Status:
UNKNOWN
Magnetic Resonance Imaging and Thermal Imaging of Adiposity in Neonates of Women With Metabolic Diseases
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Diabetes Mellitus
Intrahepatic Cholestasis of Pregnancy
Eligibility:
FEMALE
16-45 years
Brief Summary
There is limited knowledge about the extent of the impact of maternal metabolic diseases (MD) and/or alterations in maternal serum lipid content upon neonatal lipid distribution and phenotypes. This o...
Eligibility Criteria
Inclusion
- Pregnant women aged between 16 and 45 years old.
- Women with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines Or
- Pregnant women with pre-existing type 1 or type 2 diabetes mellitus Or
- Women diagnosed with ICP at any stage of pregnancy
- Fluent in English or presence of an interpreter or translation service (i.e. telephone translation services) at all visits.
- Singleton pregnancy.
- Willing and able to give written informed consent and comply with requirements of the study protocol
- Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery)
Exclusion
- 1\. Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- Known fetal congenital abnormality on ultrasound requiring fetal medicine input (excluding congenital heart disease).
- 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.
- 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).
- History of bariatric surgery.
- Hypertension requiring treatment pre-pregnancy / in pregnancy.
- Prescribed other medications that affect insulin sensitivity prior to OGTT for women diagnosed with GDM (oral antihyperglycemic agents, antipsychotic drugs, supraphysiological doses of steroids).
- 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). \[ The mother will not have an MRI scan\].
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04890886
Start Date
June 1 2021
End Date
December 1 2023
Last Update
May 18 2021
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