Maternal glucose in pregnancy

Not Applicable

• Conditions: Glycemic profile of pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN15706303
• Lead Sponsor: niversity of Leeds

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37537535/ (added 04/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-13
• Last Update Posted: 21 August 2023
• Study Completion: 2023-10-04

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. Women aged 18-45 years
2. Pregnant women in the first trimester of pregnancy
3. Singleton pregnancy
4. Have one or more of the following risk factors for developing hyperglycaemia in pregnancy:
4.1. BMI >30 kg/m²
4.2. Previous unexplained stillbirth or baby >4.5 kg
4.3. First degree relative with diabetes
4.4. Ethnic minority group (South Asian, Middle-Eastern, Afro-Caribbean)

Exclusion Criteria

1. Women presenting after 14 weeks gestation
2. Type 1 or Type 2 diabetes
3. A previous history of gestational diabetes
4. On metformin therapy for infertility
5. Multiple pregnancy
6. Fetal congenital abnormality
7. Significant co-existent medical or psychiatric conditions
8. Unable to understand English and no translator available

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 16/03/2023: <br><br>The primary maternal outcome is a clinical diagnosis of GDM, and the primary neonatal outcome is Large for Gestational Age (LGA) at birth (>90th centile defined by customised birthweight centile).<br><br>______<br><br>Previous primary outcome measure:<br><br>Large for gestational age (>90th centile defined by customised GROW birthweight centile) at birth