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The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)

NCT02053922 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2014-02-06

No results posted yet for this study

Summary

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Syntocinon

Syntocinon ampoules (10 IU Oxytocin). (Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.

DRUG

Carbetocin

Carbetocin (Ampoule 100 μg/ml) . \[Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany. Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada\] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.

DRUG

Misoprostol

Misoprostol (200 mcg Tablet) \[Misotac, Sigma Pharmaceutical Industries, SAE, Egypt\] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Karim H Abd-El-Maeboud, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Egypt

Study Locations

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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 NCT02053922 on ClinicalTrials.gov