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NCT Number: NCT01863706

Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

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.

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Key information

Conditions

Post Partum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

10 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

400µg oral misoprostol

Other names: Cytotec

Oxytocin

Drug

20 IU Oxytocin

Other names: Syntocinon

Primary outcomes

  1. Amount of bleeding

    Time frame: 1 hour

    within 1 hours after delivery

Secondary outcomes

  1. Hemoglobin decrease

    Time frame: 24 hours

  2. Hematocrite decrease

    Time frame: 24 hours

Other outcomes

  1. Side effects

    Time frame: 24 hours

    Diarrhea, Vommiting, Fever, Chills

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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