Carbohydrate drink vs low-sugar beverage during labor with epidural analgesia
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
Run by Institut Investigacio Sanitaria Pere Virgili · NCT07742748 · Data updated 2026-11-12
This pilot randomized trial tests whether a carbohydrate-rich sports gel given during labor with epidural analgesia helps with maternal and neonatal outcomes compared with a low-sugar drink.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 147 (estimated) |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili Academic / other |
| Locations | 1 site (Tortosa, Tarragona) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07742748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are term, low-risk pregnant women planning labor with epidural analgesia at the participating center, fluent in Catalan or Spanish, and able to consent before labor.
✕Probably not a fit
Patients who are not in active labor, do not require epidural analgesia, or have conditions requiring glucose/IV fluids during labor may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a pilot, triple-blind randomized trial enrolling low-risk term pregnancies to compare energy supplementation with a carbohydrate-rich sports gel against a low-sugar beverage during labor. The intervention starts 60 minutes after epidural analgesia and is repeated every 3 hours, up to four doses, until delivery. The study uses a single-center setting to estimate preliminary effects on labor outcomes, maternal comfort, and neonatal measures, addressing the metabolic demands of labor with and without carbohydrate support. Eligibility focuses on term, cephalic, Epidural-receiving pregnancies who are fluent in Catalan or Spanish, with informed consent obtained before labor.
Why it matters
Potential benefit: If successful, the approach could improve maternal energy management and potentially favor neonatal糖emia and comfort during labor.
How similar studies have gone: Prior studies have shown mixed results; some suggest benefits in maternal comfort or neonatal glycemia, while others show no significant differences, making this verification important.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Hutvc
Tortosa, Tarragona, Spain Recruiting
Study contacts
- Principal investigator: Olga Casanova Callau, Midwife — Institut de Recerca Biomèdica Catalunya Sud (IRBCatSud), Tortosa, Spain; Servei de Paritori, Hospital Universitari de Tortosa Verge de la Cinta, Institut Català de la Salut, Tortosa, Spain.
- Study coordinator: Olga Casanova Callau, Midwife
- Email: ocasanovac.ebre.ics@gencat.cat
- Phone: +34977519100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.