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Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

29 апреля 2026 г. обновлено: 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

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Sukanya Skandarajah
  • Номер телефона: 4148055337
  • Электронная почта: sskandarajah@mcw.edu

Учебное резервное копирование контактов

  • Имя: Brock Polnaszek, MD
  • Номер телефона: 4148056624
  • Электронная почта: bpolnaszek@mcw.edu

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Диетическая добавка: 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).
Устройство: 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.
Активный компаратор: 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.
Устройство: 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.
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percent Time Above Range (TAR >110 mg/dL) During Labor
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time in Range
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From admission to delivery (expected ≤72 hours)
Total insulin administered (units)
From admission to delivery (expected ≤72 hours)
Maternal Fatigue Score (VAS)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At delivery
Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.
At delivery
Neonatal Hypoglycemia
Временное ограничение: First 24 hours of life
Blood glucose <40 mg/dL.
First 24 hours of life
Neonatal Intensive Care Unit (NICU) Admission
Временное ограничение: 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
Временное ограничение: First 24 hours of life
Requirement for oral or IV glucose.
First 24 hours of life
Postpartum Time in Range
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At delivery
Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)
At delivery
Infant Healthcare Utilization
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Birth to 1 year of life
Infant weight in kilograms
Birth to 1 year of life
Infant Length
Временное ограничение: Birth to 1 year of life
Infant length in centimeters
Birth to 1 year of life
NICU Length of Stay
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: At delivery
Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.
At delivery

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Recruitment Rate
Временное ограничение: Recruitment period (up to 18 months)
Proportion of eligible patients who consent to participation.
Recruitment period (up to 18 months)
Intervention Adherence
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 48 hours postpartum
Proportion of participants completing postpartum surveys (LAS and BSS-R).
48 hours postpartum
Number of Maternal Healthcare Encounters
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Recruitment period (up to 18 months)
Proportion of consented patients successfully randomized
Recruitment period (up to 18 months)
Protocol Deviations
Временное ограничение: Recruitment period (up to 18 months)
Number and type of deviations from the study protocol.
Recruitment period (up to 18 months)
Retention
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Delivery to 7 days postpartum
Total postpartum CGM wear time (hours).
Delivery to 7 days postpartum

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Medical College of Wisconsin

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

30 июля 2028 г.

Завершение исследования (Оцененный)

30 июля 2028 г.

Даты регистрации исследования

Первый отправленный

25 марта 2026 г.

Впервые представлено, что соответствует критериям контроля качества

29 апреля 2026 г.

Первый опубликованный (Действительный)

6 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PRO00057233

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