Pregnancy

South Africa

Clinical Sites:

Dr. Jyoti Mathad is Co-PI of this study. Purpose: Tuberculosis (TB) is a leading cause of maternal mortality, especially among HIV-infected women. Women are most likely to develop active TB during and immediately after pregnancy. The immunologic conditions responsible for this phenomenon are not...

Vaginal Microbiota in HIV Infected and Uninfected Pregnant Women (Stand Alone)

Post Date:

2018-10-16

Countries:

Clinical Sites:

Amita Gupta, MD, MHS, and Shilpa Naik, MD, are PIs for this study; Rupak Shivakoti, PhD, MSPH, is Co-Investigator The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of...

Gut Microbiota of HIV Infected Pregnant Women

Post Date:

2018-06-14

Countries:

Clinical Sites:

Birth Outcomes in HIV Both antiretroviral-therapy (ART)-naïve and ART-experienced HIV-infected pregnant women have higher incidences of pre-term birth (PTB) compared to HIV-uninfected women. For example, the global prevalence of PTB is around 8%, while the rates in in HIV-infected populations are...

TB and Pregnancy Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis: Nested Study on Temporal Dynamics of Gut Microbiota in HIV Infected Pregnant Women

Post Date:

2016-07-05

Countries:

Clinical Sites:

This is a nested prospective longitudinal cohort study of 35 HIV-infected and 35 HIV-noninfected pregnant women who are part of the parent study “Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis." The objectives are to: Determine the association of gestational age with...

Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome and Preterm Birth

Post Date:

2014-10-28

Countries:

Clinical Sites:

This study was terminated May 7, 2018. P regnancy is a state of relative immunosuppression in order to protect the fetus from being rejected. It has also been shown that the Th-1 helper cell response, which is normally necessary for overcoming TB infection, is suppressed in pregnancy. Thus,...

Predictive Value of TB-symptom Screen in HIV-infected and HIV-uninfected Pregnant Women in Pune, India

Post Date:

2014-10-28

Countries:

Clinical Sites:

This study was terminated July 17, 2017. This is a cross sectional observational study will be conducted at BJGMC to establish what the predictive value of the WHO TB symptom screen is in pregnant women in India. We hypothesize that the WHO TB symptom screen will have a higher positive predictive...

Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India

Post Date:

2014-09-01

Countries:

Clinical Sites:

This study was terminated April 16, 2018. Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune changes of pregnancy, women are particularly at...

Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis

Post Date:

2014-09-01

Countries:

Clinical Sites:

This is the Parent Study for CCGHE’s PRACHITI (PRegnancy And CHanges In TuberculosIs) effort. It's supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the U.S. National Institutes of Health. Purpose: TB is a leading cause of maternal mortality,...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

Post Date:

2014-04-01

Countries:

Clinical Sites:

This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in Botswana, Haiti, South...

Immunomodulatory Properties of BCG: Implications for MTCT

Post Date:

2008-06-01

To evaluate the immune activating properties of BCG vaccination in neonatal CD4 cells and test the hypothesis that neonatal BCG vaccination leads to activation of immune response that may increase the susceptibility to HIV infection in breast-fed infants of HIV-positive mothers.

A mobile health-facilitated behavioral intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: A cluster randomized trial

Post Date:

2020-07-03

Countries:

Clinical Sites:

Publication:

Journal of the International AIDS Society

When community health workers used a mobile health intervention with HIV+ women to deliver care, there was a higher uptake of exclusive breastfeeding at two months and early infant HIV diagnosis at six weeks

Intensified short symptom screening program for Dengue infection during pregnancy, India

Post Date:

2020-04-15

Countries:

Clinical Sites:

Publication:

Emerging Infectious Diseases

Mosquitoborne diseases (e.g., malaria, dengue, and chikungunya) are endemic to India and pose diagnostic challenges during pregnancy. We evaluated an intensified short symptom screening program in India to diagnose dengue during pregnancy. During October 2017-January 2018, we screened pregnant...

TB prevention strategies and unanswered questions for pregnant and postpartum women living with HIV: the need for improved evidence

Post Date:

2020-03-23

Publication:

Journal of the International AIDS Society

World TB Day viewpoint on the need for more data about TB treatment for pregnant and postpartum women in J Int AIDS Soc by Drs. Jyoti Mathad and Amita Gupta.

Tuberculosis in children, adolescents, and women

Post Date:

2020-02-27

Publication:

Lancet Respiratory Medicine

In this Lancet Respiratory Medicine commentary, Dr. Amita Gupta and colleagues note that TB prevalence among children, adolescents, and women isn't well documented. This poses big challenges for the goal of TB elimination.

