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Clinical Trial Details

Trial ID: L6506
Source ID: NCT00835861
Associated Drug: Metformin
Title: Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Acronym: MIPOD
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00835861/results
Conditions: Non Insulin Dependent Diabetes|Pregnancy
Interventions: DRUG: Metformin|DRUG: Insulin
Outcome Measures: Primary: Blood Glucose Measurements, Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner., Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery | Secondary: Number of Patients With Obstetric Complications, Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion., Throughout pregnancy until hospital discharge following delivery.|Maternal Weight Gain, Baseline throughout pregnancy until last prenatal visit.|Number of Babies With Neonatal Hypoglycemia, Initial neonatal glucose \< 40 mg/dL, Time of delivery through hospital discharge|Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester, 1st, 2nd, and 3rd trimester|Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL), NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES \<95, Baseline throughout pregnancy until time of delivery|Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL), NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES \<130, Baseline throughout pregnancy until time of delivery|Number of Episodes Maternal Hypoglycemia, Maternal glucose \< 60 mg/dL, Baseline throughout pregnancy until time of delivery|Number of Babies With Adverse Neonatal Outcomes, Resuscitation in the delivery room, preterm birth \< 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy., Delivery until hospital discharge
Sponsor/Collaborators: Sponsor: University of North Carolina, Chapel Hill | Collaborators: WakeMed Health and Hospitals
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date: 2010-04
Results First Posted: 2014-05-26
Last Update Posted: 2017-04-25
Locations: University of North Carolina Hospitals Obstetric Clinics, Chapel Hill, North Carolina, 27599, United States
URL: https://clinicaltrials.gov/show/NCT00835861