NCT07742748 Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
| NCT ID | NCT07742748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili |
| Condition | Obstetric Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 147 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 147 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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).
Contact & Investigator
Olga Casanova Callau, Midwife
PRINCIPAL INVESTIGATOR
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.
Frequently Asked Questions
Who can join the NCT07742748 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obstetric Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07742748 currently recruiting?
Yes, NCT07742748 is actively recruiting participants. Contact the research team at ocasanovac.ebre.ics@gencat.cat for enrollment information.
Where is the NCT07742748 trial being conducted?
This trial is being conducted at Tortosa, Spain.
Who is sponsoring the NCT07742748 clinical trial?
NCT07742748 is sponsored by Institut Investigacio Sanitaria Pere Virgili. The principal investigator is Olga Casanova Callau, Midwife at 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.. The trial plans to enroll 147 participants.