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

Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02509351

Enrollment

280

Registered

2015-07-28

Start date

2015-10-31

Completion date

2016-11-30

Last updated

2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Haemorrhage

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

Interventions

DRUGmisoprostol

400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section

DRUGplaceboo

women will recive 2 identical tablets as placeboo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
mean postpartum hematocrit	24 hours	more than 10% drop in the postpartum hematocrit
placental retention	30 minutes	when the placenta is not delivered spontaneously for 30 minutes
maternal mortality	6 months	—
postpartum hemoglobin	24 hours	less than 10gm%
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
requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures	24 hours	—
mean measured blood loss	1, 2, and 24 h postpartum	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026