Caesarean SectionNCT03747016
The Use of High-energy Digestible Food in Women Undergoing Caesarean Section
A study testing high-energy digestible food E2, glucose injection G2 and normal saline N2 in people with Caesarean Section, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Caesarean Section
- What is being tested?
- high-energy digestible food E2, glucose injection G2 and normal saline N2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality
Qiwei Wu, 13564621298, 13564621298@163.com
About this study
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.
Read the detailed 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.
- Conditions
- Caesarean Section
- Being tested
- high-energy digestible food E2, glucose injection G2, normal saline N2, high-energy digestible food E1, glucose injection G1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-energy digestible food E2Dietary supplement
Also called E2
The women undergoing Cesarean section are given high energy digestible food 300ml before surgery
glucose injection G2Dietary supplement
Also called G2
The women undergoing Cesarean section are given glucose injection 300ml before surgery
normal saline N2Dietary supplement
Also called N2
The women undergoing Cesarean section are given normal saline 300ml before surgery
high-energy digestible food E1Dietary supplement
Also called E1
The women in delivery room are given high energy digestible food 300ml.
glucose injection G1Dietary supplement
Also called G1
The women in delivery room are given glucose injection 300ml.
normal saline N1Dietary supplement
Also called N1
The women in delivery room are given normal saline 300ml.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: high-energy digestible food E1 |
| Glucose1 | Active comparator | In the first step, Group G1 is given 5% glucose injection 300ml Receives: Dietary Supplement: glucose injection G1 |
| Normal saline 1 | Placebo comparator | In the first step, Group N1 is given normal saline 300ml. Receives: Dietary Supplement: normal saline N1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
body temperature
Maternal tympanic temperature measured by infrared ear thermometer
Measured: the time point when newborn delivers and 1 hour after surgery
Secondary outcomes (5)
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.
Measured: up to 24 hours after surgery
Incidence and severity of shivering
Incidence and severity of shivering is assessed with Wrench's Grade.
Measured: up to 1 hour after surgery
nausea and vomitting after surgery
The severity of postoperative nausea and vomitting is assessed with CTCAE v4.0.
Measured: up to 24 hours after surgery
flatus time
The time point when anal exhaust restarts after surgery
Measured: up to 48 hours after surgery
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.
Measured: up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747016
- Sponsor's protocol ID
- ERAS obstetric
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of High-energy Digestible Food in Women Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT03747016
- Acronym / sponsor ID
- ERAS obstetric
- Conditions
- Caesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| High energy 2 | Experimental | Dietary Supplement: high-energy digestible food E2In 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. |
| Glucose 2 | Active comparator | Dietary Supplement: glucose injection G2In the second step, Group G2 is given 5% glucose injection 300ml before the time of gastric emptying found in the first step before surgery. |
| Normal saline 2 | Placebo comparator | Dietary Supplement: normal saline N2In the second step, Group N2 is given normal saline 300ml before the time of gastric emptying found in the first step before surgery. |
| Control 2 | No intervention | –In the second step, the control group (Group C2) was not given any diet before surgery. |
| High energy 1 | Experimental | Dietary Supplement: high-energy digestible food E1In the first step,The experimental group (Group E1) is treated with high energy digestible food 300ml. |
| Glucose1 | Active comparator | Dietary Supplement: glucose injection G1In the first step, Group G1 is given 5% glucose injection 300ml |
| Normal saline 1 | Placebo comparator | Dietary Supplement: normal saline N1In the first step, Group N1 is given normal saline 300ml. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-energy digestible food E2Also: E2The women undergoing Cesarean section are given high energy digestible food 300ml before surgery | Dietary supplement | High energy 2 |
| glucose injection G2Also: G2The women undergoing Cesarean section are given glucose injection 300ml before surgery | Dietary supplement | Glucose 2 |
| normal saline N2Also: N2The women undergoing Cesarean section are given normal saline 300ml before surgery | Dietary supplement | Normal saline 2 |
| high-energy digestible food E1Also: E1The women in delivery room are given high energy digestible food 300ml. | Dietary supplement | High energy 1 |
| glucose injection G1Also: G1The women in delivery room are given glucose injection 300ml. | Dietary supplement | Glucose1 |
| normal saline N1Also: N1The women in delivery room are given normal saline 300ml. | Dietary supplement | Normal saline 1 |
Primary outcome
body temperature
Time frame: the time point when newborn delivers and 1 hour after surgery
Maternal tympanic temperature measured by infrared ear thermometer
5 secondary outcomes
Maternal comfort
Time frame: up to 24 hours after surgery
Incidence and severity of shivering
Time frame: up to 1 hour after surgery
nausea and vomitting after surgery
Time frame: up to 24 hours after surgery
flatus time
Time frame: up to 48 hours after surgery
pain after surgery
Time frame: up to 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Caesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-energy digestible food E2, glucose injection G2 and normal saline N2 in people with Caesarean Section, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body temperature (time frame: the time point when newborn delivers and 1 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.