Screening for Tuberculosis in Pregnancy
NCT04098341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310
Last updated 2024-07-08
Summary
The UK has the second highest tuberculosis (TB) incidence in Western Europe. Most active cases occur in migrants due to reactivation of latent TB infection (LTBI) acquired abroad. Screening migrants for LTBI was recently introduced by Public Health England to reduce TB rates and transmission of infectious cases. Newham, which has one of the highest TB rates in London introduced the first large-scale LTBI screening programme for migrants, but it is poorly accessed by pregnant women and screening uptake is low. The issue of how best to screen for TB during pregnancy is important because pregnant/ postpartum women are at particularly high risk of developing TB, and migrants from countries with high TB rates may only interact with healthcare services during pregnancy.
Effective strategies are urgently needed to improve screening uptake for LTBI in pregnant migrants. The Antenatal clinic is an attractive location to screen for LTBI because uptake and acceptability of opt-out screening for other infectious diseases (HIV) is high. We will evaluate the uptake, effectiveness and acceptability of routine screening for LTBI in antenatal clinics. Eligible patients are pregnant women who have entered the UK within 10 years from a country with TB rates of \>150/100,000. Screening will involve a blood test, taken with other routine antenatal blood tests. We expect that in this setting, screening will be acceptable and uptake will be high. Our main outcome will be to assess the uptake of screening in at least 200 women. Acceptability of screening and understanding barriers of healthcare professionals to test for LTBI are secondary aims. The study will provide important information about a new setting in which to screen pregnant migrants for LTBI and barriers to starting treatment postpartum, which will inform the definitive trial to guide national policy on LTBI screening in antenatal care.
Conditions
- Latent Tuberculosis
Interventions
- DIAGNOSTIC_TEST
-
IGRA blood test used as a tool for opt-out screening for latent Tuberculsis infection
All eligible pregnant migrants will be offered an opt-out screening IGRA blood test for latent Tuberculosis infection
Sponsors & Collaborators
-
University College, London
collaborator OTHER -
City, University of London
collaborator OTHER -
Imperial College London
collaborator OTHER -
Queen Mary University of London
lead OTHER
Principal Investigators
-
Heinke Kunst · Queen Mary University of London (study chief investigator)
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-01
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
Countries
- United Kingdom
Study Locations
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