None listed
Conditions
Brief summary
Background: An enhanced recovery strategy involves various pre, intra, and postoperative steps to reduce the normal stress response and organ dysfunction associated with surgical insult, with the ultimate aim of reducing time to full recovery. Preoperative carbohydrate administration is one of the components of an enhanced recovery strategy. However, preoperative carbohydrate treatment for pregnant women undergoing elective caesarean section has the potential to cause rebound hypoglycaemia in the newborn infant. The glycaemic control of newborn infants born to mothers receiving preoperative carbohydrate loading, as a part of an enhanced recovery strategy has not previously been studied. Methods: We propose a pilot randomized controlled clinical trial to investigate the effect of preoperative carbohydrate loading in pregnant women undergoing elective caesarean section, on the glycaemic control of newborn infants. One hundred pregnant women scheduled for an elective caesarean section will be recruited after informed consent. They will be randomised to either intervention or control arm, and receive preoperative carbohydrate loading or no carbohydrate loading respectively. The remainder of their peri-operative management will be as per King Edward Memorial Hospital (KEMH) protocol for enhanced recovery. Newborn infants will be monitored for the risk of hypoglycaemia using KEMH neonatal unit guidelines for “infants at risk of hypoglycaemia”. Outcomes: The primary outcomes will be blood glucose concentration in newborn infant at four and ten hours of life, and the requirement for admission to newborn nursery for the management of hypoglycaemia. Secondary outcomes will include maternal blood glucose concentration during caesarean section, maternal medication requirement for postoperative nausea, and length of hospital stay. Significance: If the study shows that should this pilot study show that pre caesarean section carbohydrate does not increase risk of hypoglycaemia in newborn infants, we can safely introduce this component to our enhanced recovery protocol. Pre caesarean section carbohydrate loading has the potential to enhance maternal recovery and decrease length of hospital stay resulting in financial saving.
Interventions
Mothers will be randomised to either control or intervention arm.
Intervention arm women will be asked to consumed 200 grams of oral complex carbohydrate drink (Nutricia PreOp which contains 50 grams of complex carbohydrate per 200mls) the evening prior to elective caesarean section, and 100 grams on the morning of caesarean section. Mother and neonatal serum blood glucose level will be tested at fixed points following delivery of the fetus. Specifically fetal blood sugar will be measured a
Mothers will be randomised to either control or intervention arm. Intervention arm women will be asked to consumed 200 grams of oral complex carbohydrate drink (Nutricia PreOp which contains 50 grams of complex carbohydrate per 200mls) the evening prior to elective caesarean section, and 100 grams on the morning of caesarean section. Mother and neonatal serum blood glucose level will be tested at fixed points following delivery of the fetus. Specifically fetal blood sugar will be measured at 4 and 10 hours of age - corresponding to before their second and fourth feed. Management of neonate blood sugar thereafter will be as per our local guideline. Following randomisation and allocation of intervention or placebo arm, our research nurse with over 15 years experience will issue each study participant with their drink. This will take place face to face. To ensure and maintain blinding, each study participant will receive a two drinks to consume. One the night prior to their caesarean section, and the second to be consumed between one and two hours prior to their surgery. The first drink will be consumed at the participants home, and the second most likely in our day of surgery admission unit. Prior to the testing of blood serum glucose concentration, study participants will be asked to verbally confirm that they have consumed both study drinks that were issued to them. verbal confirmation will be deemed adequate confirmation.
Sponsors
Associate CLinical Professor Nolan McDonnell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant women undergoing elective caesarean section 2. Term gestational age (37+0 to 41+6 weeks) 3. Singleton gestation
Exclusion criteria
1. Women with gestational diabetes and diabetes mellitus 2. Fetal intrauterine growth restriction 3. Ante-natally detected congenital anomaly which will require admission to neonatal nursery 4. Non English speaking
Outcome results
None listed