To evaluate the effectiveness and cost-effectiveness of intensive GDM treatment as compared to routine maternity care in pregnant women with a discordant OGTT result between the new (2013) WHO criteria as compared to the old (1999) WHO criteria for…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the incidence of birth weight >90th centile (LGA).
Secondary outcome
Secondary outcomes include mode of delivery (caesarean sections), maternal
outcomes, perinatal outcomes including perinatal mortality, gestational age at
delivery, shoulder dystocia, birth trauma, neonatal hypoglycaemia, neonatal
intensive care admission, need for phototherapy, quality of life and societal
costs.
Background summary
Gestational diabetes mellitus (GDM), defined as hyperglycemia in pregnancy, is
currently diagnosed in approximately 5% of all pregnancies. GDM carries
significant perinatal risks including large-for-gestational-age (LGA) infants,
shoulder dystocia, preeclampsia, caesarean section, and neonatal hypoglycemia.
There is a gradual increase in adverse perinatal outcomes with increasing
maternal glycemia at oral glucose tolerance testing (OGTT). The new (2013) WHO
criteria propose to lower the fasting threshold for GDM diagnosis in comparison
to the old (1999) WHO criteria. It is unclear whether this will lead to
improved perinatal outcomes for this group of women with GDM. We hypothesize
that intensive GDM treatment of women according to the new (2013) GDM criteria
who were considered normal in the old criteria, will result in a reduction in
infants with birth weight >90th centile (large for gestational age, LGA) at
acceptable costs, in comparison to the old criteria.
Study objective
To evaluate the effectiveness and cost-effectiveness of intensive GDM treatment
as compared to routine maternity care in pregnant women with a discordant OGTT
result between the new (2013) WHO criteria as compared to the old (1999) WHO
criteria for gestational diabetes mellitus.
Study design
Multicentre open-label randomized controlled trial (RCT).
Intervention
The intervention is intensive GDM treatment, including monitoring of blood
glucose values, dietary recommendations and pharmacotherapy for those unable to
achieve euglycemia with dietary intervention alone. The comparison will be
routine maternity care.
Study burden and risks
Burden: All participants will be asked to complete a questionnaire on 3
occasions (10-35 minutes per questionnaire). In addition to usual maternity
care, participants allocated to intensive treatment will have additional
appointments for personalized dietary advice, and will if needed be referred to
a diabetes nurse or an endocrinologist. It is more likely that they will be
referred to the obstetrician and that induction of labour before term will be
discussed. Intensive treatment also includes recording blood glucose levels
several times a day (finger stick measure), weight and (if necessary)
medication.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
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 >=10.0 mmol/l OR
o 2-hour glucose >7.8 and <8.4 mmol/l
- Gestational age <32+0 at study inclusion
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
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63013.018.18 |