Wireless Physiologic Monitoring in Postpartum Women
Phase: NA
Conditions: Maternal Death During Childbirth, Pregnancy Complications
Sponsor: Massachusetts General Hospital

NCT ID: 2019P000885 
Document Date August 20th 2021 
    
  
 
 
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Title: Wireless Physiologic Monitoring in Postpartum Women  
 
Principle Investigators:  
Adeline Boatin, MD MPH, Massachusetts General Hospital/Harvard University  
Joseph Ngonzi, MBCHB, M.Med, Mbarara University of Science and Technology 
 
Co-Investigators: 
Jessica Haberer, MD MS Massachusetts General Hospital/Harvard University  
Henry Lugobe, MBCHB, M.Med, Mbarara University of Science and Technology 
Godfrey Mugyenyi, MBCHB, M.Med, Mbarara University of Science and Technology 
Sudi Mohamed, MBCHB, Mbarara University of Science and Technology 
Kenia Martinez, MBCHB, Mbarara University of Science and Technology  
Blair Wylie, MD MPH. Beth Israel Deaconess Medical Center/Harvard University 
Christina Psaros, PHD, Massachusetts General Hospital/Harvard University  
Joshua Metlay, MD PHD, Massachusetts General Hospital/Harvard University  
Lisa Bebell, MD, Massachusetts General Hospital/Harvard University 
Sr. Judith Kyarisiima, Mbarara Regional Referral Hospital   
Nicholas Musinguzi, Msc,  Massachusetts General Hospital 
 
 
Detailed Protocol 
Version Date: 20th August 2021 
Version No. 4 
 
Background and Significance 
Between 1990 and 2015, global maternal mortality dropped by 45%, from 532,000 deaths per year to 
an estimated 303,000.1,2 While encouraging, too many women continue to die in childbirth. At current 
projections, an estimated 3.8 million maternal deaths will occur between now and 2030, with the 
majority (66%) in sub-Saharan Africa.1,2 Maternal mortality rates in Uganda mirror global patterns.  
Currently the life time risk of maternal death in Uganda is still as high as 1 in 47 compared to rates of 
1 in 6,000 in resource rich countries.1 
 
Most maternal deaths occur immediately around childbirth 3 and approximately 45% in the first 24 
hours.4 As such, the promotion of facility-based childbirth has been a corner stone of strategies to 
reduce maternal and neonatal deaths in low and middle-income countries.5,6 However, despite 
increases in the proportion of women delivering at facilities, reductions in mortality and morbidity 
have not been as rapid as expected.5 Evidence points to delays at the facility in the recognition of 
complications and timely intervention as once cause of morbidity and mortality.7-12 Recognizing the 
critical timeframe in the immediate postpartum period, current guidelines from WHO call for close 
monitoring during this time.13 Similarly, nursing standards in resource-rich settings recommend 
physiologic monitoring every 15 minutes for the first 2 hours postpartum, then every fours for the 
first 24 hours.14 15 Sustaining such high frequency monitoring remains a challenge even in resource-
rich settings.16 17 In RLS contexts such as Mbarara, Uganda, where staff-to-patient ratios may be as 
high as 1:50,18 such normative standards around monitoring are unattainable with current systems 
of physiologic monitoring. 
 
Abnormalities in physiologic signs have been shown to predict subsequent in-hospital mortality and 
morbidity amongst emergency department and medical ward patients.19-23 In response to these 
findings, health care systems in resource-rich settings have introduced “Track and Trigger” protocols 
and “Early Warning Scores” to identify abnormalities in physiologic signs and activate appropriate 
responses.24 In the case of heart disease, combining early warning of potential illness with 

NCT ID: 2019P000885 
Document Date August 20th 2021 
    
  
 
 
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appropriate medical response has reduced rates of cardiac arrest, readmissions to critical care, and 
mortality.25-27 Similar strategies have been recommended in an obstetric setting, where the most 
common causes of mortality are hemorrhage, hypertensive disease, and sepsis, accounting for 
27.1%, 14.0% and 10.7% of maternal deaths worldwide.28 These conditions are commonly associated 
with abnormal physiologic signs– hemorrhage causing tachycardia and hypotension; pre-
eclampsia/eclampsia causing hypertension and hypoxia; and sepsis causing fever, tachycardia, 
hypotension, and hypoxia.29,30 
 
We have previously studied the feasibility and preliminarily tested the acceptability of using a 
wireless biosensor (BioPatch™) to capture physiologic signs over 30 minutes in 50 healthy non-
laboring pregnant women, and transmit this data to a central monitor (ZephyrLIFE™) at the Mbarara 
Regional Referral Hospital (MRRH).18 The biosensor is compact and round, with a diameter of 4cm, 
attached to the chest with standard adhesive electrodes (Figure 1). The sensor captures HR based on 
the R-R interval of a single lead electrocardiogram, RR (via impedance), and estimates core 
temperature based on HR variability. Data from the sensor is transmitted to a central monitor over a 
wireless network. Software at the central monitor enables reception  of data, and customizable on-
screen and audible alarts . The sensor is approved by the US Food and Drug Administration for 
general adult use. Our studies of feasibility demonstrated functionality of the biosensor, with >80% 
of physiologic sign capture in the MRRH setting.18,31 We also found that with minimal training, 
clinicians in at MRRH were able to correctly apply the biosensor, input participant information into 
the central monitor and track output of data. Additionally, women wearing the device found it 
comfortable and useful. We will be building on this preliminary work and experience to test the 
impact of wireless monitoring on clinical outcomes. 
 
