MedTrace Logo

Sublingual Misoprostol & Isoflurane During Caesarean Section

NCT01466530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2011-11-08

No results posted yet for this study

Summary

Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful effects on either mother or baby. The investigators postulated that the use of sublingual misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents, without harmful effects on either mother or baby. Therefore, the present study was designed to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss, uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean delivery under isoflurane anaesthesia.

Conditions

  • Pregnancy
  • Cesarean Delivery

Interventions

DRUG

Placebo

received sublingual two moistened white coated placebo tablets which looked identical in size, colour, and packing to misoprostol tablet.

DRUG

Misoprostol

sublingual misoprostol was given by putting two moistened tablets of misoprostol (400 µg) under the tongue and allowing them to dissolve (Misotac®, Sigma Pharmaceutical Industries, Egypt) (200 µg/tablet).

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed R El Tahan, MD · College of medicine, Manoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466530 on ClinicalTrials.gov