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

Postpartum Hemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510574
• Other study ID #: 3002
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: March 11, 2013
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Mbale Regional Hospital Institution Review CommitteeUnited Kingdom: University of LiverpoolUganda: Uganda National Council for Science and Technology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
3 x 200mcg tablets of oral misoprostol
• placebo
3 x placebo tablets resembling misoprostol taken orally

Locations

Country	Name	City	State
Uganda	Busiu Health Centre	Mbale
Uganda	Lwangoli Health Centre	Mbale
Uganda	Mbale Regional Referral Hospital	Mbale
Uganda	Siira Health Centre	Mbale

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Liverpool School of Tropical Medicine, Makerere University, Mbale Regional Referral Hospital, University of Liverpool

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin	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	Measured during third trimester and 3-5 days postpartum	No
Secondary	Safety	To assess the safety of ante-natal distribution of misoprostol and its use by women at the time of their home birth, data will be collected on the number of women who report experiencing side effects (including shivering and fever), number of women who are transferred to higher level care, number of women who undergo surgical interventions, number of women who are given blood transfusions, number of maternal deaths, and number of neonatal deaths.; The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.	Assessed 3-5 days postpartum	Yes