Current partner codePEPTIDESDE
NCT03651882·Phase 4·INTERVENTIONAL

Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections

Status

Completed

Phase

Phase 4

Enrollment

550

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.

Interventions

Treatment arms and agents.

DRUG

Oxytocin

Oxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously.

DRUG

Carbetocin

Carbetocin is given 0.1mg intravenously as a bolus after delivery.

Timeline

From registration to results.

  1. First posted

    Aug 29, 2018

  2. Study start

    Aug 7, 2018

  3. Primary completion

    Jan 10, 2022

  4. Study completion

    Jan 10, 2022

  5. Results posted

    Not reported

  6. Registry updated

    May 24, 2023

Outcomes

What the study measures.

Primary outcomes

incidence of women with a delta hemoglobin ≥ 30g/l.

Time frame · 48 hours

Delta hemoglobin is defined as the difference of the hemoglobin at admission minus the hemoglobin after delivery, usually 24-48 hours after the delivery.

Secondary outcomes

adverse maternal outcome parameters

Time frame · 15 days

decrease in hemoglobin (delta hemoglobin, in g/l)

adverse maternal outcome parameters

Time frame · 15 days

estimated blood loss (in mL),

adverse maternal outcome parameters

Time frame · 15 days

incidence of PPH (in %)

adverse maternal outcome parameters

Time frame · 15 days

use of additional uterotonic agents (prostaglandines)

adverse maternal outcome parameters

Time frame · 15 days

blood transfusion (number of packed red cells)

adverse maternal outcome parameters

Time frame · 15-300 minutes

length of surgery (in minutes)

adverse maternal outcome parameters

Time frame · 15 days

number of patients with revision (second surgery in the 24hours following the primary cesarean section)

adverse maternal outcome parameters

Time frame · 15 days

admission to an intensive care unit (%)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * elective cesarean section * present informed consent * completed 36 weeks of gestation Exclusion Criteria: * need for intubation (carbetocin is only licensed for epidural or spinal anesthesia) * multiple fetus pregnancy * known coagulopathy * Placenta praevia * morbidly adherent placenta * placental abruption * thrombocyte dysfunction * HELLP-syndrome * preeclampsia * history of uterine atony

Study locations

1 registered sites.

Switzerland. Showing up to 24 locations stored in the fast local snapshot.

University Hospital Zurich

Zurich, Switzerland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.