| Trial ID: | L5899 |
| Source ID: | NCT06445946
|
| Associated Drug: |
Metformin
|
| Title: |
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
|
| Acronym: |
DECIDE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Gestational Diabetes Mellitus|Pregnancy, High Risk
|
| Interventions: |
DRUG: Metformin|DRUG: Insulin
|
| Outcome Measures: |
Primary: A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death., LGA will be defined as a birthweight ≥90th%tile for gestational age based on a US birth certificate reference adjusted for parity and/or fetal sex. Neonatal hypoglycemia will be defined as a blood glucose \<35 mg/dL or treatment \<24 hours after birth with either IV, PO, or gel glucose therapy. Neonatal hyperbilirubinemia will be defined as treated with phototherapy or exchange transfusion in the first postnatal week and either treatment in the first postnatal week or kernicterus. Fetal or neonatal death can be due to any indication between randomization to hospital discharge or 30 days postnatal if still hospitalized (excluding voluntary pregnancy termination)., LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal.|Child body mass index (BMI) at 2 years of age, Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex, 2 years of age. | Secondary: Hypertensive disorder of pregnancy, HDP (maternal), HDP will include either gestational hypertension or preeclampsia. Gestational hypertension will be defined as: systolic blood pressure of 140 mm Hg or more or diastolic blood pressure of 90 mm Hg or more on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with a previously normal blood pressure. Preeclampsia will be defined as: above blood pressure criteria AND proteinuria (300 mg or more per 24 hour urine collection, protein/creatinine ratio of 0.3 mg/dL or more, or dipstick reading of 2+) OR thrombocytopenia (platelet count less than 100 109/L), renal insufficiency (serum creatinine greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease), impaired liver function (elevated blood concentrations of liver transaminases to twice normal concentration), pulmonary edema, new-onset headache or visual symptoms not attributed to other diagnoses., Randomization to delivery|Gestational weight gain (maternal), Gestational weight gain between weight at first prenatal visit and weight at delivery based on z-score and defined as excess versus within Institute of Medicine (IOM) recommendations based on first pregnancy BMI., Initiation of prenatal care to delivery|Mode of delivery (maternal), Cesarean delivery or vaginal delivery, At birth|Obstetric perineal/anal sphincter injuries (maternal), First degree: Injury to perineal skin only; Second degree: Injury to perineum involving perineal muscles but not involving anal sphincter; Third degree: Injury to perineum involving anal sphincter complex, including 3a: Less than 50% of external anal sphincter thickness torn; 3b: More than 50% external anal sphincter thickness torn; and 3c: Both external anal sphincter and internal anal sphincter torn; and Fourth degree: Injury to perineum involving anal sphincter complex (external anal sphincter and internal anal sphincter) and anal epithelium., At birth|Preterm birth (child), Preterm birth \<37 weeks and \<34 weeks based on project gestational age, At birth|Requiring mechanical ventilation (child), Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours of birth, <72 hours after birth|NICU admission (child), Admitted to NICU or intermediate nursery ≥72 hours, any indication, Birth to delivery discharge.|Oxygen support (child), Requiring oxygen support, <72 hours after birth|Respiratory distress syndrome (child), Signs of respiratory distress with oxygen requirement and confirmed by chest x-ray., Anytime during the first 72 hours after birth|Body mass index (BMI) (maternal), Continuous measure, using standardized protocol as kg/m2., 2-year follow-up|Obesity overall and by class (maternal), BMI per the following classifications: Normal or underweight: \< 25 kg/m2; Overweight: 25 to \< 30 kg/m2; Class 1: 30 to \< 35 kg/m2; Class 2: 35 to \< 40 kg/m2; and Class 3: 40 kg/m2 or greater., 2-year follow-up|Anthropometry (maternal), Waist circumference, continuous measures in cm, 2-year follow-up|Anthropometry (maternal), Hip circumference, continuous measures in cm, 2-year follow-up|Anthropometry (maternal), Waist - to - hip ratio, continuous measure, 2-year follow-up|Adiposity (maternal), Triceps, subscapular, suprailiac skinfolds, continuous measures in cm, 2 year follow-up|Type 2 diabetes (maternal), A1c \> 6.5% OR fasting plasma glucose \> 126 mg/dL OR OGTT \> 200 mg/dL OR prior diagnosis per patient report, 2-year follow-up.|Prediabetes (maternal), A1c 5.7% to 6.4% OR fasting plasma glucose 100 mg/dl to 125 mg/dL OR OGTT 140 to 199 mg/dL, 2-year follow-up.|Hypertension (maternal), Per American Heart Association criteria as below and/or antihypertensive medication or prior diagnosis per patient report, and defined as: Elevated: Systolic between 120-129 and diastolic less than 80 mm Hg; Stage 1: Systolic between 130-139 or diastolic between 80-89 mm Hg; and Stage 2: Systolic at least 140 or diastolic at least 90 mm Hg., 2-year follow-up.|Cholesterol (maternal), Fasting state, defined as a continuous measure and dichotomous at the following thresholds for each component: Total cholesterol: \> 200 mg/dL; LDL cholesterol: \> mg/dL; HDL cholesterol: \< 40 mg/dL; Triglycerides: \> 200 mg/dL., 2-year follow-up.|Hemoglobin A1c (maternal), Continuous measure, percentage., 2-year follow-up.|Overweight (child), BMI ≥85th%tile for age and sex., 2-year follow-up.|Obesity (child), BMI ≥95th%tile for age and sex., 2-year follow-up.|Anthropometry (child), Abdominal circumference; age- and sex-adjusted per WHO z-scores for arm circumference., 2-year follow-up.|Adiposity (child), Triceps/subscapular skinfold thickness \> 90th%tile for age and sex; individual and sum of measures., 2-year follow-up.|Treatment Satisfaction Questionnaire for Medication (TSQM), The TSQM (version 1.4) comprises 14 items across four domains focusing on effectiveness (three items), side effects (five items), convenience (three items), and global satisfaction (three items) of the medication over the previous 2-3 weeks. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring., 6-weeks postpartum.|Questionnaire on Acceptability of Treatment, A set of 5 questions developed in the Rowan et al. RCT assessing patient adherence, preferences, and experiences with metformin versus insulin for GDM (Rowan et al., NEJM, 2008)., 6-weeks postpartum.
|
| Sponsor/Collaborators: |
Sponsor: Ohio State University | Collaborators: Patient-Centered Outcomes Research Institute|The George Washington University Biostatistics Center
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1572
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-08-01
|
| Completion Date: |
2030-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-04
|
| Locations: |
University of Alabama, Tuscaloosa, Alabama, 35487, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|University of California San Francisco, San Francisco, California, 94143, United States|Christiana Care, Newark, Delaware, 19718, United States|University of South Florida, Tampa, Florida, 33620, United States|Tufts University, Boston, Massachusetts, 02111, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|University of New Mexico, Albuquerque, New Mexico, 87131, United States|Columbia University Irving Medical Center, New York, New York, 10032, United States|University of North Carolina Chapel Hill, Chapel Hill, North Carolina, 27514, United States|Wake Forest University, Winston-Salem, North Carolina, 27106, United States|The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus, Ohio, 43210, United States|Premier Health - Miami Valley Hospital, Dayton, Ohio, 45409, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|Brown University, Providence, Rhode Island, 02912, United States|University of South Carolina Greenville, Greenville, South Carolina, 29605, United States|University of Texas Austin, Austin, Texas, 78705, United States|University of Texas Health Science Center, Houston, Texas, 77030, United States|Eastern Virginia Medical School, Norfolk, Virginia, 23501, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06445946
|
