Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Post Partum Hemorrhage Clinical Trial

Official title:

Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863706
• Other study ID #: Misoprostol for PPH
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2013
• Last updated: March 25, 2015
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
400µg oral misoprostol
• Oxytocin
20 IU Oxytocin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Diarrhea, Vommiting, Fever, Chills	24 hours	Yes
Primary	Amount of bleeding	within 1 hours after delivery	1 hour	No
Secondary	Hemoglobin decrease		24 hours	No
Secondary	Hematocrite decrease		24 hours	No