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临床试验/NCT05670886
NCT05670886招募中不适用

Routine Bilateral Uterine Artery Ligation During the Cesarean Delivery of Multiple Gestation

Cairo University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
mean Blood loss after placental separation

研究概览

简要总结

Multiple pregnancy is well defined to be associated with a greater risk of postpartum blood loss . Interventions to control PPH generally stepped from less to more invasive and including compression maneuvers , drugs , and further radical surgeries. Conservative management plans such as medications which cause the uterus to contract, external massage to the uterine body , and bimanual compression are overall used as 1st line interventions.

PPH was defined as a cumulative blood loss of 1,000 mL or more, or blood loss that occurred within 24 hours of childbirth and was accompanied by indications or symptoms of hypervolemia. The most frequent cause of PPH, which accounted for roughly 80% of cases, is uterine atony (3).

PPH is brought on by hyperexpansion, which impaired uterine myometrial contractility and caused uterine contraction fatigue , PPH were twice as high when pregnant with twins (4).The only effective surgical treatment for blood loss is a hysterectomy, but this is a risky procedure, especially for young women.(5)

Due to this, a number of fertility-preserving surgical procedures have been developed, including the B-Lynch technique, internal iliac artery ligation, and uterine artery ligation (UAL) One of the most widely used surgical methods for preserving fertility is UAL. It is simple to carry out and works well to control PPH. Additionally, it permits patients to have more children in the future and is generally safe. Additionally, it has a success rate of above 90%.

Concerns have been raised about its effect on women who want to become pregnant in the future regarding their ovarian reserve. The accepted practice of medicine worldwide is the prophylactic use of uterotonics. A synthetic oxytocin analogue with a lengthy half-life, carbetocin also stimulates uterine contractions .

One benefit of carbetocin over oxytocin is that it is more heat-stable, which is of greater importance to low resource settings . Studies compare the effectiveness of carbetocin and oxytocin in preventing PPH and find that carbetocin is equally effective or even more effective.

详细描述

This study is a randomized controlled study including a total number of 110 patients presenting to Kasr Al-ainy obstetrics and gynecology hospital for CS delivery. Ethical committee approved this study.

Patients are equally & randomly divided into two equal groups . Group (A) , study group (N=55) : patients with multiple pregnancy undergoing cesarean section undergoing bilateral uterine artery ligation and received carbetocin.

Group (B ) , control group (N=55) : patients with twin pregnancy undergoing cesarean section received carbetocin only.

Pregnant patients aging between 18 to 42 undergoing cesarean section for multiple pregnancy are included in this study , while Patients with Placenta previa or accrete , Ante-partum hemorrhage , patient refusing to participate , patients with medical disorders and patients with pre-operative HB less than 9 gm/dl were excluded from the study.

Informed consent was taken from involved patients after explanation of the procedures and their complications , and allocated patients were subjected to : (1) History taking regarding age , parity , previous CS , previous PPH , menstrual , medical and surgical history . (2) Examination : including general exam.(BMI , Blood Pressure ) , Abdominal examination ( Leopold's maneuvers , CS scars , fetal heart sounds , fundal level ) & local vaginal examination .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing cesarean section
  • multiple pregnancy

排除标准

  • Placenta previa.
  • Ante-partum hemorrhage.
  • patient refuse to participate

结局指标

主要结局

mean Blood loss after placental separation

时间窗: 30 minutes

by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

次要结局

  • Number of Participants with postpartum hemorrhage(12 hours)
  • The number of participant needed for blood transfusion(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bassiony Dabian

lecturer of obstetrics and gynecology

Cairo University

研究点 (1)

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