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Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor

RecruitingNAAges 18 Years - anyFemaleInstitut Investigacio Sanitaria Pere Virgili
NCT07742748 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • High carbohydrate sports gel
  • Low carbohydrate hydrogel
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Where

1 site
HUTVC
Tortosa, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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