Pregnancy Reference Range Study
Research type
Research Study
Full title
Pregnancy Reference Range Study
IRAS ID
287069
Contact name
Tricia Tan
Contact email
Sponsor organisation
Research Integrity and Governance Team Imperial College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study aims to provide up-to-date, trimester-specific reference ranges for thyroid function and other biochemical markers in pregnancy.
A woman's physiology changes dramatically when she is pregnant. This means that levels of hormones and other factors in the blood change through each trimester. In order to understand when one of these factors is out of range, and therefore offer appropriate treatment to the woman, we must have accurate reference ranges.
The primary focus of this study is to produce accurate ranges for thyroid hormones throughout pregnancy. Maternal thyroid hormones cross to the baby in early pregnancy and are essential for healthy growth and normal neurological development. In a healthy pregnancy, the mother's hormone levels fluctuate through each trimester due to the effects of placental hormones. Having accurate trimester specific reference ranges then allows the clinician to appropriately treat a woman with underlying thyroid dysfunction to mimic these normal changes. As thyroid hormone levels are not only affected by gestation of pregnancy, but by a woman's ethnicity and the assay where the bloods are analysed, this study will fulfil the American Thyroid Association guidelines 2017 that recommend each centre has local reference ranges for thyroid hormones in pregnancy to reflect their local population.
Though thyroid hormones are the primary focus of this research, other biochemical analytes are essential for fetal development and we shall look at these as well.
This study will recruit 450 healthy pregnant volunteers from the 5000 women who receive antenatal care at Queen Charlotte & Chelsea Hospital to provide accurate reference ranges for thyroid function and other biochemical markers, to allow optimal treatment for the local obstetric population going forward.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0260
Date of REC Opinion
19 Feb 2021
REC opinion
Further Information Favourable Opinion