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Changes in fetal DNA modification associated with maternal blood sugar during pregnancy

The Diabetogenic Perturbations of the Fetal Methylome Project

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13534922
Enrollment
30
Registered
2017-09-13
Start date
2017-09-20
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal-fetal effects of metabolism in pregnancy Pregnancy and Childbirth Maternal-fetal effects of metabolism in pregnancy

Interventions

Participants attend study visits at three time points in pregnancy (approximately at 12, 26, and 34 gestational weeks) during which maternal blood, questionnaire data on lifestyle, and anthropometry a

Sponsors

Lund University
Lead Sponsor
Skåne University Hospital
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: In total, we will recruit around 30 pregnant women: 1. Aged 25-35 before gestational week 12+6 Half of the recruited women (50%) will have a high risk of gestational diabetes mellitus: 1. Family history of diabetes 2. Prior pregnancy affected by diabetes 3. Current obesity Half of the recruited women (50%) are expected to have a normal pregnancy not complicated by gestational diabetes mellitus (controls). If a control woman develops gestational diabetes, she will be invited to continue to take part in the study and be monitored as per standard of care; we will then seek to recruit an additional woman to the control arm to ensure an adequate number of participants in the study.

Exclusion criteria

Exclusion criteria: 1. Not of Scandinavian origin 2. Use of assisted reproductive technology 3. History of three or more first trimester miscarriages 4. Tobacco use (smoking/snus) in the previous three months 5. Diagnosed PCOS 6. History of gastric bypass surgery 7. Type 1 diabetes 8. Non-Swedish speaker 9. Planned termination of pregnancy or planning to give up infant for adoption

Design outcomes

Primary

MeasureTime frame
Changes in fetal/placental DNA methylation at three time points in pregnancy are measured using cell-free fetal DNA isolated from maternal blood and next generation sequencing at approximately 12, 26, and 34 gestational weeks.

Secondary

MeasureTime frame
1. Maternal physical activity as measured by wrist accelerometer from early pregnancy to delivery 2. Maternal blood-glucose as measured by a continuous glucose monitor and OGTT from early pregnancy to delivery 3. Maternal weight gain and body composition (daily weighing using a medical scale and/or clinically measured using the Styku 3D body scanning system) throughout pregnancy and postpartum

Countries

Sweden

Contacts

Public ContactAngela Estampador

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026