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临床试验/NCT04468568
NCT04468568已完成不适用

Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年10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
25
试验地点
1
主要终点
Maternal arterial blood pH at the start of surgery

研究概览

简要总结

Myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. Fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects such as maternal acidosis.

详细描述

The objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary outcome was maternal arterial pH at the end of surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Pregnant women over 18 years
  • Single fetus pregnancy
  • Fetus with myelomeningocele
  • Gestational age from 19 to 26
  • Fetus with normal karyotype

排除标准

  • Multiple pregnancy
  • Fetal abnormality not related to myelomeningocele
  • Kyphosis greater than or equal to 30 degrees
  • Placenta previa
  • Maternal disease that increases the risk of pregnancy (insulin-dependent DM, hypertension poorly controlled)
  • History of incompetent cervix
  • Carrier of HIV, hepatitis B or hepatitis C
  • Maternal-fetal isoimmunization
  • Uterine Alteration
  • Obesity (IMC greater than 30)

研究组 & 干预措施

Atosiban

Intravenous Atosiban as main tocolytic agent

干预措施: Atosiban (Drug)

Terbutaline

Intravenous Terbutaline as main tocolytic agent

干预措施: Terbutaline (Drug)

结局指标

主要结局

Maternal arterial blood pH at the start of surgery

时间窗: Right after intubation

Arterial blood pH

Maternal arterial blood pH at the end of surgery

时间窗: Before extubation

Arterial blood pH

Maternal arterial blood pH at 120 minutes after surgery

时间窗: Two hours after the end of surgery

Arterial blood pH

次要结局

  • Short-term fetal repercussions(In the end of the surgery, before extubation)
  • Long-term fetal repercussions(At the birth)

研究者

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

Hermann dos Santos Fernandes

Attending Anesthetist

University of Sao Paulo General Hospital

研究点 (1)

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