CompletedNot Applicable

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

Tanzania3,087 participantsStarted 2014-10-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All women in labour delivering at the study site and their outcome, October 2014 - January 2015 and October 2015 - January 2016 * All health care providers at the department during the baseline and intervention period, October 2014 - January 2016 For the different substudies, sub-groups are selected (please see the secondary outcomes for a description).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite outcome of stillbirths and birth asphyxia

Timeframe: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).

Trial details

NCT IDNCT02318420

SponsorIb Christian Bygbjerg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03-01

View on ClinicalTrials.gov More Obstetric Labor Complications trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.