COMPARISON OF INJECTION CARBETOCIN WITH INJECTION OXYTOCIN IN VAGINAL DELIVERY FOR PREVENTION OF BLOOD LOSS
- Conditions
- Other immediate postpartum hemorrhage,
- Registration Number
- CTRI/2024/03/063466
- Lead Sponsor
- DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH
- Brief Summary
Approximately one-fourth of all maternal deaths are caused by postpartumhaemorrhage (PPH), which has a prevalence of 6% worldwide and is a significantcontributor to maternal mortality and morbidity. “PPH typically manifestswithin 24 hours of delivery, however it can also appear up to 12 weeks afterthe deliveryâ€. PPH has reportedly became more prevalent and severe in a numberof industrialised nations . Up to 80% of PPH cases are caused by uterineatony , which is also the most common cause of PPH. As a result, it iscrucial to timely and effectively induce the uterine contractions soon afterthe childbirth.
It is seen that when active management of third stage of labour is done,probability of severe primary PPH, need for transfusion, and subsequentuterotonic therapy are all decreased . The most used and efficientuterotonic drug for preventing PPH is oxytocin . However, because to itsearly onset and short duration of action, it is best administered to initiatepersistent uterotonic activity.
Oxytocin often requires several doses or other uterotonics to arresthaemorrhage which adds to various side effects and increase in expenditure oftreatment.
In contrast to oxytocin, carbetocin(octapeptide) is a long-acting synthetic analogue of oxytocin (nonapeptide)which requires only single dose administration. .Even after a single bolusinjection of carbetocin, the uterotonic effects lasts for several hours.
Currently oxytocin is most frequently used as agent of first choiceafter vaginal delivery. Due to its short half-life (4 to 10 minutes), itrequires continuous or frequently repeated administration. More recentlycarbetocin has been developed as a long acting oxytocin agonist and whenadministered it results in a sustained uterine contraction.
There is currently less data to evaluate the efficacy of carbetocin inwomen undergoing vaginal delivery for prevention of post-Partum haemorhage,hence we aim to do this study.
Ø **Study Type :** ComparativeObservational Study
Ø **Estimated sample size:** 200
Ø **Allocation:** Randomized
Ø **Masking:** Single(Investigator)
Ø **Primary Purpose:** Treatment
**Placeof study:** Department of Obstetrics and GynecologyJNMC, AVBRH, DMIHER (Deemed University), Wardha.
**Durationof Study**: 2023-2025
**Studydesign**: Comparative Observational Study
**Samplesize: 200**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 200
REPRODUCTIVE AGE GROUP AND ELIGIBLE FOR STUDY SINGLETON PREGNANCY TERM GESTATION.
WOMEN WITH KNOWN COAGULOPATHY STUDY DRUG HYPERSENSITIVITY OLIGOHYDRAMNIOS OR POLYHYDRAMNIOS CARDIAC DISEASES (INCLUDING DYSRHYTHMIA) HYPERTENSION LIVER,RENAL OR ENDOCRINE DISEASES (EXCEPT GESTATIONAL DIABETES) UTERINE FIBROIDS OR SUSPICION OF PLACENTAL PATHOLOGY (ACRETA, PREVIA OR ABRUPTIO).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method INTRA-PARTUM BLOOD LOSS 24 HOURS UTERINE TONE 24 HOURS
- Secondary Outcome Measures
Name Time Method DIFFERENCE IN HEMOGLOBIN TAKEN BEFORE THE VAGINAL DELIVERY AND 48 HOURS AFTER VAGINAL DELIVERY NEED FOR ADDITIONAL UTEROTONICS
Trial Locations
- Locations (1)
In- patient department, Department of Obstetrics and Gynaecology,ACHARYA VINOBA BHAVE RURAL HOSPITAL
🇮🇳Wardha, MAHARASHTRA, India
In- patient department, Department of Obstetrics and Gynaecology,ACHARYA VINOBA BHAVE RURAL HOSPITAL🇮🇳Wardha, MAHARASHTRA, IndiaPALLAVIPrincipal investigator7310595854PALLAVIYDV97@GMAIL.COM