Screening for Tuberculosis in Pregnancy

NCT04098341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2024-07-08

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098341 on ClinicalTrials.gov