 
 
 
Specific Aims 
1. To estimate the clinical effectiveness of wireless physiologic monitoring of women in the 
first 24 hours after emergency cesarean delivery at Mbarara Regional Referral Hospital 
(MRRH) 
2. To evaluate the clinical adoption of wireless physiologic monitoring at MRRH using an 
implementation science approach. 
3. To use qualitative methods to explore clinical adoption and acceptability of wireless 
physiologic monitoring among postpartum women at MRRH and understand facilitators and 
barriers to uptake of wireless physiologic monitoring. 
4. To estimate the cost of providing wireless physiologic monitoring of women in the first 24 
hours after emergency cesarean delivery at MRRH 
5. To estimate the incremental cost-effectiveness, measured as cost per severe maternal 
outcome adverted using wireless physiologic monitoring compared to current standard of 
care monitoring.   
6. To explore the ethical considerations of obtaining intrapartum consent among women 
enrolling in this study 
7. To evaluate if motion in the early post-operative period is related to functionality, mobility 
and wellness during recovery from cesarean delivery and how recovery relates to financial 
risks after cesarean delivery.  
 
Methodology 
Setting: The research will be carried out in the Department of OB/GYN MRRH in Mbarara, Uganda. 
This facility is the primary referral hospital in southwest Uganda. It performs ~ 10,000 deliveries per 
year (~ 30/day), has a maternal mortality ratio of 460 per 100,000 live births (~50-60 deaths per year) 

NCT ID: 2019P000885 
Document Date August 20th 2021 
    
  
 
 
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and a cesarean delivery rate of 40%. All women delivered by cesarean are followed and monitored by 
postgraduate doctors with assistance from midwives. In this facility, postgraduate doctors complete 
medical training including a two-year internship and practice independently for several years prior to 
postgraduate training in OB/GYN. Consultant/Specialist OB/GYN supervisors oversee clinical care from 
home or in-hospital depending on clinical acuity There are currently 13 consultants/specialists, 39 
postgraduate doctors in the institution, and 40 midwives with clinical privileges in the department. 
The physician to patient ratio ranges from 1:8 during the day to 1:25 during the night and weekends. 
 
Study Population: 
The following types of participants will be recruited for study purposes:  
1) Clinicians: Consultants/Specialists and nurse/midwives with clinical duty on the maternity ward at 
MRRH during the study period.  
2) Peripartum women delivered by emergency cesarean during the study period.  
 
Study Intervention: 
The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of 
women undergoing emergency cesarean delivery for the first 24 hours after completion of the 
cesarean.  
The wireless monitor to be used is a wearable wireless vital sign monitor called Current ™. The 
device provides continuous real-time transmission of oxygen saturation, respiration rate, pulse rate, 
temperature, motion and activity, and posture captured every 2 seconds. It is integrated with the 
Omron Evolv blood™ pressure cuff to allow automated capture of blood pressure. Physiologic data 
from the sensor is transmitted via WiFi to a secure cloud storage (hosted by Amazon Web Services).  
Current™ is fully HIPAA 1compliant and HITrust2 certified and has received US FDA approval.  
Physiologic data can then be accessed via a secure password protected mobile phone app or 
displayed on a monitor for real-time viewing. Pre-defined criteria can be used to program alerts or 
notifications should vital signs fall outside of the range. These notifications can be received via SMS 
or a mobile app notification. Notifications can be sent to multiple providers at a time. Providers can 
also log on or off from the device corresponding to their duty shifts.  
 
To complete Aim 1, we will enroll all willing attending doctors and staff midwives with clinical duties 
covering the maternity ward, emergency cesarean delivery and postoperative care during the study 
period to use the wireless physiologic system and receive message alerts. Due to staffing the 
numbers of clinicians may fluctuate during the enrollment period We will also enroll 1235 women 
undergoing emergency cesarean delivery during the study period during intervention blocks to wear 
a wireless physiologic monitor for 24 hours after birth. An additional 1235 women, also undergoing 
emergency cesarean during the study period during non-intervention blocks, will form a control 
group and have medical record review only. We request to waive consent for this record review only. 
Clinicians and peripartum women participating in wireless physiologic monitoring will form the same 
participants for Aim 2, which will involve participant observation, record review, and retrieval of 
data from the wireless monitoring system and clinician responder phones. To complete Aim 3, We 
will perform semi-structured interviews on 30 clinicians and 30 postpartum women drawn from 
 
1 HIPAA: Health Insurance Portability and Accountability Act of 1996) is United States legislation that provides data 
privacy and security provisions for safeguarding medical information 
 
2 HITRUST, in collaboration with private sector, government, technology and information privacy and security 
leaders, has established the HITRUST CSF, a certifiable framework that can be used by any organization that 
creates, accesses, stores or exchanges sensitive information. The framework provides a way to comply 
with HIPAA standards 
 
 

NCT ID: 2019P000885 
Document Date August 20th 2021 
    
  
 
 
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those participants enrolled in Aim 1 and 2. To complete Aim 4 and 5 activity-based costing will be 
used to identify the main activities, resources and specific inputs used to support implementation of 
the wireless monitoring system and current standard of care. Time-based tracking will be used to 
perform time and motion studies to determine the time and processes to implement the monitoring 
system. To complete Aim 6, women will be administered a pain and anxiety assessments, as well as 
assessment of trust in medical providers, and a questionnaire assessing the quality of the informed 
consent process. 15-20 women consent and 15 women declining will be invited to participate in a 
semi-structured interview (drawn from participants in Aim 1, and not including any women 
participating in Aim 2).  
 
Study Population Overview 
Participants 
Activities 
Consent 
Total 
Number 
Midwives and 
consultant/specialis
ts 
Placement of monitors on enrolled women; Hold responder 
phone for possible text alerts; In-depth interviews (30 
clinicians) 
Yes 
~ 52 
Peripartum women  
Wear wireless monitor for 24 hours after delivery 
Record review; Semi-structured interviews (30 women) 
Yes 
1235 
Peripartum women 
(controls) 
Record review only 
No 
1235 
Total Study Population 
2522 
 
Subject Selection 
Clinicians 
Inclusion Criteria 
Rationale 
1. Clinical privileges at MRRH 
 
Given this is a hybrid efficacy-implementation trial, the research aims require 
integration of the intervention into routine clinical care. As such and for 
logistical purposes we will recruit those clinicians who will be providing 
clinical care to participants.  
2. Clinical duty during study 
period 
 
The research intervention will require clinicians to receive alerts of potentially 
critically ill participants, however we will not provide guidance on 
management or the appropriate clinical intervention. As such we require that 
all clinicians enrolled have sufficient experience to provide appropriate 
clinical care for women should that be required.  
3.  
 
