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CompletedNCT01863706Updated Mar 26, 2015

Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

A Phase 1 interventional study of Misoprostol and Oxytocin in Post Partum Hemorrhage, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 10 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Hormozgan University of Medical Sciences · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
10 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Partum Hemorrhage

Keywords

  • Misoprostol
  • Oxytocin
  • Post Partum Hemorrhage (PPH)
  • Third stage of labour
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's planned enrollment of 400 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • placenta previa
  • placental detachment
  • coagulation problems
  • previous CS
  • macrosomia
  • Polyhydramnios
  • and uncontrolled asthma
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Misoprostol

    400µg oral misoprostol

    Drug: Misoprostol

  • Active comparator
    Oxytocin

    20 IU oxytocin

    Drug: Oxytocin

Interventions

  • DrugMisoprostol

    400µg oral misoprostol

    Also known as: Cytotec

  • DrugOxytocin

    20 IU Oxytocin

    Also known as: Syntocinon

06

What researchers measure

Primary outcomes

  1. Amount of bleeding

    within 1 hours after delivery

    Time frame: 1 hour

Secondary outcomes

  1. Hemoglobin decrease

    Time frame: 24 hours

  2. Hematocrite decrease

    Time frame: 24 hours

Other outcomes

  1. Side effects

    Diarrhea, Vommiting, Fever, Chills

    Time frame: 24 hours

07

Study locations

1 site
  • Hormozgan University of Medical Sciences
    Bandar Abbas, Hormozgan 097145-3388, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 24734184 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01863706
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Hamidreza Mahboobi (Dr, Hormozgan University of Medical Sciences) — Principal investigator
First posted
May 29, 2013
Start date
May 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 26, 2015

Study contacts

Minoo Rajaei, Dr
study chair · Hormozgan University of Medical Sciences
Zohreh Shahboodaghi, Dr
study director · Hormozgan University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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