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

NCT06273007 | Recruiting

• 1 other identifier: EFP_2023_02_19
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Conditions

Stillbirth; Obstetric Complication; Maternal Death; Perinatal Death; Perinatal Morbidity

Keywords

Obstetrics; perinatal; maternal; Intrapartum; Quality; PartoMa; LDHF

Outcome Measures

Primary Outcomes (2)

• stillbirth

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

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

• Birth Asphyxia

  newborns with a 5minute APGAR score \<7

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

Secondary Outcomes (5)

• Maternal death

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

• Cesarean sections and vacuum extractions

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

• Process indicators of quality of intrapartum care

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

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

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

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

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

Study Arms (2)

woman in labor

EXPERIMENTAL

All women in labour during the study period (3 months baseline and the 3rd-6th month of the intervention) will be included for this pre- vs post-study of the PartoMa intervention. The following subgroups will be studied in-depth: 1. All stillbirths 2. 5th Minute APGAR score \<7 3. All maternal deaths 4. All women with severe obstetric complication (postpartum hemorrhage, hypertensive disorders of pregnancy, uterine rupture, obstructed labor)

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

Birth attendants

EXPERIMENTAL

All health care providers (physicians and midwives) working at the department of obstetrics during the study period will be invited to participate in knowledge tests of obstetric care and qualitative study. participant observations as well as in-depth interviews regarding quality of intrapartum care. This is a part of evaluating the use and effectiveness of the PartoMa intervention.

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

Interventions

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

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

Also known as: LDHF trainings, Partograph

Birth attendants; woman in labor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Haramaya Unversity: lead
• University of Copenhagen: collaborator
• Leiden University Medical Center: collaborator
• Laerdal Foundation: collaborator

Study Sites (2)

Haramaya Hospital

Harar, Oromiya, Ethiopia

RECRUITING

Hiwot Fana University Hospital

Harar, Ethiopia

NOT YET RECRUITING

MeSH Terms

Conditions

Stillbirth; Maternal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parental Death

Central Study Contacts

Abera Tura, PhD

CONTACT

+251912048026; daberaf@gmail.com

Habtamu Bekele, MSc

CONTACT

+251917440496; habti.bekele@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ET (2)