NCT07742748

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 25, 2026

Last Update Submit

July 29, 2026

Conditions

Obstetric LaborEnergy MetabolismNeonatal OutcomesLabor NutritionMaternal Outcomes

Keywords

Maternal OutcomesLabor OutcomesEpidural Analgesiaoral carbohydrate supplementationDietary Supplementsmaternal energy intake

Outcome Measures

Primary Outcomes (1)

  • Duration of Labor

    Time elapsed from epidural catheter insertion until delivery, measured in minutes. Recorded by attending midwife on data collection form.

    Timing of epidural analgesia administration to delivery (approximately 1-12 hours).

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

High carbohydrate sports gel

EXPERIMENTAL

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 hydrogel

ACTIVE 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

Interventions

High carbohydrate sports gelDIETARY_SUPPLEMENT

High carbohydrate sports gel (Intervention): The gel provides energy intake with low gastric volume. Low carbohydrate hydrogel (Control Description): A lower-sugar solution. The product is thickened using a food-grade agent to match the viscosity and palatability of the sports gel, ensuring comparability between interventions.

High carbohydrate sports gel
Low carbohydrate hydrogelDIETARY_SUPPLEMENT

Low carbohydrate hydrogel. Matched in appearance, texture, and administration schedule to the experimental intervention to maintain participant and provider blinding.

Low carbohydrate hydrogel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUTVC

Tortosa, Tarragona, 43500, Spain

RECRUITING

Related Publications (3)

  • Becker CE, Lorenz W, de Abreu MG, Koch T, Kiss T. Airway management and pulmonary aspiration during surgical interventions in pregnant women in the 2nd/3rd trimester and immediate postpartum - a retrospective study in a tertiary care university hospital. BMC Anesthesiol. 2024 May 3;24(1):166. doi: 10.1186/s12871-024-02551-4.

    PMID: 38702641BACKGROUND

  • Bruce-Hickman K, Fan K, Plaat F, Sheth S. Decision-making on the labour ward during the COVID-19 pandemic. Int J Obstet Anesth. 2021 Feb;45:150-151. doi: 10.1016/j.ijoa.2020.10.005. Epub 2020 Oct 16. No abstract available.

    PMID: 33218871BACKGROUND

  • 14.Kaleta T Dr. The Effect of Altered Metabolism on Uterine Contractility [Thesis submitted in accordance with the requirements of the University of Liverpool for the degree of Doctor in Philosophy]. University of Liverpool; 2023.

    BACKGROUND

Related Links

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Casanova Callau, Midwife

CONTACT

+34977519100ocasanovac.ebre.ics@gencat.cat

Jael Lorca Cabrera, PhD

CONTACT

+34977519227jlorca.ebre.ics@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel-group, 1:1 randomized controlled pilot trial in which participants are assigned to receive High carbohydrate sports gel or Low carbohydrate hydrogel. Each participant remains in the same intervention arm throughout the study, with no crossover between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador principal

Study Record Dates

First Submitted

July 25, 2026

First Posted

August 3, 2026

Study Start

September 1, 2025

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. This is a single-center, investigator-initiated pilot randomized controlled trial conducted within a public healthcare setting, and there is currently no formal data sharing infrastructure in place. All data are de-identified and securely stored in accordance with institutional and data protection regulations. Data sharing may be considered in the future following publication of the primary results and development of appropriate data governance procedures.

Locations

ES(1)