Exclusion criteria 
Rationale 
1. Inability to speak English or 
Runyankole 
Lack of available interpreters for effective communication in other languages; 
It is anticipated 100% of clinicians at this facility speaks one of these two 
languages 
 
Peripartum Women 
Inclusion criteria 
Rationale 
1. Age >18 
We will exclude women under the age of 18 because even if they are 
considered emancipated minors, most are not adults physiologically. Our 
research questions are designed to study physiologic monitoring in adult 
women, and may not apply equally to pregnant children under the age of 18. 
Moreover, this the wireless device currently only has food and drug safety 
approval for adult use. 
2. Undergoing emergency 
cesarean delivery at MRRH  
 
Women undergoing emergency cesarean are chosen due to increased risk of 
morbidity and mortality in this population. Additionally, the study proposes to 
test monitoring in the first 24 hours after birth, therefore women delivered 
outside of MRRH and arriving in the postpartum period will arrive after this 
period has begun and will miss the critical window to initiate monitoring.  

NCT ID: 2019P000885 
Document Date August 20th 2021 
    
  
 
 
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3. Able to provide consent or 
have a guardian/attendant 
present who can consent 
on their behalf. 
The latter is included as monitoring critically ill women who may be unable to 
provide their own consent is paramount to ultimately affecting clinical 
outcomes 
4. Willing to wear the 
biosensor for 24 hours 
 
Wearing the monitor is integral to the proposed intervention. Given the 
technical capabilities of the monitor, current wireless signals will only be 
available on the postpartum ward, therefore women will need to be present 
on the ward for the device to transmit signals to the central monitor and alerts 
to clinicians should abnormalities occur. 
5. Willing to remain in the 
postpartum unit for 24 
hours 
 
Exclusion Criteria 
Rationale 
1. Admitted to ICU directly 
after delivery 
The ICU at MRRH is a closed unit in a separate building from the postpartum 
ward, as such, monitoring systems in use there are different from on the 
postpartum ward. The aim of this study is to investigate the use of wireless 
monitoring for women admitted to the postpartum ward after delivery. 
2. Known allergies or 
hypersensitivity to device 
materials 
 
For this research we will be limited to using standard electrode adhesives to 
apply the device. To avoid adverse reactions, any women with allergies or 
known hypersensitivity to the device will be excluded.  
3. Scheduled or Elective 
Surgery  
Excluded due to the decreased morbidity in this population.  
4. In ability to speak English or 
Runyankole 
Lack of available interpreters for effective communication in other languages; 
It is anticipated >95% of the local population at this facility speaks one of these 
two languages 
 
 
Subject Enrollment and Consent Procedures 
1. Clinicians: Prior to the initiation of the study, a group meeting will be held with clinicians 
(midwives and specialists/consultants) explaining the background of the study, rationale of the 
study and anticipated study procedures. This meeting will be timed to be held during routine 
maternity administration time to avoid impacting clinical activities. Clinicians who are interested 
in the study will then be approached individually and given more details on the study 
procedures, and the potential risks and benefits. A trained member of the research team will be 
responsible for conducting this consent. The PI will oversee the consenting process but not 
participate directly to avoid any potential conflicts and unintended pressure on clinicians to 
participate. The trained team member will approach participants, introduce the study, and 
gauge interest. S/he will explain study procedures to the doctor and include potential risks and 
benefits. Consents will be written to maximize understanding of the study procedures and 
potential risks and to comply with standards in place by MUST ethical review committee and 
Partners institutional review board. Clinicians who agree to participate will sign consent in the 
language of their choice (English or Runyankole). A copy of the consent will be given to the 
participant. Information on how to contact study staff, report adverse events or concerns 
associated with study will be provided on the consent forms. Clinicians will have over 24 hours 
from explanation of the study with risks and benefits to choose to participate or not and sign 
informed consent.  
 
2. Peripartum women: To enable wireless monitoring to begin immediately or as soon as possible 
after cesarean delivery, the RA will approach all women waiting in labor or registering for 
delivery during the study period.  Women cannot be approached prior to presentation for 
delivery due to logistical constraints with patient scheduling and follow-up in this setting. The RA 
will screen for eligibility and explain the study to eligible women and obtain assent for potential 
inclusion. Women will only be enrolled if the decision is made for an emergency cesarean 

NCT ID: 2019P000885 
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delivery during their labor or antepartum course. This decision will be made per the standard of 
care in the clinic and not influenced by research goals or procedures 
 
In a private space, potential participants will have the study and study procedures described 
verbally in their preferred language (English or Runyankole) and given written information about 
the study in their preferred language. The RA recruiting and seeking consent will be carefully 
trained to fully explain the risks and benefits and to ensure women understand that they will still 
receive current standard of care at the hospital should they decline to participate in. Prior to 
describing the study and study procedures the RA will conduct a pain assessment using the 
facies and numerical pain scale and anxiety assessing using the State Trait Anxiety Scale 
(Appendix 10)  
 
It will be clearly explained to women that actual enrollment will occur if the decision is made for 
an emergency cesarean delivery and that  study explanation is being done ahead of time due to 
the due to the nature of childbirth with an unpredictable timing for a decision for emergency 
cesarean delivery, and often need for urgent medical care and the potential for a high level of 
emotional and physical stress at that time. For all women who provide assent, the RA will obtain 
written consent to study enrolment immediately after informed consent for the cesarean 
delivery has been obtained by the overseeing doctor performing the cesarean. 
 
All consents will be translated into Runyankole and back translated to English.  Consent forms 
will be read aloud in their entirety to potential participants. Women will be informed that 
participation is voluntary, there are no repercussions for not participating, and they can drop out 
at any point also without repercussion.  
 
