The PartoMa Project: Enabling Best Post Possible Childbirth Care in Tanzania.

NCT04685668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65181

Last updated 2026-03-09

No results posted yet for this study

Summary

Introduction

Childbirth care remains suboptimal in many low-resource settings, causing unacceptable maternal and perinatal mortality and morbidity. Realistic, context-tailored clinical support is called for to assist birth attendants in providing best possible evidence-based and respectful care. The PartoMa pilot study from Zanzibar suggested that co-created clinical practice guidelines and low-dose, high-frequency training were associated with care improvements and perinatal survival. In the present study we will modify, implement and evaluate this intervention in five urban, high-volume maternity units in Tanzania.

Methods and Analysis

The study design is based on a theory of change, and includes three main steps: I. A mixed-methods situational analysis will explore factors affecting care. Step II. Based on step I., the PartoMa guidelines and training will be contextually modified through discussions with birth attendants and postpartum women. III. The modified intervention will be implemented through a stepped-wedge cluster trial, with embedded qualitative and economic analyses. Women in active labour and their offspring will be followed until discharge to assess intra-hospital stillbirths, intra-facility neonatal deaths and caesarean sections without medical indications, and the incremental cost-effectiveness ratio will be measured. Central intermediate outputs include health providers' knowledge, barriers and facilitators to intervention use, and clinical performance.

Conditions

  • Stillbirth
  • Delivery Complication
  • Delivery Delayed
  • Apgar; 4-7 at 1 Minute
  • Apgar; 0-3 at 1 Minute
  • Cesarean Section Complications

Interventions

BEHAVIORAL

The PartoMa guidelines and training

All health care providers (physicians and nurse-midwives) working at the Department of Obstetrics in five study sites during the study period will be invited to participate in knowledge tests of obstetric care and qualitative participant observations as well as in-depth interviews regarding quality of care. This is a part of evaluating the use and effectiveness of the PartoMa intervention. The intervention includes the following two components: 1. Implementation of a pocket booklet with simple and locally achievable clinical guidance for safe and respectful care at birth developed by the research team and birth attendants at the five hospital study sites; 2. Quarterly, the birth attendants will be offered training in the use of the booklet in 3-hour case-based seminars.

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER
  • Hvidovre University Hospital

    collaborator OTHER
  • VU University of Amsterdam

    collaborator OTHER
  • Comprehensive Community Based Rehabilitation in Tanzania

    collaborator UNKNOWN
  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Dan W. Meyrowitsch, PhD · University of Copenhagen

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Tanzania

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 NCT04685668 on ClinicalTrials.gov