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临床试验/NCT04323241
NCT04323241已完成不适用

The Effect of Placenta Removal Method On Postpartum Leucocytosis : A Randomized Controlled Trial

Haydarpasa Numune Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Detection of Leukocyte Count

研究概览

简要总结

Cesarean delivery is one of the most common major abdominal operation in women worldwide. The incidence of postpartum infection has been estimated to be 1-4% after vaginal delivery and 10-20% after Cesarean delivery. Although it is widely performed, manual removal of the placenta is still a conflicting issue due to the risk of post-partum endometritis. All cesarean patients are randomized according to the removal of placenta from the uterus after childbirth; manually (Group 1) or controlled cord traction without putting fingers inside the uterus (Group 2). The aim of this study is to examine whether there is an association between the method of removal of the placenta and postpartum white blood cell increase in nonanemic, singleton, low-risk group of women with term pregnancies, who underwent elective cesarean delivery under general anesthesia.

详细描述

Objective

Cesarean section is one of the most common major abdominal operation in women worldwide and its rate is increasing every year. Although cesarean birth is considered as safe, it is a potentially morbid procedure with associated risks of hemorrhage, thromboembolic events, infection, and anesthesia risks. The incidence of postpartum infection has been estimated to be 1-4% after vaginal delivery and 10-20% after cesarean section. Manual removal of the placenta is widely accepted by surgeons worldwide. This method enables the surgeon quick intervention. Beside, it helps uterine cavity to be examined for damage and the presence of placental remnants. However, manual removal of the placenta is still a conflicting issue due to the risk of post-partum endometritis, post-partum hemorrhage and abnormal placentation in subsequent pregnancies. It is assumed that controlled cord traction reduces the risk of postpartum hemorrhage and infection.

The aim of this study is to examine whether there is an association between the method of removal of the placenta and increase in postpartum white blood cell counts

After informed consent, all patients are randomized according to the removal of placenta from the uterus after childbirth; manually (Group 1) or controlled cord traction without putting hands inside the uterus (Group 2). Patients are examined regarding to maternal infection. BMI measurement, obstetrics and medical history are recorded. The operative procedures are similar in all patients and followed the same technical steps. In both groups, oxytocin and a first-generation cephalosporin antibiotic are administered intravenously after the delivery of the infant. All uterine incisions were low transverse and all were closed without exteriorisation of the uterus. Complete blood count before delivery, on pastpartum day 1 and 2, fever during hospitalisation, average blood loss during operation and the endometritis cases are recorded. All the patients are asked to come to control on postpartum day 10. Also, patients are asked to come to control if they have fever, abnormal vaginal bleeding, abnormal vaginal discharge, general feeling of sickness and pain in the pelvis. Fever is defined as a temperature above 38.5°C on two consecutive days, excluding the first 24 hours.

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
Single (Investigator)

盲法说明

Investigator will not know the interventional group.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nonanemic pregnancies
  • Singleton pregnancies
  • Term pregnancies
  • Elective cesarean sections

排除标准

  • Patients having umbilical cord prolapse,
  • Patients having placenta previa
  • Patients having preterm rupture of mebranes
  • Patients having maternal infection
  • Patients having multiple gestation
  • Patients having antepartum hemorrhage
  • Patients having severe pre-eclampsia
  • Patients having placenta previa
  • Patients having placental abruption
  • Patients having uncontrolled gestational diabetes
  • Heart disease
  • Liver disorders
  • Renal disorders
  • Coagulopathy

结局指标

主要结局

Detection of Leukocyte Count

时间窗: Postpartum day 2

Measurement of complete blood count

Detection of Number of Patients with Fever

时间窗: On postpartum day 2

Body temperature is measured 4 times in a day. Highest temparature will be record on postpartum day 2.

Change from Baseline Leukocyte Level at Postpartum Day 1

时间窗: Before delivery and postpartum day 1

Measurement of complete blood count

Number of Participants with Postpartum Endometritis

时间窗: Postpartum day 10

All the patients are asked to come to control on postpartum day 7. Also, patients are asked to come to control if they have fever, abnormal vaginal bleeding, abnormal vaginal discharge, general feeling of sickness and pain in the pelvis.

次要结局

  • Measurement of average blood loss during caesarean section by change from baseline hematocrit level at postpartum day 1.(Before operation and postpartum day 1)

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevcan Arzu Arinkan

Medical Doctor, Principal Investigator

Saglik Bilimleri Universitesi

研究点 (1)

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