Research assistants will be asked to document field notes at the time of consent to capture 
information on the length of time taken for the consent, if the participant had others present, 
and observations during the process of the consent (e.g. discussion by the participant with an 
attendant or family member)  
 
If women are unconscious or in a mental state where they are unable to consent for themselves, 
an attendant or guardian will be approached for consent. As women in this condition are at high 
risk for morbidity and/or mortality inclusion in this study is key to achieve the objectives of 
reducing this risk. Additionally, women in this condition are the most likely to gain direct benefit 
from vital sign monitoring.  As such if an attendant is not available the woman will be enrolled 
without consent to enable monitoring to begin immediately. Consent will be sought as soon as 
possible after the woman regains capacity to consent or an attendant becomes available. If the 
woman and/or her attendant declines to participate at that time all study procedures will be 
discontinued.  
 
Study Procedures  
1. A group meeting detailing the study background, procedures, risks and benefits will be held for 
all clinical providers in the department prior to study initiation. 
2. We will obtain informed consent for clinicians and peripartum women admitted for delivery as 
described above.  
3. A 2-hour training session on the use of the wireless monitoring system, nature of alerts and 
emergency mobile phone will be held for enrolled clinicians at a time convenient to them.  
4. Alternative two-week blocks will be assigned to “intervention” vs “control”. During an 
“intervention block” all women delivering by emergency cesarean and consenting to participate 
will be monitored using the wireless device for the first 24 hours after delivery. During a “control 

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block” standard of care for monitoring will be used and women delivering via emergency 
cesarean will have record review only.  
5. Maternity ward coverage schedules for enrolled specialist and midwives will be obtained. This 
will be used to determine the clinicians on call during each intervention block.   
6. During the intervention block, midwives present in the theatre will be asked to perform the 
following tasks for any emergency cesarean deliveries s/he is present for: 
a. Placement of the biosensor on any enrolled women s/he delivers by emergency 
cesarean delivery immediately after completion of the surgery.  
b. Input postpartum women’s data (name, age, medical identification number) into the 
central monitor of the monitoring system. This is anticipated to take 1-2 minutes once 
enrolled midwives have received training on the system. The central monitor will require 
password access and only clinicians trained in the use of the system and responsible for 
the care of participants will be provided with password access. 
c. If a midwife is not available in the theatre, a research assistant will perform the above 
tasks.  
7. At a convenient time after consent that does not interfere with clinical care, height, weight and 
arm circumference will be measured by an RA.  
 
8. Physiologic sign data from the biosensor worn by enrolled women will be automatically 
transmitted via cellular networks to the central monitor for display. As above, this information 
will be password protected. Physiologic data will also be available in a stored format on the 
device (for up to 6 hours) and in cloud storage. Once physiologic data is no longer needed for the 
clinical care of postpartum women, all data on the cloud storage will be de-identified – within 
24-48 hours after monitoring is complete. Participants will be assigned a code to link physiologic 
data to clinical data performed through record review. Enrolled postpartum women will be given 
a participant study identification number. All data downloaded from the central monitor or 
biosensor will be de-identified and study numbers used to link data to participants. All data will 
be stored on encrypted password protected storage.  
9. Call schedules will also be used to determine specialist and midwives responsible for postpartum 
care of women during the intervention block. Midwives will be asked to hold an assigned 
emergency mobile phone to which alerts would be sent if abnormalities occur in the physiologic 
signs of enrolled women. This mobile phone will require password/pin access which will only be 
given to the enrolled clinicians. Specialists/consultants will also have the option to install a 
password protected mobile app to receive notifications and alerts and visualize data on their 
personal mobile phones as long as their phones meet minimum security and privacy measures 
(password protected and encrypted phone). Enrolled attending physicians with clinical 
responsibility during the intervention block will also be given the option to receive alerts to their 
personal mobile phones should abnormalities occur. Alerts will be sent to the emergency mobile 
phone and personal phones of enrolled specialists who mark themselves as on duty if any of 
abnormalities occur in 
physiologic signs as 
described in Table 1.  
Alert messages will include 
the following text: 
- 
Medical 
identification 
number and name 
(to allow the covering doctor 
to find and review relevant 
clinical information for the patient and fine the patient if needed.   
Table 1: Predefined limits for clinician alerts 
Physiologic sign 
Cut off for alert 
Heart rate (beats per minute), noted for >5 minutes 
>120 
Systolic Blood pressure (mmHg), any 
>160 or <70 
Diastolic blood pressure (mmHg), any 
>110 or <30 
Temperature (C) noted for >2 minutes 
>40C 
Respiratory Rate (breaths per min) noted for >5 
minutes 
>30 

