Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postpartum Haemorrhage

Treatments: Drug: misoprostol; Drug: placeboo

Study type: Interventional

Funder types: Other

Identifiers

NCT02509351

POMCS

Details and patient eligibility

About

• Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
• The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Full description

Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

Enrollment: 280 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 38-41 weeks of amenorrhea
• scheduled for elective lower segment cesarean section

Exclusion criteria

• confirmed intrauterine fetal death
• more than previous 2 ceserean sections
• multiple pregnancy
• antepartum haemorrhage
• self-reported maternal heart disease
• current diagnosis of severe malaria or acute bacterial infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups

misoprostol

Experimental group

Description:

women receiving pre-operative rectally administered 400 microgram misoprostol

Treatment:

Drug: misoprostol

placeboo

Active Comparator group

Description:

women receiving placebo

Treatment:

Drug: placeboo