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Clinical Trial Details

Trial ID: L2547
Source ID: NCT03380546
Associated Drug: Acarbose
Title: Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
Acronym: ACARB-GDM
Status: TERMINATED
Study Results: NO
Results:
Conditions: Gestational Diabetes Mellitus in Pregnancy
Interventions: DRUG: Acarbose|DRUG: Prandial insulin
Outcome Measures: Primary: Composite endpoint: birth weight ≥ 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury., LGA defined as birth weight greater than the 90th percentile for a standard French population * Neonatal hypoglycemia defined as at least a blood glucose value less than a 2.0 mmol/l during the two first days of life; * Shoulder dystocia, defined as vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed. We will only consider rotational maneuvers such as Rubin II or Woods corkscrew or Jaquemier maneuvers * Birth injury defined as plexus injury or clavicle fracture., At delivery | Secondary: GLUCOSE CONTROL: Capillary glucose levels, The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary., From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery|GLUCOSE CONTROL: HbA1c, Centralized measurement, At delivery|GLUCOSE CONTROL: Need for and dose/day of basal and prandial insulin in both arms, This information will be retrieved from the glucose meter, and if not available, from the woman's diary., At delivery|Neonatal complications : Birth weight and height,, Birth weight ≥ 4000g Birth weight ≥ 4500g, At delivery|Neonatal complications : Small for gestational age infant, SGA: birth weight lower than the 10th percentile for a standard French population, At delivery|Maternal complications : Preeclampsia, Preeclampsia (blood pressure ≥ 140/90 mmHg on two measurements four hours apart and proteinuria of at least 300 mg/24 hours or 3+ or more on dipstick testing or proteinuria/creatininuria \>30 in a random urine sample)., From two weeks after inclusion to delivery|Maternal complications : Pregnancy-induced hypertension, In women with no known hypertension before pregnancy, blood pressure ≥ 140/90 mmHg on two measurements four hours apart without proteinuria and having needed to begin anti-hypertensive therapy, From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery|Neonatal complications : Preterm delivery, * Late preterm infant (between 32 and 37 completed weeks' gestation) * Very preterm infant (28-31 completed weeks' gestation) * Extreme preterm infant (less than 28 completed weeks' gestation), At delivery|Neonatal complications : Low Apgar score, 5-min Apgar score \< 7, At delivery|Neonatal complications : Neonatal respiratory distress syndrome, based on the clinical course, chest X-ray finding, blood gas and acid-base values, At delivery|Neonatal complications : Intrauterine fetal or neonatal death;, These endpoints will be extracted from the women' charts, From two weeks after inclusion to delivery|Acceptance/satisfaction of two strategies : -Quality of life -Satisfaction questionnaires, Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) - use of analogic scales, At delivery|Side effects of drugs : Maternal hypoglycemia, * Severe hypoglycemia: requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma/capillary glucose to normal is considered sufficient evidence that the event was induced by a low plasma/capillary glucose concentration. * event during which typical symptoms of hypoglycemia are accompanied by a measured capillary glucose concentration \<70 mg/dL (\<3.9 mmol/L). * Asymptomatic hypoglycemia: event not accompanied by typical symptoms of hypoglycemia but with a measured capillary glucose concentration \<60 mg/dL (\<3.3 mmol/L)., during the 7 months of treatment|Gastro-intestinal side effects, The events occuring during the last 14 days of pregnancy or gastro-intestinal side effects leading to treatment withdrawl, from two weeks after inclusion : 14 to 36 weeks of gestation to delivery|Results of oral glucose tolerance test and HbA1c measurement, Test will be performed by the women before follow up visit, 3 months after delivery|Infant anthropometrics., These data will be collected from children's health record, At month 1, month 2 and month 3|Conservation of serum and plasma; cord fluid. The samples may be used for further analyses ancillary studies and which could be beneficial for GDM care based on evolution in scientific knowledge., * The blood samples will be collected at the same time as the sample routinely collected just before delivery for irregular agglutinin test measurement. * Cord fluid will be collected, within 10 years after the end of the study
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: FEMALE
Age: ADULT
Phases: PHASE3
Enrollment: 341
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-04
Completion Date: 2024-02-22
Results First Posted:
Last Update Posted: 2024-07-03
Locations: Jean Verdier Hospital, Bondy, 93140, France
URL: https://clinicaltrials.gov/show/NCT03380546