Condition category
Pregnancy and Childbirth
Date applied
27/11/2017
Date assigned
15/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.cdc4g.com

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 measures

Large for Gestational Age (LGA) is measured as the weight of the baby will be measured at time of birth.

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

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

www.regionorebolan.se

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes