Clinical trial NCT03757598: ePartogram Effectiveness Study in Kenya
Official title: ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Complication
Obstetric Labor Complications
Newborn Morbidity
Keywords: partograph, labor, birth, complications, newborn, Kenya
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2018-11-29
Enrollment: 113
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two study groups, each with 6 health facilities. All providers offering maternity care were trained in labor management practices and use of the partograph approved for national use in Kenya. In the intervention group only, providers were offered training and Android tablets to use the electronic partogram with clients. The 6-month intervention phase was simultaneous in both groups.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Quasi-experimental study to evaluate whether clinical care offered to clients was more appropriate and in line with WHO recommendations for care in normally progressing labor and in labor with complications, among providers using the novel intervention, ePartogram (an electronic version of the WHO paper partograph) vs. providers who offered care using the standard paper partograph, and whether fetal/newborn outcomes were improved among cases where partograph was used.

Detailed description: The ePartogram is an electronic version of the WHO Partograph and is developed by Jhpiego. Seventy-eight clinical rules, programmed into the ePartogram, are based on global guidelines in the WHO manual "Managing complications in pregnancy and childbirth: a guide for midwives and doctors" and the expert opinion of Jhpiego physicians and nurse-midwives. The rules underwent a validation process by 65 expert skilled birth attendants (SBAs) (working in maternity wards of health facilities) from a variety of geographic and clinical settings affiliated with Jhpiego. In the ePartogram application ("app") that is put on an Android tablet computer, the clinical rules trigger "reminders" to SBAs to take a routine clinical measurement, such as fetal heart rate (every 30 minutes) or maternal temperature (every 2 hours). The rules also trigger "low-level" alarms indicating a measurement that falls in the abnormal range that could be cause for concern (i.e. meconium-stained liquor), and "high-level" alarms that could indicate need for immediate action (i.e. maternal systolic blood pressure ≥160 mm Hg).

Litwin et al. reported on the feasibility and acceptability of use of an electronic partogram in Zanzibar and concluded that health workers felt the ePartogram improved timeliness of care and supported decision making. Health workers quickly became competent and confident in using the tablet device and ePartogram application. This study in Kenya has an objective to evaluate whether providers' use of the ePartogram improves labor outcomes and labor management in health facilities. The study design is a quasi-experimental design evaluation comparing data collected at 6 intervention sites and 6 comparison sites with similar facility characteristics and in two regions of Kenya.

Eligibility criteria: Inclusion Criteria:

Facilities:

* 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) 24 hours per day

Providers:

* Providers meeting the WHO definition of Skilled Birth Attendant (SBA) clinical provider working in care for laboring women who will be working at the facility during the study.
* 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
* Intervention sites only: Providers passing the ePartogram post-training test will be asked to use the ePartogram during clinical care.

Exclusion Criteria:

Facilities:

* 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

Providers:

* Providers not meeting the WHO definition of SBA
* Providers not completing the labor management training or (intervention sites only) not passing the ePartogram post-training test

Primary outcomes:
measure: Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
timeFrame: All partographs within the 6 month intervention period; the partograph is started in the active phase of labor - at 4 cm dilatation - and may last up to 12 hours
Secondary outcomes:
measure: Percent of partographs with a suboptimal maternal outcome
timeFrame: All partographs within the 6 month intervention period; the partograph is started in the active phase of labor - at 4 cm dilatation - and may last up to 12 hours
measure: Action recorded on partograph to maintain normal labor, among all partographs or partograms
timeFrame: Six-month intervention period
measure: Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms
timeFrame: Six-month intervention period
measure: Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data
timeFrame: Six-month intervention period and six-month pre-intervention period
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Ahero Hospital
city: Kisumu
country: Kenya
facility: Kisumu Hospital
city: Kisumu
country: Kenya
facility: Kombewa Health Center
city: Kisumu
country: Kenya
facility: Lumumba Health Center
city: Kisumu
country: Kenya
facility: Nyabondo Hospital
city: Kisumu
country: Kenya
facility: Nyakach Health Center
city: Meru
country: Kenya
facility: Maua Methodist Hospital
city: Meru
country: Kenya
facility: Meru Teaching and Referral Hospital
city: Meru
country: Kenya
facility: Mikinduri Health Center
city: Meru
country: Kenya
facility: Muthara Health Center
city: Meru
country: Kenya
facility: Mutuati Health Center
city: Meru
country: Kenya
facility: Nyambene Hospital
Study officials:
affiliation: Jhpiego
name: Sanghvi Harshad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Managing complications in pregnancy and childbirth: a guide for midwives and doctors - 2nd ed. Editors: World Health Organization Publication date: 2017 Languages: English ISBN: 9789241565493
citation: Litwin LE, Maly C, Khamis AR, Hiner C, Zoungrana J, Mohamed K, Drake M, Machaku M, Njozi M, Muhsin SA, Kulindwa YK, Gomez PP. Use of an electronic Partograph: feasibility and acceptability study in Zanzibar, Tanzania. BMC Pregnancy Childbirth. 2018 May 9;18(1):147. doi: 10.1186/s12884-018-1760-y.