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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510574
First Posted: January 16, 2012
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Liverpool
Liverpool School of Tropical Medicine
Makerere University
Mbale Regional Referral Hospital
Information provided by (Responsible Party):
Gynuity Health Projects
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510574


Locations
Uganda
Busiu Health Centre
Mbale, Uganda
Lwangoli Health Centre
Mbale, Uganda
Mbale Regional Referral Hospital
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

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01510574     History of Changes
Other Study ID Numbers: 3002
First Submitted: January 4, 2012
First Posted: January 16, 2012
Last Update Posted: March 13, 2013
Last Verified: March 2013

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics