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Clinical Trial Details

Trial ID: L5243
Source ID: NCT03620890
Associated Drug: Neutral Protamine Hagedorn (Nph)
Title: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Acronym: Determin
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03620890/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Neutral Protamine Hagedorn (NPH)|DRUG: Detemir insulin
Outcome Measures: Primary: Number of Neonates With Composite Adverse Neonatal Outcome, Composite Adverse Neonatal Outcome includes 1 or more of any of the following: * Neonatal intensive care unit (NICU) admission or * Neonatal hypoglycemia (\<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or * Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or * Shoulder dystocia - defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head in order to deliver the fetal body after the fetal head has been delivered or * Large for gestational age (LGA) -weight over 90th percentile of the expected value according to gestational age or * Macrosomia- Fetal weight above 4000g, From the time of delivery to the time of discharge (about 2-14 days) | Secondary: Maternal Mean Fasting Glucose, perinatal to postpartum (32 weeks)|Maternal Mean Post Prandial Glucose, perinatal to postpartum (32 weeks)|Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy, perinatal to postpartum (32 weeks)|Change in Maternal Weight During Pregnancy, perinatal to postpartum (32 weeks)|Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy, Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia., perinatal to postpartum (32 weeks)|Number of Maternal Subjects Who Had Preeclampsia With Severe Features, perinatal to postpartum (32 weeks)|Number of Subjects Who Had Cesarean Delivery, at delivery|Number of Subjects Who Had Operative Vaginal Delivery, at delivery|Gestational Weeks at Delivery, at delivery|Number of Neonates Who Where Small for Gestational Age (SGA), Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile., at delivery|Neonatal Hospital Admission Days, From the time of delivery to the time of discharge (about 2-14 days)|# of Neonates Who Had 5-minute Apgar Score < 7, The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome., 5 minutes after delivery|Number of Neonates Who Had Jaundice Requiring Therapy, From the time of delivery to the time of discharge (about 2-14 days)
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center, Houston
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-04
Completion Date: 2020-07-29
Results First Posted: 2021-08-18
Last Update Posted: 2021-09-16
Locations: University of Texas Health Science Center of Houston, Houston, Texas, 77030, United States
URL: https://clinicaltrials.gov/show/NCT03620890