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ePartogram Effectiveness Study in Kenya

NCT ID: NCT03757598

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-05-30

Brief Summary

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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

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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.

Conditions

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Obstetric Complication Obstetric Labor Complications Newborn Morbidity

Keywords

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partograph, labor, birth, complications, newborn, Kenya

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

ePartogram use

Intervention Type OTHER

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.

Interventions

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ePartogram use

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Jhpiego

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanghvi Harshad, MD

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

Locations

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Ahero Hospital

Kisumu, , Kenya

Site Status

Kisumu Hospital

Kisumu, , Kenya

Site Status

Kombewa Health Center

Kisumu, , Kenya

Site Status

Lumumba Health Center

Kisumu, , Kenya

Site Status

Nyabondo Hospital

Kisumu, , Kenya

Site Status

Nyakach Health Center

Kisumu, , Kenya

Site Status

Maua Methodist Hospital

Meru, , Kenya

Site Status

Meru Teaching and Referral Hospital

Meru, , Kenya

Site Status

Mikinduri Health Center

Meru, , Kenya

Site Status

Muthara Health Center

Meru, , Kenya

Site Status

Mutuati Health Center

Meru, , Kenya

Site Status

Nyambene Hospital

Meru, , Kenya

Site Status

Countries

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Kenya

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29743032 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ePartogram Kenya

Identifier Type: -

Identifier Source: org_study_id