NCT07571343 Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
| NCT ID | NCT07571343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Diabetes During Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-07-01 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07571343 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Diabetes During Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07571343 currently recruiting?
Yes, NCT07571343 is actively recruiting participants. Contact the research team at sskandarajah@mcw.edu for enrollment information.
Where is the NCT07571343 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT07571343 clinical trial?
NCT07571343 is sponsored by Medical College of Wisconsin. The trial plans to enroll 60 participants.
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