Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jawaharlal Nehru Medical College
• Collaborators: AstraZeneca; Cipla Ltd.
• Treatments: Misoprostol; Oxytocin

Criteria

Inclusion Criteria:

• Women with a gestational age >28weeks

• singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)

• a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum

Exclusion Criteria:

• Women with pregnancy induced hypertension

• antepartum haemorrhage

• previous caesarean section or presence of uterine scar

• diagnosed chorioamnionitis

• oxytocin induction or augmentation of labour

• intrauterine death

• diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as >4 cm dilatation)