000 Kenyan Shillings transportation 
allowance for each round trip to the training site.  
 
Accommodation and lunch will be provided for the duration of the training. 
 
If you are selected for and complete the interview, you will receive an additional 500 Kenyan Shillings for your time.” 
 
B. Include the possible total remuneration and any consequences for not completing all phases of the research. 
 
SBAs would receive a maximum of 10750 Kenyan Shillings (~ US$108) remuneration comprised of 1750 
Kenyan Shillings per diem for each of five training days and 2000 Kenyan Shillings for roundtrip ground 
transportation to the training. Accommodation and lunch will be provided during the trainings. An additional 500 
Shillings will be offered to participants completing a qualitative interview; providers can participate in a maximum of 
2 qualitative interviews.  There are no consequences for providers if they choose to withdraw or not participate in the 
study at any time. 
 
Facility records management staff person or, in the absence of such a person, the nurse in-charge selected to scan 
partograph data at the control sites and to photograph maternity registers will receive 2000 Kenyan Shillings 
(~US$20) per day worked.  Nurse in-charges will work at most 2 hours per day for 5 days in a week, equivalent to 1 
day worked per week.  Study implementation will take up to 3 months (or 12 weeks).  The possible total remuneration 
for a nurse in-charge is 24,000 Kenyan Shillings (~ US$240). 
 
In Kenya, Jhpiego has instituted a policy of electronic compensation for study participants, with the aim of minimizing the 
risk of carrying money while in the field for the purpose of reimbursing participants. This system uses mobile electronic 
money transfer (M-PESA) as an alternative to the cash advance system.  To receive reimbursement, the system collects 
each participant’s name, phone number, national identification number, and thumbprint. During reimbursement the 
registered participant is asked to place their thumb on the biometric reader, this information is sent to the Jhpiego Nairobi 
finance servers, and this is reviewed against the budgeted amount, and the money released through Mpesa into the 
participants Mpesa account.  The finance department will retain these digital records indefinitely for future audit. This 
information will not be used for any other purpose other than audits. In addition it will not be accessible to the research 
team or any other person after the research activity. Security measures are maintained to protect the data stored on the 
Jhpiego servers. 
 
 
 
 
X. Study Management 
A. Oversight Plan:  
1. Describe how the study will be managed. 
 
The study will be managed by a multi-disciplinary team of OB/GYNs, clinicians, public health practitioners and expert 
researchers based in the U.S. and Kenya.  The PI for the study, Dr. Harshad Sanghvi, will be responsible for overseeing 
the activities and research staff and ensuring compliance with approved study protocols and practices.  The PI will work 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
closely with co-investigators to facilitate trainings of data collectors and providers in the paper partograph and 
ePartogram group, oversee partograph review, research ethics, and ensure data quality and confidentiality. 
 
To ensure study activities are carried out ethically and within the allotted study period, the PI and co-investigators will carry 
out roles as outlined below:   
 
Table 8. Management plan: 
Role 
Responsibilities 
Study Manager (co-
investigator) 
 
Provide day-to-day management and oversight for study implementation at 
facilities 
 
Conduct site orientations and stockups 
 
Oversee research team and data collection, and liaise with study sites 
 
Conduct qualitative interviews 
 
Share weekly progress updates and facilitate bi-weekly study team calls during 
data collection 
Study Clinical Advisors 
(PI and co-investigators) 
 
Provide technical and clinical advising for the ePartogram study 
 
Advise on any severe adverse events (SAEs) 
 
Lead a team of clinicians to evaluate partograms for study endpoints 
 
Develop SOPs for partograph review and clinical use of ePartogram 
 
Contribute to labor management training materials and/or conduct trainings 
 
Study Coordinator (co-
investigator) 
 
Verify collected data and ensure confidentiality of study documents 
 
Conduct ePartogram training and support sites on use of the ePartogram 
 
Facilitate study logistics, including procurement and hiring 
Co-investigators, including 
Data management /analysis 
team 
 
Develop SOPs 
 
Contribute to development of training materials and/or conduct trainings 
 
Develop databases and data extraction tools 
 
Perform statistical analyses 
 
Ensure processes for confidentiality and IRB compliance are communicated to 
all members of the study team, and quality of data 
 
