No registrations found.
ID
Source
Brief title
Health condition
Gestational diabetes
Diabetes gravidarum
Zwangerschapsdiabetes
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number 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
Study objective
Oral antidiabetic medication in the form of metformin and if needed supplementary glibenclamide are a safe and effective first choice treatment strategy for gestational diabetes.
Study design
• 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
Intervention
Intervention: metformin and if needed supplementary glibenclamide
Comparator: insulin
L. de Wit
Lundlaan 6
Utrecht 3584 EA
The Netherlands
0031 88 755 4913
l.dewit-3@umcutrecht.nl
L. de Wit
Lundlaan 6
Utrecht 3584 EA
The Netherlands
0031 88 755 4913
l.dewit-3@umcutrecht.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5953 |
| NTR-old | NTR6134 |
| CCMO | NL57195.041.16 |
| OMON | NL-OMON47522 |