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Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

29 aprile 2026 aggiornato da: Brock E. Polnaszek, MD MPH, Medical College of Wisconsin

Fueling Labor: A Pilot Randomized Controlled Trial of High-Protein Supplementation During Labor to Improve Glucose Control in Insulin-Treated Diabetes Using Continuous Glucose Monitoring

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with insulin-treated diabetes. It will also help us learn if this approach is acceptable and well-tolerated by patients. The main questions it aims to answer are:

  • Does drinking high-protein beverages during labor keep blood sugar in a healthier range compared to drinking standard clear liquids?
  • How do participants feel about drinking protein beverages during labor, and does it affect their energy levels and birth experience?
  • Is the baby less likely to have low blood sugar after birth when the mother drinks protein beverages during labor?

Researchers will compare women who drink high-protein beverages to women who drink standard clear liquids (like juice, broth, and popsicles) to see if protein drinks help keep blood sugar more stable during labor.

Participants will:

  • Wear a small, painless glucose sensor on their arm from when labor starts until about one week after giving birth
  • Be randomly assigned to either drink a clear protein beverage every 4 hours during labor OR drink standard clear liquids as usual
  • Complete short surveys about how tired they feel during labor, their overall birth experience, and their overall experience with the glucose sensor

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background and Rationale:

Optimal nutrition during labor for patients with insulin-treated diabetes in pregnancy remains poorly defined. While current guidelines support clear liquid intake during labor, the metabolic effects of different nutritional strategies-particularly high-protein supplementation-have not been studied. Maintaining stable maternal glucose levels during labor is essential to reducing neonatal complications, including hypoglycemia. However, standard clear liquids may cause glucose excursions, while prolonged fasting may contribute to maternal fatigue and metabolic stress.

Continuous glucose monitoring (CGM) technology provides real-time assessment of glucose patterns during labor, offering a novel opportunity to evaluate how targeted nutritional interventions influence maternal glycemic stability. Recent evidence suggests that maternal time above glucose target range during labor is associated with neonatal hypoglycemia, yet no studies have examined whether protein-based oral supplementation can improve intrapartum glucose control compared to standard clear liquids.

Study Objectives:

This pilot randomized controlled trial evaluates the feasibility and metabolic impact of high-protein oral supplementation during labor in patients with insulin-treated gestational or type 2 diabetes undergoing induction of labor. The study aims to:

  1. Assess feasibility and acceptability of implementing a CGM-guided intrapartum nutritional protocol
  2. Compare CGM-derived glycemic metrics (including percent time above range >110 mg/dL, time in range, and glycemic excursions) between high-protein supplementation and standard clear liquids
  3. Explore associations with maternal experience (fatigue, birth satisfaction) and neonatal outcomes

Study Design:

Sixty participants with insulin-treated gestational diabetes (GDM A2) or type 2 diabetes will be randomized 1:1 to receive either high-protein nutritional supplements (30g protein, 0g carbohydrate) every 4 hours during labor or standard institutional clear liquid diet. All participants will wear a blinded CGM (Abbott Freestyle Libre) from admission through delivery and for up to 7 days postpartum. The primary outcome is percent time above glucose range (>110 mg/dL) during labor. Secondary outcomes include other CGM metrics, maternal fatigue and satisfaction scores, labor outcomes, and neonatal hypoglycemia.

Significance:

This pilot study will generate critical preliminary data on the metabolic effects, patient-centered outcomes, and feasibility of high-protein intrapartum supplementation, informing the design of future larger trials to optimize evidence-based nutritional management during labor for patients with insulin-treated diabetes.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Froedtert Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age ≥18 years
  • Singleton pregnancy
  • Gestational age ≥37 0/7 weeks at time of induction
  • Diagnosis of gestational diabetes requiring insulin therapy (GDM A2) or pre-existing Type 2 diabetes managed with insulin during pregnancy
  • Admission to labor and delivery for induction of labor
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Multifetal gestation
  • Major fetal anomalies or conditions affecting neonatal glucose regulation
  • Stillbirth
  • Planned cesarean delivery
  • Inability to provide consent
  • Contraindication to oral intake (e.g., NPO status for clinical indication)
  • Known allergy or intolerance to study materials, including components of the high-protein supplement or CGM device

