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NCT Number: NCT07571343

Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

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

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Key information

Conditions

Diabetes During Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

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:

  • Assess feasibility and acceptability of implementing a CGM-guided intrapartum nutritional protocol
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Protein Beverage (Genius Gourmet Sparkling Protein Water)

Dietary Supplement

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).

Standard Clear Liquid Diet

Other

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.

Continuous Glucose Monitoring (Abbott Freestyle Libre)

Device

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.

Primary outcomes

  1. Percent Time Above Range (TAR >110 mg/dL) During Labor

    Time frame: 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.

Secondary outcomes

  1. Time in Range

    Time frame: From admission to delivery (expected ≤72 hours)

    Percentage of CGM readings within target range during labor (70-110 mg/dL)

  2. Glycemic Variability

    Time frame: From admission to delivery (expected ≤72 hours)

    Standard deviation and coefficient of variation of CGM glucose values during labor.

  3. Hyperglycemic Excursions

    Time frame: From admission to delivery (expected ≤72 hours)

    Number of episodes of CGM glucose >140 mg/dL, separated by ≥15 minutes below threshold.

  4. Hypoglycemic Events

    Time frame: From admission to delivery (expected ≤72 hours)

    Number of CGM glucose values <70 mg/dL during labor.

  5. Total Insulin Use During Labor

    Time frame: From admission to delivery (expected ≤72 hours)

    Total insulin administered (units)

  6. Maternal Fatigue Score (VAS)

    Time frame: Admission and every 4 hours until delivery (expected ≤72 hours)

    Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue.

  7. Labor Agentry Scale Score (LAS)

    Time frame: 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.

  8. Birth Satisfaction Scale-Revised Score

    Time frame: 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.

  9. Maternal Emesis

    Time frame: From admission to delivery (expected ≤72 hours)

    Number of vomiting episodes during labor documented by clinical record or participant report.

  10. Mode of Delivery

    Time frame: At delivery

    Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.

  11. Neonatal Hypoglycemia

    Time frame: First 24 hours of life

    Blood glucose <40 mg/dL.

  12. Neonatal Intensive Care Unit (NICU) Admission

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Admission to neonatal intensive care unit (yes/no).

  13. Neonatal Glucose Supplementation

    Time frame: First 24 hours of life

    Requirement for oral or IV glucose.

  14. Postpartum Time in Range

    Time frame: Delivery to 7 days postpartum

    Percentage of CGM readings within postpartum target range (70-140 mg/dL).

  15. Composite Maternal Morbidity

    Time frame: 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.

  16. Umbilical Cord Blood Gas Values

    Time frame: At delivery

    Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)

  17. Infant Healthcare Utilization

    Time frame: 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.

  18. Labor Duration

    Time frame: From admission to delivery (expected ≤72 hours)

    Duration of first, second, and third stages of labor measured in hours

  19. Infant Weight

    Time frame: Birth to 1 year of life

    Infant weight in kilograms

  20. Infant Length

    Time frame: Birth to 1 year of life

    Infant length in centimeters

  21. NICU Length of Stay

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Duration of NICU hospitalization measured in days.

  22. Respiratory Support

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation).

  23. Neonatal Jaundice Requiring Phototherapy

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Need for phototherapy for neonatal hyperbilirubinemia.

  24. Neonatal Hypoglycemia Treatment

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Requirement for glucose supplementation (oral or intravenous).

  25. Neonatal Sepsis

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Documented clinical suspicion or laboratory-confirmed neonatal sepsis.

  26. Perinatal Death

    Time frame: From birth through hospital discharge (expected ≤28 days)

    Fetal or neonatal death occurring from birth through hospital discharge.

  27. Neonatal Resuscitation Level

    Time frame: At delivery

    Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.

Other outcomes

  1. Recruitment Rate

    Time frame: Recruitment period (up to 18 months)

    Proportion of eligible patients who consent to participation.

  2. Intervention Adherence

    Time frame: From admission to delivery (expected ≤72 hours)

    Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed)

  3. CGM Data Completeness

    Time frame: From admission to delivery (expected ≤72 hours)

    Proportion of the intrapartum period with valid CGM data

  4. Survey Completion Rate

    Time frame: 48 hours postpartum

    Proportion of participants completing postpartum surveys (LAS and BSS-R).

  5. Number of Maternal Healthcare Encounters

    Time frame: From hospital discharge to 6 weeks postpartum

    Number of healthcare encounters including hospitalizations, emergency department visits, urgent care visits, and primary care visits.

  6. Developmental screening

    Time frame: 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.

  7. Randomization Success

    Time frame: Recruitment period (up to 18 months)

    Proportion of consented patients successfully randomized

  8. Protocol Deviations

    Time frame: Recruitment period (up to 18 months)

    Number and type of deviations from the study protocol.

  9. Retention

    Time frame: From randomization through delivery hospitalization(expected ≤7 days)

    Proportion of randomized participants with complete primary outcome data

  10. Postpartum CGM Tolerability

    Time frame: 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.

  11. Postpartum CGM Wear Time

    Time frame: Delivery to 7 days postpartum

    Total postpartum CGM wear time (hours).

Study contacts

Contact information is provided by the study sponsor or research team.

Brock Polnaszek, MD

CONTACT

[email protected]

4148056624

Sukanya Skandarajah

CONTACT

[email protected]

4148055337

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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