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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70408620
Enrollment
Unknown
Registered
2011-12-28
Start date
2012-01-01
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum hemorrhage (PPH) Pregnancy and Childbirth Postpartum haemorrhage

Interventions

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

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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.

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026