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Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01863706
Enrollment
400
Registered
2013-05-29
Start date
2013-05-31
Completion date
2013-12-31
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Partum Hemorrhage

Keywords

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

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.

Interventions

DRUGMisoprostol

400µg oral misoprostol

DRUGOxytocin

20 IU Oxytocin

Sponsors

Hormozgan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of bleeding1 hourwithin 1 hours after delivery

Secondary

MeasureTime frame
Hemoglobin decrease24 hours
Hematocrite decrease24 hours

Other

MeasureTime frameDescription
Side effects24 hoursDiarrhea, Vommiting, Fever, Chills

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026