Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 18 of 18

List	Outcome	Time frame	Description
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.	At delivery	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.
Secondary	GLUCOSE CONTROL: Capillary glucose levels	From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery	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.
Secondary	GLUCOSE CONTROL: HbA1c	At delivery	Centralized measurement
Secondary	GLUCOSE CONTROL: Need for and dose/day of basal and prandial insulin in both arms	At delivery	This information will be retrieved from the glucose meter, and if not available, from the woman's diary.
Secondary	Neonatal complications : Birth weight and height,	At delivery	Birth weight ≥ 4000g Birth weight ≥ 4500g
Secondary	Neonatal complications : Small for gestational age infant	At delivery	SGA: birth weight lower than the 10th percentile for a standard French population
Secondary	Maternal complications : Preeclampsia	From two weeks after inclusion to delivery	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).
Secondary	Maternal complications : Pregnancy-induced hypertension	From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery	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
Secondary	Neonatal complications : Preterm delivery	At 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)
Secondary	Neonatal complications : Low Apgar score	At delivery	5-min Apgar score \< 7
Secondary	Neonatal complications : Neonatal respiratory distress syndrome	At delivery	based on the clinical course, chest X-ray finding, blood gas and acid-base values
Secondary	Neonatal complications : Intrauterine fetal or neonatal death;	From two weeks after inclusion to delivery	These endpoints will be extracted from the women' charts
Secondary	Acceptance/satisfaction of two strategies : -Quality of life -Satisfaction questionnaires	At delivery	Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) \- use of analogic scales
Secondary	Side effects of drugs : Maternal hypoglycemia	during the 7 months of treatment	* 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).
Secondary	Gastro-intestinal side effects	from two weeks after inclusion : 14 to 36 weeks of gestation to delivery	The events occuring during the last 14 days of pregnancy or gastro-intestinal side effects leading to treatment withdrawl
Secondary	Results of oral glucose tolerance test and HbA1c measurement	3 months after delivery	Test will be performed by the women before follow up visit
Secondary	Infant anthropometrics.	At month 1, month 2 and month 3	These data will be collected from children's health record
Secondary	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.	within 10 years after the end of the study	* 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

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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