Screening for Tuberculosis in Pregnancy

NCT04098341 | Completed

• 1 other identifier: IRAS247388 REC19/LO/0557
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• Uptake of screening for LTBI in antenatal care assessed by calculating the percentage of patients who accepted LTBI screening.

  as above

  12 months

• Offer of IGRA blood test screening by healthcare providers assessed by the percentage of eligible women who were offered a test.

  as above

  12 months

• Process outcomes for the feasibility study

  Proportion of eligible women who are screened, all pregnant women booked for antenatal care will be screened if fulfilling the eligibility criteria, and we will monitor the reasons for ineligibility.

  21 months

Secondary Outcomes (11)

• Disease related outcomes

  12 months

• Disease related outcomes

  12 months

• Acceptability outcomes

  18 months

• Acceptability outcomes

  18 months

• Acceptability outcomes

  18 months

Study Arms (1)

Screening

OTHER

All eligible migrants will be offered opt-out IGRA blood test to screen for for latent Tuberculosis infection

Diagnostic Test: IGRA blood test used as a tool for opt-out screening for latent Tuberculsis infection

Interventions

IGRA blood test used as a tool for opt-out screening for latent Tuberculsis infection DIAGNOSTIC_TEST

All eligible pregnant migrants will be offered an opt-out screening IGRA blood test for latent Tuberculosis infection

Screening

Eligibility Criteria

• Age: 16 Years - 35 Years
• Gender Eligibility Details: biological females who are pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pregnant migrants aged 16-35 who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,000 or sub-Saharan Africa

You may not qualify if:

• Patients who do not meet the criteria for LTBI screening will be excluded which include:
• Previous history of TB or LTBI.
• Individuals who are unable to consent.
• Evidence of active TB (based on history, examination, blood tests, chest X-ray finding or other radiological findings).

Sponsors & Collaborators

• Queen Mary University of London: lead
• University College, London: collaborator
• City, University of London: collaborator
• Imperial College London: collaborator

Study Sites (3)

Royal London Hospital

London, Essex, E1 1FR, United Kingdom

Location

Whipps Cross Hospital

London, Essex, E11 1NR, United Kingdom

Location

Newham University Hospital

London, Essex, E13 8SL, United Kingdom

Location

Related Publications (1)

• Rahman A, Thangaratinam S, Copas A, Zenner D, White PJ, Griffiths C, Abubakar I, McCourt C, Kunst H. A feasibility study evaluating the uptake, effectiveness and acceptability of routine screening of pregnant migrants for latent tuberculosis infection in antenatal care: a research protocol. BMJ Open. 2022 Apr 4;12(4):e058734. doi: 10.1136/bmjopen-2021-058734.

  PMID: 35379641 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Heinke Kunst

  Queen Mary University of London (study chief investigator)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: as above
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational study assessing the feasibility and acceptability of opt-out screening for latent Tuberculosis infection amongst pregnant migrants in antenatal clinics. All pregnant migrants who meet the inclusion criteria will be offered an opt-out IGRA blood test as screening for latent TB infection

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: September 23, 2019
• Study Start: July 1, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)