NCT07380529

Brief Summary

This study will be conducted to compare the effects of pabal and oxytocin administered to prevent postpartum hemorrhage in patients who were followed in the delivery room due to vaginal labor but underwent cesarean section due to emergency situations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

January 18, 2026

Last Update Submit

February 12, 2026

Conditions

Postpartum Hemorrhage \(PPH\)

Keywords

carbetocinpostpartum hemorrhageoxytocinemergency caesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Postoperative change in hemoglobin at 24 hours

    Change in hemoglobin (g/dL) from preoperative baseline to the lowest hemoglobin value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups.

    Baseline (preoperative) and within 24 hours after emergency cesarean delivery

Secondary Outcomes (2)

  • Need for additional uterotonic agents

    Within 24 hours after cesarean delivery

  • Postoperative change in hematocrit at 24 hours

    Baseline (preoperative) and within 24 hours after emergency cesarean delivery

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Standard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean)

Drug: Oxytocin

carbetocin

EXPERIMENTAL

Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

Drug: Carbetocin

Interventions

CarbetocinDRUG

Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

carbetocin
OxytocinDRUG

Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage

Oxytocin

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Term pregnancy (\>37 weeks gestation)
  • Singleton pregnancy
  • Vertex presentation
  • not having had a cesarean section before
  • emergency cesarean delivery (category 1)
  • low risk for postpartum hemorrhage

You may not qualify if:

  • Non-term pregnancy (\< 37 weeks gestation)
  • Non- vertex presentation
  • antenatal high risk pregnancy for postpartum hemorrhage (preeclampsia/eclampsia, previous uterine surgery, placental anomalies)
  • Twin pregnancy
  • Elective cesarean section planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06010, Turkey (Türkiye)

Location

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (1)

  • Razali N, Md Latar IL, Chan YK, Omar SZ, Tan PC. Carbetocin compared to oxytocin in emergency cesarean section: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:35-39. doi: 10.1016/j.ejogrb.2015.12.017. Epub 2015 Dec 30.

    PMID: 26773246RESULT

Related Links

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

carbetocinOxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • TAHİR ERYILMAZ, M.D. Dr.

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecology and Obstetrics M.D. specialist

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 2, 2026

Study Start

October 1, 2024

Primary Completion

August 4, 2025

Study Completion

August 4, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations

TU(2)