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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2016 |
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Main ID: |
NCT01508429 |
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Date of registration:
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01/12/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births
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Scientific title:
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Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries. |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01508429 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Afghanistan
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Contacts
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Name:
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Jill Durocher |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Shafiq Mirzazada |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan Health Services |
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Name:
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Dina Abbas |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Gijs Walraven |
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Address:
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Telephone:
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Email:
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Affiliation:
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Secretariat of His Highness the Aga Khan, Aiglemont |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women must be pregnant
- Must be able to provide informed consent
- Must agree to have a community health worker present at the time of delivery
- Must agree to participate in a follow up interview by the study midwife
- Must agree to have pre and postpartum haemoglobin taken
Exclusion Criteria:
- Women who do not meet the inclusion criteria
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Hemorrhage (PPH)
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Intervention(s)
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Drug: Misoprostol
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Other: placebo
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Primary Outcome(s)
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Hb of greater than or equal to 2 g/dl from pre- to post-delivery
[Time Frame: 3-5 days after delivery]
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Secondary Outcome(s)
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additional interventions
[Time Frame: immediately after delivery; 3-5 days post delivery]
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Side effects
[Time Frame: immediately after delivery; 3-5 days post delivery]
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Acceptability
[Time Frame: immediately after delivery; 3-5 days post delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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