The PartoMa Project: For Improving Monitoring, Action and Triage During Labour

NCT02318420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3087

Last updated 2019-09-27

No results posted yet for this study

Summary

OVERALL OBJECTIVE In an East African referral hospital, to develop and analyze the effect of locally agreed and achievable guidelines and a continual in-house training program for strengthening partogram-based monitoring-to-action during labour.

INTERVENTION Paper partograms (WHO), locally developed labour management guidelines (the PartoMa guidelines) and continual in-house education.

OVERALL DESIGN A quasi-experimental pre-post-study (The PartoMa study).

SETTING Department of Obstetrics and Gynaecology, Mnazi Mmoja Hospital, Zanzibar.

POPULATION Labouring women delivering at the study site from October 2014 to January 2016 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after unset of labour and followed until discharge.

ENDPOINTS The primary composite endpoint is stillbirths and birth asphyxia. For further description and secondary outcomes, please see below.

STUDY TIME Data collection from October 2014 to January 2016, supplemented by a post-exit collection of case file data from October 2016 - January 2017.

Conditions

  • Obstetric Labor Complications
  • Stillbirth
  • Maternal Death

Interventions

OTHER

The PartoMa intervention

WHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Free University Medical Center

    collaborator OTHER
  • Mnazi Mmoja Hospital

    collaborator UNKNOWN
  • Lundbeck Foundation

    collaborator OTHER
  • Laerdal Foundation

    collaborator OTHER
  • Ib Christian Bygbjerg

    lead OTHER

Principal Investigators

  • Ib C Bygbjerg, Professor · University of Copenhagen

  • Nanna Maaløe, MD · University of Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2016-03-01
Completion
2018-07-01

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 NCT02318420 on ClinicalTrials.gov