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

NCT04685668 | Completed

• 1 other identifier: 18-08-KU
• Study Type: interventional
• Target: 65,181
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Stillbirths.

  Intrahospital stillbirths (\>=1000g, recorded positive FHR on admission) per 1000 total births. Data collection method: Prospective case file reviews. Data on stillbirths will be prospectively collected from baseline and until 12 months after the last facility receives the intervention, including stillbirths weighing at least 1000g with positive foetal heart rate on admission. The data will be will be gathered daily from hospital files, i.e. hospital registers and medical records, and cross-checked with the facilities' routinely kept birth registers.

  2 years

Secondary Outcomes (4)

• Newborn with low Apgar score.

  2 years.

• Cesarean deliveries.

  2 years.

• Vacuum-assisted deliveries.

  2 years.

• Costs and cost-effectiveness of intervention.

  2 years.

Study Arms (1)

Women in labour

EXPERIMENTAL

All women in labour during the study period 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. All children born with low Apgar score

Behavioral: The PartoMa guidelines and training

Interventions

The PartoMa guidelines and training BEHAVIORAL

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.

Women in labour

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All deliveries recorded at the five hospital sites during the entire study period.
• All women in labour delivering at the five study sites.
• All health care providers in delivery wards at the five study sites during the baseline and intervention period.
• For the different substudies, sub-groups are selected (please see the secondary outcomes for a description)
• (Please notice that all women and newborn children will be included in the the study, irrespectively of their health status)
• Exlusion Criteria:

Sponsors & Collaborators

• University of Copenhagen: lead
• Aga Khan University: collaborator
• Hvidovre University Hospital: collaborator
• VU University of Amsterdam: collaborator
• Comprehensive Community Based Rehabilitation in Tanzania: collaborator

Study Sites (1)

Mbagala Ragi Tatu Hospital

Dar es Salaam, Dar es Salaam Region, Tanzania

Location

Related Publications (4)

• Hansen S, Kujabi ML, Maimburg RD, Macha A, Maembe L, Kabanda I, Hudson M, Msumi RJ, Sangalala M, Housseine N, D'mello BS, Hussein K, Akker TVD, Meyrowitsch DW, Maaloe N. Disclosing possible nonmedically indicated cesarean sections in 5 high-volume urban maternity units in Tanzania: a criterion-based clinical audit. AJOG Glob Rep. 2024 Dec 21;5(1):100437. doi: 10.1016/j.xagr.2024.100437. eCollection 2025 Feb.

  PMID: 39898001 DERIVED

• Osaki H, Skovdal M, Sorensen JB, Maaloe N, Housseine N, Dmello BS, Mbekenga C. The Dilemmas and Opportunities of Co-Creating Health Interventions to Fit Local Contexts: An Ethnographic Study on the Adaptation of Clinical Guidelines in Tanzania. Health Expect. 2024 Oct;27(5):e70073. doi: 10.1111/hex.70073.

  PMID: 39445810 DERIVED

• Osaki H, Sorensen JB, Maaloe N, Mbekenga C, Skovdal M. "It is because the treatment of this lady is a cascade": Accumulation of delays and the occurrence of obstetric emergencies in an urban maternity unit in Tanzania. Midwifery. 2024 Mar;130:103926. doi: 10.1016/j.midw.2024.103926. Epub 2024 Jan 9.

  PMID: 38217929 DERIVED

• Maaloe N, Housseine N, Sorensen JB, Obel J, Sequeira DMello B, Kujabi ML, Osaki H, John TW, Khamis RS, Muniro ZSS, Nkungu DJ, Pinkowski Tersbol B, Konradsen F, Mookherji S, Mbekenga C, Meguid T, van Roosmalen J, Bygbjerg IC, van den Akker T, Jensen AK, Skovdal M, L Kidanto H, Wolf Meyrowitsch D. Scaling up context-tailored clinical guidelines and training to improve childbirth care in urban, low-resource maternity units in Tanzania: A protocol for a stepped-wedged cluster randomized trial with embedded qualitative and economic analyses (The PartoMa Scale-Up Study). Glob Health Action. 2022 Dec 31;15(1):2034135. doi: 10.1080/16549716.2022.2034135.

  PMID: 35410590 DERIVED

MeSH Terms

Conditions

Stillbirth

Condition Hierarchy (Ancestors)

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

Study Officials

• Dan W. Meyrowitsch, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist, PhD, Associate Professor, Head of research,

Model Details: Intervention implementation and evaluation The overall implementation design will be a pragmatic, stepped-wedge cluster-randomized trial in which each of the five maternity units (hospitals) will be randomized into three clusters (1+2+2 hospitals). Each cluster will receive the intervention at the cluster level. In a random order, the clusters will receive the intervention at three-month intervals. Informed by the logic model, the evaluation levels follow the Kirkpatrick model and include birth attendants' perceptions and reactions, changes in their learning and clinical care practices, and the resulting changes in birth outcomes.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: December 28, 2020
• Study Start: January 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)