このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

2026年4月29日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53226
        • Froedtert Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：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).
デバイス：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.
アクティブコンパレータ：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.
デバイス：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Time Above Range (TAR >110 mg/dL) During Labor
時間枠：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)

二次結果の測定

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

その他の成果指標

結果測定
メジャーの説明
時間枠
Recruitment Rate
時間枠：Recruitment period (up to 18 months)
Proportion of eligible patients who consent to participation.
Recruitment period (up to 18 months)
Intervention Adherence
時間枠：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
時間枠：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
時間枠：48 hours postpartum
Proportion of participants completing postpartum surveys (LAS and BSS-R).
48 hours postpartum
Number of Maternal Healthcare Encounters
時間枠：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
時間枠：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
時間枠：Recruitment period (up to 18 months)
Proportion of consented patients successfully randomized
Recruitment period (up to 18 months)
Protocol Deviations
時間枠：Recruitment period (up to 18 months)
Number and type of deviations from the study protocol.
Recruitment period (up to 18 months)
Retention
時間枠：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
時間枠：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
時間枠：Delivery to 7 days postpartum
Total postpartum CGM wear time (hours).
Delivery to 7 days postpartum

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Medical College of Wisconsin

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2028年7月30日

研究の完了 (推定)

2028年7月30日

試験登録日

最初に提出

2026年3月25日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月6日

QC基準を満たした最後の更新が送信されました

2026年4月29日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PRO00057233

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する