Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor (NCT07742748) | Clinical Trial Compass
RecruitingNot Applicable
Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
Spain147 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of Labor
Timeframe: Timing of epidural analgesia administration to delivery (approximately 1-12 hours).
Trial details
NCT IDNCT07742748
SponsorInstitut Investigacio Sanitaria Pere Virgili