ePartogram Effectiveness Study in Kenya

December 10, 2019 updated by: Jhpiego

ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kisumu, Kenya
        • Ahero Hospital
      • Kisumu, Kenya
        • Kisumu Hospital
      • Kisumu, Kenya
        • Kombewa Health Center
      • Kisumu, Kenya
        • Lumumba Health Center
      • Kisumu, Kenya
        • Nyabondo Hospital
      • Kisumu, Kenya
        • Nyakach Health Center
      • Meru, Kenya
        • Maua Methodist Hospital
      • Meru, Kenya
        • Meru Teaching and Referral Hospital
      • Meru, Kenya
        • Mikinduri Health Center
      • Meru, Kenya
        • Muthara Health Center
      • Meru, Kenya
        • Mutuati Health Center
      • Meru, Kenya
        • Nyambene Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Paper Partograph
The comparison group used the standard WHO Standard Paper Partograph approved in Kenya to monitor labor. Copies of the partograph were made available to the facilities.
Experimental: ePartogram
ePartogram use by skilled birth attendant providers in health facilities. The intervention arm used the novel ePartogram or electronic partogram. The interface was of the same WHO approved partograph on an Android tablet. There were reminders to spur provider actions and alerts that were programmed in an algorithm.
Electronic partograph based on WHO standard paper partograph is given in Android tablet used by provider monitoring clients in labor. Providers had received training in using the ePartogram and ongoing trouble shooting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
Time Frame: 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
Percent of partographs with a suboptimal fetal/newborn outcome (defined by presence of fresh stillbirth, newborn Apgar score of 5 or below at 1 minute, or Apgar score of 7 or below at 5 minutes or newborn resuscitation needed -- as recorded on the partograph by the health provider)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of partographs with a suboptimal maternal outcome
Time Frame: 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
Percent of partographs with a suboptimal maternal outcome (defined by presence of retained placenta, blood loss at greater to or equal to 500 ml, systolic blood pressure of less than 90 or greater than 140, diastolic blood pressure of less than 60 or more than 90, and pulse at less than 60 or greater than or equal to 100), as recorded by the provider on the partograph
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
Action recorded on partograph to maintain normal labor, among all partographs or partograms
Time Frame: Six-month intervention period
To support the objective of supporting decision-making and actions to maintain normal labor, there were additional items added to both the paper partograph and the electronic partogram that providers answered by ticking off actions to maintain normal labor. These 5 actions were: encouraging ambulation, giving food, giving fluids, offering the position of choice, encouraging a companion to be present. This indicator refers to any of these actions, and among all partographs or partograms
Six-month intervention period
Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms
Time Frame: Six-month intervention period
To support the objective of: Detection, decision-making and action to address deviations from normal labor and complications arising during labor. Seven actions included: providing oxygen, changing the position of the laboring woman in response to FHR abnormalities, checking for bleeding, consulting with a supervisor, and referring a client to another facility, inducing labor during the first stage, and conducting an episiotomy. The indicator is any action taken.
Six-month intervention period
Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data
Time Frame: Six-month intervention period and six-month pre-intervention period
Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data recorded on facility registers by providers and aggregated by facility records staff
Six-month intervention period and six-month pre-intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Sanghvi Harshad, MD, Jhpiego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ePartogram Kenya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

There is no plan to share study data. An investigator can contact harshad.sanghvi@jhpiego.org with a request. Jhpiego is developing an open data sharing process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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