Understanding how tuberculosis affects the placenta during pregnancy
Effects of Tuberculosis Infection on Placental Development and Function
Lund University · NCT06352970
This study is trying to see how tuberculosis affects the placenta and pregnancy outcomes in women giving birth in Ethiopia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Lund University (other) |
| Locations | 1 site (Addis Ababa) |
| Trial ID | NCT06352970 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of tuberculosis (TB) infection on the development and function of the placenta in pregnant women. It will enroll women attending delivery clinics in Addis Abeba, Ethiopia, and classify them based on TB infection using a blood test. The study will compare outcomes such as pathological lesions of the placenta, gene and protein expression patterns, and infant outcomes at birth and six weeks after birth between women with and without TB infection. The goal is to uncover potential pregnancy-related disorders linked to TB infection.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 years or older who are admitted for delivery.
Not a fit: Patients with chronic comorbidities other than TB, HIV, or pregnancy-related disorders, as well as those with twin pregnancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how TB infection affects pregnancy outcomes, potentially leading to improved care for pregnant women with TB.
How similar studies have performed: While there is limited research specifically on TB's effects on the placenta, studies have shown that TB can significantly impact maternal health, suggesting that this area of investigation is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women admitted for delivery to study sites * Written informed consent * Age 18 years or greater Exclusion Criteria: * Chronic comorbidities (other than TB, HIV or pregnancy-related disorder) * Twin pregnancy
Where this trial is running
Addis Ababa
- Gandhi Memorial Hospital — Addis Ababa, Ethiopia (RECRUITING)
Study contacts
- Principal investigator: Per Bjorkman, MD, PhD — Lund University
- Study coordinator: Per Bjorkman, MD, PhD
- Email: per.bjorkman@med.lu.se
- Phone: +46-40337711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy Related, Tuberculosis Infection, Placenta Diseases, placenta, tuberculosis, pregnancy complication