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

January 4, 2012
March 11, 2013
May 2012
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01510574 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Postpartum Hemorrhage
  • Drug: Misoprostol
    3 x 200mcg tablets of oral misoprostol
  • Drug: placebo
    3 x placebo tablets resembling misoprostol taken orally
  • Active Comparator: misoprostol
    3 tablets of 200mcg misoprostol self-administered following home birth, taken orally immediately after delivery of baby
    Intervention: Drug: Misoprostol
  • Placebo Comparator: placebo
    3 tablets of placebo resembling misoprostol self-administered following home birth, taken orally immediately after delivery of baby
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
749
October 2012
October 2012   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01510574
3002
Yes
Gynuity Health Projects
Gynuity Health Projects
  • University of Liverpool
  • Liverpool School of Tropical Medicine
  • Makerere University
  • Mbale Regional Referral Hospital
Principal Investigator: Andrew Weeks University of Liverpool
Gynuity Health Projects
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP