A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)
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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 |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
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
| Uganda | |
| Busiu Health Centre | |
| Mbale, Uganda | |
| Lwangoli Health Centre | |
| Mbale, Uganda | |
| Mbale Regional Referral Hospital | |
| Mbale, Uganda | |
| Siira Health Centre | |
| Mbale, Uganda | |
| 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 |