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

NCT01510574 | Completed DMC

• 1 other identifier: 3002
• Study Type: interventional
• Target: 749
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage, PPH, misoprostol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety

  Assessed 3-5 days postpartum

Study Arms (2)

misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Misoprostol DRUG

3 x 200mcg tablets of oral misoprostol

misoprostol

placebo DRUG

3 x placebo tablets resembling misoprostol taken orally

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gynuity Health Projects: lead
• University of Liverpool: collaborator
• Liverpool School of Tropical Medicine: collaborator
• Makerere University: collaborator
• Mbale Regional Referral Hospital: collaborator

Study Sites (4)

Busiu Health Centre

Mbale, Mbale, Uganda

Location

Lwangoli Health Centre

Mbale, Mbale, Uganda

Location

Mbale Regional Referral Hospital

Mbale, Mbale, Uganda

Location

Siira Health Centre

Mbale, Mbale, Uganda

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Andrew Weeks

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 16, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

UG (4)