search
Back to results

Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring Misoprostol, Oxytocin, Post Partum Hemorrhage (PPH), Third stage of labour

Eligibility Criteria

10 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hormozgan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Misoprostol

Oxytocin

Arm Description

400µg oral misoprostol

20 IU oxytocin

Outcomes

Primary Outcome Measures

Amount of bleeding
within 1 hours after delivery

Secondary Outcome Measures

Hemoglobin decrease
Hematocrite decrease

Full Information

First Posted
May 23, 2013
Last Updated
March 25, 2015
Sponsor
Hormozgan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01863706
Brief Title
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Official Title
Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
Misoprostol, Oxytocin, Post Partum Hemorrhage (PPH), Third stage of labour

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
400µg oral misoprostol
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
20 IU oxytocin
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
400µg oral misoprostol
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
20 IU Oxytocin
Primary Outcome Measure Information:
Title
Amount of bleeding
Description
within 1 hours after delivery
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Hemoglobin decrease
Time Frame
24 hours
Title
Hematocrite decrease
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Side effects
Description
Diarrhea, Vommiting, Fever, Chills
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minoo Rajaei, Dr
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zohreh Shahboodaghi, Dr
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
097145-3388
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24734184
Citation
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.
Results Reference
derived

Learn more about this trial

Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

We'll reach out to this number within 24 hrs