AzTrials
AzTrials

StillbirthPartoMa-EthNCT06273007

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

A study testing PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings in people with Stillbirth and Obstetric Complication, run by Haramaya Unversity at 2 sites in Ethiopia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Stillbirth, Obstetric Complication, Maternal Death
What is being tested?
PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
2 sitesEthiopia
Study dates
1 Jun 2023to 31 Dec 2027
Phase
Interventional

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 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • NA

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Abera Tura, PhD contact

+251912048026

daberaf@gmail.com

Habtamu Bekele, MSc contact

+251917440496

habti.bekele@gmail.com

Ethiopia2 sites, 2 recruiting
  • Haramaya Hospital

    Harar, Oromiya

    Roba Ararsa, MD

    Recruiting
  • Hiwot Fana University Hospital

    Harar

    Redwan Ahmed, MD

    Not yet recruiting

Other trials in Ethiopia

About this study

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

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.

Read more

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.

Read the detailed description

METHODS

The embedded study consists of four phases of activities:

  1. 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.

Being tested
PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
Keywords
Obstetrics, perinatal, maternal, Intrapartum, Quality, PartoMa, LDHF
Medical subject headings
Stillbirth, Maternal Death, Perinatal Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called LDHF trainings, Partograph

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

Study groups in NCT06273007
Study groupRoleWhat they receive
woman in laborExperimentalAll 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)
Receives: Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings
Birth attendantsExperimentalAll 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.
Receives: Other: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stillbirth

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

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

  2. Birth Asphyxia

    newborns with a 5minute APGAR score <7

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

Secondary outcomes (5)
  1. Maternal death

    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

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

  2. Cesarean sections and vacuum extractions

    All woman who gave birth through Cesarian Sections and Vacuum extractions

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

  3. Process indicators of quality of intrapartum care

    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

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

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

    Participant observations and in-depth interviews

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

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

    By focus group discussion

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06273007
Sponsor's protocol ID
EFP_2023_02_19
Acronym
PartoMa-Eth
Status last verified
Feb 2024
First submitted
15 Feb 2024
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bekele H, van den Akker T, Maaloe N, Girma S, Mohammed RA, Wale H, Ararso R, Jemal E, van Roosmalen J, Housseine N, Tura AK. Coadaptation and implementation of intrapartum clinical guidelines to save lives during childbirth: Protocol for an adapted PartoMa intervention in Eastern Ethiopia. BMC Health Serv Res. 2026 Feb 20;26(1):407. doi: 10.1186/s12913-026-14228-4.

    PubMed 41715069

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in