Obstetric ComplicationNCT03757598
ePartogram Effectiveness Study in Kenya
A study testing ePartogram use in people with Obstetric Complication and Obstetric Labor Complications, run by Jhpiego at 12 sites in Kenya.
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)… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Complication, Obstetric Labor Complications, Newborn Morbidity
- What is being tested?
- ePartogram use
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 12 sitesKenya
- Study dates
- 1 Aug 2016to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Kenya12 sites
Ahero Hospital
Kisumu
Kisumu Hospital
Kisumu
Kombewa Health Center
Kisumu
Lumumba Health Center
Kisumu
Nyabondo Hospital
Kisumu
Nyakach Health Center
Kisumu
Maua Methodist Hospital
Meru
Meru Teaching and Referral Hospital
Meru
Mikinduri Health Center
Meru
Muthara Health Center
Meru
Mutuati Health Center
Meru
Nyambene Hospital
Meru
About this study
Official title: 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.
Read the 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.
- Being tested
- ePartogram use
- Keywords
- partograph, labor, birth, complications, newborn, Kenya
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePartogram useOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ePartogram use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: 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
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
Measured: Six-month intervention period
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.
Measured: Six-month intervention period
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
Measured: Six-month intervention period and six-month pre-intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Aug 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Sanghvi Harshad, MD, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757598
- Sponsor's protocol ID
- ePartogram Kenya
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2017
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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
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.
PubMed 29743032
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ePartogram Effectiveness Study: A Mixed Methods Quasi-experimental Study in Kisumu and Meru, Kenya.
- ClinicalTrials.gov ID
- NCT03757598
- Acronym / sponsor ID
- ePartogram Kenya
- Keywords
- partograph, labor, birth, complications, newborn, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: ePartogram useePartogram 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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 not meeting the WHO definition of SBA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePartogram useElectronic 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. | Other | ePartogram |
Primary outcome
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)
4 secondary outcomes
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
Action recorded on partograph to maintain normal labor, among all partographs or partograms
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- BackgroundManaging 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: PubMed 29743032Litwin 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanghvi Harshad, MD principal investigator
Jhpiego
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePartogram use in people with Obstetric Complication and Obstetric Labor Complications, run by Jhpiego at 12 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757598, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.