Tuberculosis Infection in Women of Reproductive Age and Their Infants

NCT03305991 | Completed

• 1 other identifier: LundU-2015
• Study Type: observational
• Target: 2,120
• Locations: 1 country
• Sites: 3

Brief Summary

Women living in low-income countries are at elevated risk of death in connection to pregnancy, as well as infants born to women in such settings. It is probable that several factors are involved, such as poverty, lack of education and access to healthcare. Infectious diseases constitute important threats to maternal health in resource-limited settings. Tuberculosis (TB) is reported to be the third leading cause of maternal death globally. Furthermore, TB can be transmitted from mother to child during pregnancy, with high risk of severe consequences for the infant. Despite these data, neither the role of TB in relation to co-existing risk factors for adverse pregnancy outcomes, nor the mechanisms involved, are well understood. It is likely that TB interacts with other characteristics, in particular socio-economic condition and HIV infection, which could obscure associations between TB and pregnancy outcomes. For this reason, it is critical to design studies so that the independent role of TB can be deduced. This project aims to investigate how TB infection in women affects the risk of adverse pregnancy outcomes in relation to co-existing factors, and how exposure to TB infection may impact growth and development of infants born to women with TB. In addition, mechanisms in which TB and the immune system during pregnancy will be explored. The project is conducted at public health facilities in Ethiopia, where 2 000 women have been recruited during antenatal care. These women will be followed until 5 years after delivery, along with their offspring born during the study period. Detailed data is collected at inclusion and at study visits during follow-up, with submission of samples for TB testing and immunological analyses. Better knowledge on the characteristics of TB infection in association with pregnancy, and how TB affects maternal and child health, can be used to construct new guidelines for management of TB in women of fertile age. This may contribute to reductions in adverse pregnancy outcomes, including maternal and infant deaths.

Conditions

Tuberculosis; Pregnancy Complications

Keywords

tuberculosis; pregnancy; ethiopia

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse pregnancy outcomes

  Reports of pregnancy outcomes of participating women, collected and assessed during study follow-up and categorized with regard to normal or adverse pregnancy outcomes

  2015-2023

Secondary Outcomes (3)

• Incidence of active tuberculosis in participants during pregnancy, post-partum period and periods outside pregnancy, respectively

  2015-2023

• Pattern of child growth with regard to maternal tuberculosis infection status during pregnancy

  2016-2023

• Incidence of tuberculosis infection in Ethiopian infants during the first four years of life

  2021-2023

Eligibility Criteria

• Gender Eligibility Details: Pregnant women are eligible for inclusion
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants are identified at antenatal care clinics at three public health facilities. The study population consists of women of reproductive age who are identified and recruited in antenatal care and followed until delivery and 4 years post-partum. Children born to participants of the study are followed for 4 years after birth for assessment of survival, growth and development.

You may qualify if:

• Pregnant women attending antenatal care at any of the study facilities
• First antenatal care visit for current pregnancy
• Written informed consent
• Accepts HIV testing
• Residence in uptake area during pregnancy period

Sponsors & Collaborators

• Lund University: lead

Study Sites (3)

Adama Health Center

Ādama, Ethiopia

Location

Adama Regional Hospital

Ādama, Ethiopia

Location

Gheda Health Center

Ādama, Ethiopia

Location

Related Publications (10)

• Getahun H, Sculier D, Sismanidis C, Grzemska M, Raviglione M. Prevention, diagnosis, and treatment of tuberculosis in children and mothers: evidence for action for maternal, neonatal, and child health services. J Infect Dis. 2012 May 15;205 Suppl 2:S216-27. doi: 10.1093/infdis/jis009. Epub 2012 Mar 22.

  PMID: 22448018 BACKGROUND

• Grange J, Adhikari M, Ahmed Y, Mwaba P, Dheda K, Hoelscher M, Zumla A. Tuberculosis in association with HIV/AIDS emerges as a major nonobstetric cause of maternal mortality in Sub-Saharan Africa. Int J Gynaecol Obstet. 2010 Mar;108(3):181-3. doi: 10.1016/j.ijgo.2009.12.005. Epub 2010 Jan 13.

  PMID: 20070964 BACKGROUND

• Jana N, Vasishta K, Saha SC, Ghosh K. Obstetrical outcomes among women with extrapulmonary tuberculosis. N Engl J Med. 1999 Aug 26;341(9):645-9. doi: 10.1056/NEJM199908263410903.

  PMID: 10460815 BACKGROUND

• Mathad JS, Bhosale R, Sangar V, Mave V, Gupte N, Kanade S, Nangude A, Chopade K, Suryavanshi N, Deshpande P, Kulkarni V, Glesby MJ, Fitzgerald D, Bharadwaj R, Sambarey P, Gupta A. Pregnancy differentially impacts performance of latent tuberculosis diagnostics in a high-burden setting. PLoS One. 2014 Mar 21;9(3):e92308. doi: 10.1371/journal.pone.0092308. eCollection 2014.

  PMID: 24658103 BACKGROUND

• Kothari A, Mahadevan N, Girling J. Tuberculosis and pregnancy--Results of a study in a high prevalence area in London. Eur J Obstet Gynecol Reprod Biol. 2006 May 1;126(1):48-55. doi: 10.1016/j.ejogrb.2005.07.025. Epub 2005 Sep 9.

  PMID: 16154251 BACKGROUND

• Rustveld LO, Kelsey SF, Sharma R. Association between maternal infections and preeclampsia: a systematic review of epidemiologic studies. Matern Child Health J. 2008 Mar;12(2):223-42. doi: 10.1007/s10995-007-0224-1. Epub 2007 Jun 19.

  PMID: 17577649 BACKGROUND

• Rowe JH, Ertelt JM, Way SS. Foxp3(+) regulatory T cells, immune stimulation and host defence against infection. Immunology. 2012 May;136(1):1-10. doi: 10.1111/j.1365-2567.2011.03551.x.

  PMID: 22211994 BACKGROUND

• Espinal MA, Reingold AL, Lavandera M. Effect of pregnancy on the risk of developing active tuberculosis. J Infect Dis. 1996 Feb;173(2):488-91. doi: 10.1093/infdis/173.2.488.

  PMID: 8568319 BACKGROUND

• Whittaker E, Kampmann B. Perinatal tuberculosis: new challenges in the diagnosis and treatment of tuberculosis in infants and the newborn. Early Hum Dev. 2008 Dec;84(12):795-9. doi: 10.1016/j.earlhumdev.2008.09.005. Epub 2008 Sep 27.

  PMID: 18823726 BACKGROUND

• Bekker A, Du Preez K, Schaaf HS, Cotton MF, Hesseling AC. High tuberculosis exposure among neonates in a high tuberculosis and human immunodeficiency virus burden setting. Int J Tuberc Lung Dis. 2012 Aug;16(8):1040-6. doi: 10.5588/ijtld.11.0821. Epub 2012 Jun 12.

  PMID: 22691968 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen aliquots of plasma samples stored at Adama Regional Laboratory, Ethiopia.

MeSH Terms

Conditions

Tuberculosis; Pregnancy Complications

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Per Bjorkman, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 10, 2017
• Study Start: December 1, 2015
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

ET (3)