Oral glucose tolerance test in first trimester of pregnancy
| ISRCTN | ISRCTN18906333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18906333 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/01/2016
- Registration date
- 23/01/2016
- Last edited
- 24/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
Kypros Nicolaides Fetal Medicine Unit
Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff on Sea
SS16 5ES
United Kingdom
 ORCID ID |
0000-0003-4398-4356 |
|---|---|
| Phone | +44 7931 539900 |
| mandeep.singh@southend.nhs.uk |
Study information
| Study design | Single-centre cross sectional feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Single center study to assess the feasibility of undertaking an oral glucose tolerance test in first trimester of pregnancy |
| Study hypothesis | Oral glucose tolerance test can be performed in first trimester (11- 14 weeks) of pregnancy. |
| Ethics approval(s) | Wales Research Ethics Committee 6 Proportionate Review Sub-Committee, 02/02/2016, ref: 16/WA/0056 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2016 |
| Overall study end date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 |
| 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 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
- England
- United Kingdom
Study participating centre
Westcliff on Sea
SS0 0RY
United Kingdom
Sponsor information
Hospital/treatment centre
Prittlewell Chase
Westcliff on Sea
SS0 0RY
England
United Kingdom
"ROR" |
https://ror.org/05fa42p74 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
24/03/2016: Ethics approval information added.
