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

NCT02053922 | Completed Phase 3 DMC

• 2 other identifiers: OCMCSASU maternity Hospital
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Hemorrhage

Keywords

caesarean section, ecbolics, postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section

  an expected average 1 week

Secondary Outcomes (1)

• Adverse events recorded during the study.

  an expected average 1 week

Study Arms (3)

Syntocinon

ACTIVE COMPARATOR

Drug is given just after delivery of the neonate during cesarean section.

Drug: Syntocinon

Carbetocin

ACTIVE COMPARATOR

Drug is given just after delivery of the neonate during cesarean section.

Drug: Carbetocin

Misoprostol

ACTIVE COMPARATOR

Drug is given just after delivery of the neonate during cesarean section.

Drug: Misoprostol

Interventions

Syntocinon DRUG

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.

Syntocinon

Carbetocin DRUG

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.

Also known as: Pabal

Carbetocin

Misoprostol DRUG

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.

Also known as: Misotac

Misoprostol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 years or more.
• Gestational age of pregnancy of 37 completed weeks or more.
• Written and signed informed consent by the patient to participate in the study.

You may not qualify if:

• fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.
• Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.
• Women planned to have any other type of uterine incision other than transverse lower segment.
• Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .
• Women with placental abruption are excluded because there is a higher risk of hemorrhage with this condition and it was therefore felt to be inappropriate to recruit these women.
• Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.
• Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).
• Women with history of hypersensitivity to oxytocin or carbetocin.
• Women with any severe allergic condition or severe asthma.
• Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.
• Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

• Elbohoty AE, Mohammed WE, Sweed M, Bahaa Eldin AM, Nabhan A, Abd-El-Maeboud KH. Randomized controlled trial comparing carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following an elective cesarean delivery. Int J Gynaecol Obstet. 2016 Sep;134(3):324-8. doi: 10.1016/j.ijgo.2016.01.025. Epub 2016 May 25.

  PMID: 27350226 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; 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)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Karim H Abd-El-Maeboud, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: Professor

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: February 4, 2014
• Study Start: December 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 6, 2014

Record last verified: 2014-02

Locations

EG (1)