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

Postpartum Haemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509351
• Other study ID #: POMCS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2015
• Last updated: November 9, 2016
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• misoprostol
400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section
• placeboo
women will recive 2 identical tablets as placeboo

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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