Assist study manger and study coordinator with tasks as required 
 
 
 
2. What are the qualifications of study personnel managing the project? 
Table 9 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Name 
Role  
Institution 
Background 
Study Responsibilities 
Dr. 
Harshadkumar 
Chandulal 
Sanghvi 
Principal 
Investigator 
Jhpiego, USA 
Dr. Sanghvi is the Vice President of 
Innovations and Jhpiego Medical 
Director. For more than 25 years, Dr. 
Sanghvi has made invaluable 
contributions to the field of obstetrics, 
gynecology and clinical epidemiology. 
He has extensive experience assisting 
more than 25 low-resource countries to 
adopt evidence-based guidelines, 
design training systems, develop health 
trainers and leaders, scale up training 
programs, and seek innovative 
solutions to improve the performance 
of health services for women. For the 
last 10 years, he has led the global 
effort in expanding emergency 
obstetric care as well as seeking 
solutions for preventing postpartum 
hemorrhage and cervical cancer in low-
resource settings. 
 
Responsible for oversight of 
study implementation and 
management, and 
communication with study 
team. Dr. Sanghvi will 
provide leadership for 
development of articles, 
presentations and other 
publications. 
Patricia 
Gomez 
Co-
Investigator 
Jhpiego, USA 
Patricia Gomez, CNM, MPH, is a 
certified nurse-midwife with over 30 
years of experience in the development 
of maternal, newborn and reproductive 
health curricula; use and expansion of 
innovative best practices for MNH; 
assessment of quality of MNH care and 
health service delivery; and pre-service 
and in-service education of nurse-
midwives and physicians in Central 
America, Asia, Africa and the United 
States.  She is a senior technical 
advisor for maternal and newborn 
health at Jhpiego. Ms. Gomez was PI 
on the ePartogram feasibility study 
IRB 6146. 
Patricia Gomez will provide 
overall technical guidance 
and clinical advising for the 
study.  She is the lead writer 
for the training materials, and 
will lead a team of Jhpiego 
master trainers in training 
study participants from the 
ePartogram and paper 
partograph study groups.  She 
will contribute to reports and 
publications related to the 
study. 
Dr. Zahida 
Qureshi 
Co-
Investigator 
University of 
Nairobi 
Zahida Qureshi is a Senior Lecturer 
and Consultant, respectively, at the 
Department of Obstetrics and 
Gynaecology, University of Nairobi, 
Nairobi, Kenya, and Kenyatta National 
Hospital, Nairobi, Kenya. Her main 
research interests are maternal and 
neonatal health and evidence-based 
medical care. 
Dr. Qureshi will primarily 
oversee the partograph 
review activities, including 
pilot testing of data collection 
tools, training of reviews, and 
managing the review process. 
She will also provide 
technical guidance and 
clinical advising for the 
study, and participate in 
stakeholder meetings and 
dissemination activities. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Dr. Anthony 
Gichangi 
Co-
Investigator 
Jhpiego, 
Kenya 
Dr. Gichangi is the acting Monitoring, 
Evaluation and Research (MER) 
Director for Jhpiego in Kenya. Dr. 
Gichangi, a Kenyan, has a Ph.D. in 
biostatistics and over 10 years of 
experience in applied statistics, 
statistical consulting, leading research, 
surveillance and programmatic 
activities in public health. Dr. Gichagi 
recently oversaw two studied in Kenya 
as Principal Investigator. 
 
Dr. Gichangi with manage 
the data collection and 
analysis team, providing 
overall coordination and 
oversight for data analyses 
and development of 
databases.  He will lead site 
selection and randomization.  
He will lead 
conceptualization of 
publications, and writing of 
articles, presentations and 
other publications. 
 
