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

This study has been completed.
Sponsor:
Collaborators:
University of Liverpool
Liverpool School of Tropical Medicine
Makerere University
Mbale Regional Referral Hospital
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01510574
First received: January 4, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Postpartum Hemorrhage
Drug: Misoprostol
Drug: placebo

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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Change in hemoglobin [ Time Frame: Measured during third trimester and 3-5 days postpartum ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety [ Time Frame: Assessed 3-5 days postpartum ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 749
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: misoprostol
3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby
Drug: Misoprostol
3 x 200mcg tablets of oral misoprostol
Placebo Comparator: placebo
3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby
Drug: placebo
3 x placebo tablets resembling misoprostol taken orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510574

Locations
Uganda
Mbale Regional Referral Hospital
Mbale, Uganda
Lwangoli Health Centre
Mbale, Uganda
Busiu Health Centre
Mbale, Uganda
Siira Health Centre
Mbale, Uganda
Sponsors and Collaborators
Gynuity Health Projects
University of Liverpool
Liverpool School of Tropical Medicine
Makerere University
Mbale Regional Referral Hospital
Investigators
Principal Investigator: Andrew Weeks University of Liverpool
  More Information

No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01510574     History of Changes
Other Study ID Numbers: 3002
Study First Received: January 4, 2012
Last Updated: March 11, 2013
Health Authority: Uganda: Mbale Regional Hospital Institution Review Committee
United Kingdom: University of Liverpool
Uganda: Uganda National Council for Science and Technology

Keywords provided by Gynuity Health Projects:
postpartum hemorrhage, PPH, misoprostol

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014