Health Trials

Effects of Tuberculosis Infection on Development and Function of the Placenta

ConditionsPregnancy RelatedTuberculosis InfectionPlacenta Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorLund University

About this trial

The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.

The main questions it aims to answer are:

* Does TB infection affect the structure of the placenta? * Does TB infection affect the function of the placenta?

Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:

* Pathological lesions of the placenta * Gene and protein expression patterns linked to pregnancy-related disorders * Infant outcome at birth and at 6 weeks after birth

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women admitted for delivery to study sites

Written informed consent

Age 18 years or greater

Disqualifiers

Chronic comorbidities (other than TB, HIV or pregnancy-related disorder)

Twin pregnancy

Trial population

Pregnant women with incipient delivery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • TB infection

    Other intervention

    Outcomes will be compared with regard to result of interferon-gamma release assay test for TB infection

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Women in labor1 intervention

Trial outcomes

Primary outcomes

1

Proportion of women with pathological placental findings according to the Amsterdam consensus criteria

Histopathological abnormalities linked to placental dysfunction and pregnancy-related disorders

Time frame
2025-2026

Secondary outcomes

1

Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders

RNA and protein expression patterns in placenta linked to pregnancy-related disorders

Time frame
2026-2027
2

Proportions of infants (born to participating women) with adverse outcome

Outcome of infants born to participants (at birth and 6 weeks after birth)

Time frame
2025-2026

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Addis Ababa University

Collaborator

Armauer Hansen Research Institute, Ethiopia

Collaborator

Source ClinicalTrials.gov
Apply now