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OpenTrials
Completed

NCT Number: NCT03651882

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

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.

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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.

Carbetocin

Drug

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

Primary outcomes

  1. 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

  1. adverse maternal outcome parameters

    Time frame: 15 days

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

  2. adverse maternal outcome parameters

    Time frame: 15 days

    estimated blood loss (in mL),

  3. adverse maternal outcome parameters

    Time frame: 15 days

    incidence of PPH (in %)

  4. adverse maternal outcome parameters

    Time frame: 15 days

    use of additional uterotonic agents (prostaglandines)

  5. adverse maternal outcome parameters

    Time frame: 15 days

    blood transfusion (number of packed red cells)

  6. adverse maternal outcome parameters

    Time frame: 15-300 minutes

    length of surgery (in minutes)

  7. adverse maternal outcome parameters

    Time frame: 15 days

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

  8. adverse maternal outcome parameters

    Time frame: 15 days

    admission to an intensive care unit (%)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2018
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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