RECRUITING Not applicable ClinicalTrials.gov

Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor

Sponsor: Institut Investigacio Sanitaria Pere Virgili • ClinicalTrials.gov ID: NCT07742748

Registry updated: 2026-09-09

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Description

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.

Interventions

High carbohydrate sports gel (Dietary supplement)
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 (Dietary supplement)
Low carbohydrate hydrogel. Matched in appearance, texture, and administration schedule to the experimental intervention to maintain participant and provider blinding.

Eligibility criteria

Inclusion Criteria: * Pregnancy classified as Normal Pregnancy, Low-Risk Pregnancy, or Medium-Risk Pregnancy according to the "Protocol de seguiment de l'embaràs a Catalunya" and "Protocol de naixement i acompanyament al naixement de Catalunya". * Use of epidural analgesia during labor. * Ability to understand Catalan and/or Spanish. * Term pregnancy (≥37 weeks gestation). * Cephalic presentation. * Spontaneous onset of labor, OR induced labor due to prolonged pregnancy or premature rupture of membranes (regardless of duration). * Prenatal care at ASSIR Terres de l'Ebre with planned delivery at Hospital Universitari Tortosa Verge de la Cinta. * Signed informed consent prior to labor. Exclusion Criteria: * Gestational diabetes (including diet and exercise controlled). * Multiple gestation. * Labor not documented in partograph. * Informed consent not signed prior to labor. * Medical indication requiring administration of glucose or glucose-saline intravenous solution during labor (withdrawal criterion).

Conditions

Obstetric Labor

Locations

HUTVC — Tortosa, Tarragona, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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