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

NCT02509351 | Completed Phase 2 DMC

• 1 other identifier: POMCS
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• maternal mortality

  6 months

• mean measured blood loss

  1, 2, and 24 h postpartum

• placental retention

  30 minutes

• requirement for blood transfusion

  24 hours

• requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures

  24 hours

Study Arms (2)

misoprostol

EXPERIMENTAL

women receiving pre-operative rectally administered 400 microgram misoprostol

Drug: misoprostol

placeboo

ACTIVE COMPARATOR

women receiving placebo

Drug: placeboo

Interventions

misoprostol DRUG

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

Also known as: mesotac

misoprostol

placeboo DRUG

women will recive 2 identical tablets as placeboo

Also known as: control

placeboo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• weeks of amenorrhea
• scheduled for elective lower segment cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Helmy Dr metawe, MD

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 28, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)