Dr. Eva 
Bazant  
Co-
Investigator 
Jhpiego, USA 
Eva Bazant, DrPH, is a health services 
evaluator and researcher with more 
than 15 years of experience in 
international maternal and reproductive 
health, using both quantitative and 
qualitative methods. Dr. Bazant leads 
the Research Team and has served as 
Principal Investigator or Co-
investigator of studies in maternal and 
newborn health, HIV-related care and 
disability services in African and Asian 
countries. Dr. Bazant will ensure the 
data systems are set up to collect and 
analyze data and protect human 
subjects. Dr. Bazant recently oversaw 
two studies in Kenya as PI, IRB 6159 
and IRB 5839. 
Dr. Bazant will contribute to 
study design, training of data 
collectors and reviewers, 
development of data analysis 
and validation plans, 
quantitative and qualitative 
analyses, and writing and 
dissemination.   
Lindsay 
Litwin 
Co-
Investigator 
Jhpiego, USA 
Lindsay Litwin is a master of science in 
public health (MSPH) and the Program 
Officer for the Innovations Unit at 
Jhpiego and has been involved with 
development of the ePartogram for the 
past two years. She has six years of 
experience in international 
development and public health 
research, as well as experience in south 
and east Africa.  She was a co-
investigator on the ePartogram 
feasibility study IRB 6146. 
Lindsay works closely with 
local staff and travels to the 
field during study 
implementation.  She will 
provide overall oversight of 
study staff and activities.  She 
is responsible for developing 
ePartogram training 
materials, SOPs, and 
troubleshooting device-
related issues. 
Dr. Lynn 
Kanyuuru,  
Co-
Investigator 
Jhpiego, 
Kenya 
Dr. Kanyuuru is a medical officer with 
many years’ experience in public health. 
She is the Maternal and Newborn Health 
Advisor for Maternal Child Survival 
Program in Kenya and Innovations 
Advisor for Jhpiego Kenya. She has 
been a principal investigator in multiple 
studies in Kenya. 
Dr. Kanyuuru will provide 
overall technical guidance 
and clinical advising for the 
study.  She will assist in site 
selection and randomization 
and oversight of local study 
staff.  

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Levis Onsase 
Co-
Investigator 
Jhpiego, 
Kenya 
Levis Onsase is Public Health specialist 
with vast experience in MNH, 
HIV/AIDS and NCDs. He is a program 
Associate for the Innovations unit and 
also Healthy Heart Africa project in 
Kenya. He was the field supervisor for 
the recently completed Wheelchair 
study.  
 
Levis Onsase will coordinate 
the study.  He will be 
responsible for data 
validation and 
communications with study 
sites.  He will contribute to 
development of SOPs and 
training materials. 
Dr. Dickens 
Onyango,  
Co-
Investigator 
Ministry of 
Health, 
Kisumu 
County 
Dr.  Dickens is the County Director for 
Health in Kisumu County. He is a 
medical 
officer 
specializing 
in 
epidemiology and has over 10years 
experience in the medical field. He has 
been involved in various studies as a co-
investigator. These include Maternal 
Morbidity Measurement Pilot Tool 
Study, 
integrated 
bio-behavioral 
surveillance of HIV among the fisher-
folk in Kenya, HIV case based 
surveillance and mortality surveillance 
among others. 
Dr. Dickens will coordinate 
study activities in Kisumu 
and conduct site visits with 
the study manager.  He will 
participate in stakeholder 
meetings. 
Valentino 
Wabwile 
Co-
Investigator 
Jhpiego, 
Kenya 
Valentino Wabwile, BScN, is a service 
delivery officer for the Tupange project 
and AphiaPlus Kamili program, 
coordinating RHMNCH and FP 
activities.  He currently supervises the 
contraceptive implant failure study 
among women on ARTs in Nyanza 
Region, Kenya. 
Valentino Wabwile is the 
study manager.  He will be 
responsible for day-to-day 
management of study 
activities. He will lead site 
orientation and stakeholder 
meetings.  Valentino will 
contribute to dissemination 
activities and developing 
publications. 
Timothy 
Kibidi 
Co-
Investigator 
(Jhpiego, 
Kenya) 
Timothy is 
an 
Information 
Systems 
professional 
with Jhpiego. 
He is 
currently in-
charge of the 
data systems 
for the 
contraceptive 
implant 
failure study 
among 
women on 
ARTs in 
Nyanza 
Region, 
Kenya, being 
implemented 
by Jhpiego. 
Timothy will be the data systems 
support person for the study. He will 
monitor the flow of data sequentially as 
it is being submitted for analysis. 
Timothy Kibidi 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Ruth Muia 
Co-
Investigator 
Ruth is 
currently 
working with 
the Ministry 
of Health in 
Reproductive 
and maternal 
health 
services unit. 
She holds a 
MSc. 
Reproductive 
health. She is 
also an 
EmONC 
trainer. 
Ruth will coordinate and contribute to 
study implementation activities in 
Kisumu and Meru Counties. She will 
participate in national and local 
stakeholder engagement activities. 
Ruth Muia 
Dr. James 
Gitonga 
Co-
Investigator 
Dr. Gitonga is 
currently 
working with 
the Meru 
County as 
the Chief 
Officer of 
Health. He 
holds a MPH 
from the 
University of 
Nairobi 
Dr. Gitonga will coordinate study 
activities in Meru and conduct site 
visits with the study manager.  He will 
participate in stakeholder meetings. 
Dr. James Gitonga 
 
