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Clinical Trials/NCT06776926
NCT06776926CompletedNot Applicable

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

Mehmet Mete Kırlangıç1 site in 1 country200 target enrollmentStarted: January 10, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Carbetosin effect

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

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)),

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mehmet Mete Kırlangıç
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Mehmet Mete Kırlangıç

Dr. Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study Sites (1)

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