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临床试验/NCT05208515
NCT05208515Unknown不适用

A Randomized, Standard-controlled Study of Establishing Independent Obstetric Operating Centre and Decision-to-delivery Interval for Emergency Cesarean Section

Maternal and Child Health Hospital of Foshan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
decision to delivery interval

研究概览

简要总结

The study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section.

详细描述

The newest define of decision-to-delivery interval (DDI) is the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered. The recommended DDI by the American College of Obstetricians and Gynecologists and the Royal College of Obstetricians and Gynecologists is within 30 minutes. The 30 minutes rule is also used to measure the overall performance of an obstetric unit in our country. Lower rate of DDI over 30 minutes will improve the outcome of neonatal outcomes.

Affiliated Foshan Maternity & Child Healthcare Hospital is a tertiary care hospital in south of our country. Obstetric operations in this hospital are used to perform in a big general operating center, which is shared by all departments of the hospital. In December 23, 2020, a new wing of the hospital opened in response to the growing number of patients. In the new wing, an independent obstetric operating center was established to provide health care for obstetric operating. The original and new obstetric units were built according to the same standard. The medical staff shifts between original and new obstetric units every three months. Six months after the new wing of hospital opened, we set off a randomized and controlled trial (RCT). The RCT is aimed to investigate whether the independent obstetric operating center can shorten the DDI, decrease the rate of DDI over 30 minutes and improve neonatal outcomes.

Women who are over 18 years old, meet the conditions of vaginal delivery and decided to give birth vaginally by doctor and patient will be random distributed to original or new obstetric unit from July 1, 2021 to June 30,2022. Women need ECS in original obstetric unit will be send to the general operating center (named standard group), those need ECS in the new wing will be send to the obstetric operating center (named new group). DDI and other related variables of those who need ECS will be recorded. Data of a total of 60 ECS in each group will be collected and analyzed at last. Women who with missing data should be excluded.

研究设计

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

入排标准

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

入选标准

  • over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally

排除标准

  • with missing data

结局指标

主要结局

decision to delivery interval

时间窗: labor day

the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered.

anesthetic time

时间窗: labor day

Arrival of the patient in theatres to anaesthetic ready time

Operation waiting time

时间窗: labor day

Time at which the anaesthetic is ready to the first skin incision

delivery time

时间窗: labor day

Skin incision-to-delivery of the first fetus

transfer time

时间窗: labor day

Time of decision to time of arrival of the patient in theatre

次要结局

  • five minutes Apgar score(labor day)
  • number of still birth(labor day)
  • degree of neonatal asphyxia(labor day)
  • number of newborn transferred to NICU(From delivery to one week after delivery)
  • number of neonatal death(labor day)
  • first minute Apgar score(labor day)

研究者

发起方
Maternal and Child Health Hospital of Foshan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhengping Liu, MD

Director

Maternal and Child Health Hospital of Foshan

研究点 (1)

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