Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505915
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
Carbohydrate Loading Fasting Protocol Versus Sip Til Send
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Carbohydrate Loading Fasting Protocol Versus Sip Til Send a Randomised Trial of Two Different Fasting Protocols At Elective Caesarean Delivery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery Recently Rotunda Maternity Hospital have started using two fasting protocols at the Rotunda prior to elective caesarean section one uses carbohydrate drinks and the other encourages women to sip water until they are called to the operating theatre The evidence to support the use of either one is very limited This study would help streamline one of the protocols
Detailed Description:
This is a study focused on comparing fasting policies that are in use at the Rotunda
Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience
A Sip til send fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery This policy was implemented at the Rotunda in 2022 and was studied prospectively investigators demonstrated improvements in the comfort that women experience in their perioperative journey compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre
It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries but there is very limited evidence in obstetrics The Rotunda is increasingly providing women with carbohydrate drinks prior to CD These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery ERAS package There is little evidence to support the use of carbohydrate drinks but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting
Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively Carbohydrate reserves are rapidly exhausted causing hypoglycemia increased urine nitrogen secretion indicating muscle catabolism and increased urinary ketone body concentration It has been recommended that Mothers in their third trimester avoid skipping meals
Investigators wish to study the effects of integrating carbohydrate drinks into the current sip til send fasting protocol and determine if these women benefit from either protocol
Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience
A Sip til send fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery This policy was implemented at the Rotunda in 2022 and was studied prospectively investigators demonstrated improvements in the comfort that women experience in their perioperative journey compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre
It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries but there is very limited evidence in obstetrics The Rotunda is increasingly providing women with carbohydrate drinks prior to CD These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery ERAS package There is little evidence to support the use of carbohydrate drinks but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting
Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively Carbohydrate reserves are rapidly exhausted causing hypoglycemia increased urine nitrogen secretion indicating muscle catabolism and increased urinary ketone body concentration It has been recommended that Mothers in their third trimester avoid skipping meals
Investigators wish to study the effects of integrating carbohydrate drinks into the current sip til send fasting protocol and determine if these women benefit from either protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None