Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009567
NCT ID: NCT03494868
Sponsor Protocol Number: 16-009567
About this study
Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Oral carbohydrate loading has been shown to attenuate the development of insulin resistance in the non-pregnant population undergoing many different types of surgery. Pregnant women have an increase in insulin resistance and therefore may further benefit from a preoperative carbohydrate load prior to cesarean delivery. Although woman in the UK receive a carbohydrate drink prior to elective cesarean delivery, the metabolic effects of these drinks on the mother and neonate have not been evaluated.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ASA physical status II-III women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia
- Singleton gestation at term (37-42 weeks)
- Female, age 18-50 years old.
Exclusion Criteria:
- Preexisting diabetes (Gestational diabetes, Type I DM, Type II DM).
- Taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism.
- Kidney, heart, or liver disease. Severe lipid disorders.
- History of bariatric surgery.
- Pre-pregnancy BMI > 40.
- Prolonged period of time (>4 hours) between ingestion of carbohydrate drink and surgery.
- Four or more repeat cesarean sections.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Emily Sharpe, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available