NCT06352970

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Oct 2024Dec 2027

First Submitted

Initial submission to the registry

March 20, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 20, 2024

Last Update Submit

March 14, 2025

Conditions

Pregnancy RelatedTuberculosis InfectionPlacenta Diseases

Keywords

placentatuberculosispregnancy complication

Outcome Measures

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

    2025-2026

Secondary Outcomes (2)

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

    2026-2027

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

    2025-2026

Study Arms (1)

Women in labor

Women admitted to labor wards for delivery

Other: TB infection

Interventions

TB infectionOTHER

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

Women in labor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with incipient delivery

You may qualify if:

  • Women admitted for delivery to study sites
  • Written informed consent
  • Age 18 years or greater

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gandhi Memorial Hospital

Addis Ababa, Ethiopia

RECRUITING

Related Publications (14)

  • 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: 10.1111/1471-0528.14408. Epub 2016 Nov 11.

    PMID: 27862893RESULT

  • 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 Mar.

    PMID: 31862768RESULT

  • Zenner D, Kruijshaar ME, Andrews N, Abubakar I. Risk of tuberculosis in pregnancy: a national, primary care-based cohort and self-controlled case series study. Am J Respir Crit Care Med. 2012 Apr 1;185(7):779-84. doi: 10.1164/rccm.201106-1083OC. Epub 2011 Dec 8.

    PMID: 22161161RESULT

  • 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. 2021 Jul 15;73(2):203-210. doi: 10.1093/cid/ciaa561.

    PMID: 32412638RESULT

  • 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 Sep 20;59(10):e0086821. doi: 10.1128/JCM.00868-21. Epub 2021 Jul 28.

    PMID: 34319803RESULT

  • 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):e0117822. doi: 10.1128/spectrum.01178-22. Epub 2022 Aug 15.

    PMID: 35969076RESULT

  • 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 27;11:587617. doi: 10.3389/fimmu.2020.587617. eCollection 2020.

    PMID: 33584652RESULT

  • Walles J, Winqvist N, Hansson SR, Sturegard E, Baqir H, Westman A, Kjerstadius T, Schon T, Bjorkman P. Pregnancy Outcomes in Women Screened for Tuberculosis Infection in Swedish Antenatal Care. Clin Infect Dis. 2024 Jan 25;78(1):125-132. doi: 10.1093/cid/ciad465.

    PMID: 37572363RESULT

  • 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.

    PMID: 35177220RESULT

  • 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 abstract available.

    PMID: 29978556RESULT

  • 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, Schoots MH, Sebire NJ, Timmer A, Turowski G, van der Voorn JP, van Lijnschoten I, Gordijn SJ. Sampling and Definitions of Placental Lesions: Amsterdam Placental Workshop Group Consensus Statement. Arch Pathol Lab Med. 2016 Jul;140(7):698-713. doi: 10.5858/arpa.2015-0225-CC. Epub 2016 May 25.

    PMID: 27223167RESULT

  • 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.

    PMID: 35035549RESULT

  • 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 tuberculosis in HIV negative and HIV positive patients. Thorax. 2013 Mar;68(3):269-76. doi: 10.1136/thoraxjnl-2012-201817. Epub 2012 Aug 24.

    PMID: 22923457RESULT

  • 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.

    PMID: 36558815RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Placenta tissue specimens Peripheral blood cell pellets Plasma aliquots

MeSH Terms

Conditions

Latent TuberculosisPlacenta DiseasesTuberculosisPregnancy Complications

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Per Bjorkman, MD, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Bjorkman, MD, PhD

CONTACT

+46-40337711per.bjorkman@med.lu.se

Selam Ghebrechristos, MD

CONTACT

selam3148@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 8, 2024

Study Start

October 1, 2024

Primary Completion

March 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

ET(1)