Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02520973

Enrollment

1400

Registered

2015-08-13

Start date

2015-05-31

Completion date

2017-06-30

Last updated

2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Brief summary

Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .

Interventions

OTHERSputum sample

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA \>1000 copies/mL 2. Pregnancy confirmed by urine pregnancy test or clinical exam 3. Estimated gestational age of 13 weeks or older 4. Age 18 years or greater 5. Willing to provide verbal consent

Exclusion criteria

1. Currently diagnosed with TB 2. Completed TB treatment within the last 6 months 3. Inability to communicate in one of the study languages. 4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of women diagnosed with TB	One year	1\. Proportion of women who are diagnosed with TB in each arm

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026