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- 
Nature of abnormality e.g. Heart Rate = 140bpm, or Blood pressure= 180/110. Any clinical 
response to the abnormality will be left to the discretion of the covering doctor in 
accordance to current standard care guidelines at MRRH.  
10.  For clinical safety of the women participants, midwives receiving any alerts indicating the above 
vital sign abnormalities will be asked to inform one of the doctors on call. In the event of 
technical issues with the monitoring system, midwives will be able to access a research assistant 
who will be on 24 hours a day.  
11. Every 24 hours a research assistant will perform medical chart review on enrolled participants to 
assess for documentation of the occurrence of any severe maternal outcome (Table 2). The 
research assistant will also review daily 24-hour reports generated by covering clinicians 
(standard maternity ward practice) to identify potential severe maternal outcomes not 
documented in the medical record. 
Table 2: Severe Maternal Outcomes based on WHO Near Miss Criteria with demonstrated feasibility of collection in a 
RLS28,29,71 
Outcome 
Definition/Measurement 
Death 
Mortality occurring at any time point after delivery and prior to discharge 
Clinical based near-miss criteria 
Acute cyanosis 
Blue or purple coloration of the skin or mucous membranes due to low 
oxygen saturation 
Gasping 
Terminal respiratory pattern, the breath is convulsively and audibly 
caught. 
Severe bradypnea or tachypnea 
Respiratory rate < 6 or Respiratory rate > 40 
Shock 
Persistent systolic BP ≤ 80 mmHg or a persistent systolic BP ≤ 90 mmHg 
with a HR ≥ 120. 
Oliguria 
Urinary output < 30 ml/hour for 4 hours or < 400 ml/24 hours non-
responsive to fluids/diuretics. 
Failure to form clots 
Bedside clotting test or absence of clotting from the IV site after 7 
minutes 
Prolonged unconsciousness 
Complete or near-complete lack of responsiveness to external stimuli. 
Cardiac arrest 
Sudden absence of pulse and loss of consciousness. 
Stroke 
Neurological deficit of cerebrovascular cause persisting ≥ 24 hours. 
Uncontrollable fits 
Refractory, persistent convulsions or status epilepticus. 
Total paralysis 
Complete or partial paralysis of both sides of the body. 
Jaundice in the presence of pre-eclampsia 
BP > 140/90) with proteinuria (> 1 + dipstick in ≥ 2 samples) and jaundice. 
Laboratory-based near miss criteria 
Acute severe azotemia 
Creatinine > 300 mmol/l or > 3,5 mg/dl 
Severe acute hyperbilirubinemia 
Bilirubin > 100 μmol/l or > 6.0 mg/dl. 
Severe acute thrombocytopenia 
<50 000 platelets/ml 
Management-based near-miss criteria 
Use of continuous vasoactive drugs 
Uninterrupted infusion of dopamine, epinephrine, or norepinephrine. 
Hysterectomy 
Surgical removal of the uterus following infection or hemorrhage. 
Massive transfusion 
Transfusion of ≥ 5 units of blood 
Intubation and ventilation not related to 
anesthesia 
Placement of an endotracheal tube or ventilation for > 60 minutes 
purposes other than anesthesia 
Dialysis for acute renal failure 
 
Cardiopulmonary resuscitation 
Emergency procedures including chest compressions and lung ventilation. 
 
12. The research assistant will also extract data on (age, district of origin, education level, 
occupation, referred in from another facility), obstetric history (parity, gestational age at 
delivery, antenatal complications) and medical comorbidities (HIV, chronic hypertension, 
cardiac, pulmonary or kidney disease). Information on timing of delivery, indication for cesarean 

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delivery and decision to incision time for emergency caesarean delivery, documentation of 
physiologic signs will also be extracted. See Appendix 1 – Chart Review 
13. At the end of each clinical duty or shift enrolled midwives and specialist doctors will be asked to 
complete a brief questionnaire which will be administered via electronic survey using redcap 
survey on the responder phone. This will be to assess if the midwife received any alerts, how 
they responded and if it influenced clinical management.  See Appendix 2 – Call Duty Follow up 
Questionnaire. This is estimated to take ~5-10mins to complete.  
14. Up to 30 enrolled clinicians who participated in the monitoring system will also be approached 
at a convenient time for a in depth interview. We will also approach other key stakeholders 
including clinicians in leadership positions who may not have participated in the monitoring 
system. These interviews are intended to gather qualitative data on the facilitators and barriers 
to use and uptake of the monitoring system.  Purposively sampling will be used to approach 
midwives with high use of the system and low use of the system. See Appendix 3 – Clinician 
Interview guide. Interviews will occur in a private room. Interviews will occur at a time 
convenient to clinicians (within one week of interaction or observation with the wireless 
monitoring system) so as not to interrupt clinical care. A digital recorder will be used to record 
interviews and the trained research assistant will then transcribe and translate interviews 
administered to clinician and post-partum women participants. 
15. During the study period approximately 20 of the enrolled midwives will be observed using the 
wireless monitoring system to determine time performed to perform the steps for initiating 
monitoring for a woman. See Appendix 5 – Time Tracking Form. 
16. At the end of 24 hours of monitoring each enrolled woman who participated in monitoring will 
have a brief structured questionnaire on the acceptability of the monitoring, which will be 
administered by the research assistant. See Appendix 4 – Postpartum Woman Acceptability 
Questionnaire. This is estimated to take ~15 minutes.  
17. Up to 30 enrolled women will be asked to participate in an in-depth interview on the experience 
of wearing the wireless monitor.  This is conducted to provide context to the above quantitative 
measures and to understand acceptability and facilitators and barriers to uptake of wireless 
physiologic monitoring. Women will be purposively sampled for age (18-34 and >35 years) and 
level of use of the monitor (~15 women who completed 24 hours of monitoring and ~ 15 women 
with less than 24 hours of monitoring). Interviews will be conducted until thematic saturation is 
reached. See Appendix 6 – Postpartum Woman Interview Guide. This interview is estimated to 
take ~45 minutes. Interviews will occur in a private room, and prior to discharge but after 
wireless monitoring is complete (postpartum day 2 and 3 at a time convenient to women. A 
digital recorder will be used to record interviews and the trained research assistant will then 
transcribe and translate administered to clinician and post-partum women participants. 
18. After these study procedures are complete women will be approached to complete the medical 
trust researcher scale (Appendix 11) and the QuiC scale (Appendix 12). Additionally, the pain 
assessment and state trait scale will be repeated (Appendix 10 and 11). 
19. Up to 15 enrolled women (distinct from those participating in step 17 above) will be invited to 
participate in an in-depth interview (Appendix 13) to explore their experiences of going through 
the informed consent process. Up to 15 women who declined monitoring will be invited to 
participate in the in-depth interview only (no monitoring) (Appendix 15). A separate consent 
form will be used for these women (Appendix 14)  
20. After every 24 hours of monitoring, data from biosensors which includes continuous physiologic 
sign data, start and stop time of monitoring and potential interruptions will be downloaded by 
the research assistant into a secure database. Data from the emergency cellular phone including 
number of alerts received, time received and time read will also be downloaded and extracted 
from the cellular phone. 
21.  The research assistant will also document any external factors that may affect monitoring every 
24 hours e.g. electricity outages or cellular network disruptions, and stock outs 

