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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053922
• Other study ID #: OCMCS
• Secondary ID: ASU maternity Ho
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2013
• Last updated: February 5, 2014
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

The use of Oxytocin, Carbetocin and buccal misoprostol in patients undergoing elective Cesarean Section in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 18 years or more.

2. Gestational age of pregnancy of 37 completed weeks or more.

3. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

1. fetal or maternal distress where, due to time constraints, it will not possible and/or appropriate to recruit or randomize.

2. Women undergoing caesarean section with general anesthesia are also excluded, because carbetocin is licensed for use with regional anaesthesia only.

3. Women planned to have any other type of uterine incision other than transverse lower segment.

4. Women with HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), eclampsia, and epilepsy .

5. 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.

6. Women with thrombocytopenia, known coagulopathies, or receiving anticoagulant therapy.

7. Women with history of significant heart disease, a history or evidence of liver, renal, vascular disease or endocrine disease (other than gestational diabetes).

8. Women with history of hypersensitivity to oxytocin or carbetocin.

9. Women with any severe allergic condition or severe asthma.

10. Women with any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs) or glaucoma.

11. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events recorded during the study.		an expected average 1 week	Yes