Comparing early and late blood glucose monitoring in pregnant women with a history of gestational diabetes
An Observational Nested Multicenter Cohort Study of Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes
This study tests if pregnant women with a history of gestational diabetes do better when they monitor their blood sugar early in pregnancy instead of waiting until later.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 17 Years to 45 Years |
| Sex | Female |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06545227 on ClinicalTrials.gov |
What this trial studies
This study investigates whether pregnant women with a history of gestational diabetes (GDM) achieve better pregnancy outcomes through early blood glucose monitoring compared to traditional oral glucose tolerance testing later in pregnancy. Participants will be divided into two groups: one receiving continuous glucose monitoring early in pregnancy and the other undergoing testing at 28-32 weeks. The study will collect data on various pregnancy outcomes, including the need for labor induction and cesarean sections, to assess the effectiveness of early monitoring. Additionally, biological samples will be collected to explore underlying mechanisms related to GDM.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 16 years old with a previous diagnosis of gestational diabetes in a singleton pregnancy.
Not a fit: Patients with multiple pregnancies, a history of bariatric surgery, or those taking certain medications like metformin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy outcomes for women with a history of gestational diabetes.
How similar studies have performed: Other studies have shown promising results with early monitoring approaches, suggesting potential benefits in managing gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>16 2. Pregnant 3. Previous pregnancy with gestational diabetes diagnosed by an Oral Glucose Tolerance Test 4. Singleton pregnancy Exclusion Criteria: Women with the following risk factors will be excluded: 1. Multiple pregnancy 2. History of bariatric surgery 3. Taking metformin or other oral hypoglycaemic agents 4. HbA1c more than or equal to 48
Where this trial is running
London
- Chelsea and Westminster Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Natasha Singh, MBBS FRCOG
- Email: n.mohammed@imperial.ac.uk
- Phone: 02033159892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.