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

Caesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03747016
• Other study ID #: ERAS obstetric
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 are enrolled, who are full term singleton pregnancy subjects ranging 18 to 50 years old and fasting for more than 8 hours. They 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 gastric antrum cross-sectional area (CSA) measured with ultrasonography before drinking and once every hour after drinking. Once CSA is less than 3.81 cm2, the time is recorded as gastric emptying time of the woman. The overall gastric emptying time of high energy digestible food is determined with the 90 percentile gastric emptying time of women drinking high energy digestible food.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Caesarean Section

Intervention

Dietary Supplement:
• high-energy digestible food E2
The women undergoing Cesarean section are given high energy digestible food 300ml before surgery
• glucose injection G2
The women undergoing Cesarean section are given glucose injection 300ml before surgery
• normal saline N2
The women undergoing Cesarean section are given normal saline 300ml before surgery
• high-energy digestible food E1
The women in delivery room are given high energy digestible food 300ml.
• glucose injection G1
The women in delivery room are given glucose injection 300ml.
• normal saline N1
The women in delivery room are given normal saline 300ml.

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body temperature	Maternal tympanic temperature measured by infrared ear thermometer	the time point when newborn delivers and 1 hour after surgery
Secondary	Maternal comfort	Maternal comfort is measured by the women undergoing Cesarean section with visual analogy scale. Respondents mark the location on the 10-centimeter line corresponding to the amount of comfort they experienced.	up to 24 hours after surgery
Secondary	Incidence and severity of shivering	Incidence and severity of shivering is assessed with Wrench's Grade.	up to 1 hour after surgery
Secondary	nausea and vomitting after surgery	The severity of postoperative nausea and vomitting is assessed with CTCAE v4.0.	up to 24 hours after surgery
Secondary	flatus time	The time point when anal exhaust restarts after surgery	up to 48 hours after surgery
Secondary	pain after surgery	Maternal pain is measured by the women undergoing Cesarean section with visual analogy scale. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced.	up to 48 hours after surgery