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Clinical Trial Details

Trial ID: L5507
Source ID: NCT04599075
Associated Drug: Insulin
Title: Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04599075/results
Conditions: Type 1 Diabetes|Pregnancy, High Risk
Interventions: DRUG: Insulin|DRUG: Insulin
Outcome Measures: Primary: Neonatal Hypoglycemia, First neonatal blood sugar obtained within 2 hours of birth, Within 2 hours of birth | Secondary: Number of Maternal Hypoglycemic Events, Number of maternal blood sugars \< 60 mg/dL, During labor|Development of Diabetic Ketoacidosis During Labor, Development of Diabetic Ketoacidosis during labor, During Labor|Mode of Delivery, Mode of Delivery (vaginal versus cesarean), At birth|Neonatal Birthweight, Neonatal Birthweight, At Birth|Number of Participants With Shoulder Dystocia, Number of participants with shoulder dystocia, At birth|Number of Participants With Brachial Plexus Injury, Number of participants with brachial plexus injury, At birth|5 Minute Apgar Score < 7, Neonatal Apgar Score: The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health., At delivery (5 minutes)|Received Neonatal Intervention for Hypoglycemia, Received intervention for hypoglycemia (any oral, IV, or both), Within 24 hours of life|Neonatal Intensive Care Unit Admission, Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery., At delivery and within first 2 day of life|Gestational Age at Delivery, Gestational age at delivery, At birth|Number of Participants With Neonatal Respiratory Distress, Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis, At delivery|Number of Participants With Neonatal Hyperbilirubinemia, Requiring phototherapy, Within first 2 days of life
Sponsor/Collaborators: Sponsor: Gianna Wilkie
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-03-15
Completion Date: 2023-05-02
Results First Posted: 2024-07-08
Last Update Posted: 2024-07-08
Locations: University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01605, United States
URL: https://clinicaltrials.gov/show/NCT04599075