 
 
3. How will personnel involved with the data collection and analysis be trained in human subjects research 
protections?  (Use the JHSPH Ethics Field Training Guide on our website.) 
 
The principal investigators and all co-investigators have CITI certification in protection of human subjects in 
research. All additional study team members will sign off on their understanding of the research protocol, data 
collection tools and recruitment/consent scripts.  
 
The study manager and study data coordinators and all co-investigators will read and acknowledge having 
read Jhpiego’s IRB Policy and  be trained on protection of human subjects using JHSPH IRB Research Ethics 
Training Guide.  
 
4. If the PI will not personally be on-site throughout the data collection process, provide details about PI site 
visits, the supervision over consent and data collection, and the communication plan between the PI and 
study team. 
Dr. Sanghvi is based in Baltimore, USA.  During implementation, he will visit the sites at least one time.  
He will oversee study staff and ensure ethical study implementation.  Dr. Sanghvi as PI will have bi-weekly 
calls with the study manager and co-investigators.  He will have direct access to all collected data via 
Dropbox, and will be immediately contacted in the unlikely case of an adverse event during the study. 
 
 
 
B. Recordkeeping:   

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Describe how you plan to ensure that the study team follows the protocol and properly records and stores study 
data collection forms, IRB regulatory correspondence, and other study documentation.  For assistance, contact 
housecall@jhsph.edu. 
 
C.  Safety Monitoring  
1. Describe how participant safety will be monitored as the study progresses, by whom, and how often.  Will 
there be a medical monitor on site?  If yes, who will serve in that role? 
 
Services will be provided to clients as part of routine MOH service provision. No adverse events as a result of this 
study are anticipated. If complications arise during routine service provision, the regular mechanisms will be 
followed, such as contacting senior providers and initiating referrals. 
 
2. If a Data Safety Monitoring Board (DSMB), or equivalent will be established, describe the following:  
a.    The DSMB membership, affiliation and expertise. 
b. The charge or charter to the DSMB. 
c.   Plans for providing DSMB reports to the IRB. 
3. Describe plans for interim analysis and stopping rules, if any. 
 
D.  Reporting unanticipated problems/adverse events (AE’s) to the IRB (all studies must complete this section):   
Describe your plan for reporting to the IRB and (if applicable) to the sponsor.  Include your plan for government-
mandated reporting of abuse or illegal activity.  
NOTE:  The IRB does not require submission for all AEs, only those that are unanticipated, pose risk of harm to 
participants or others, and are related to the study. 
 
ADVERSE EVENTS EXPECTED & UNEXPECTED 
 
 
At baseline,  study staff (or a designated provider onsite) will  visit the study sites to scan registers  for the three 
previous  months  to establish the baseline rate for maternal and early newborn deaths and fresh stillbirths. . . 
 
Every 2 weeks, the study team will obtain the maternity register scan from each facility. We will determine  the 
number of deliveries, number of live births, and the number of maternal and early newborn deaths and fresh 
stillbirths. We will determine the appropriate rates and whether any are  more than 10% above the 
expected/normal rate.  
 
