The Use of High-energy Digestible Food in Women Undergoing Caesarean Section

NCT03747016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-11-20

No results posted yet for this study

Summary

Traditionally, Fasting for more than 8 hours before operation is administered to reduce the risk of reverse flow and aspiration. ASA guidelines suggest a 2-hour fasting for clear fluid in healthy people before elective surgery. But in delivery women, the gastric emptying time is affected by the physiological change. This study is a prospective randomized controlled study to investigate the gastric emptying time of high energy digestible foods in delivery women, and the effect of high energy digestible food given before surgery on the comfort and metabolism of women undergoing Cesarean section. In the first step, 60 women in delivery room whose gastric volume less than 3.81 cm2 are randomly divided into three groups, 20 cases in each group. The experimental group (Group E1) is treated with high energy digestible food 300ml, Group G1 is given 5% glucose injection 300ml and Group N1 is given normal saline 300ml. The gastric volume was determined by ultrasonography once every hour until gastric volume less than 3.81cm2, and the time of gastric emptying was determined. The second step was to recruit 80 cases of full-term elective cesarean section. They were randomly divided into four groups, 20 cases in each group. The experimental group (Group E2) was given high energy digestible food 300ml before the time of gastric emptying found in the first step , Group G2 is given 5% glucose injection 300ml and Group N2 is given normal saline 300ml, while the control group (Group C2) was not given any diet. After admission to the operation room, the volume of the stomach was measured by ultrasound, and the differences of comfort, body temperature, shivering, blood glucose and postoperative anal exhaust time between the two groups were observed. This study is going to investigate the gastric emptying time of high energy digestible foods in delivery women, and the effect of high energy digestible food on the comfort, body temperature and blood glucose of women undergoing Cesarean section, so as to provide a good basis for reducing the surgery stress in women undergoing Cesarean section.

Conditions

  • Caesarean Section

Interventions

DIETARY_SUPPLEMENT

high-energy digestible food E2

The women undergoing Cesarean section are given high energy digestible food 300ml before surgery

DIETARY_SUPPLEMENT

glucose injection G2

The women undergoing Cesarean section are given glucose injection 300ml before surgery

DIETARY_SUPPLEMENT

normal saline N2

The women undergoing Cesarean section are given normal saline 300ml before surgery

DIETARY_SUPPLEMENT

high-energy digestible food E1

The women in delivery room are given high energy digestible food 300ml.

DIETARY_SUPPLEMENT

glucose injection G1

The women in delivery room are given glucose injection 300ml.

DIETARY_SUPPLEMENT

normal saline N1

The women in delivery room are given normal saline 300ml.

Sponsors & Collaborators

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-08-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747016 on ClinicalTrials.gov