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: High-Protein Supplementation
Participants will be offered Genius Gourmet Sparkling Protein Water (approximately 30 g protein, 0 g carbohydrate, 0 g fat, 130 kcal per 12-ounce serving) every 4 hours beginning at randomization until delivery. Consumption is voluntary. All participants will wear a blinded CGM from admission through 7 days postpartum.
Integratore alimentare: High-Protein Beverage (Genius Gourmet Sparkling Protein Water)
Clear, carbonated, commercially available high-protein nutritional supplement containing approximately 30 g protein, 0 g carbohydrate, 0 g fat, and 130 kcal per 12-ounce serving. Offered every 4 hours during labor. Multiple flavors available (participant's choice).
Dispositivo: Continuous Glucose Monitoring (Abbott Freestyle Libre)
Abbott Freestyle Libre 2 or Libre 3 CGM sensor placed on upper arm upon admission. Sensor remains in place through delivery and up to 7 days postpartum. CGM data blinded to participants and clinical staff during labor.
Comparatore attivo: Standard Clear Liquid Diet
Participants will receive standard institutional clear liquid diet (water, ice chips, clear fruit juices, clear carbonated beverages, popsicles, clear broth, gelatin) ad libitum throughout labor per routine institutional practice. All participants will wear a blinded CGM from admission through 7 days postpartum.
Dispositivo: Continuous Glucose Monitoring (Abbott Freestyle Libre)
Abbott Freestyle Libre 2 or Libre 3 CGM sensor placed on upper arm upon admission. Sensor remains in place through delivery and up to 7 days postpartum. CGM data blinded to participants and clinical staff during labor.
Altro: Standard Clear Liquid Diet
Standard institutional clear liquid diet including water, ice chips, clear fruit juices (e.g., apple juice), clear carbonated beverages (e.g., ginger ale), popsicles, clear broth, and gelatin. Carbohydrate-containing clear liquids permitted per standard practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Time Above Range (TAR >110 mg/dL) During Labor
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Percentage of CGM readings exceeding 110 mg/dL during labor, calculated as the proportion of valid CGM readings >110 mg/dL divided by total valid readings, expressed as a percentage.
From admission to delivery (expected ≤72 hours)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time in Range
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Percentage of CGM readings within target range during labor (70-110 mg/dL)
From admission to delivery (expected ≤72 hours)
Glycemic Variability
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Standard deviation and coefficient of variation of CGM glucose values during labor.
From admission to delivery (expected ≤72 hours)
Hyperglycemic Excursions
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Number of episodes of CGM glucose >140 mg/dL, separated by ≥15 minutes below threshold.
From admission to delivery (expected ≤72 hours)
Hypoglycemic Events
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Number of CGM glucose values <70 mg/dL during labor.
From admission to delivery (expected ≤72 hours)
Total Insulin Use During Labor
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Total insulin administered (units)
From admission to delivery (expected ≤72 hours)
Maternal Fatigue Score (VAS)
Lasso di tempo: Admission and every 4 hours until delivery (expected ≤72 hours)
Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue.
Admission and every 4 hours until delivery (expected ≤72 hours)
Labor Agentry Scale Score (LAS)
Lasso di tempo: 24-48 hours postpartum
Labor Agentry Scale (LAS), a 29-item validated measure of perceived control during labor. Each item is scored on a 7-point Likert scale. Total scores range from 29 to 203, with higher scores indicating greater perceived control.
24-48 hours postpartum
Birth Satisfaction Scale-Revised Score
Lasso di tempo: 24-48 hours postpartum
A 10-item validated measure of overall birth satisfaction. Each item is scored on a 0-4 scale. Total scores range from 0 to 40, with higher scores indicating greater birth satisfaction.
24-48 hours postpartum
Maternal Emesis
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Number of vomiting episodes during labor documented by clinical record or participant report.
From admission to delivery (expected ≤72 hours)
Mode of Delivery
Lasso di tempo: At delivery
Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.
At delivery
Neonatal Hypoglycemia
Lasso di tempo: First 24 hours of life
Blood glucose <40 mg/dL.
First 24 hours of life
Neonatal Intensive Care Unit (NICU) Admission
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Admission to neonatal intensive care unit (yes/no).
From birth through hospital discharge (expected ≤28 days)
Neonatal Glucose Supplementation
Lasso di tempo: First 24 hours of life
Requirement for oral or IV glucose.
First 24 hours of life
Postpartum Time in Range
Lasso di tempo: Delivery to 7 days postpartum
Percentage of CGM readings within postpartum target range (70-140 mg/dL).
Delivery to 7 days postpartum
Composite Maternal Morbidity
Lasso di tempo: Up to 6 weeks postpartum
Composite maternal morbidity defined as occurrence of any of the following conditions: postpartum hemorrhage requiring intervention such as estimated blood loss >1000 milliliters (mL) or uterotonics, tranexamic acid, blood transfusion or surgical interventions (dilation and curettage, Bakri, Jada, laparotomy, interventional radiology), endometritis, intraamniotic infection, obstetric anal sphincter injury (OASIS), ICU admission, amniotic fluid embolism, and death.
Up to 6 weeks postpartum
Umbilical Cord Blood Gas Values
Lasso di tempo: At delivery
Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)
At delivery
Infant Healthcare Utilization
Lasso di tempo: Birth to 1 year of life
Healthcare utilization including hospitalizations, emergency department visits, urgent care visits, and primary care visits assessed via medical record and parental report.
Birth to 1 year of life
Labor Duration
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Duration of first, second, and third stages of labor measured in hours
From admission to delivery (expected ≤72 hours)
Infant Weight
Lasso di tempo: Birth to 1 year of life
Infant weight in kilograms
Birth to 1 year of life
Infant Length
Lasso di tempo: Birth to 1 year of life
Infant length in centimeters
Birth to 1 year of life
NICU Length of Stay
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Duration of NICU hospitalization measured in days.
From birth through hospital discharge (expected ≤28 days)
Respiratory Support
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation).
From birth through hospital discharge (expected ≤28 days)
Neonatal Jaundice Requiring Phototherapy
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Need for phototherapy for neonatal hyperbilirubinemia.
From birth through hospital discharge (expected ≤28 days)
Neonatal Hypoglycemia Treatment
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Requirement for glucose supplementation (oral or intravenous).
From birth through hospital discharge (expected ≤28 days)
Neonatal Sepsis
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Documented clinical suspicion or laboratory-confirmed neonatal sepsis.
From birth through hospital discharge (expected ≤28 days)
Perinatal Death
Lasso di tempo: From birth through hospital discharge (expected ≤28 days)
Fetal or neonatal death occurring from birth through hospital discharge.
From birth through hospital discharge (expected ≤28 days)
Neonatal Resuscitation Level
Lasso di tempo: At delivery
Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.
At delivery

