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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent Time Above Range (TAR >110 mg/dL) During Labor
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: High-Protein Beverage (Genius Gourmet Sparkling Protein Water) (Dietary Supplement)
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.
干预措施: Continuous Glucose Monitoring (Abbott Freestyle Libre) (Device)
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.
干预措施: Standard Clear Liquid Diet (Other)
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.
干预措施: Continuous Glucose Monitoring (Abbott Freestyle Libre) (Device)
结局指标
主要结局
Percent Time Above Range (TAR >110 mg/dL) During Labor
时间窗: 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.
次要结局
- Time in Range(From admission to delivery (expected ≤72 hours))
- Glycemic Variability(From admission to delivery (expected ≤72 hours))
- Hyperglycemic Excursions(From admission to delivery (expected ≤72 hours))
- Hypoglycemic Events(From admission to delivery (expected ≤72 hours))
- Total Insulin Use During Labor(From admission to delivery (expected ≤72 hours))
- Maternal Fatigue Score (VAS)(Admission and every 4 hours until delivery (expected ≤72 hours))
- Labor Agentry Scale Score (LAS)(24-48 hours postpartum)
- Birth Satisfaction Scale-Revised Score(24-48 hours postpartum)
- Maternal Emesis(From admission to delivery (expected ≤72 hours))
- Mode of Delivery(At delivery)
- Neonatal Hypoglycemia(First 24 hours of life)
- Neonatal Intensive Care Unit (NICU) Admission(From birth through hospital discharge (expected ≤28 days))
- Neonatal Glucose Supplementation(First 24 hours of life)
- Postpartum Time in Range(Delivery to 7 days postpartum)
- Composite Maternal Morbidity(Up to 6 weeks postpartum)
- Umbilical Cord Blood Gas Values(At delivery)
- Infant Healthcare Utilization(Birth to 1 year of life)
- Labor Duration(From admission to delivery (expected ≤72 hours))
- Infant Weight(Birth to 1 year of life)
- Infant Length(Birth to 1 year of life)
- NICU Length of Stay(From birth through hospital discharge (expected ≤28 days))
- Respiratory Support(From birth through hospital discharge (expected ≤28 days))
- Neonatal Jaundice Requiring Phototherapy(From birth through hospital discharge (expected ≤28 days))
- Neonatal Hypoglycemia Treatment(From birth through hospital discharge (expected ≤28 days))
- Neonatal Sepsis(From birth through hospital discharge (expected ≤28 days))
- Perinatal Death(From birth through hospital discharge (expected ≤28 days))
- Neonatal Resuscitation Level(At delivery)
研究者
Brock E. Polnaszek, MD MPH
Assistant Professor & Clinical Investigator
Medical College of Wisconsin