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

Phase 2

Completed

• Conditions: Postpartum Haemorrhage
• Interventions: Drug: misoprostol; Drug: placeboo

• Registration Number: NCT02509351
• Lead Sponsor: Ain Shams University

Brief Summary

* 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

Detailed 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

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Study Start: 2015-10
• Status Verified: 2016-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	misoprostol	women receiving pre-operative rectally administered 400 microgram misoprostol
placeboo	placeboo	women receiving placebo

Primary Outcome Measures

Name	Time	Method
volume of intraoperative blood loss	30 minute	volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor

Secondary Outcome Measures

Name	Time	Method
mean measured blood loss	1, 2, and 24 h postpartum
maternal mortality	6 months
mean postpartum hematocrit	24 hours	more than 10% drop in the postpartum hematocrit
requirement for blood transfusion	24 hours	indicated per clinical protocol at the study site for mothers with a hemoglobin \<100 g/l and/or severe pallor
placental retention	30 minutes	when the placenta is not delivered spontaneously for 30 minutes
requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures	24 hours
postpartum hemoglobin	24 hours	less than 10gm%

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt