Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain

Insel Gruppe AG, University Hospital Bern

Status and phase: Unknown; Phase 4

Conditions: Cesarean Delivery

Treatments: Drug: Carbetocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02642263

Uterotonic Carbetocin

Details and patient eligibility

About

Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a double-blind, prospective design patients will be either attributed to the oxytocin or the carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the cesarean delivery scar. This will be performed with a von Frey hair, resulting in a unpleasant feeling in the area of hyperalgesia.

Enrollment: 78 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-45, uneventful pregnancy, on term (>37 0/7 weeks of gestation), scheduled elective CS including repeat CS

Exclusion criteria

• lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Oxytocin

No Intervention group

Description:

Oxytocin 20 IE in 500 ml G Na intravenous infusion over 6 hours (GlucoSalin 2:1; 2/3 glucose 5%+1/3 NaCl 0.9%), Sintetica-Bioren, Switzerland, after birth of the baby. For blinding purposes a 3ml NaCl 0.9% syringe is administered intravenously after birth of the baby as well.

Carbetocin

Experimental group

Description:

100 mcg of Carbetocin, Ferring, Switzerland, as iv administration after birth of the baby. For blinding purposes an intravenous infusion of 500 ml G Na (GlucoSalin 2:1; 2/3 glucose 5%+1/3 NaCl 0.9%) is administered over 6 hours.

Treatment:

Drug: Carbetocin