Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
2026년 4월 29일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sukanya Skandarajah
- 전화번호: 4148055337
- 이메일: sskandarajah@mcw.edu
연구 연락처 백업
- 이름: Brock Polnaszek, MD
- 전화번호: 4148056624
- 이메일: bpolnaszek@mcw.edu
연구 장소
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Froedtert Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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).
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.
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활성 비교기: 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.
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Time Above Range (TAR >110 mg/dL) During Labor
기간: From admission to delivery (expected ≤72 hours)
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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.
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From admission to delivery (expected ≤72 hours)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time in Range
기간: From admission to delivery (expected ≤72 hours)
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Percentage of CGM readings within target range during labor (70-110 mg/dL)
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From admission to delivery (expected ≤72 hours)
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Glycemic Variability
기간: From admission to delivery (expected ≤72 hours)
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Standard deviation and coefficient of variation of CGM glucose values during labor.
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From admission to delivery (expected ≤72 hours)
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Hyperglycemic Excursions
기간: From admission to delivery (expected ≤72 hours)
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Number of episodes of CGM glucose >140 mg/dL, separated by ≥15 minutes below threshold.
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From admission to delivery (expected ≤72 hours)
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Hypoglycemic Events
기간: From admission to delivery (expected ≤72 hours)
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Number of CGM glucose values <70 mg/dL during labor.
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From admission to delivery (expected ≤72 hours)
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Total Insulin Use During Labor
기간: From admission to delivery (expected ≤72 hours)
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Total insulin administered (units)
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From admission to delivery (expected ≤72 hours)
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Maternal Fatigue Score (VAS)
기간: Admission and every 4 hours until delivery (expected ≤72 hours)
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Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue.
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Admission and every 4 hours until delivery (expected ≤72 hours)
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Labor Agentry Scale Score (LAS)
기간: 24-48 hours postpartum
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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.
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24-48 hours postpartum
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Birth Satisfaction Scale-Revised Score
기간: 24-48 hours postpartum
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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.
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24-48 hours postpartum
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Maternal Emesis
기간: From admission to delivery (expected ≤72 hours)
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Number of vomiting episodes during labor documented by clinical record or participant report.
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From admission to delivery (expected ≤72 hours)
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Mode of Delivery
기간: At delivery
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Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.
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At delivery
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Neonatal Hypoglycemia
기간: First 24 hours of life
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Blood glucose <40 mg/dL.
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First 24 hours of life
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Neonatal Intensive Care Unit (NICU) Admission
기간: From birth through hospital discharge (expected ≤28 days)
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Admission to neonatal intensive care unit (yes/no).
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From birth through hospital discharge (expected ≤28 days)
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Neonatal Glucose Supplementation
기간: First 24 hours of life
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Requirement for oral or IV glucose.
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First 24 hours of life
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Postpartum Time in Range
기간: Delivery to 7 days postpartum
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Percentage of CGM readings within postpartum target range (70-140 mg/dL).
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Delivery to 7 days postpartum
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Composite Maternal Morbidity
기간: Up to 6 weeks postpartum
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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.
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Up to 6 weeks postpartum
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Umbilical Cord Blood Gas Values
기간: At delivery
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Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)
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At delivery
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Infant Healthcare Utilization
기간: Birth to 1 year of life
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Healthcare utilization including hospitalizations, emergency department visits, urgent care visits, and primary care visits assessed via medical record and parental report.
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Birth to 1 year of life
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Labor Duration
기간: From admission to delivery (expected ≤72 hours)
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Duration of first, second, and third stages of labor measured in hours
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From admission to delivery (expected ≤72 hours)
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Infant Weight
기간: Birth to 1 year of life
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Infant weight in kilograms
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Birth to 1 year of life
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Infant Length
기간: Birth to 1 year of life
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Infant length in centimeters
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Birth to 1 year of life
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NICU Length of Stay
기간: From birth through hospital discharge (expected ≤28 days)
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Duration of NICU hospitalization measured in days.
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From birth through hospital discharge (expected ≤28 days)
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Respiratory Support
기간: From birth through hospital discharge (expected ≤28 days)
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Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation).
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From birth through hospital discharge (expected ≤28 days)
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Neonatal Jaundice Requiring Phototherapy
기간: From birth through hospital discharge (expected ≤28 days)
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Need for phototherapy for neonatal hyperbilirubinemia.
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From birth through hospital discharge (expected ≤28 days)
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Neonatal Hypoglycemia Treatment
기간: From birth through hospital discharge (expected ≤28 days)
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Requirement for glucose supplementation (oral or intravenous).
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From birth through hospital discharge (expected ≤28 days)
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Neonatal Sepsis
기간: From birth through hospital discharge (expected ≤28 days)
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Documented clinical suspicion or laboratory-confirmed neonatal sepsis.
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From birth through hospital discharge (expected ≤28 days)
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Perinatal Death
기간: From birth through hospital discharge (expected ≤28 days)
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Fetal or neonatal death occurring from birth through hospital discharge.
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From birth through hospital discharge (expected ≤28 days)
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Neonatal Resuscitation Level
기간: At delivery
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Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.
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At delivery
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Rate
기간: Recruitment period (up to 18 months)
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Proportion of eligible patients who consent to participation.
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Recruitment period (up to 18 months)
|
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Intervention Adherence
기간: From admission to delivery (expected ≤72 hours)
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Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed)
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From admission to delivery (expected ≤72 hours)
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CGM Data Completeness
기간: From admission to delivery (expected ≤72 hours)
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Proportion of the intrapartum period with valid CGM data
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From admission to delivery (expected ≤72 hours)
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Survey Completion Rate
기간: 48 hours postpartum
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Proportion of participants completing postpartum surveys (LAS and BSS-R).
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48 hours postpartum
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Number of Maternal Healthcare Encounters
기간: From hospital discharge to 6 weeks postpartum
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Number of healthcare encounters including hospitalizations, emergency department visits, urgent care visits, and primary care visits.
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From hospital discharge to 6 weeks postpartum
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Developmental screening
기간: First year of life
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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.
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First year of life
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Randomization Success
기간: Recruitment period (up to 18 months)
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Proportion of consented patients successfully randomized
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Recruitment period (up to 18 months)
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Protocol Deviations
기간: Recruitment period (up to 18 months)
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Number and type of deviations from the study protocol.
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Recruitment period (up to 18 months)
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Retention
기간: From randomization through delivery hospitalization(expected ≤7 days)
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Proportion of randomized participants with complete primary outcome data
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From randomization through delivery hospitalization(expected ≤7 days)
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Postpartum CGM Tolerability
기간: Within 7 days postpartum
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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.
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Within 7 days postpartum
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Postpartum CGM Wear Time
기간: Delivery to 7 days postpartum
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Total postpartum CGM wear time (hours).
|
Delivery to 7 days postpartum
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 7월 30일
연구 완료 (추정된)
2028년 7월 30일
연구 등록 날짜
최초 제출
2026년 3월 25일
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2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
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2026년 5월 6일
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2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PRO00057233
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