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

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Drug: Carbetocin; Drug: Syntocinon; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02053922

OCMCS

ASU maternity Hospital (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 3 patient groups

Syntocinon

Active Comparator group

Description:

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

Treatment:

Drug: Syntocinon

Carbetocin

Active Comparator group

Description:

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

Treatment:

Drug: Carbetocin

Misoprostol

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol