Plain English Summary
Background and study aims
Gestational diabetes mellitus (GDM) is high blood sugar that develops during pregnancy. In June 2015, the Swedish National Board of Health reviewed the evidence on the current Swedish and WHO GDM criteria and recommended adoption of the new, stricter WHO diagnostic criteria for what is considered GDM. GDM is currently being treated differently in different hospitals/regions and the care is not equal. It is unknown if the change of the diagnostic criteria will lead to any benefits in Sweden. The new criteria mean a major change in the number of pregnant women who gets diagnosed (estimated a triple increase based on studies in other countries). The CDC4G study is a randomized national multicenter study to evaluate the Swedish National Board of Health's new recommendation for gestational diabetes mellitus (GDM) diagnostic criteria in Sweden. The new diagnostic criteria will be compared to the old criterions used in Sweden. The aim of this study is to examine if treating women with GDM defined by the new criteria will reduce risks of adverse pregnancy outcomes in the Swedish population.
Who can participate?
Pregnant woman in the maternity hospitals.
What does the study involve?
Participating hospitals are randomly allocated to when they switch from the pre-existing Swedish diagnostic criteria for GDM to the WHO 2013 criteria for GDM to the 3 point OGTT with fasting, one hour and/or two hour diagnostic thresholds. Participants are followed up to assess if their babies are large for their gestation age, if they develop hypertension, pre-eclampsia or any other complications at labour.
What are the possible benefits and risks of participating?
The expected outcome is a significant reduction in the proportion of large children and complications related to this during childbirth. Follow-up of mothers, children and their long-term health will be performed through the national health and quality records.
The results of the study are expected to be of great significance for the clinics that treats pregnant women with diabetes. Hopefully it will also lead to a more equal care for when it comes to GDM and for the future pregnant individual, no matter where in Sweden they might live.
Where is the study run from?
This study is being run by the University Hospital Örebro (Sweden) and takes place in hospitals in Sweden.
When is the study starting and how long is it expected to run for?
October 2015 to December 2025
Who is funding the study?
Region Örebro County (Sweden)
Who is the main contact?
Dr Helena Fadl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helena Fadl
ORCID ID
http://orcid.org/0000-0002-2691-7525
Contact details
Dept of Obstetrics and Gynecology
University Hospital Örebro
Örebro
70185
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OLL-597601
Study information
Scientific title
Impact of Changing Diagnostic criteria for Gestional diabetes in Sweden- a national stepped wedge randomized controlled trial
Acronym
CDC4G-trial
Study hypothesis
1. Treating women with GDM defined by the new criteria will reduce risks of adverse pregnancy outcomes in the Swedish population.
2. the new criteria will be cost effective. Even though there will be more costs in obstetrics, reduced costs will be seen in neonatal care and probably later on in primary health care.
Ethics approval
The Ethical Committee in Uppsala County, 2016/12/07, ref: Dnr2016/487
Study design
National multicenter unblinded interventional study with a stepped wedge randomized controlled design
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available.
Condition
Gestational diabetes mellitus
Intervention
The intervention is the switch from the pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM to the 3 point OGTT with fasting, 1 hour and/or 2 hour diagnostic thresholds of ≥5.1, ≥10.0, ≥8.5 mmol/l. This stepped wedge randomised controlled study design allows each participating center (cluster) to be their own controls before and after randomization. All eligible women from the participating centres are randomised for starting time to the new regime. Randomisation is done through a RCT module from the Pregnancy Register.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Large for Gestational Age (LGA) is measured as the weight of the baby will be measured at time of birth.
