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

NCT06273007 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-02-22

No results posted yet for this study

Summary

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.

Conditions

  • Stillbirth
  • Obstetric Complication
  • Maternal Death
  • Perinatal Death
  • Perinatal Morbidity

Interventions

OTHER

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

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Leiden University Medical Center

    collaborator OTHER
  • Laerdal Foundation

    collaborator OTHER
  • Haramaya Unversity

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273007 on ClinicalTrials.gov