Timing of Carbetocin Administration in Postpartum Hemorrhage

NCT ID: NCT06776926

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Postpartum Hemorrhage Carbetocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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After placenta is delivered

The group that received carbetocin after placenta delivery

Group Type EXPERIMENTAL

Carbetocin

Intervention Type BEHAVIORAL

Use of carbetocin

Before placenta is delivered

The group that received carbetocin before placenta delivery

Group Type EXPERIMENTAL

Carbetocin

Intervention Type BEHAVIORAL

Use of carbetocin

Interventions

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Carbetocin

Use of carbetocin

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mehmet Mete Kırlangıç

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Mete Kırlangıç

Dr. Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22513931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39722234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25579116 (View on PubMed)

Other Identifiers

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2023/514/258/20

Identifier Type: -

Identifier Source: org_study_id

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