Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Type 1 diabetes mellitus

Multifetal gestation

Major fetal anomalies or conditions affecting neonatal glucose regulation

Stillbirth

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Standard Clear Liquid Diet

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: High-Protein SupplementationExperimental treatment 2 interventions
Group B: Standard Clear Liquid DietActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From admission to delivery (expected ≤72 hours)

Secondary outcomes

1

Time in Range

Percentage of CGM readings within target range during labor (70-110 mg/dL)

Time frame
From admission to delivery (expected ≤72 hours)
2

Glycemic Variability

Standard deviation and coefficient of variation of CGM glucose values during labor.

Time frame
From admission to delivery (expected ≤72 hours)
3

Hyperglycemic Excursions

Number of episodes of CGM glucose \>140 mg/dL, separated by ≥15 minutes below threshold.

Time frame
From admission to delivery (expected ≤72 hours)
4

Hypoglycemic Events

Number of CGM glucose values \<70 mg/dL during labor.

Time frame
From admission to delivery (expected ≤72 hours)

Other outcomes

1

Recruitment Rate

Proportion of eligible patients who consent to participation.

Time frame
Recruitment period (up to 18 months)
2

Intervention Adherence

Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed)

Time frame
From admission to delivery (expected ≤72 hours)
3

CGM Data Completeness

Proportion of the intrapartum period with valid CGM data

Time frame
From admission to delivery (expected ≤72 hours)
4

Survey Completion Rate

Proportion of participants completing postpartum surveys (LAS and BSS-R).

Time frame
48 hours postpartum

Sponsors and contacts

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