Pregnancy Related Clinical Trial
Official title:
Effects of Tuberculosis Infection on Placental Development and Function
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
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Lund University | Addis Ababa University, Armauer Hansen Research Institute, Ethiopia |
Ashenafi S, Aderaye G, Zewdie M, Raqib R, Bekele A, Magalhaes I, Lema B, Habtamu M, Rekha RS, Aseffa G, Maeurer M, Aseffa A, Svensson M, Andersson J, Brighenti S. BCG-specific IgG-secreting peripheral plasmablasts as a potential biomarker of active tuberc — View Citation
Erez O, Romero R, Jung E, Chaemsaithong P, Bosco M, Suksai M, Gallo DM, Gotsch F. Preeclampsia and eclampsia: the conceptual evolution of a syndrome. Am J Obstet Gynecol. 2022 Feb;226(2S):S786-S803. doi: 10.1016/j.ajog.2021.12.001. — View Citation
Jonsson J, Kuhlmann-Berenzon S, Berggren I, Bruchfeld J. Increased risk of active tuberculosis during pregnancy and postpartum: a register-based cohort study in Sweden. Eur Respir J. 2020 Mar 20;55(3):1901886. doi: 10.1183/13993003.01886-2019. Print 2020 — View Citation
Khong TY, Mooney EE, Ariel I, Balmus NC, Boyd TK, Brundler MA, Derricott H, Evans MJ, Faye-Petersen OM, Gillan JE, Heazell AE, Heller DS, Jacques SM, Keating S, Kelehan P, Maes A, McKay EM, Morgan TK, Nikkels PG, Parks WT, Redline RW, Scheimberg I, Schoot — View Citation
Mathad JS, Yadav S, Vaidyanathan A, Gupta A, LaCourse SM. Tuberculosis Infection in Pregnant People: Current Practices and Research Priorities. Pathogens. 2022 Dec 6;11(12):1481. doi: 10.3390/pathogens11121481. — View Citation
Migliori GB, Ong CWM, Petrone L, D'Ambrosio L, Centis R, Goletti D. The definition of tuberculosis infection based on the spectrum of tuberculosis disease. Breathe (Sheff). 2021 Sep;17(3):210079. doi: 10.1183/20734735.0079-2021. — View Citation
Myers JE, Myatt L, Roberts JM, Redman C; Global Pregnancy Collaboration (CoLab). COLLECT, a collaborative database for pregnancy and placental research studies worldwide. BJOG. 2019 Jan;126(1):8-10. doi: 10.1111/1471-0528.15393. Epub 2018 Aug 23. No abstr — View Citation
Naik S, Alexander M, Kumar P, Kulkarni V, Deshpande P, Yadana S, Leu CS, Araujo-Pereira M, Andrade BB, Bhosale R, Babu S, Gupta A, Mathad JS, Shivakoti R. Systemic Inflammation in Pregnant Women With Latent Tuberculosis Infection. Front Immunol. 2021 Jan — View Citation
Sobhy S, Babiker Z, Zamora J, Khan KS, Kunst H. Maternal and perinatal mortality and morbidity associated with tuberculosis during pregnancy and the postpartum period: a systematic review and meta-analysis. BJOG. 2017 Apr;124(5):727-733. doi: 10.1111/1471 — View Citation
Tesfaye F, Sturegard E, Walles J, Bekele B, Bobosha K, Bjorkman P, Jansson M. Dynamics of Mycobacterium tuberculosis-Specific and Nonspecific Immune Responses in Women with Tuberculosis Infection during Pregnancy. Microbiol Spectr. 2022 Oct 26;10(5):e0117 — View Citation
Tesfaye F, Walles J, Sturegard E, Winqvist N, Balcha TT, Kefeni M, Jansson M, Bjorkman P. Longitudinal Mycobacterium tuberculosis-Specific Interferon Gamma Responses in Ethiopian HIV-Negative Women during Pregnancy and Postpartum. J Clin Microbiol. 2021 S — View Citation
Walles J, Tesfaye F, Jansson M, Balcha TT, Sturegard E, Kefeni M, Merga G, Hansson SR, Winqvist N, Bjorkman P. Tuberculosis Infection in Women of Reproductive Age: A Cross-sectional Study at Antenatal Care Clinics in an Ethiopian City. Clin Infect Dis. 20 — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of women with pathological placental findings according to the Amsterdam consensus criteria | Histopathological abnormalities linked to placental dysfunction and pregnancy-related disorders | 2025-2026 | |
Secondary | 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 | 2026-2027 | |
Secondary | Proportions of infants (born to participating women) with adverse outcome | Outcome of infants born to participants (at birth and 6 weeks after birth) | 2025-2026 |
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