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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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 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.
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.
Froedtert Hospital
Milwaukee, Wisconsin, United States
Percent Time Above Range (TAR >110 mg/dL) During Labor
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.
Time frame: From admission to delivery (expected ≤72 hours)
Time in Range
Percentage of CGM readings within target range during labor (70-110 mg/dL)
Time frame: From admission to delivery (expected ≤72 hours)
Glycemic Variability
Standard deviation and coefficient of variation of CGM glucose values during labor.
Time frame: From admission to delivery (expected ≤72 hours)
Hyperglycemic Excursions
Number of episodes of CGM glucose \>140 mg/dL, separated by ≥15 minutes below threshold.
Time frame: From admission to delivery (expected ≤72 hours)
Hypoglycemic Events
Number of CGM glucose values \<70 mg/dL during labor.
Time frame: From admission to delivery (expected ≤72 hours)
Total Insulin Use During Labor
Total insulin administered (units)
Time frame: From admission to delivery (expected ≤72 hours)
Maternal Fatigue Score (VAS)
Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue.
Time frame: Admission and every 4 hours until delivery (expected ≤72 hours)
Labor Agentry Scale Score (LAS)
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.
Time frame: 24-48 hours postpartum
Birth Satisfaction Scale-Revised Score
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.
Time frame: 24-48 hours postpartum
Maternal Emesis
Number of vomiting episodes during labor documented by clinical record or participant report.
Time frame: From admission to delivery (expected ≤72 hours)
Mode of Delivery
Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.
Time frame: At delivery
Neonatal Hypoglycemia
Blood glucose \<40 mg/dL.
Time frame: First 24 hours of life
Neonatal Intensive Care Unit (NICU) Admission
Admission to neonatal intensive care unit (yes/no).
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Glucose Supplementation
Requirement for oral or IV glucose.
Time frame: First 24 hours of life
Postpartum Time in Range
Percentage of CGM readings within postpartum target range (70-140 mg/dL).
Time frame: Delivery to 7 days postpartum
Composite Maternal Morbidity
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.
Time frame: Up to 6 weeks postpartum
Umbilical Cord Blood Gas Values
Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)
Time frame: At delivery
Infant Healthcare Utilization
Healthcare utilization including hospitalizations, emergency department visits, urgent care visits, and primary care visits assessed via medical record and parental report.
Time frame: Birth to 1 year of life
Labor Duration
Duration of first, second, and third stages of labor measured in hours
Time frame: From admission to delivery (expected ≤72 hours)
Infant Weight
Infant weight in kilograms
Time frame: Birth to 1 year of life
Infant Length
Infant length in centimeters
Time frame: Birth to 1 year of life
NICU Length of Stay
Duration of NICU hospitalization measured in days.
Time frame: From birth through hospital discharge (expected ≤28 days)
Respiratory Support
Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation).
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Jaundice Requiring Phototherapy
Need for phototherapy for neonatal hyperbilirubinemia.
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Hypoglycemia Treatment
Requirement for glucose supplementation (oral or intravenous).
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Sepsis
Documented clinical suspicion or laboratory-confirmed neonatal sepsis.
Time frame: From birth through hospital discharge (expected ≤28 days)
Perinatal Death
Fetal or neonatal death occurring from birth through hospital discharge.
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Resuscitation Level
Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.
Time frame: At delivery
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