Fueling Labor: Protein Supplementation for Intrapartum Glucose Control (NCT07571343) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
United States60 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Time Above Range (TAR >110 mg/dL) During Labor
Timeframe: From admission to delivery (expected ≤72 hours)