Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

NCT ID: NCT01863706

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.

Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Misoprostol

400µg oral misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

400µg oral misoprostol

Oxytocin

20 IU oxytocin

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

20 IU Oxytocin

Interventions

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Misoprostol

400µg oral misoprostol

Intervention Type DRUG

Oxytocin

20 IU Oxytocin

Intervention Type DRUG

Other Intervention Names

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Cytotec Syntocinon

Eligibility Criteria

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Inclusion Criteria

* were women with singleton pregnancy
* with cephalic presentation
* who had NVD spontaneously or by induction

Exclusion Criteria

* placenta previa
* placental detachment
* coagulation problems
* previous CS
* macrosomia
* Polyhydramnios
* and uncontrolled asthma
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minoo Rajaei, Dr

Role: STUDY_CHAIR

Hormozgan University of Medical Sciences

Zohreh Shahboodaghi, Dr

Role: STUDY_DIRECTOR

Hormozgan University of Medical Sciences

Locations

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Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 24734184 (View on PubMed)

Other Identifiers

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Misoprostol for PPH

Identifier Type: -

Identifier Source: org_study_id

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