Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor | NCT07742748

NCT07742748

Overview

NCT ID: NCT07742748
Lead Sponsor: Institut Investigacio Sanitaria Pere VirgiliOTHER
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
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Sep 1, 2025Actual
Primary Completion Date: Aug 1, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
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).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 147Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Olga Casanova Callau, MidwifeContact
ocasanovac.ebre.ics@gencat.cat

Similar Studies

Participant Group/Arms

High carbohydrate sports gelExperimental

Participants receive a carbohydrate solution named High carbohydrate sports gel.The solution contains a mixture of carbohydrates designed to support sustained energy availability. The product is administered 60 minutes after epidural placement and subsequently every 3 hours during active labor, up to a maximum of four administrations. Water intake is encouraged throughout labor.

Dietary Supplement: High carbohydrate sports gel

Low carbohydrate hydrogelActive Comparator

Participants receive a low carbohydrate hydrogel. It is modified with xanthan gum (a food-grade thickening agent) to match the viscosity and palatability of the High carbohydrate sports gel. Administration follows the same schedule as the intervention group: first dose 60 minutes after epidural placement and then every 3 hours during active labor, up to a maximum of four administrations.

Dietary Supplement: Low carbohydrate hydrogel