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Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
Sponsor: Institut Investigacio Sanitaria Pere Virgili
Summary
This is a pilot randomized, triple-blind clinical trial (pilot RCT) evaluating the preliminary effects of energy supplementation with carbohydrate-rich sports gels compared to a low-sugar sports drink during labor in low-risk pregnant women receiving epidural analgesia. Labor is associated with substantially increased metabolic demands, while current evidence on intrapartum carbohydrate supplementation remains heterogeneous. This study investigates whether a carbohidrate solution formulation containing improves maternal and neonatal outcomes compared to an other. A total of 142 term, low-risk pregnant women will be recruited at a single hospital center and randomized to receive either the sports gel or the control beverage. The intervention will begin 60 minutes after epidural analgesia and be repeated every 3 hours until delivery, with a maximum of 4 units administered per participant. The primary objective is to obtain preliminary estimates of the intervention effects on labor duration and obstetric and neonatal outcomes. Secondary outcomes include cardiotocography patterns, maternal and neonatal glucose levels, postpartum hemorrhage, vomiting episodes, and maternal satisfaction. This trial was prospectively registered. The study was initially conceived as a pilot randomized controlled trial within an institutional research framework, and registration was completed after participant recruitment had been completed to ensure transparency and adherence to international reporting standards. The results of this pilot study will inform the design of a future large-scale randomized controlled trial.
Official title: Pilot Randomized Controlled Trial Evaluating Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Active Labor With Epidural Analgesia in Low-Risk Pregnant Women
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
147
Start Date
2025-09-01
Completion Date
2026-08-01
Last Updated
2026-08-03
Healthy Volunteers
No
Interventions
High carbohydrate sports gel
High carbohydrate sports gel (Intervention): The gel provides energy intake with low gastric volume. Low carbohydrate hydrogel (Control Description): A lower-sugar solution. The product is thickened using a food-grade agent to match the viscosity and palatability of the sports gel, ensuring comparability between interventions.
Low carbohydrate hydrogel
Low carbohydrate hydrogel. Matched in appearance, texture, and administration schedule to the experimental intervention to maintain participant and provider blinding.
Locations (1)
HUTVC
Tortosa, Tarragona, Spain