NCT01373359

Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

A One Year Double Blind Randomized Controlled Trial of Sublingual Misoprostol (400 µg) Versus Intramuscular Oxytocin (10 IU) in the Prevention of Postpartum Bloodloss at KLE Hospital, Belgaum

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: Jawaharlal Nehru Medical College · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Misoprostol	400 µg sublingual misoprostol
DRUG	Oxytocin	10 IU IM

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2011-06-14
• Last updated: 2011-06-14

Locations

1 site across 1 country: India