Trial | NCT01510574  Report issue

Title

A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    misoprostol ...

  • Study Participants

    749
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.

The investigators 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.
Study Started
May 31
2012
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Mar 13
2013
Estimate

Drug Misoprostol

3 x 200mcg tablets of oral misoprostol

Drug placebo

3 x placebo tablets resembling misoprostol taken orally

misoprostol Active Comparator

3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby

placebo Placebo Comparator

3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby

Criteria 

Inclusion Criteria:

pregnant women living in the recruitment villages of Mbale district at >34 weeks gestation

Exclusion Criteria:

Any woman with a known allergy to misoprostol or other prostaglandins will be excluded as will any woman under 18 years old (unless she is an emancipated minor)
No Results Posted