Prophylactic application of trans abdominal uterine artery clamp immediately after delivery of baby vs standard care to reduce blood loss in cesarean section - a randomised control study in a tertiary care centre
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Blood loss in cesarean section
研究概览
简要总结
Global prevalence of cesarean section is 21.50 percentage. With
increasing trend of cesarean, one of the main concern is the blood loss which is twice the amount of vaginal delivery.
Bleeding associated with cesarean section has
become an important cause of hemorrhage - related maternal deaths and
morbidity. One third of deaths followed by cesarean section is attributed
to Postpartum hemorrhage, inspite of Active management of third stage
of labour, The major reasons of bleeding after delivery of fetus is Atonic
PPH and Arterial bleeders from uterine tears. Usually we address this
after delivery of placenta but a quick method of promptly arresting the
bleeding is by clamping the bleeders on arterial bleeders on uterine edges and angles and uterine artery vessels on both sides using a T
clamp without waiting for placental separation
The Purpose of this study is to evaluate the efficacy of prophylactic
transabdominal uterine artery clamp application immediately after
delivery of baby in reducing the blood loss and incidence of Postpartum
hemorrhage in cesarean section.
A Randomised control study is planned to be conducted in the
Department of obstetrics and gynecology, Rajagiri hospital, Aluva. Since
there are no published articles regarding efficacy of Transabdominal
uterine artery clamp in cesarean section, we are planning to conduct a
pilot study
We hypothesise that prophylactic application of Transabdominal uterine
artery clamp in cesarean section immediately after delivery of baby
reduces the blood loss and incidence of Postpartum hemorrhage, need for
blood transfusions, need for secondary interventions, incidence of
postpartum anaemia. Our study sample will be divided into two groups by
simple randomization with one group receiving prophylactic transabdominal uterine artery clamp immediately after delivery and the
other group receiving only the standard care.
We shall compare the amount of blood loss between two groups,
incidence of PPH,need of blood transfusion, incidence of anaemia at
discharge, need of secondary surgical interventions, surgical
complications in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women undergoing caesarean section(Emergency and elective caesarean section) Gestational age 34 weeks – 40 weeks.
排除标准
- •Women refusing to give informed consent Placenta previa, Placenta accreta, Placental abruption Crash Lower Segment Cesarean Section.
- •cord prolapse, prolonged fetal bradycardia, placental abruption Blood dyscarias.
结局指标
主要结局
Blood loss in cesarean section
时间窗: Time point 1 - calculated at the end of surgery
次要结局
- Drop in Haemoglobin cesarean section(Time point 1- measured 24 hours preoperatively)
- Need of blood transfusion(Time point 1 - intraoperatively,)
- Need for secondary surgical interventions(Time point 1 - intraoperatively,)
- Incidence of surgical complications(Time point 1 - intraoperatively,)
研究者
Dr. Sismitha B
rajagiri hospital