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NCT Number: NCT06273007

Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach

Overall Objective

To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.

Interventions

1. Locally agreed and achievable intrapartum guidelines 2. Low dose high frequency trainings (LDHF) 3. Partograph Overall Design

A quasi-experimental pre-post study (PartoMa study)

Setting

Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.

Population

Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.

Endpoints

The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.

Study Time

Data collection from June 2023 to May 2025.

Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.

iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.

iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.

Setting

PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haramaya Hospital, Harar, Oromiya, Ethiopia

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About this study

METHODS

The embedded study consists of four phases of activities:

I. Baseline assessment, II. Co-creation context specific intrapartum care guideline, III. Implementation of PartoMa seminars, and IV. Post intervention evaluation.

Phase I:

Baseline Assessment of Current Practice (the first three month) Using a mixed method design, detail baseline quality of care assessment will be conducted which include FHR monitoring practice, criterion-based audit of intrapartum management in cases of still births, compliance with obstetric guidelines and basic maternal and child health indicators, through interview of staff, review of records, and observations.

Phase II:

Co-creation of PartoMa guidelines to Ethiopia (month 3-6) Input from the baseline assessment, local birth attendants and stakeholders will be used to adapt the PartoMa guidelines from Tanzania to the hospital context. Together with local birth attendants (doctors and midwifes) evidence from inter(national) adapted to locally achievable guidelines. We will integrate PartoMa Ethiopia with MOYO device for monitoring FHR for improving the still births and supporting the decision-making process. The guideline will be peer reviewed by the international PartoMa team, national consultant obstetricians, and senior midwives.

Phase III:

Introduction of PartoMa Ethiopia in Haramaya Hospital (month 7-18) After completing co-creation of PartoMa Ethiopia guidelines, PartoMa seminars and FHR monitoring will be introduced in Haramaya Hospital. Once PartoMa Ethiopia seminar is introduced, monitoring and evaluation of the process will be conducted. Using the Kirkpatrick's model-which is ideal for evaluating impact of training at different level-will be used for evaluation purpose. Comprehensive data collection, including non-participatory observation of labor ward and interview of birth attendants and the women will be used for data collection (objective II and III). PartoMa seminars will be complemented with real case scenarios obtained from Ethiopian Obstetric Surveillance System (EthOSS) database. Different level of training outcomes will be evaluated following the different level of Following the Kirkpatrick's model, we will evaluate the training outcomes at level one (reaction), level two (learning), level three (behavior), and level four (results).

Phase IV:

Post implementation evaluation and sustainability (Month 19-24) Following implementation of PartoMa Ethiopia packages with MOYO FHR monitoring for 12 months, final data collection will be done following similar approach: the same measuring tools, data collection technique and outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women in labour delivering at the study site and their outcome, July - September 2023 and July -September 2025
  • All birth attendant at the study site in obstetrics and gynecology departments during the baseline and intervention period, July - September 2023 and July -September 2025

Exclusion criteria

  • NA

Treatment and study plan

PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings

Other

We will implement PartoMa interventions: seminars, LDHF training, and supportive supervision

Other names: LDHF trainings, Partograph

Primary outcomes

  1. stillbirth

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    Still birth= fetal death after 28 wk of gestation or weighing >/= 1000g (both with /without positive fetal heart rate on admission).

  2. Birth Asphyxia

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    newborns with a 5minute APGAR score <7

Secondary outcomes

  1. Maternal death

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    Deaths of women at the study site while pregnant or within 42 days postpartum, from any cause related to or aggravated by pregnancy or its management

  2. Cesarean sections and vacuum extractions

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    All woman who gave birth through Cesarian Sections and Vacuum extractions

  3. Process indicators of quality of intrapartum care

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    This includes partograph utilization, timely monitoring of ( fetal heart rate, labour progress, and maternal vital signs), and oxytocin use for labour augmentation. Management is compared to pre-selected audit criteria.Management will be compared to pre-selected audit criteria

  4. Birth attendant's perception of their work condition in the labour and delivery rooms

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    Participant observations and in-depth interviews

  5. The women's experience of care received during delivery.

    Time frame: A comparison of the baseline (July - September 2023) with 6th -9th month of the intervention

    By focus group discussion

Study contacts

Contact information is provided by the study sponsor or research team.

Abera Tura, PhD

CONTACT

[email protected]

+251912048026

Habtamu Bekele, MSc

CONTACT

[email protected]

+251917440496

Sponsors and collaborators

Lead sponsor

Haramaya Unversity

Other

Collaborators

  • Laerdal Foundation
  • Leiden University Medical Center
  • University of Copenhagen

Registry information

Official study title

Introducing PartoMa Approach to Ethiopia for Improving Intrapartum Care and Maternal Survival: The Case of the Ethiopian Obstetric Surveillance System (PartoMa-Ethiopia)

Acronym: PartoMa-Eth

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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