跳至主要内容
临床试验/NCT03461913
NCT03461913已完成不适用

Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?

Cairo University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
umbilical cord Ph

研究概览

简要总结

Patients were classified into two equal groups using the presence or absence of hypertension during pregnancy into: hypertensive group (BP>140/90) and normotensive group (BP≤140/90. The surgical time intervals are assessed and classified the patients accordingly into short and log time interval subgroups (induction of regional anesthesia to delivery (I-D), initial skin incision to delivery (S-D), and uterine incision to delivery (U-D)

详细描述

Surgical times components; induction of regional anesthesia till delivery (I-D interval); incision of the skin till delivery (S-D interval); and incision of the uterus till delivery (U-D interval)) were recorded using a stopwatch.

Immediately after delivery, umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe. PH, base excess (BE), carbon dioxide pressure (PCO2), Oxygen pressure (PO2) and Bicarbonate (HCO3) levels were measured at 37oC by pH and gas analyzer (Gem, Premier3000, USA). The gas analysis was done in less than 30 minutes after sampling.

Apgar score was assessed by a neonatologist at the 1st and 5th minutes after birth . Advanced resuscitation included positive pressure ventilation, chest compression and/or drugs administration. All resuscitated babies were transferred to neonatal intensive care unit for post resuscitation care. Fetal distress was defined by an umbilical cord pH <7.12

研究设计

研究类型
Interventional
分配方式
Non 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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • full term pregnancy
  • singleton pregnancy
  • no medical disorders except hypertension in group 2

排除标准

  • Multiple pregnancies
  • complicated pre-eclamptic cases as placental abruption, eclampsia or HELLP syndrome,
  • preterm pregnancies,
  • true knots of the cord
  • reduced liquor,
  • in labour patients,
  • fetal distress
  • infants with major congenital malformations

研究组 & 干预措施

normal pregnancy

Active Comparator

women at full term healthy pregnancy who underwent elective Cesarean section

干预措施: Cesarean section (Procedure)

pregnancy hypertension

Active Comparator

women at full term pregnancy associated with hypertension who underwent elective Cesarean section

干预措施: Cesarean section (Procedure)

结局指标

主要结局

umbilical cord Ph

时间窗: immediately after delivery

umbilical cords were clamped on both ends and an arterial blood sample was collected anaerobically in a pre-heparinized insulin syringe

次要结局

  • Apgar score(1 and 5 minutes after delivery)

研究者

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

Ahmed Maged

professor

Cairo University

研究点 (2)

Loading locations...

相似试验