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22. After discharge, all patients who completed at least 12 hours of monitoring will receive an 
invitation to complete a short mobile phone survey to measure functionality, mobility, and 
wellness at day 1, and at 2,4,6 and 12 weeks post discharge (Appendix 16). At 6 weeks post 
discharge they will also receive survey assessing for health expenditure, depression and 
postpartum complications (Appendix 17). The questionnaire will be administered by an 
automated mobile phone survey system , that allows the participants to receive a prerecorded 
voice call with the survey and instructs them on answer choices. This will be administered 
through Engage Spark.  EngageSPARK is a social enterprise that offers a browser-based, cloud-
hosted platform used to launch interactive Voice IVR and SMS text message campaigns globally. 
This platform has previously been used in studies of providing airtime incentives to survey 
participants in Uganda as well as Bangladesh and Colombia. A research assistant will call 
participants to administer the survey for participants unable to access or complete automated 
phone surveys. Up to 5 attempts will be made to reach the participant to complete the survey. 
Participants will receive instruction from a RA on the automated survey at the time of their 
baseline/acceptability interview conducted as part of the parent study (study procedure #16) 
23. At 12 weeks post discharge a research assistant will call participants to administer the last set of 
surveys as well as an acceptability questionnaire on the use of automated surveys to collect 
patient reported outcome measures (PROMS) (Appendix 17).  Up to 5 attempts will be made to 
research participants for the survey at these time points.  
 
Table 3: Survey administration timeline  
 
Day after 
discharge 
2 weeks 
post 
discharge 
4 weeks 
post 
discharge 
6 weeks 
post 
discharge 
12 weeks 
post 
discharge 
Mobility  
survey 
x 
x 
x 
x 
x 
Financial  
Survey 
 
 
 
x 
x 
General  
Survey 
 
 
 
x 
x 
EPDS 
 
 
 
x 
x 
Acceptability  
Survey 
 
 
 
x 
x 
 
 
Biostatistical Analysis 
Aim 1: The primary outcome measure is the rate of severe maternal outcome (SMO). This is a 
composite measure drawn from WHO near miss morbidity criteria (Table 2). Secondary outcome 
measures include: the maternal mortality rate, maternal near miss rate and case fatality rates for 
postpartum hemorrhage, hypertensive disease and sepsis – the three most common causes of 
maternal death. The event rates for both primary and secondary outcomes will be compared using 
logistic regression models with the Generalized Estimating Equations approach to take into account 
of patients within clustering (due to time blocks).  Exploratory analyses will be used to determine if a) 
the intervention is more powerful in certain subgroups of women and b) if any provider was 
consistently different in maternal outcomes regardless of intervention. The interaction between study 
arm and comorbidities (HIV, hypertension, pulmonary, cardiac or kidney disease, malaria) or provider 
will be tested in the logistic regression models. Subgroup effects will be reported if there is strong 
evidence of heterogeneity of intervention effect 
 
Aim 2: We will apply the RE-AIM model to conduct a quantitative evaluation of the implementation of 
the intervention used in Aim. Table 4 describes the primary metrics to be measured and data sources 
from which it will be collected.  

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11 
 
RE-AIM Implementation Science Framework37,38 
Metric 
Dimension 
Study Measure 
Data source 
Reach 
Proportion of 
target 
population that 
participated in 
the 
intervention 
• Percent of women with successful placement 
of biosensor after delivery 
• Total length of time for monitoring over 24hrs 
postpartum 
• Percent of women participating in monitoring 
for 24 hrs 
• Physiologic data from 
biosensor 
• Time of delivery from chart 
records & theatre log books 
Efficacy 
Success rate if 
implemented 
as in guidelines 
• Percent of women with HR, BP, RR and Tp 
available at least every 4 hours for 24 hrs after 
delivery 
• Percent of appropriate SMS alerts sent 
• Physiologic data from 
biosensor 
• RA review of mobile phones 
for SMS alerts and time of 
receipt 
Adoption 
Proportion of 
practitioners 
adopting this 
intervention 
• Percent of clinicians participating in wireless 
monitoring 
• No. of clinical actions in response to SMS 
alerts 
• RA review of medical record 
• RA review of mobile phones 
and medical record 
Implementation 
Extent to which 
the 
intervention is 
implemented 
in the real 
world 
• Fidelity of implementation to the training 
protocol 
• Documentations of any 
necessary adjustment to the 
protocol after study 
enrollment begins 
Maintenance 
Sustainability 
of program is 
over time 
• Sustainability of reach, efficacy and adoption 
as measured by stability over measures over 
study period 
• Above sources reviewed 
over time 
The study measures for each of the 5 metrics will be compared by provider. Exploratory analyses will 
be used to determine if metrics are different by provider age, gender, years in clinical practice, and if 
timing of use (e.g. day vs night, week vs weekend) impacts implementation. 
 
Aim 3: All qualitative data will be analyzed using standard qualitative methodologies. Specifically, data 
will be analyzed using content analysis, in an iterative, multi-step process.39,40 We  will review 
transcripts for key concepts used to develop a codebook, which will be used to code the data using 
software (NVivo) and to develop descriptive categories. Descriptive categories will be compared to 
the technology acceptance model as a framework for interpretation and used to qualitatively 
understand clinical adoption as measured in Aim 2 
 
Aim 4 & 5:  Through activity-based costing and time-tracking, we will estimate the costs of all observed 
activities. This micro-costing data will be used to estimate the average cost and effort of wireless 
monitoring a postpartum woman for 24 hours. Cost data will be estimated using Uganda Ministry of 
Health cost data where possible and other research cost inputs if necessary. Using the estimates of 
cost, we will combine this with outcome data from Aim 1 to estimate the cost-effectiveness of wireless 
monitoring for reducing SMO in postpartum women.  
 