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rate
Lasso di tempo: Recruitment period (up to 18 months)
Proportion of eligible patients who consent to participation.
Recruitment period (up to 18 months)
Intervention Adherence
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed)
From admission to delivery (expected ≤72 hours)
CGM Data Completeness
Lasso di tempo: From admission to delivery (expected ≤72 hours)
Proportion of the intrapartum period with valid CGM data
From admission to delivery (expected ≤72 hours)
Survey Completion Rate
Lasso di tempo: 48 hours postpartum
Proportion of participants completing postpartum surveys (LAS and BSS-R).
48 hours postpartum
Number of Maternal Healthcare Encounters
Lasso di tempo: From hospital discharge to 6 weeks postpartum
Number of healthcare encounters including hospitalizations, emergency department visits, urgent care visits, and primary care visits.
From hospital discharge to 6 weeks postpartum
Developmental screening
Lasso di tempo: First year of life
Development assessed using Ages and Stages Questionnaire, Third Edition (ASQ-3), a parent-completed developmental screening tool with five domains (communication, gross motor, fine motor, problem-solving, personal-social). Domain scores range from 0 to 60, with lower scores indicating greater developmental concern. This is a screening tool; scores are interpreted relative to age-specific cutoffs.
First year of life
Randomization Success
Lasso di tempo: Recruitment period (up to 18 months)
Proportion of consented patients successfully randomized
Recruitment period (up to 18 months)
Protocol Deviations
Lasso di tempo: Recruitment period (up to 18 months)
Number and type of deviations from the study protocol.
Recruitment period (up to 18 months)
Retention
Lasso di tempo: From randomization through delivery hospitalization(expected ≤7 days)
Proportion of randomized participants with complete primary outcome data
From randomization through delivery hospitalization(expected ≤7 days)
Postpartum CGM Tolerability
Lasso di tempo: Within 7 days postpartum
Structured questionnaire assessing irritation, comfort, interference, and willingness to reuse CGM using structured Likert-style responses (e.g., none/mild/moderate/severe for irritation; yes/no for willingness to use CGM again). No composite score is generated.
Within 7 days postpartum
Postpartum CGM Wear Time
Lasso di tempo: Delivery to 7 days postpartum
Total postpartum CGM wear time (hours).
Delivery to 7 days postpartum

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical College of Wisconsin

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

30 luglio 2028

Completamento dello studio (Stimato)

30 luglio 2028

Date di iscrizione allo studio

Primo inviato

25 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRO00057233

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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