NCT06776926

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

January 10, 2025

Last Update Submit

September 13, 2025

Conditions

Postpartum HemorrhageCarbetocin

Keywords

Postpartum hemorrhagePPHCarbetocinPlacental retention

Outcome Measures

Primary Outcomes (1)

  • Carbetosin effect

    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

Study Arms (2)

After placenta is delivered

EXPERIMENTAL

The group that received carbetocin after placenta delivery

Behavioral: Carbetocin

Before placenta is delivered

EXPERIMENTAL

The group that received carbetocin before placenta delivery

Behavioral: Carbetocin

Interventions

CarbetocinBEHAVIORAL

Use of carbetocin

After placenta is deliveredBefore placenta is delivered

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Istanbul, 34880, Turkey (Türkiye)

Location

Related Publications (3)

  • Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD005457. doi: 10.1002/14651858.CD005457.pub4.

    PMID: 22513931BACKGROUND

  • Maged AM, El-Goly NA, Turki D, Bassiouny N, El-Demiry N. A systematic review and meta-analysis of randomized trials comparing carbetocin to oxytocin in prevention of postpartum hemorrhage after cesarean delivery in low-risk women. J Obstet Gynaecol Res. 2025 Jan;51(1):e16194. doi: 10.1111/jog.16194.

    PMID: 39722234BACKGROUND

  • Jin B, Du Y, Zhang F, Zhang K, Wang L, Cui L. Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2016;29(3):400-7. doi: 10.3109/14767058.2014.1002394. Epub 2015 Sep 4.

    PMID: 25579116BACKGROUND

MeSH Terms

Conditions

Postpartum HemorrhagePlacenta, Retained

Interventions

carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPlacenta Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

January 10, 2025

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)