Aim 6: From the QUIC scale  two scores are calculated: 1) the  Informed Consent Aggregate Score 
(ICAS) and 2) the Therapeutic Misconception Aggregate Score (TMAS). ICAS assesses the quality of 
consent, ranging from 0-10 (10 is a perfect score)  and TMAS assesses the presence of a therapeutic 
misconception (TMAS), ranging from 0-5 (5 is a perfect score). The ICAS and TMAS scores will be 
calculated and the means and standard deviations summarized for all participants. We will also 
summarize individual questions to understand the quality of specific elements of informed consent 
process. We will compare ICAS and TMAS between women in different stages of labor using one-way 
ANOVA, and with different pain scores using Spearman correlation and linear regression.  Multiple  

NCT ID: 2019P000885 
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linear regression will be used to assess the independent association of covariates of interest  
(demographics, stage of labor, pain score, anxiety, obstetric history and trust) with ICAS and  
TMAS scores.  
 
Aim 7: Using the motion metric on the wireless device we will summarize mobility in the first 24 hours 
after their cesarean both as a continuous variable ,and categorizing women into those with low and 
high mobility.  We will summarize the functional status of women in the post discharge period 
according to the five dimensions measured by the mobility survey : (ability to move independently, 
ability to selfcare, ability to perform usual activities, level of energy, and overall health, as well as a 
compositive variable with scores of 1-4.  1 being poorest functional status and 4 being better functional 
status) We will describe functionality at the different time points after discharge using frequency and 
percent. We will compare return to functionality at the different time points by mobility category in 
the first 24 hours using regression modelling. We will also describe the rates of impoverishing and 
catastrophic expenditure after surgery.  Summary statistics will be calculated for all expense types. We 
will compare impoverishing and catastrophic expenditure rates between women with different 
functional status and early mobility.   
 
Sample Size:  
On average approximately 8-10 emergency cesarean deliveries are performed at MRRH daily. Thus, in a 
two week block we estimate ~ 112 emergency cesareans performed. We plan to capture all women 
delivered by emergency cesarean during an intervention block thus minimizing the risk of selection 
bias based on the severity level. Assuming 85% of women consent to participation (conservative 
estimate based on >90% recruitment in prior studies)5,74,75, this yields an estimated 95 women per 
block. Over 12 months of enrollment, we will therefore have 13 intervention blocks and 13 control 
blocks. This yields an estimated 1,235 women in the intervention group and 1,235 in the control group. 
Assuming an intraclass correlation coefficient of 0.01, the effective sample size after taking account 
of clustering is 633 per group. This will allow us to detect a difference of 5.7% in the SMO rate between 
the two study arms, with a two-sided significance level of 0.05, and 80% power, assuming a baseline 
rate of SMO of 13% 71,73  
 
 
Risk/Discomforts and protections 
Clinicians: 
• 
Risk of false alerts, alert fatigue: Clinicians will be asked to hold a mobile phone and respond to 
alerts. It is possible that alerts of physiologic sign abnormalities may not correspond to a 
developing or established clinical abnormality and in responding to the alert clinicians may 
become fatigued from alerts. Study investigators will monitor for this occurrence and the impact 
on clinician performance and duties and adjust study protocols as necessary 
• 
Risk of diversion and interruptions to work on other patients: Alerts sent to clinicians may also 
prompt them to perform additional exams or clinical procedures that may or may not be 
beneficial to the patients from which alerts were received. This may divert attention or human 
resource away from other clinical needs. We will monitor for any diversions resulting in 
substandard clinical care. If these occur we will consider protocol modifications.  Any safety 
concerns or adverse events arising because of false alerts or diversions will be communicated to 
the IRB within 10 days. 
 
 
 
Peritpartum women: 
• 
Theoretical risk of exposure to radio emissions from Wi-Fi from the biosensor: There is a 
theoretical risk of exposure to Wi-Fi signals from the biosensor worn by women participating in 

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the study. The FDA has indicated the majority of studies dealing with radio emissions from 
devices, such as mobile phones, have failed to show an association between exposure to 
radiofrequency from a cell phone and health problem. Regulatory bodies in both the United 
States and Canada have set Specific Absorption Rates (SAR) of <1.6 watts per kilogram, for radio 
emitting devices such as Bluetooth devices and cell phones sold in the United States. The SAR 
indicates the rate at which energy is absorbed when exposed to radio frequency. Mobile phones 
in the United States transmit in the range of 0.25 watts per kilogram when used near the ear. 
Bluetooth devices transmit a SAR of 0.001 watts per kilogram. Based on this data, 
Radiofrequency emissions from the biosensor are significantly lower than cell phone 
transmissions (Federal Communications Commission, "OET Bulletin 56: Questions and Answers 
about Biological Effects and Potential Hazards of Radiofrequency Electromagnetic Fields," 
www.fcc.gov, Aug. 1999). Moreover the biosensor and monitoring system to be used in this 
research protocol has been tested MRRH and approved for general use by the FDA 
 
• 
Mild discomfort/skin irritation from wearing the device: The biosensor to be used is attached to 
the sternum using standard adhesives for electrode applications which have been approved and 
are in routine clinical use. In preliminary work women reported high acceptability related to the 
comfort of the device18,31; however, this study will require women to wear a different device and 
for a longer period of time and during a phase were breastfeeding is likely to occur. To minimize 
this risk, potential participants with known allergies or hypersensitivity to device materials will 
be excluded from the study. In addition, we will actively monitor for safety concerns (e.g. skin 
irritation, physical discomfort, disruptions to breastfeeding, and emotional concern with the 
monitoring) throughout the above described procedures through observation of the 
participants. We will review all reports of safety concerns within 24 hours and communicate any 
adverse events to the IRB within 10 days. The study team will also facilitate referral for any 
necessary medical care. If any adverse events are deemed related to the biosensor device, the 
study will be stopped until the safety issue is resolved.   
• 
Risk of additional clinical interventions or exams that may or may not be beneficial: Alerts of 
abnormal physiologic signs may prompt doctors to perform additional exams and clinical 
interventions. If abnormalities in physiologic signs do not correspond to developing or 
established clinical abnormalities this may mean additional procedures are performed without 
benefit. We will monitor for any substandard clinical care to participants, or participant distress 
caused by this and modify study protocols as necessary. 
• 
Less than 24 hours between recruitment and consent: As noted above peripartum woman will be 
approached for recruitment into the study once admitted to the unit for delivery to allow 
monitoring to begin immediately after delivery. Due to this timeline, there will be less than 24 
hours between initial approach and consent. Particularly given the high intensity time around 
childbirth, this exposes the women to some vulnerability in decision-making. The RA recruiting 
and seeking consent will be carefully trained to fully explain the risks and benefits and to ensure 
women understand that they will still receive current standard of care at the hospital should 
they decline to participate. Women indicating interest in participating will be approached again 
once the decision has been made for an emergency cesarean delivery. Due to potential 
unpredictable changes in clinical course and the development of complications that may render 
a woman unable to provide consent for herself, we have limited enrolment to those women who 
can either consent for themselves or who have a guardian available to consent for themselves. 
Consent via a guardian is included as monitoring critically ill women who may be unable to 
provide their own consent is paramount to ultimately affecting clinical outcomes  
 
