ePartogram Effectiveness Study in Kenya

NCT03757598 | Completed

• 1 other identifier: ePartogram Kenya
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 12

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.

Conditions

Obstetric Complication; Obstetric Labor Complications; Newborn Morbidity

Keywords

partograph, labor, birth, complications, newborn, Kenya

Outcome Measures

Primary Outcomes (1)

• 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)

  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 (4)

• Percent of partographs with a suboptimal maternal outcome

  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

  Six-month intervention period

• Action recorded by the provider to address any sign of non-normalcy in labor, among all partographs or partograms

  Six-month intervention period

• Fresh stillbirth and neonatal death <24 hours out of all births, according to aggregate monthly routine facility data

  Six-month intervention period and six-month pre-intervention period

Study Arms (2)

Paper Partograph

NO INTERVENTION

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

EXPERIMENTAL

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.

Other: ePartogram use

Interventions

ePartogram use 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.

ePartogram

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jhpiego: lead
• GE Healthcare: collaborator

Study Sites (12)

Ahero Hospital

Kisumu, Kenya

Location

Kisumu Hospital

Kisumu, Kenya

Location

Kombewa Health Center

Kisumu, Kenya

Location

Lumumba Health Center

Kisumu, Kenya

Location

Nyabondo Hospital

Kisumu, Kenya

Location

Nyakach Health Center

Kisumu, Kenya

Location

Maua Methodist Hospital

Meru, Kenya

Location

Meru Teaching and Referral Hospital

Meru, Kenya

Location

Mikinduri Health Center

Meru, Kenya

Location

Muthara Health Center

Meru, Kenya

Location

Mutuati Health Center

Meru, Kenya

Location

Nyambene Hospital

Meru, Kenya

Location

Related Publications (2)

• 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

  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.

  PMID: 29743032 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sanghvi Harshad, MD

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: November 29, 2018
• Study Start: August 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

KE (12)