Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/01/2016
Date assigned
23/01/2016
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gestational diabetes is a type of diabetes that some women develop during pregnancy. It happens when there is too much sugar (glucose) in the blood. Normally, the amount of glucose in the blood is controlled by a hormone called insulin. However during pregnancy, some women have high levels of glucose in their blood that insulin cannot control. This can happen in as many as 1 in 20 pregnancies and can be linked with complications at birth and long term problems for mother and baby. The main way to treat gestational diabetes is by controlling blood sugar with a strict diet and exercise regime however some women need medication to keep their blood glucose under control. It usually develops in the third trimester (final part of pregnancy), however it is possible that it actually develops earlier. The main way of testing for gestational diabetes is by using the oral glucose tolerance test (OGTT). This test is usually carried out when a woman is between 24 and 28 weeks pregnant, however by this time in pregnancy, it can lead to serious complications. The aim of this study is to find out whether it would be possible to complete an OGTT on pregnant women who are between 11 and 14 weeks pregnant.

Who can participate?
Women over 18 years old, who are 11-14 weeks pregnant.

What does the study involve?
All women are asked not to eat or drink anything other than water for 12 hours before the test (overnight fasting). When the participants arrive for the test, a blood sample is taken in order to get a baseline (starting) measurement to compare the results of the OGTT to. The participants are then asked to drink a sweet liquid containing a specific amount of glucose and a further blood sample is taken at 1 and 2 hours. The number of participants who successfully complete the testing are then recorded.

What are the possible benefits and risks of participating?
Participants may benefit from an earlier diagnosis of gestational diabetes and so they would be able to be treated sooner than they would otherwise. There are no risks of taking part in this study, although participants may experience pain or bruising when having blood taken.

Where is the study run from?
Southend University Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2016 to September 2016

Who is funding the study?
Southend University Hospital NHS Foundation Trust (UK)

Who is the main contact?
Mr Mandeep Singh

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mandeep Singh

ORCID ID

http://orcid.org/0000-0003-4398-4356

Contact details

Kypros Nicolaides Fetal Medicine Unit
Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff on Sea
SS16 5ES
United Kingdom
+44 7931 539900
mandeep.singh@southend.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Single center study to assess the feasibility of undertaking an oral glucose tolerance test in first trimester of pregnancy

Acronym

Study hypothesis

Oral glucose tolerance test can be performed in first trimester (11- 14 weeks) of pregnancy.

Ethics approval

Wales Research Ethics Committee 6 Proportionate Review Sub-Committee, 02/02/2016, ref: 16/WA/0056

Study design

Single-centre cross sectional feasibility study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Gestational diabetes

Intervention

After fasting for 8-12 hours pre-test before a fasting blood glucose measurement is taken. Participants then consume a drink containing 75g glucose and blood glucose measurements are repeated at 1 and 2 hours.
No further follow up is needed. The blood results will be reviewed and is found abnormal then treatment will be planned as usual.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Rate of successful completion of OGTT, as defined as the percentage of participants who complete the intervention, is determined at the end of the study period.

Secondary outcome measures

N/A

Overall trial start date

01/01/2016

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female participants
2. Pregnancy between 11-14 weeks gestation confirmed by ultrasound scan
3. Able to give informed consent
4. Aged 18 years or over

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Participant exclusion criteria

1. Pre-existing diabetes
2. Unable to provide informed consent
3. Under 18 years of age
4. Hyperemesis gravidum

Recruitment start date

10/02/2016

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff on Sea
SS0 0RY
United Kingdom

Sponsor information

Organisation

Southend Hospital NHS Foundation Trust

Sponsor details

Prittlewell Chase
Westcliff on Sea
SS0 0RY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Southend Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/09/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.