Secondary outcome measures
Current secondary outcome measures as of 28/02/2019 in accordance with approved ethical protocol from 07/12/2016:
1. Composite of severe adverse outcomes (stillbirth, neonatal death, Erbs palsy, metabolic acidosis defined as pH <7.05 and BE >12 mmol/l in umbilical artery or pH <7.0 in umbilical artery, Apgar score <4 at 5 minutes, HIE I-III, intracranial haemorrhage, neonatal convulsions, meconium aspiration syndrome, mechanical ventilation)
2. 5-Min Apgar score <7
3. Fractured clavicle
4. Blood glucose in the infants
5. Prematurity <37 weeks
6. NICU admission yes/no
7. NICU days
8. Small for Gestational Age
9. Health economic outcome
10. Incremental Cost Effectiveness Ratio
11. Hypoglycaemia needing IV therapy
12. Phototherapy
13. Blood glucose in the infants
Maternal outcomes:
1. Hypertension, Pre-eclampsia-defined is measured using blood pressure and proteinuria at labour and/or discharge
2. Shoulder dystocia is measured using pregnancy quality register (Shoulder dystocia ICD O660) at labour and/or discharge
3. Perineal trauma-3 and 4 degree measured using pregnancy quality register (Perineal trauma ICD O70) at labour and/or discharge
4. Induction of labour is measured using medical records at labour
5. Breastfeeding at hospital discharge
6. Emergency C-section is measured using medical records at labour and/or discharge
7. Elective C-section is measured using medical records at labour and/or discharge
8. Instrumental delivery is recorded using medical records at labour and/or discharge
9. Length of maternal postnatal stay is recorded using medical records at discharge
Previous secondary outcome measures:
1. Hypertension, Pre-eclampsia-defined is measured using blood pressure and proteinuria at labour and/or discharge
2. Shoulder dystocia is measured using pregnancy quality register (Shoulder dystocia ICD O660) at labour and/or discharge
3. Perineal trauma-3 and 4 degree measured using pregnancy quality register (Perineal trauma ICD O70) at labour and/or discharge
4. Induction of labour is measured using medical records at labour
5. Breastfeeding at hospital discharge
6. Emergency C-section is measured using medical records at labour and/or discharge
7. Elective C-section is measured using medical records at labour and/or discharge
8. Instrumental delivery is recorded using medical records at labour and/or discharge
9. Length of maternal postnatal stay is recorded using medical records at discharge
Overall trial start date
01/10/2015
Overall trial end date
31/12/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All pregnant women in the participating hospitals and their uptake regions.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
12 clusters, total sample size of 71 500 pregnant women (35750 before change and 35750 after change of the new GDM criteria).
Participant exclusion criteria
Preexisting diabetes mellitus.
Recruitment start date
01/01/2018
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Sweden
Trial participating centre
University Hospital Örebro
Örebro
701 85
Sweden
Trial participating centre
Sahlgrenska University Hospital
Västra Götaland County
Gothenburg
41685
Sweden
Trial participating centre
Falun Regional Hospital
Dalarna County
Falun
79185
Sweden
Trial participating centre
Uppsala academy Hospital
Uppsala county
Uppsala
75375
Sweden
Trial participating centre
Västerås Hospital
Västmanland County
Västerås
72187
Sweden
Trial participating centre
Serafen Maternal Health Care Unit
Stockholm County
Stockholm
10535
Sweden
Trial participating centre
Gotland Hopsital
Gotland County
Gotland
62266
Sweden
Trial participating centre
Skåne University Hospital
Skåne county
Lund
22242
Sweden
Trial participating centre
Skåne University Hospital
Malmö
21428
Sweden
Trial participating centre
Kristianstad Hospital
J A Hedlunds väg 5
Kristianstad
291 33
Sweden
Trial participating centre
Varberg Hospital
Träslövsvägen 68
Varberg
43281
Sweden
Trial participating centre
Kungsbacka Hospital
Tölö vägen
Kungsbacka
43480
Sweden
Sponsor information
Organisation
Region Örebro County
Sponsor details
Box 161
Örebro
70185
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Region Örebro County
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal. Study protocol will be submitted and published after the last clinic has been randomized fall 2018.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
N/A
Publication list
N/A