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Clinical Trial Details

Trial ID: L5492
Source ID: NCT03765359
Associated Drug: Metforminhydrochloride
Title: Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Pregnancy|Insulin Resistance|Type1diabetes
Interventions: DRUG: metforminhydrochloride|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: Changes in the insulin need during pregnancy, The insulin dosage (IU/ml) in two weeks sets, from 5-10 gestational weeks until the delivery | Secondary: Blood glucose balance during pregnancy HbA1c, HbA1c (mmol/mol), from gestational weeks 5 until the delivery|Blood glucose balance during pregnancy AVG, SD, CV, mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels, from gestational weeks 5 until the delivery|Change in the weight, Weight gain (g) during pregnancy, from gestational weeks 5 until the delivery|Change in the blood pressure, Blood pressure (mmHg), from gestational weeks 5 until the delivery|Incidence of pre-eclampsia, Incidence of pre-eclampsia (%), from gestational weeks 20 until the delivery|Incidence hepatogestosis, Incidence hepatogestosis (%), from gestational weeks 20 until the delivery|Pregnancy complications, Incidence proteinuria (mg/mmol or mg/d), from gestational weeks 5 until the delivery|macrosomia, estimated fetal weight in ultrasound (grams), from gestational weeks 20 until the delivery|Pregnancy complications, incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%), 12-22 weeks of gestation|Pregnancy complications, incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%), 22-40 weeks of gestation|Thigh fractional volume ultrasound, Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program, from gestational weeks 20 until delivery|Rate of the caesarean sections, Rate of the caesarean sections (%), The delivery|Labour, rate of spontaneous delivery (%), The delivery|Rate of the operative vaginal deliveries, Rate of the operative vaginal deliveries (%), The delivery|Rate of the shoulder dystocia, Rate of the shoulder dystocia (%), The delivery|Labor complications, rate of induced delivery (%), The delivery|Rate of the perineal tears, Rate of the perineal tears (%), The delivery|Postpartum bleeding, postpartum bleeding (ml), The delivery|Newborn variables (gestational age), Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%), After the delivery|Newborn variables, weight of the newborn (g), After the delivery|Newborn outcome, Acidosis of the newborn (pH), After the delivery|Newborn outcome (intensive care), The need of NICU (neonatal intensive care unit) treatment (days), After the delivery|Newborn outcome (hypoglycemia), The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%), After the delivery|Newborn outcome (Erb's), Incidence of the Erb's paresis (%), After the delivery|Cost benefit calculations (sick leaves), The need of sick leaves during pregnancy (days), from gestational weeks 12 until delivery|Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic), The need of polyclinical controls during pregnancy (number of visits/pregnancy), 14-40 weeks of gestation|Cost benefit calculations (hospitalization), The need of hospitalization during pregnancy (days/pregnancy), 14-40 weeks of gestation|Cost benefit calculations (all outpatient visits after delivery ), The need of policlinical controls of the diabetic mother after the delivery (number of visits), One year after the delivery|Cost benefit calculations (hospitalization after delivery, all departments), The need of hospitalization of the diabetic mother after the delivery (days), Up to one year after the delivery|Cost benefit calculations (all hospitalization of the child), The need of hospitalization of the child (days), Until the age of one year|Cost benefit calculations (all policlinical controls of the child), The need of policlinical controls of the child (number of visits), Until the age of one year|high sensitive-CRP, high sensitive-CRP (mg/l), 7-10, 26-28 and 34-36 weeks of gestation|lipids, cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l), 7-10, 26-28 and 34-36 weeks of gestation|Inflammatory markers, adiponectin, leptin, resistin, IL-6, TNF-α (pg/ml), 7-10, 26-28 and 34-36 weeks of gestation
Sponsor/Collaborators: Sponsor: Tampere University Hospital | Collaborators: Turku University Hospital|Oulu University Hospital|Helsinki University Central Hospital|Central Finland Hospital District
Gender: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 101
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-08-05
Completion Date: 2022-12-19
Results First Posted:
Last Update Posted: 2023-06-07
Locations: Helsinki University Hospital, Helsinki, Finland|Central Finland Health Care District, Jyväskylä, Finland|Oulu University hospital, Oulu, Finland|Tampere University Hospital, Tampere, Finland|Turku University Hospital, Turku, Finland
URL: https://clinicaltrials.gov/show/NCT03765359