Maternal and perinatal mortality and morbidity associated with tuberculosis during pregnancy and the postpartum period: a systematic review and meta-analysis.
S Sobhy, Zoe Babiker, J Zamora...
https://pubmed.ncbi.nlm.nih.gov/27862893Actively Recruiting
Age: 18Years +
FEMALE
ID06352970
Effects of Tuberculosis Infection on Placental Development and Function
Led by Lund University · Updated on 2025-03-17
500
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
L
Lund University
Lead Sponsor
A
Addis Ababa University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how tuberculosis (TB) infection affects the development and function of the placenta in pregnant women. This observational study focuses on whether TB infection can cause changes in the placenta's structure and function, possibly contributing to pregnancy complications. The study is conducted in public hospitals in Addis Abeba, Ethiopia, where pregnant women are tested for TB infection using a blood test. Participants are enrolled when admitted to labor wards for delivery. The study involves collecting blood samples before delivery to test for TB infection and immune responses. The placenta is collected immediately after birth for detailed examination, including tissue analysis, RNA and protein expression studies, and detection of TB bacteria. Additional infant outcomes are assessed at birth and at a 6-week follow-up visit. Throughout the study, researchers collect detailed information on maternal and infant health, pregnancy history, and delivery details using questionnaires and medical records. Participants with suspected active TB provide sputum samples for further testing. The main outcome measured is the presence of pathological changes in the placenta, with additional assessments including gene and protein expression linked to pregnancy disorders and infant health outcomes. Follow-up visits and laboratory analyses support comprehensive monitoring of TB's impact on pregnancy over the study period.
CONDITIONS
Brief Title
Effects of Tuberculosis Infection on Development and Function of the Placenta
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women admitted for delivery to study sites
- Written informed consent
- Age 18 years or greater
You will not qualify if you...
- Chronic comorbidities (other than TB, HIV or pregnancy-related disorder)
- Twin pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at labor ward admission
Diagnostic Evaluation
Duration - Day of delivery
Participants provide samples and undergo tests to determine TB infection status and to assess placental condition at delivery.
1 visit (in-person) at labor ward for blood, sputum, and placenta sample collection
Long-term Monitoring
Duration - 6 weeks post-delivery
Participants are followed up to collect additional health information and receive test results related to TB infection and pregnancy outcomes.
1 follow-up visit (in-person) approximately 6 weeks after delivery
Trial Site Locations
Total: 1 location
1
Gandhi Memorial Hospital
Addis Ababa, Ethiopia
Actively Recruiting
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Research Team
P
Per Bjorkman, MD, PhD
S
Selam Ghebrechristos, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Increased risk of active tuberculosis during pregnancy and postpartum: a register-based cohort study in Sweden.
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https://pubmed.ncbi.nlm.nih.gov/31862768Risk of tuberculosis in pregnancy: a national, primary care-based cohort and self-controlled case series study.
Dominik Zenner, Michelle E Kruijshaar, Nick Andrews...
https://pubmed.ncbi.nlm.nih.gov/22161161Tuberculosis Infection in Women of Reproductive Age: A Cross-sectional Study at Antenatal Care Clinics in an Ethiopian City.
John Walles, Fregenet Tesfaye, Marianne Jansson...
https://pubmed.ncbi.nlm.nih.gov/32412638Longitudinal Mycobacterium tuberculosis-Specific Interferon Gamma Responses in Ethiopian HIV-Negative Women during Pregnancy and Postpartum.
Fregenet Tesfaye, John Walles, Erik Sturegård...
https://pubmed.ncbi.nlm.nih.gov/34319803Dynamics of Mycobacterium tuberculosis-Specific and Nonspecific Immune Responses in Women with Tuberculosis Infection during Pregnancy.
Fregenet Tesfaye, Erik Sturegård, John Walles...
https://pubmed.ncbi.nlm.nih.gov/35969076Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection.
Shilpa Naik, Mallika Alexander, Pavan Kumar...
https://pubmed.ncbi.nlm.nih.gov/33584652Pregnancy Outcomes in Women Screened for Tuberculosis Infection in Swedish Antenatal Care.
John Walles, Niclas Winqvist, Stefan R Hansson...
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Offer Erez, Roberto Romero, Eunjung Jung...
https://pubmed.ncbi.nlm.nih.gov/35177220COLLECT, a collaborative database for pregnancy and placental research studies worldwide.
J E Myers, L Myatt, J M Roberts...
https://pubmed.ncbi.nlm.nih.gov/29978556