ePartogram Effectiveness Study in Kenya

Newborn Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757598
• Other study ID #: ePartogram Kenya
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: December 2019
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Newborn Morbidity
• Obstetric Complication
• Obstetric Labor Complications

Intervention

Other:
• 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.

Locations

Country	Name	City	State
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	Kisumu
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	Meru

Sponsors (2)

Lead Sponsor	Collaborator
Jhpiego	GE Healthcare

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	Six-month intervention period
Secondary	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.	Six-month intervention period
Secondary	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	Six-month intervention period and six-month pre-intervention period