Pilot Randomized Controlled Trial Evaluating Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Active Labor With Epidural Analgesia in Low-Risk Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Duration of Labor
Study Overview
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.
Detailed Description
Background Pregnancy involves an increase in anabolic metabolism, especially during the third trimester due to continuous fetal and placental growth. During active labor, metabolic demands increase further, reaching levels comparable to moderate or intense physical exercise. A 10-hour labor with epidural analgesia may not be adequately supported by clear liquids, saline, or glucose alone; nutritional support should be better adapted to the energy needs of laboring women.
Recent studies have shown mixed results regarding carbohydrate intake during labor, without a consistent effect on labor duration or mode of delivery, although some evidence suggests benefits for maternal comfort and neonatal glycemia
. A 2016 meta-analysis involving 691 women found that oral carbohydrate supplements in small amounts (mean difference of 195 kcal) did not significantly alter labor duration, cesarean rates, or instrumental delivery rates. A large multicenter trial with 3,984 women found no differences in instrumental delivery rates between carbohydrate and fasting groups.
However, a Chinese multicenter trial involving 1,953 primigravid women with epidural analgesia reported reduced maternal hunger and lower neonatal hypoglycemia with carbohydrate supplementation, although higher rates of maternal and neonatal hyperglycemia were observed.
Aspiration Concerns and Modern Practice Historical restrictions on oral intake during labor stem from Mendelson's 1946 description of aspiration risk during general anesthesia. However, modern obstetric anesthesia has evolved considerably, with neuraxial techniques now standard and general anesthesia rarely used for childbirth. Current guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the American Society of Anesthesiologists (ASA) recommend a moderate intake of clear liquids during an uncomplicated labor, while solid foods are generally avoided.The incidence of aspiration in modern obstetric practice is extremely low.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Triple-blind design: The hospital pharmacy prepares and codes all gel packs (G1-G148) and maintains the only record linking codes to gel type. Participants, attending midwives (care providers), investigators conducting the study, and outcomes assessors remain blinded to group assignment until data collection is complete. Only pharmacy staff have access to the randomization key.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
High carbohydrate sports gel
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.
Intervention: High carbohydrate sports gel (Dietary Supplement)
Low carbohydrate hydrogel
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.
Intervention: Low carbohydrate hydrogel (Dietary Supplement)
Outcomes
Primary Outcomes
Duration of Labor
Time Frame: Timing of epidural analgesia administration to delivery (approximately 1-12 hours).
Time elapsed from epidural catheter insertion until delivery, measured in minutes. Recorded by attending midwife on data collection form.
Secondary Outcomes
- Postpartum Hemorrhage(Within 24 hours postpartum)
- Maternal Vomiting Episodes(From first study product administration to delivery)
- Maternal Blood Glucose(60 minutes after study product administration (repeated if labor exceeds 3 hours))
- Maternal Satisfaction(Within 24 hours postpartum)
- Neonatal APGAR Score (1, 5, 10 minutes).(1, 5 and 10 minutes after birth.)
- Cardiotocographic Classification(During active labor until delivery)
- Neonatal Blood Glucose(60-120 minutes after birth)
Investigators
Olga Casanova
Investigador principal
Institut Investigacio Sanitaria Pere Virgili