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The SUGAR-DIP trial; oral medication versus insulin for diabetes in pregnancy


- candidate number25614
- NTR NumberNTR6134
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-nov-2016
- Secondary IDsNL57195.041.16 
- Public TitleThe SUGAR-DIP trial; oral medication versus insulin for diabetes in pregnancy
- Scientific TitleThe SUGAR-DIP trial; oral medication strategy versus insulin for diabetes in pregnancy
- ACRONYMSUGAR-DIP
- hypothesisOral antidiabetic medication in the form of metformin and if needed supplementary glibenclamide are a safe and effective first choice treatment strategy for gestational diabetes.
- Healt Condition(s) or Problem(s) studiedGestational diabetes
- Inclusion criteria- Aged 18 years or over
- Singleton pregnancy
- Diagnosis of GDM as per national guidelines
- Indication for pharmacological treatment of GDM
- Gestational age between 16 and 34 weeks
- Ability to understand Dutch or English
- Ability to provide written informed consent
- Exclusion criteria- Known pre-existent type 1 or type 2 diabetes mellitus
- Severe medical or psychiatric comorbidities
- Serious liver disease or kidney failure, or any other condition with contraindications for the use of either metformin or glibenclamide
- Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 29-nov-2016
- planned closingdate1-mei-2019
- Target number of participants810
- InterventionsIntervention: metformin and if needed supplementary glibenclamide
Comparator: insulin
- Primary outcomeNumber of infants born large-for-gestational-age (LGA)
- Secondary outcome Maternal hypoglycemia
Primary / secondary caesarean section
Pregnancy related hypertensive disorders: pregnancy induced hypertension, preeclampsia
Preterm delivery (<37 weeks of gestation)
Neonatal hypoglycemia: moderate (serum glucose <2.6 mmol/l), severe (serum glucose <2.0 mmol/l)
Neonatal hyperbilirubinemia requiring phototherapy
Neonatal Medium care / NICU admission
- Timepoints Maternal hypoglycemia: study period until 6 weeks postpartum
Primary / secondary caesarean section: delivery
Pregnancy related hypertensive disorders: study period until 6 weeks postpartum
Preterm delivery: delivery
Neonatal hypoglycemia: delivery until discharge
Neonatal hyperbilirubinemia requiring phototherapy: delivery intil 6 weeks postpartum
Neonatal Medium care / NICU admission: delivery until 6 weeks postpartum
fetal umbilical cord blood C-peptide: delivery
maternal HbA1c measures: study intake, week 30 and 35 of pregnancy
- Trial web sitewww.studies-obsgyn.nl/sugar-dip
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L. de Wit
- CONTACT for SCIENTIFIC QUERIES B.B. van Rijn
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD29-nov-2016 - 3-jan-2017


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