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

Primary Purpose

Postpartum Hemorrhage

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Syntocinon

Carbetocin

Misoprostol

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring caesarean section, ecbolics, postpartum hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Syntocinon

Carbetocin

Misoprostol

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events recorded during the study.

Full Information

NCT ID

NCT02053922

First Posted

March 27, 2013

Last Updated

February 5, 2014

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02053922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage

Keywords

caesarean section, ecbolics, postpartum hemorrhage

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Syntocinon

Arm Type

Active Comparator

Arm Description

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

Arm Title

Carbetocin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Misoprostol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Syntocinon

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Carbetocin

Other Intervention Name(s)

Pabal

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Misotac

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

an expected average 1 week

Secondary Outcome Measure Information:

Title

Adverse events recorded during the study.

Time Frame

an expected average 1 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim H Abd-El-Maeboud, MD

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ain Shams Maternity Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

27350226

Citation

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.

Results Reference

derived

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

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