Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · May 13, 2021
Trial Information
Current as of May 08, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Pregnant women aged between 16 and 45 years old.
- • 2. Women with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines Or
- • 3. Pregnant women with pre-existing type 1 or type 2 diabetes mellitus Or
- • 4. Women diagnosed with ICP at any stage of pregnancy
- • 5. Fluent in English or presence of an interpreter or translation service (i.e. telephone translation services) at all visits.
- • 6. Singleton pregnancy.
- • 7. Willing and able to give written informed consent and comply with requirements of the study protocol
- • 8. Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery)
- Exclusion Criteria:
- • 1. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- • 1. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- • 2. Significant pre-pregnancy co-morbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI.
- • 3. Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the study results in the opinion of the responsible clinician or the CI. (This does not include diabetes mellitus).
- • 4. History of bariatric surgery.
- • 5. Hypertension requiring treatment pre-pregnancy / in pregnancy.
- • 6. Prescribed other medications that affect insulin sensitivity prior to OGTT for women diagnosed with GDM (oral antihyperglycemic agents, antipsychotic drugs, supraphysiological doses of steroids).
- • 7. For the baby after birth: Not meeting the safety criteria to undergo MRI scan (e.g. metal implants, non MRI compatible devices, metal fragments in the body). \[ The mother will not have an MRI scan\].
About Guy's And St Thomas' Nhs Foundation Trust
Guy's and St Thomas' NHS Foundation Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and clinical excellence. As a prominent academic health science center, the Trust integrates cutting-edge research with clinical practice, facilitating the translation of scientific discoveries into improved treatment options. With a diverse portfolio of clinical trials across various medical specialties, Guy's and St Thomas' NHS Foundation Trust plays a pivotal role in advancing healthcare knowledge and enhancing patient outcomes, while maintaining the highest ethical standards in research and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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