Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Hormozgan University of Medical Sciences

Status and phase: Completed; Phase 1

Conditions: Post Partum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01863706

Misoprostol for PPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 10 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

Misoprostol

Experimental group

Description:

400µg oral misoprostol

Treatment:

Drug: Misoprostol

Oxytocin

Active Comparator group

Description:

20 IU oxytocin

Treatment:

Drug: Oxytocin