A summary log will be created for recording the number of deliveries, births, and adverse maternal or newborn 
outcomes for each 2 week period. This log will have the woman’s facility admission number id on it obtained 
from the register. If this log indicates that  normal levels have occurred, this summary AE log will be submitted 
to IRB along with progress report. 
 
If the normal level is exceeded (>10% higher than the average monthly total from 3 months prior to the 
intervention),   Jhpiego will  prepare a severe adverse events (SAE) report and the SAE policy will take effect  
with expedited reporting to IRB. 
 
REPORTING 
 
If any unanticipated problems or adverse events occur, the study team will follow JHSPH IRB policy no. 103.06, 
“Reports of Unanticipated Problems Involving Risks to Participants or to Others”.  
 
Should any adverse event occur in relation to or at the time of the data collection, the data collectors will be 
trained to notify their team leader immediately by phone, who will notify the co-investigators in Kenya and the PI 
and headquarters co-investigators within 2 business days. 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
 
If a severe adverse event (SAE) occurs, the study team will immediately inform the principal investigator and 
follow Jhpiego’s SAE Policy. The SAE policy requires immediate notification of the Kenya Country Director,  
local PI and  overall study PI and completion and submission of Jhpiego’s SAE Report Form. The Country 
Director will then send the relevant documentation to the Jhpiego headquarters-based Medical Director and 
Contracts Administrative Manager. Advice will then be provided to the Country Director for next steps.  
 
A summary of unanticipated problems and AEs will be reported to JHSPH IRB in the annual progress report.  
 
Severe unanticipated problems  will be reported to JHSPH IRB as soon as possible after the PI learns of the event, 
but not later than 10 days. 
 
 
 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name and contact information for each IRB/ethics review 
board and its Federal Wide Assurance, if it has one (available on OHRP’s website at 
http://www.hhs.gov/ohrp/assurances).   
 
IORG0006771 - Kenya Medical Research Institute (KEMRI) , IRB00008118 
Kenya Medical Research Institute (KEMRI) 
KEMRI IRB00008118 
P.O. Box 54840-0020, Nairobi, Kenya 
Tel#(254)(020)2722541, Email: director@kemri.org http://www.kemri.org 
 
(for reporting of adverse events): The Secretary, KEMRI Ethics Review Committee, P. 0. Box 54840-00200, 
Nairobi; Telephone numbers: 020-2722541, 0722205901, 0733400003; Email address: ERCadmin@kemri .org 
 
 
 
ALL SECTIONS AFTER THIS ARE NOT APPLICABLE. 
 
 
F.  
 
 

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APPENDIX A: WHO Modified Partogram 
 
 
 

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APPENDIX B: ePartogram 
 
 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
Appendix C: ePartogram testing 
 
Functional testing  
 
Navigation testing scripts to confirm that users can navigate between screens and the software responds 
correctly to user inputs 
 
Quality assurance testing scripts to prove accurate data output on all screens of the ePartogram 
 
Entry of test scenarios in the ePartogram to ensure that data fields populate correctly, data constraints function 
correctly, and alarm cutoffs are accurate 
 
Testing will be repeated by 3 individual testers for quality control 
 
Functional testing conducted in the United States, Tanzania and Kenya 
Performance testing of the system 
 
Load testing to confirm the ePartogram performs as intended with varying numbers of simultaneous users 
 
Testing performance metrics for 0-250 users 
 
Testing will be repeated by 3 individual testers for quality control 
 
Functional testing conducted in the United States, Tanzania and Kenya 
Clinical rules testing 
 
Front-end input of partograph cases into the ePartogram to verify that ePartogram reminders and alarms fire 
consistently and correctly 
 
Excel-based simulations to test the clinical reminders and alerts against the ePartogram code to ensure 100% 
accuracy 
 
125 scenarios used to test 78 clinical rules 
Field refinements 
 
User feedback sessions to verify software design choices and features 
 
Testing of connectivity at facilities to facilitate optimal data connection for ePartogram 
 
 
 

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Research Plan: Sanghvi PI/  ePartogram Effectiveness Study. IRB Number 6598. 25 March 2016. V1 
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