A study of self-administered Misoprostol to prevent bleeding after childbirth in the community (MamaMiso)

ISRCTN	ISRCTN70408620
DOI	https://doi.org/10.1186/ISRCTN70408620
Protocol serial number	v5.6 10/07/2011
Sponsor	University of Liverpool (UK)
Funder	Bill and Melinda Gates Foundation

Submission date: 17/11/2011
Registration date: 28/12/2011
Last edited: 19/06/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Heavy bleeding after childbirth, known as postpartum haemorrhage (PPH), is a major cause of maternal death in the developing world. PPH can be prevented using uterotonic drugs, which cause the uterus (womb) to contract. Misoprostol can be used to prevent PPH as it is affordable, has a long shelf-life, and can be taken by mouth (orally). Currently misoprostol is mostly used in healthcare facilities and self-administration at home is not promoted. The aim of this study is to assess the effectiveness and safety of misoprostol tablets taken immediately after home delivery for the prevention of PPH.

Who can participate?
Pregnant women (more than 34 weeks gestation) living in the participating villages of Mbale district of Eastern Uganda.

What does the study involve?
Participants are randomly allocated to be given either a trial pack of misoprostol or placebo (dummy) tablets to be self-administered orally after delivery. Participants are trained on how to take the pills following delivery and a picture guide will also be included with the pills.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Liverpool Women's Hospital (UK).

When is the study starting and how long is it expected to run for?
January 2012 to January 2015.

Who is funding the study?
Bill and Melinda Gates Foundation (USA).

Who is the main contact?
Prof. Andrew Weeks
aweeks@liv.ac.uk

Contact information

Prof Andrew Weeks
Scientific

International Maternal Health
Sanyu Research Unit
Department of Women's and Children's Health
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 706 4101
Email	aweeks@liv.ac.uk

Study information

Primary study design	Interventional
Study design	Placebo-controlled randomized trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study of self-administered Misoprostol to prevent bleeding after childbirth in the community (MamaMiso)
Study objectives	Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally. We envisage that the use of self-administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot). The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.
Ethics approval(s)	1. Mbale Regional Hospital Institutional Research Committee (MRHIRC), 25/03/2011, ref: REIRC 010/2011 2. University of Liverpool (UK), 05/08/2011, ref: UoL000694 3. Uganda National Council for Science and Technology (UNCST), 07/10/2011, ref: HS 1059
Health condition(s) or problem(s) studied	Postpartum hemorrhage (PPH)
Intervention	Once the pregnant women are seen in antenatal clinic and give informed consent to participate in the trial, they will be given either trial pack of misoprostol (600mcg) or identical placebo to be self-administered orally after delivery. She will be trained to take the pills following delivery using adapted teaching tools used successfully in Nepal and Afghanistan. A picture guide on how to take the medication will also be included with the mediation in the study neck purse.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth
Key secondary outcome measure(s)	1. The rate of poor maternal and fetal health at 3-5 days after delivery 2. Side effects, and safety (to include transfer to hospital, surgical intervention, blood transfusion and maternal death) The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.
Completion date	01/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	1. Pregnant women living in the recruitment villages of Mbale district at more than 34 weeks gestation 2. High risk women will not be excluded from the pilot study, even if they state their intention to deliver in a health facility
Key exclusion criteria	1. Any pregnant woman with a known allergy to misoprostol or other prostaglandins 2. Any woman under 18 years old (unless she is an emancipated minor)
Date of first enrolment	01/01/2012
Date of final enrolment	01/01/2015

Locations

Countries of recruitment

United Kingdom
England
Uganda

Study participating centre

Liverpool Women's Hospital

Liverpool
L8 7SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/09/2015		Yes	No
Results article	results	26/10/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/06/2018: Publication reference added.