Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

Jawaharlal Nehru Medical College

Status and phase: Completed; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01373359

MDC/DOME/3707

Details and patient eligibility

About

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.

Enrollment: 652 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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652 participants in 2 patient groups

Sublingual misoprostol

Experimental group

Description:

400 µg powdered misoprostol administered sublingually; IM placebo

Treatment:

Drug: Misoprostol

Oxytocin

Active Comparator group

Description:

10 IU IM oxytocin; placebo powder

Treatment:

Drug: Oxytocin