Timing of Carbetocin Administration in Postpartum Hemorrhage

September 13, 2025 updated by: Mehmet Mete Kırlangıç

When Should Carbetocin be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?

Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34880
        • Kartal Dr Lutfi Kirdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Vaginal delivery at or beyond 38 weeks of gestation
  • Primipar

Exclusion Criteria:

  • Multiparity
  • Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
  • High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
  • Anemia or
  • body mass index (BMI) over 35
  • Baby weight over 4000 grams
  • Comorbidities or chronic diseases
  • History of curettage
  • Use of propess or oxytocin during labor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: After placenta is delivered
The group that received carbetocin after placenta delivery
Behavioral: Carbetocin
Use of carbetocin
Experimental: Before placenta is delivered
The group that received carbetocin before placenta delivery
Behavioral: Carbetocin
Use of carbetocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbetosin effect
Time Frame: 24 hours after delivery
incidence of postpartum hemorrhage >500 ml (percent (%)), additional uterotonics using (yes/no), placenta retention (yes/no), adverse effects (hypotension (yes/no), tachycardia (yes/no), headache(yes/no) oliguria (yes/no)),
24 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Mete Kırlangıç

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/514/258/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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