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Obstetric LaborNCT07742748

Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor

A study testing High carbohydrate sports gel and Low carbohydrate hydrogel in people with Obstetric Labor, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Obstetric Labor
What is being tested?
High carbohydrate sports gel and Low carbohydrate hydrogel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteSpain
Study dates
1 Sep 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Olga Casanova Callau, Midwife contact

+34977519100 ext. 2120

ocasanovac.ebre.ics@gencat.cat

Spain1 site, 1 recruiting
  • HUTVC

    Tortosa, Tarragona, 43500

    C, Olga. Mdiwife, +34689905678, ocasanovac.ebre.ics@gencat.cat

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Read the 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.

Myometrial Energy Metabolism and Uterine Perfusion From a physiological perspective, the uterus is an extraordinarily active muscle that significantly increases its energy demand during pregnancy and labor.As a myogenic organ, it generates rhythmic contractions without direct nerve stimulation, and its function critically depends on a continuous supply of metabolic substrates. Uterine perfusion illustrates this need: blood flow increases from approximately 45 mL/min in the non-pregnant state to nearly 750 mL/min at the end of gestation.

The causes of delayed labor can be related to the four "P"s: power, passenger, passage, and psyche. Insufficient power can occur when the myometrium is not adequately loaded with glycogen before labor, leading to myometrial dysfunction. Uterine atony, associated with low contractility, causes between 70 and 80% of postpartum hemorrhages, which are estimated to occur in 5-10% of all births.

Glucose as the Primary Myometrial Fuel Glucose is the primary energy source for the myometrium. Glucose concentrations in uterine tissue at the end of pregnancy vastly exceed those in striated muscle. Glycogen stores increase during gestation as a strategic reserve but are rapidly consumed once labor begins. This depletion has been associated with a higher risk of ineffective contractions and uterine dysfunction.

Mitochondria play a central role in this process. Oxytocin increases mitochondrial depolarization, stimulating ATP production and modulating the rhythmicity of contractions.When glucose availability decreases, the myometrium increases its reliance on anaerobic glycolysis, manifesting in an accumulation of lactate and adenosine, which are classic markers of myometrial fatigue. Despite clear physiological evidence highlighting glucose and adequate hydration as critical components for optimal myometrial contractility, restrictive oral intake policies continue to influence modern obstetric care.

To address this clinical discrepancy, this Randomized Clinical Pilot Trial was designed.

Study Design and Methodology This is an experimental, analytical, and triple-blind randomized controlled pilot trial conducted according to CONSORT guidelines. Participants, clinical staff (midwives), and outcome assessors are blinded to group allocation. The study takes place at the Hospital Universitari de Tortosa Verge de la Cinta (HUTVC), Tarragona, Spain.

Group allocation is random and concealed. The hospital pharmacy prepares intervention packages (4 units per participant) and assigns a unique code to each package. The pharmacy maintains a database linking the codes with the intervention type, but does not have access to the identities of the participants. Midwives dispensing the products are unaware of the group allocation. Both interventions were prepared in identical opaque containers with standardized volume, appearance, and labeling.

Interventions and Administration Protocol Intervention Group (High-carbohydrate sports gel): The gel contains a carbohydrate blend designed to promote sustained energy availability.

Control Group (Low-carbohydrate hydrogel): The product contains a lower carbohydrate content. It is modified using a food-grade thickening agent (xanthan gum) to match the viscosity and mouthfeel of the sports gel, ensuring both interventions are indistinguishable.

The first dose is administered 60 minutes after epidural insertion to prevent confounding effects related to the epidural. Subsequent doses are administered every 3 hours during active labor, up to a maximum of 4 doses per participant. Oral water intake is encouraged throughout labor (150-200 mL/hour)

Conditions
Obstetric Labor
Being tested
High carbohydrate sports gel, Low carbohydrate hydrogel
Keywords
Maternal Outcomes, Labor Outcomes, Epidural Analgesia, oral carbohydrate supplementation, Dietary Supplements, maternal energy intake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Low carbohydrate hydrogelDietary supplement

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

Study groups in NCT07742748
Study groupRoleWhat they receive
High carbohydrate sports gelExperimentalParticipants 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.
Receives: Dietary Supplement: High carbohydrate sports gel
Low carbohydrate hydrogelActive comparatorParticipants 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.
Receives: Dietary Supplement: Low carbohydrate hydrogel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Labor

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

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

Secondary outcomes (7)
  1. Postpartum Hemorrhage

    Presence of postpartum hemorrhage defined as blood loss > 500 mL (yes/no).

    Measured: Within 24 hours postpartum

  2. Maternal Vomiting Episodes

    Number of vomiting episodes during active labor (count variable).

    Measured: From first study product administration to delivery

  3. Maternal Blood Glucose

    Capillary blood glucose level measured 60 minutes after intervention administration. Recorded in mg/dL.

    Measured: 60 minutes after study product administration (repeated if labor exceeds 3 hours)

  4. Maternal Satisfaction

    Maternal satisfaction with labor nutritional support measured using CSTA scale (Client Satisfaction Scale). 5-point ordinal scale: very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied.

    Measured: Within 24 hours postpartum

  5. Neonatal APGAR Score (1, 5, 10 minutes).

    Standard APGAR score (0-10).

    Measured: 1, 5 and 10 minutes after birth.

  6. Cardiotocographic Classification

    Fetal heart rate tracing classification according to Spanish clinical practice guidelines for normal birth care. Categorized as: reassuring, non-reassuring, or abnormal.

    GUIDELINE: Fetal monitoring in labor. NICE guideline [NG229] Published:14 December 2022

    Measured: During active labor until delivery

  7. Neonatal Blood Glucose

    Capillary blood glucose level in the newborn. Recorded in mg/dL.

    Measured: 60-120 minutes after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start1 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
147 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742748
Sponsor's protocol ID
084/2023
Status last verified
Sep 2026
First submitted
25 Jul 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 38702641
  • 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.

    PubMed 33218871
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing High carbohydrate sports gel and Low carbohydrate hydrogel in people with Obstetric Labor, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olga Casanova Callau, Midwife (+34977519100 ext. 2120, ocasanovac.ebre.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Labor (time frame: Timing of epidural analgesia administration to delivery (approximately 1-12 hours).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742748, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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