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临床试验/CTRI/2024/03/063466
CTRI/2024/03/063466尚未招募不适用

INJECTION CARBETOCIN VERSUS INJECTION OXYTOCIN IN VAGINAL DELIVERY FOR PREVENTION OF POST-PARTUM HEMORRHAGE

DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
UTERINE TONE

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • REPRODUCTIVE AGE GROUP AND ELIGIBLE FOR STUDY SINGLETON PREGNANCY TERM GESTATION.

排除标准

  • 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).

结局指标

主要结局

UTERINE TONE

时间窗: 24 HOURS

INTRA-PARTUM BLOOD LOSS

时间窗: 24 HOURS

次要结局

  • DIFFERENCE IN HEMOGLOBIN TAKEN BEFORE THE VAGINAL DELIVERY AND 48 HOURS AFTER VAGINAL DELIVERY(NEED FOR ADDITIONAL UTEROTONICS)

研究者

发起方
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH
申办方类型
Research institution and hospital

研究点 (1)

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