Both clinicians and peripartum women: 
• 
Stress and anxiety related to study procedures: Post-graduate doctors may experience some 
stress and anxiety due to the requirement to hold the responder phone particularly given they 

NCT ID: 2019P000885 
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14 
will have other clinical responsibilities at the same time e.g. performing other procedures and 
evaluating other patients. Study investigators will actively monitor for impact on clinicians. We 
will review all reports of safety concerns within 24 hours and communicate any adverse events 
to the IRB within 10 days. 2)Any woman undergoing childbirth can have high levels of physical 
and emotional stress. Research participation during process may increase this stress and anxiety. 
During recruitment of both doctors and women it will be emphasized that participation is 
voluntary, and they are free to decline to participate or drop out at any point without 
repercussion. 
• 
Risk of fatigue from interviewing: In depth interviews will be designed to take less than one 
hour. However, this time frame may induce fatigue in participants. We will ensure interviews last 
no more than one hour, and the qualitative RA is trained to take regular breaks as needed. 
Participants will be informed in advance that they can take a break or stop at any time. As there 
are two types of qualitative interviews, we will ensure that no one participant has to participate 
in more than one interview.  
• 
Loss of privacy and confidentiality: Participants in all studies are subject to loss of privacy and 
confidentiality. In particular, physiologic sign data from postpartum women will be transferred 
to a central CPU or tablet for display and review by clinicians and abnormalities in physiologic 
signs sent a responder phone. In addition, medical information extracted from charts could be 
subject to loss of privacy. To ensure confidentiality all data will be maintained on password-
protected, encrypted computers (if electronic) and/or locked cabinet (if hardcopy). All interviews 
will be held in a private location at a time convenient to the interviewee. All data, other than 
physiologic sign data for clinician review, will be coded by subject number. All RAs and 
interviewers will receive training on procedures for maintaining privacy.  
 
 
Potential Benefits 
 
Doctors will benefit from having easier and more timely access to physiologic data, reducing their 
work burden and improving their ability to more fully care for their patients. Postpartum women will 
have the direct benefit of increased physiologic monitoring. In some cases, this can be life-saving as 
developing complications may be averted from earlier intervention. In addition, I anticipate that 
wireless maternal monitoring will ultimately help reduce rates of maternal and newborn morbidity 
and mortality, particularly in resource-limited settings. The results of the proposed study will help 
establish the preliminary efficacy of this strategy for monitoring and how to improve implementation.  
Furthermore, understanding mobility in the postpartum period and the financial risks associated with 
childbirth and its recovery, may help us reduce these risks and improve recovery from cesarean 
deliveries. Both type of participants may feel good about contributing to research in this area. 
 
Monitoring and Quality Assurance 
 
Prior to conducting the study, the research assistants will receive training on how to use the data 
collection tool, as well as standard clinical research ethics (i.e., the online CITI course available 
through Massachusetts General Hospital [MGH]).    
A member of the study staff will verify completion of data as entered into the chart review forms prior 
to data analysis. Missing or inconsistent data that can be verified with the participant’s chart or 
interviewed clinician prior to discharge will be entered retrospectively. Data that cannot be verified 
with the participant or their chart will not be included in data analysis.  All quality control measures will 
be performed on a weekly basis and as needed.  
Qualitative data will be transcribed within 48 hours of data collection and then translated into English 
if need be.  

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The principal investigators shall provide oversight and review of study protocols throughout the study.  
Quality checks will be performed on a weekly basis by the principal and co-investigators to ensure 
accurate data collection. 
 
The principal investigators will review all potential instances of privacy violations or other concerns 
within 24 hours and communicate any adverse events to the MUST and MGH IRBs within 10 days.  
 
A Data and Safety Monitoring Board (DSMB) will be convened.  
  
Our chosen DSMB will include the following 
1. Dr. Josephat Byamugisha – Former Chair Dept of OB/GYN Makerere University  
2. Dr. Sam Okello – Lecturer, Dept of Medicine, MUST  
3. Dr. Bethany Hedt-Gauthier – Associate Professor of Global Health and Social Medicine, 
Biostatisticia, Harvard Medical School 
 
The DSMB will meet 4 times during the anticipated 12-month study duration (prior to initiation, 
twice during the study, and at the end). Stopping rules will be discussed by the DSMB at the first 
meeting to establish criteria against which study progress and safety are measured at each further 
DSMB meeting. Specifically, we will ask the DSMB to review if there is a signal of higher rates of 
severe maternal outcome than expected to determine if these are related to the study intervention 
and then provide recommendations to study changes including but not limited to potential 
consideration of study termination. We will also ask their assistance in monitoring study 
implementation, including participant burden. 
 
Additionally, we will convene a community advisory board who will review the planned study prior 
to it beginning and provide a resource for advice and recommendation should unexpected 
challenges arise during study implementation. We will again meet with the community advisory 
board to help disseminate the findings of our research to the community.