跳至主要内容
临床试验/NCT03949166
NCT03949166Unknown不适用

Does Oral Intake During Labor and Delivery Have an Effect on Complications and Outcome

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年12月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
2
主要终点
prolonged second stage of labor

研究概览

简要总结

The recommendations regarding eating and drinking during the labor and delivery process are not clear.

The objective of this study is to assess whether eating and drinking during the labor process improves obstetric outcomes and maternal satisfaction.

Patients admitted for the birthing center during the first stage of the delivery and after having a regional anesthesia are instructed as a routine in our birthing center for fasting and drinking only water and clear fluids during their stay at the labor and delivery room and until after giving birth.

The patients will be asked if they are interested in participating in the study. A patient that is interested will be randomized to join one of the two arms: Fasting arm, with the routine management of water and clear fluids or eating, she will be asked to eat every 2 hours or less a food from a list supplied by the study team.

The list of food was created with the anesthesiologist team according the review board demand.

The data regarding the patients' history, pregnancy and labor and delivery process. Obstetrical and neonatal outcome will be collected. A satisfactory questioner well be sent to all participants.

详细描述

Vaginal birth can be a prolonged process, especially during the first delivery. The recommendations regarding eating and drinking during the labor and delivery process are not clear. There is no agreement between the physicians regarding eating and drinking while being in labor in the birthing center. This disagreement is due to lack of research in this field and inconclusive results in previous studies.

Prolonged fasting during labor can lead to execution of the patients making them tired and less tolerant to the pain, decreasing their ability to cooperate during the pushing phase. However, the recommendation to avoid eating has justified by the risk for unplanned cesarean section which is done under fasting. In general, cesarean sections are done under regional anesthesia but if there is a need for general anesthesia (due to pain or urgency), there is a risk for aspiration if the patient has not been fasting.

We also know that the stomach is clearing slower in the labor process, therefore some recommend fasting during labor.

In recent years there is a decrease in the use of general anesthesia during cesarean sections and since the incidence of aspiration during cesarean section is rare and due to the demand from the patients for autonomy and controlling their labor process including the option of eating the debate regarding eating during labor and delivery is justified.

In 2009 an ACOG(American College of Obstetricians and Gynecologists ) committee report concluded that there is not enough evidence regarding the link between drinking clear fluids and reflux , vomiting and aspiration during labor.

研究设计

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

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

  • Pregnancy at 37 weeks or more
  • After an epidural anaesthesia

排除标准

  • Preterm delivery before 37 weeks of pregnancy
  • Known anomalies or chromosomal abnormalities
  • Patient at increased risk for aspiration based on anesthesiologist assesment
  • A patient post epidural anesthesia with pain indicating the need for a new epidural insertion

结局指标

主要结局

prolonged second stage of labor

时间窗: the delivery

The mean time from full dilatation to the delivery of the baby on each group

operative vaginal delivery

时间窗: the delivery

The mean incidence of operative vaginal delivery in each group

cesarean section

时间窗: the delivery

The mean incidence of cesarean section in each group

duration of pushing

时间窗: the delivery

The mean time from beginning of pushing with the midwife to the delivery of the baby in each group

次要结局

  • Maternal satisfaction(from 2 days after delivery until 6 months after the delivery , she will be asked once)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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