Impact on pregnancy outcomes when changing diagnostic criteria for gestational diabetes in Sweden
| ISRCTN | ISRCTN41918550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41918550 |
| Secondary identifying numbers | OLL-597601 |
- Submission date
- 27/11/2017
- Registration date
- 15/12/2017
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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 Backman
Contact information
Scientific
Dept of Obstetrics and Gynecology
University Hospital Örebro
Örebro
70185
Sweden
 ORCID ID |
0000-0002-2691-7525 |
|---|
Study information
| Study design | National multicenter unblinded interventional study with a stepped wedge randomized controlled design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available. |
| Scientific title | Impact of Changing Diagnostic criteria for Gestional diabetes in Sweden - a national stepped wedge randomized controlled trial |
| Study acronym | CDC4G |
| Study objectives | 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(s) | The Ethical Committee in Uppsala County, 2016/12/07, ref: Dnr2016/487 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2015 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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). |
| Key inclusion criteria | All pregnant women in the participating hospitals and their uptake regions. |
| Key exclusion criteria | Preexisting diabetes mellitus. |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centres
701 85
Sweden
Gothenburg
41685
Sweden
Falun
79185
Sweden
Uppsala
75375
Sweden
Västerås
72187
Sweden
Stockholm
10535
Sweden
Gotland
62266
Sweden
Lund
22242
Sweden
21428
Sweden
Kristianstad
291 33
Sweden
Varberg
43281
Sweden
Kungsbacka
43480
Sweden
Sponsor information
Hospital/treatment centre
Box 161
Örebro
70185
Sweden
| Website | www.regionorebolan.se |
|---|---|
"ROR" |
https://ror.org/00maqj547 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | Data can be shared based on the decision of the steering group for CDC4G and according to local regulations and laws. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2019 | 06/11/2019 | Yes | No |
| Statistical Analysis Plan | version 8 | 28/10/2022 | 19/12/2022 | No | No |
| Statistical Analysis Plan | Corrections | 12/05/2023 | 12/05/2023 | No | No |
| Results article | 08/07/2024 | 09/07/2024 | Yes | No |
Additional files
Editorial Notes
09/07/2024: Publication reference added.
12/05/2023: The following changes have been made:
1. SAP file uploaded.
2. The intention to publish date has been changed from 01/12/2019 to 30/09/2023.
3. The Individual participant data (IPD) sharing statement and summary were added.
19/12/2022: The following changes have been made:
1. SAP file uploaded.
2. The scientific contact's details have been changed.
06/11/2019: Publication reference added.
12/03/2019: Internal review.
28/02/2019: The secondary outcome measures were updated.
