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ePartogram Effectiveness Study in Kenya

Primary Purpose

Obstetric Complication, Obstetric Labor Complications, Newborn Morbidity

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
ePartogram use
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstetric Complication focused on measuring partograph, labor, birth, complications, newborn, Kenya

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Paper Partograph

ePartogram

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
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)

Secondary Outcome Measures

Percent of partographs with a suboptimal maternal outcome
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
Action recorded on partograph to maintain normal labor, among all partographs or partograms
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
Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms
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.
Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data
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

Full Information

First Posted
November 28, 2017
Last Updated
December 10, 2019
Sponsor
Jhpiego
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03757598
Brief Title
ePartogram Effectiveness Study in Kenya
Official Title
ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jhpiego
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Complication, Obstetric Labor Complications, Newborn Morbidity
Keywords
partograph, labor, birth, complications, newborn, Kenya

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paper Partograph
Arm Type
No Intervention
Arm Description
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.
Arm Title
ePartogram
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ePartogram use
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of partographs showing fetal/newborn with a suboptimal fetal/newborn outcome
Description
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)
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
Secondary Outcome Measure Information:
Title
Percent of partographs with a suboptimal maternal outcome
Description
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
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
Title
Action recorded on partograph to maintain normal labor, among all partographs or partograms
Description
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
Time Frame
Six-month intervention period
Title
Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms
Description
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.
Time Frame
Six-month intervention period
Title
Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data
Description
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
Time Frame
Six-month intervention period and six-month pre-intervention period

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanghvi Harshad, MD
Organizational Affiliation
Jhpiego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahero Hospital
City
Kisumu
Country
Kenya
Facility Name
Kisumu Hospital
City
Kisumu
Country
Kenya
Facility Name
Kombewa Health Center
City
Kisumu
Country
Kenya
Facility Name
Lumumba Health Center
City
Kisumu
Country
Kenya
Facility Name
Nyabondo Hospital
City
Kisumu
Country
Kenya
Facility Name
Nyakach Health Center
City
Kisumu
Country
Kenya
Facility Name
Maua Methodist Hospital
City
Meru
Country
Kenya
Facility Name
Meru Teaching and Referral Hospital
City
Meru
Country
Kenya
Facility Name
Mikinduri Health Center
City
Meru
Country
Kenya
Facility Name
Muthara Health Center
City
Meru
Country
Kenya
Facility Name
Mutuati Health Center
City
Meru
Country
Kenya
Facility Name
Nyambene Hospital
City
Meru
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.
Citations:
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
Results Reference
background
PubMed Identifier
29743032
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.
Results Reference
background

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ePartogram Effectiveness Study in Kenya

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