Misoprostol for Preventing Postpartum Hemorrhage

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: placebo; Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00124540

2.4.5

Details and patient eligibility

About

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

Enrollment: 1,200 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women who have given birth to 1 or more live-born infants (para 1 or more)
• Vaginal delivery

Exclusion criteria

• Refusal or inability to give informed consent
• Delivery regarded as abortion according to local gestational age limits
• Inability to take misoprostol sublingually
• Cesarean section
• Assisted vaginal delivery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo resembling misoprostol

Treatment:

Drug: placebo

2

Experimental group

Description:

misoprostol

Treatment:

Drug: misoprostol