Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
1 other identifier
interventional
400
1 country
1
Brief Summary
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 26, 2015
March 1, 2015
7 months
May 23, 2013
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of bleeding
within 1 hours after delivery
1 hour
Secondary Outcomes (2)
Hemoglobin decrease
24 hours
Hematocrite decrease
24 hours
Other Outcomes (1)
Side effects
24 hours
Study Arms (2)
Misoprostol
EXPERIMENTAL400µg oral misoprostol
Oxytocin
ACTIVE COMPARATOR20 IU oxytocin
Interventions
Eligibility Criteria
You may qualify if:
- were women with singleton pregnancy
- with cephalic presentation
- who had NVD spontaneously or by induction
You may not qualify if:
- placenta previa
- placental detachment
- coagulation problems
- previous CS
- macrosomia
- Polyhydramnios
- and uncontrolled asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 097145-3388, Iran
Related Publications (1)
Rajaei M, Karimi S, Shahboodaghi Z, Mahboobi H, Khorgoei T, Rajaei F. Safety and efficacy of misoprostol versus oxytocin for the prevention of postpartum hemorrhage. J Pregnancy. 2014;2014:713879. doi: 10.1155/2014/713879. Epub 2014 Mar 5.
PMID: 24734184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Minoo Rajaei, Dr
Hormozgan University of Medical Sciences
- STUDY DIRECTOR
Zohreh Shahboodaghi, Dr
Hormozgan University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 23, 2013
First Posted
May 29, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 26, 2015
Record last verified: 2015-03