Study to establish reference ranges for pregnancy for blood tests
| ISRCTN | ISRCTN17018939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17018939 |
| IRAS number | 287069 |
| Secondary identifying numbers | IRAS 287069, CPMS 47473 |
- Submission date
- 10/02/2022
- Registration date
- 07/03/2022
- Last edited
- 03/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
A woman’s body changes through pregnancy. This means the levels of many different hormones and other substances in the blood vary in pregnancy. Doctors, midwives, and other people who look after pregnant women should use reference ranges for these blood markers that are specific to each trimester of pregnancy, and not just use the ranges used for the non-pregnant population. This is in line with international guidance. We are therefore asking healthy pregnant women to given a sample of blood or urine so that we can provide up-to-date reference ranges for blood tests in pregnancy.
In particular we plan to make reference ranges for levels of different thyroid hormones. Thyroid hormone is vital for the neurological development of the baby, so ensuring that a mother’s thyroid hormone levels are normal is essential. We will also measure urine iodine levels as these affect how the body makes thyroid hormones. We also plan to measure some blood pressure hormones (renin and aldosterone) and a heart marker (troponin). We know that more women are suffering from blood pressure problems and heart disease in pregnancy, so being able to diagnoses these accurately is really important for good care of the mother.
Who can participate?
Women over 18 years of age with singleton pregnancies who are receiving antenatal care at Imperial College London NHS Trust.
What does the study involve?
Participants are asked to give an extra sample of blood during their routine blood tests in pregnancy. These samples are stored and then routine biochemical analytes (such as thyroid hormone levels) will be ascertained by running through a laboratory analyser.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
February 2021 to February 2023
Who is funding the study?
Abbott Laboratories (USA)
Who is the main contact?
Prof. Tricia Tan, rebecca.scott22@nhs.net
Contact information
Principal Investigator
Department of Digestion, Metabolism and Reproduction
6th Floor Commonwealth Building
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 7970742784 |
|---|---|
| rebecca.scott22@nhs.net |
Study information
| Study design | Cross sectional laboratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 41136 PIS v2.0 07Jan2021.pdf |
| Scientific title | Pregnancy Reference Ranges Study |
| Study acronym | PREGRRS |
| Study objectives | The aim of this study is to establish accurate, trimester specific reference ranges for biochemical analytes |
| Ethics approval(s) | Approved 18/02/2021, East of England Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 2071048227; essex.rec@hra.nhs.uk), ref: 20/EE/0260 |
| Health condition(s) or problem(s) studied | Looking at normal ranges in healthy pregnancy |
| Intervention | Women who are pregnant will be asked, as a one off, to given an extra sample of blood at the time that they have routine blood tests in pregnancy, plus in some instances a urine sample at the same time. They will also be asked to complete a brief, online questionnaire about their pregnancy and underlying health. The blood and urine samples will be stored, before being processed to establish levels of certain routine biochemical markers at each stage in pregnancy. Once the women have given their sample and completed the questionnaire, their participation in the study is complete. |
| Intervention type | Other |
| Primary outcome measure | Levels of biochemical analytes in sampled blood will be analysed in accordance with national/international guidance: 1. Thyroid function - TSH, free T3, free T4 2. Thyroid peroxidase antibodies 3. Renin 4. Aldosterone 5. Folate 6. Iron 7. Troponin 8. Iodine |
| Secondary outcome measures | Gestation of the pregnancy, the mother’s underlying health, and some demographic data measured at a single time point using a questionnaire |
| Overall study start date | 01/02/2021 |
| Completion date | 01/02/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1200 |
| Total final enrolment | 725 |
| Key inclusion criteria | 1. Women over 18 years of age who are receiving antenatal care at Imperial College London NHS Trust 2. Singleton pregnancies |
| Key exclusion criteria | 1. Multiple pregnancies 2. Current or previous history of thyroid disease 3. Current or previous use of thyroid medications 4. Inability to understand and write in the English Language 5. Unable to participate for other factors as assessed by the Chief Investigators |
| Date of first enrolment | 07/04/2021 |
| Date of final enrolment | 01/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Sponsor information
University/education
Room 215, Level 2
Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 2075949459 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Abbott, Abbott U.S., Abbott Alkaloidal Company
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer reviewed journal Results will also be disseminated throughout the ICS |
| IPD sharing plan | If requested from Chief Investigators (rebecca.scott22@nhs.net) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Participant questionnaire version 1.0 |
01/01/2021 | 11/02/2022 | No | No |
| Participant information sheet | version 2.0 | 07/01/2021 | 11/02/2022 | No | Yes |
| Protocol file | version 2.0 | 01/01/2021 | 11/02/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 28/03/2025 | 01/04/2025 | Yes | No |
Additional files
- 41136 Protocol v2.0 01Jan2021.pdf
- 41136 participant questionnaire V1.0 01Jan2021.pdf
- Participant questionnaire
- 41136 PIS v2.0 07Jan2021.pdf
Editorial Notes
03/04/2025: Total final enrolment added.
01/04/2025: Publication reference added.
19/03/2024: The intention to publish date was changed from 01/01/2024 to 01/08/2024.
01/04/2022: added CPMS number to Protocol /serial number field.
11/02/2022: Trial's existence confirmed by NHS HRA.
