We hypothesized that intensive GDM treatment according to the new (2013) GDM criteria would result in a reduction in infants with birth weight >90th centile (large for gestational age, LGA), in comparison to treatment according to the old…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Health condition
GDM Diabetes gravidarum Gestational diabetes zwangerschapsdiabetes
Research involving
Sponsors and support
Intervention
- Food (substances)
Outcome measures
Primary outcome
Large for gestational age (LGA, defined as birth weight >90th centile, using the Dutch Perined reference charts)
Secondary outcome
Secondary perinatal outcomes will include:
• Perinatal mortality (up until 6 weeks postpartum)
• Birth weight
• Birth weight >4000 g
• Small for gestational age ( • Gestational age at delivery
• Preterm delivery (<37 weeks)
• Reason for preterm delivery (iatrogenic, spontaneous)
• 1-min Apgar score
• 5-min Apgar score
• 10-min Apgar score
• Shoulder dystocia
• Birth injury (i.e. fractures, nerve palsy)
• Cord blood C peptide (in a subset, where available)
• Neonatal glucose postpartum: 1-3-6-12-24 hours or similar (in GDM treatment group) • Neonatal hypoglycaemia (moderate, serum glucose <2.6 mmol/l; severe, serum glucose <2.0 mmol/l)
• Neonatal intensive care/medium care admission
• Hyperbilirubinemia necessitating phototherapy
• Respiratory support > 24 hours
• Neonatal encephalopathy
Secondary outcomes of delivery:
• Mode of delivery (spontaneous, assisted vaginal, caesarean). We will split instrumental deliveries for fetal distress or non-progressive labour
• Induction of labour
• Post-partum haemorrhage
Secondary maternal outcomes will include:
• Hypertensive disorders of pregnancy (including preeclampsia and pregnancy induced hypertension)
• Need for treatment with insulin or oral glucose lowering medication
• Maternal total weight gain in gestation
• Glycemic control: diary (in GDM treatment group)
• Puerperal sepsis requiring antibiotics
• Maternal admission postpartum
• Serious health outcomes up to the time of primary hospital discharge assessed from patient medical records23.
• Intention to breastfeed prior to giving birth
• Breastfeeding at the end of postpartum period
Cost effectiveness analysis:
• Societal costs
• Quality-adjusted life years
Both from a societal and healthcare perspective
Background summary
Gestational diabetes mellitus (GDM), or hyperglycemia first diagnosed in pregnancy, affects 7-10% of all pregnancies worldwide. Perinatal risk rises with increasing glycemia at oral glucose tolerance test (OGTT). The new (2013) WHO criteria recommend a lower fasting, and a higher post-load threshold for GDM diagnosis in comparison to the old (1999) WHO criteria. To date, however, outcomes of GDM treatment for those affected by the altered diagnostic criteria, has not been well investigated.
Study objective
We hypothesized that intensive GDM treatment according to the new (2013) GDM criteria would result in a reduction in infants with birth weight >90th centile (large for gestational age, LGA), in comparison to treatment according to the old criteria (1999).
Study design
Multicentre open-label randomized controlled trial (RCT).
Intervention
The intervention under investigation will be intensive GDM treatment of women with OGTT results discordant between the new and the old criteria. Treatment will comply with the NVOG guideline: monitoring of blood glucose, dietary recommendations and pharmacotherapy for those unable to achieve euglycemia with dietary intervention alone. The comparator will be routine obstetric care.
Age
Inclusion criteria
- Singleton pregnancy
- Aged >18 years
- OGTT for all indications
- OGTT conducted between gestational ages 16+0 and 30+0 weeks
- Discordant result on a 3-point 75-gram OGTT i.e.:
o Fasting glucose > 5.1 and <7.0 mmol/l OR
o 1-hour glucose ¡Ý10.0 mmol/l OR
o 2-hour glucose >7.8 and <8.4 mmol/l
- Gestational age <32+0 at study inclusion
- Written informed consent
Exclusion criteria
- known preconception diabetes
- major fetal congenital /chromosomal abnormality (eg trisomy 21, spina bifida), known at time of randomization
- significant medical or psychiatric co-morbidities as judged by the investigator (e.g. high dose corticosteroid treatment)
- inability to understand written informed consent without help as indicated by their usual care provider
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL7127 |
| NTR-old | NTR7473 |
| CCMO | NL63013.018.18 |
| OMON | NL-OMON52951 |