Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.

NCT02277067 | Unknown Phase 4 DMC

• 1 other identifier: Beni-Suef 7
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.

Conditions

Postpartum Hemorrhage

Keywords

PPH

Outcome Measures

Primary Outcomes (1)

• Uterine tone and size

  The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.

  One hour after the cesarean section

Secondary Outcomes (1)

• Blood loss

  One hour after cesarean section

Other Outcomes (1)

• Hemoglobin concentration

  Before and 24 hours after the operation

Study Arms (2)

Pabal ( carbetocin)

ACTIVE COMPARATOR

Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.

Drug: Carbetocin

Misoprostol

ACTIVE COMPARATOR

Misoprostol ( Misotac, Sigma, Egypt) is a stable, synthetic form of prostaglandin E1 analogue. Patients wil be given 600 microgram of misotac immediately postoperative.

Drug: Misoprostol

Interventions

Carbetocin DRUG

Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.

Also known as: Pabal

Pabal ( carbetocin)

Misoprostol DRUG

600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.

Also known as: Misotac

Misoprostol

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.
• Any medical disorder with pregnancy that carries a risk factor for PPH.

You may not qualify if:

• Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
• women undergoing cesarean section at less than 37 weeks of gestation.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (1)

Beni-Suef University

Cairo, Egypt

RECRUITING

Related Links

• • Almog B,Malabarey O, Brown R, Abenhaim HA, Shrim A. (2011), Postpartum hemorrhage in low risk population. J Perinat Med. 2011 Sep; 39(5):495-8. Epub 2011 Jun 30. Department of Obstetrics and Gynecology, McGill University Health Center, Montreal, QC,
• Advance misoprostol distribution for preventing and treating postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Feb 15; 2:CD009336. Maternal and Fetal Health Research Unit, Department of Obstetrics and Gynaecology, Obafemi Awolowo College of Health
• Maternal consequences of caesarean section. A retrospective study of intra-operative and postoperative maternal complications of caesarean section during a 10- year period. Eur J Obstet Gynecol Reprod Biol. 2009;74(1):1-6.
• • Dansereau J, Joshi AK, Helewa ME, Doran TA, Lange IR, Luther ER, et al. Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol 1999; 180:670-6.

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocin; 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

• Nesreen A Shehata, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nesreen A Shehata, MD

CONTACT

00201227866337; nesoomar@yahoo.com

Abdelgany M Hassan, MD

CONTACT

00201017801604; abdelgany2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

EG (1)