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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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Protein Supplementation | Experimental | 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. |
|
| Standard Clear Liquid Diet | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From admission to delivery (expected ≤72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Percentage of CGM readings within target range during labor (70-110 mg/dL) | From admission to delivery (expected ≤72 hours) |
| Glycemic Variability | Standard deviation and coefficient of variation of CGM glucose values during labor. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Proportion of eligible patients who consent to participation. | Recruitment period (up to 18 months) |
| Intervention Adherence | Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukanya Skandarajah | Contact | 4148055337 | sskandarajah@mcw.edu | |
| Brock Polnaszek, MD | Contact | 4148056624 | bpolnaszek@mcw.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
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Participants and clinical care providers cannot be blinded to group assignment due to the nature of the nutritional intervention. CGM data will be blinded to participants, nursing staff, and obstetric providers during labor to prevent CGM-guided clinical decisions.
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| 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. |
|
| From admission to delivery (expected ≤72 hours) |
| Hyperglycemic Excursions | Number of episodes of CGM glucose >140 mg/dL, separated by ≥15 minutes below threshold. | From admission to delivery (expected ≤72 hours) |
| Hypoglycemic Events | Number of CGM glucose values <70 mg/dL during labor. | From admission to delivery (expected ≤72 hours) |
| Total Insulin Use During Labor | Total insulin administered (units) | From admission to delivery (expected ≤72 hours) |
| Maternal Fatigue Score (VAS) | 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) | 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 | 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 | Number of vomiting episodes during labor documented by clinical record or participant report. | From admission to delivery (expected ≤72 hours) |
| Mode of Delivery | Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery. | At delivery |
| Neonatal Hypoglycemia | Blood glucose <40 mg/dL. | First 24 hours of life |
| Neonatal Intensive Care Unit (NICU) Admission | Admission to neonatal intensive care unit (yes/no). | From birth through hospital discharge (expected ≤28 days) |
| Neonatal Glucose Supplementation | Requirement for oral or IV glucose. | First 24 hours of life |
| Postpartum Time in Range | Percentage of CGM readings within postpartum target range (70-140 mg/dL). | 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. | 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) | 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. | Birth to 1 year of life |
| Labor Duration | Duration of first, second, and third stages of labor measured in hours | From admission to delivery (expected ≤72 hours) |
| Infant Weight | Infant weight in kilograms | Birth to 1 year of life |
| Infant Length | Infant length in centimeters | Birth to 1 year of life |
| NICU Length of Stay | Duration of NICU hospitalization measured in days. | 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). | From birth through hospital discharge (expected ≤28 days) |
| Neonatal Jaundice Requiring Phototherapy | Need for phototherapy for neonatal hyperbilirubinemia. | From birth through hospital discharge (expected ≤28 days) |
| Neonatal Hypoglycemia Treatment | Requirement for glucose supplementation (oral or intravenous). | From birth through hospital discharge (expected ≤28 days) |
| Neonatal Sepsis | Documented clinical suspicion or laboratory-confirmed neonatal sepsis. | From birth through hospital discharge (expected ≤28 days) |
| Perinatal Death | Fetal or neonatal death occurring from birth through hospital discharge. | 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. | At delivery |
| From admission to delivery (expected ≤72 hours) |
| CGM Data Completeness | Proportion of the intrapartum period with valid CGM data | From admission to delivery (expected ≤72 hours) |
| Survey Completion Rate | Proportion of participants completing postpartum surveys (LAS and BSS-R). | 48 hours postpartum |
| Number of Maternal Healthcare Encounters | 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 | 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 | Proportion of consented patients successfully randomized | Recruitment period (up to 18 months) |
| Protocol Deviations | Number and type of deviations from the study protocol. | Recruitment period (up to 18 months) |
| Retention | Proportion of randomized participants with complete primary outcome data | From randomization through delivery hospitalization(expected ≤7 days) |
| Postpartum CGM Tolerability | 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 | Total postpartum CGM wear time (hours). | Delivery to 7 days postpartum |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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