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

NCT03747016 | Unknown

• 1 other identifier: ERAS obstetric
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• body temperature

  Maternal tympanic temperature measured by infrared ear thermometer

  the time point when newborn delivers and 1 hour after surgery

Secondary Outcomes (5)

• Maternal comfort

  up to 24 hours after surgery

• Incidence and severity of shivering

  up to 1 hour after surgery

• nausea and vomitting after surgery

  up to 24 hours after surgery

• flatus time

  up to 48 hours after surgery

• pain after surgery

  up to 48 hours after surgery

Study Arms (7)

High energy 2

EXPERIMENTAL

In the second step, the experimental group (Group E2) was given high energy digestible food 300ml before the time of gastric emptying found in the first step before surgery.

Dietary Supplement: high-energy digestible food E2

Glucose 2

ACTIVE COMPARATOR

In the second step, Group G2 is given 5% glucose injection 300ml before the time of gastric emptying found in the first step before surgery.

Dietary Supplement: glucose injection G2

Normal saline 2

PLACEBO COMPARATOR

In the second step, Group N2 is given normal saline 300ml before the time of gastric emptying found in the first step before surgery.

Dietary Supplement: normal saline N2

Control 2

NO INTERVENTION

In the second step, the control group (Group C2) was not given any diet before surgery.

High energy 1

EXPERIMENTAL

In the first step,The experimental group (Group E1) is treated with high energy digestible food 300ml.

Dietary Supplement: high-energy digestible food E1

Glucose1

ACTIVE COMPARATOR

In the first step, Group G1 is given 5% glucose injection 300ml

Dietary Supplement: glucose injection G1

Normal saline 1

PLACEBO COMPARATOR

In the first step, Group N1 is given normal saline 300ml.

Dietary Supplement: normal saline N1

Interventions

high-energy digestible food E2 DIETARY_SUPPLEMENT

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

Also known as: E2

High energy 2

glucose injection G2 DIETARY_SUPPLEMENT

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

Also known as: G2

Glucose 2

normal saline N2 DIETARY_SUPPLEMENT

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

Also known as: N2

Normal saline 2

high-energy digestible food E1 DIETARY_SUPPLEMENT

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

Also known as: E1

High energy 1

glucose injection G1 DIETARY_SUPPLEMENT

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

Also known as: G1

Glucose1

normal saline N1 DIETARY_SUPPLEMENT

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

Also known as: N1

Normal saline 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA (American Society of Anesthesiologist) grade II, full term singleton pregnancy subjects aged 18 to 50 years old;
• subjects undergoing elective cesarean section under combined spinal epidural anesthesia;
• volunteered to participate in the study and signed informed consent.

You may not qualify if:

• related drug allergies or taboo;
• Severe cardiopulmonary disorders (New York Heart Association Classification III-IV, or left ventricular ejection fraction \< 30%) and liver and kidney dysfunction (alanine aminotransferase exceeding the upper limit of normal value twice, creatinine exceeding the upper limit of normal value 1.5 times), alcoholism history;
• there are metabolic diseases such as gestational diabetes mellitus, or using drugs that affect metabolism;
• the subjects were unable to cooperate or to communicate;
• the subjects suffered from psychosocial diseases;
• participated in other clinical trials within one month;
• there is drug abuse.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

methyl N-acetylsibirosaminide

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 20, 2018
• Study Start: December 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

CN (1)