NCT02318420: PartoMa

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

Completed NA Last updated 27 September 2019

What this trial tests

NA trial testing The PartoMa intervention in Obstetric Labor Complications in 3,087 participants. Completed in 1 July 2018.

Timeline

1 October 2014

Primary endpoint
1 March 2016

1 July 2018

Quick facts

Lead sponsor	Ib Christian Bygbjerg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3,087
Start date	1 October 2014
Primary completion	1 March 2016
Estimated completion	1 July 2018
Sites	1 location across Tanzania

Drugs / interventions tested

• The PartoMa intervention

Conditions studied

• Obstetric Labor Complications — all drugs for Obstetric Labor Complications →
• Stillbirth — all drugs for Stillbirth →
• Maternal Death — all drugs for Maternal Death →

Sponsor

Ib Christian Bygbjerg

Who can join

Eligibility, any sex, with Obstetric Labor Complications or Stillbirth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stillbirths and quality of care during labour at the low resource referral hospital of Zanzibar: a case-control study.
   Maaløe N, Housseine N, Bygbjerg IC, Meguid T, et al · · 2016 · cited 47× · PMID 27832753 · DOI 10.1186/s12884-016-1142-2
2. Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions.
   Maaløe N, Housseine N, van Roosmalen J, Bygbjerg IC, et al · · 2017 · cited 21× · PMID 28592237 · DOI 10.1186/s12884-017-1360-2
3. Local adaption of intrapartum clinical guidelines, United Republic of Tanzania.
   Maaløe N, Meguid T, Housseine N, Tersbøl BP, et al · · 2019 · cited 20× · PMID 31551633 · DOI 10.2471/blt.18.220830
4. Effect of locally tailored clinical guidelines on intrapartum management of severe hypertensive disorders at Zanzibar's tertiary hospital (the PartoMa study).
   Maaløe N, Andersen CB, Housseine N, Meguid T, et al · · 2019 · cited 12× · PMID 30307609 · DOI 10.1002/ijgo.12692