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.
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).
Gestational diabetes (including diet and exercise controlled).
Multiple gestation.
Labor not documented in partograph.
Informed consent not signed prior to labor.
Parallel
High carbohydrate sports gel
Dietary supplementHigh 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 supplementLow carbohydrate hydrogel. Matched in appearance, texture, and administration schedule to the experimental intervention to maintain participant and provider blinding.
Duration of Labor
Time elapsed from epidural catheter insertion until delivery, measured in minutes. Recorded by attending midwife on data collection form.
Postpartum Hemorrhage
Presence of postpartum hemorrhage defined as blood loss \> 500 mL (yes/no).
Maternal Vomiting Episodes
Number of vomiting episodes during active labor (count variable).
Maternal Blood Glucose
Capillary blood glucose level measured 60 minutes after intervention administration. Recorded in mg/dL.
Maternal Satisfaction
Maternal satisfaction with labor nutritional support measured using CSTA scale (Client Satisfaction Scale). 5-point ordinal scale: very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied.
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Institut Investigacio Sanitaria Pere Virgili
Lead sponsor
Institut Catala de Salut
Collaborator
