When Should Carbetocin be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?
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
Mehmet Mete Kırlangıç
Dr. Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Dr. Lutfi Kirdar Kartal Training and Research Hospital