Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
A legfontosabb adatok
- Ki végzi
- Medical College of Wisconsin
- Hol
- Milwaukee (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 60 fő, tervezett
- Kezdés
- 2026. júl. 1.
- Várható befejezés
- 2028. júl. 30.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- High-Protein Beverage (Genius Gourmet Sparkling Protein Water)
- Standard Clear Liquid Diet
- Continuous Glucose Monitoring (Abbott Freestyle Libre)
- A regiszteradat frissítve
- 2026. október 26.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Type 1 diabetes mellitus
- Known allergy or intolerance to study materials, including components of the high-protein supplement or CGM device
- Major fetal anomalies or conditions affecting neonatal glucose regulation
- Multifetal gestation
- Stillbirth
- Planned cesarean delivery
- Inability to provide consent
- Contraindication to oral intake (e.g., NPO status for clinical indication)
Helyszínek itt: Egyesült Államok
- Froedtert HospitalMilwaukee, Egyesült ÁllamokContact: Sukanya SkandarajahRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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:
A teljes eredeti leírásKevesebb
* 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
A vizsgálat 2 csoportja
- High-Protein SupplementationA vizsgált kezelés
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.
Kezelés: High-Protein Beverage (Genius Gourmet Sparkling Protein Water) és Continuous Glucose Monitoring (Abbott Freestyle Libre)
- Standard Clear Liquid DietMár használt kezelés, összehasonlításként
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.
Kezelés: Standard Clear Liquid Diet és Continuous Glucose Monitoring (Abbott Freestyle Libre)
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- A regiszteradat frissítve
- 2026. október 26.