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date:

2019-10-03

Countries:

Clinical Sites:

Publication:

New England Journal of Medicine

New England Journal of Medicine: Dr. Amita Gupta and colleagues found that the current standard of care given to HIV+ pregnant women to prevent TB should wait until 12 weeks after delivery. The study underscores the need to include pregnant women in clinical trials.

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

Post Date:

2019-08-15

Countries:

Clinical Sites:

Publication:

PLOS Medicine

PLOS Medicine: Dr. Amita Gupta and colleagues discuss the scientific and ethical basis for including pregnant and lactation women, children, and HIV+ patients in tuberculosis therapeutic clinical trials.

Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities

Post Date:

2019-07-15

Publication:

Lancet HIV

Lancet HIV : This paper summarizes findings of the Long acting/Extended Release Antiretroviral Resource Program workshop, and offers recommendations for developing ARV products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women

Symptom screening for active tuberculosis in pregnant women living with HIV

Post Date:

2019-01-24

Publication:

Cochrane Database of Systematic Reviews

This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows: To assess the accuracy of the four-symptom screen (cough, fever, night sweats, or weight loss) for identifying active TB in pregnant PLHIV who are screened in an outpatient or community setting...

Is there a connection between gestational diabetes, human immunodeficiency virus infection, and tuberculosis?

Post Date:

2019-01-01

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

IJTLD article reviews the epidemiology and immunology of gestational diabetes and finds there's a lot we don't know about interactions between diabetes, pregnancy, and tuberculosis in both HIV+/- women

Missed opportunities to address pregnancy prevention with young men in primary care

Post Date:

2018-11-15

Countries:

United States

Publication:

Clinical Pediatrics

Young men (aged 15-24 years) have pregnancy prevention needs, yet little is known about whether they perceive they learn about pregnancy prevention in primary care. A sample of 190 young men seen in primary care in one city from April 2014 to September 2016 were assessed on perceived learning...

Screening and diagnosis of gestational diabetes in India: A systematic review and meta analysis

Post Date:

2018-03-26

Countries:

Publication:

Acta Diabetologica

Review article on prevalence and screening and diagnostic methods for gestational diabetes in India.

Intestinal barrier dysfunction and microbial translocation in HIV-infected pregnant women is associated with preterm birth

Post Date:

2018-03-24

Countries:

Clinical Sites:

Publication:

Clinical Infectious Diseases

Our results show select immune markers can identify women at higher risk for PTB in HIV-1-infected populations and suggest modulating gut barrier integrity and microbial translocation may affect PTB.

Household food insecurity is associated with low interferon-gamma levels in pregnant Indian women

Post Date:

2017-07-01

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Objective: To determine the association between household food insecurity and interferon-gamma (IFN-γ) levels in pregnancy. Design: Pregnant women in India were administered the Household Food Insecurity Access Scale (HFIAS) questionnaire and underwent an IFN-γ release assay...

Pulmonary infections in pregnancy

Post Date:

2017-06-01

Publication:

Seminars in Respiratory and Critical Care Medicine

Clinical review from Drs. Amita Gupta & Jyoti Mathad on improving tuberculosis treatment outcomes for pregnant women.

Quantitative IFN-y,IL-2 response and latent tuberculosis test discordance in HIV-infected pregnant women

Post Date:

2016-06-15

Countries:

Clinical Sites:

Publication:

American Journal of Respiratory and Critical Care Medicine

Rationale: Pregnant women with latent tuberculosis infection (LTBI) are at high risk for development of TB, especially if infected with HIV. Objectives: To assess the performance of LTBI tests in pregnant and postpartum women infected with HIV, investigate the...

The availability of emergency obstetric care in the context of the JSY cash transfer programme in Madhya Pradesh, India

Post Date:

2016-05-18

Countries:

Publication:

BMC Pregnancy and Childbirth

Abstract Background: Since 2005, India has implemented a national cash transfer programme, the Janani Suraksha Yojana (JSY), which provides women a cash transfer upon giving birth in an existing public facility. This has resulted in a steep rise in facility births across the...

Assessment of the quality of clinical documentation in India's JSY cash transfer program for facility births in Madhya Pradesh

Post Date:

2016-02-15

Countries:

Publication:

International Journal of Gynaecology and Obstetrics

Abstract Objective: To gain insight into the quality of care in facilities implementing the Janani Suraksha Yojana (JSY) cash transfer program in Madhya Pradesh, India, by reviewing the level of documentation in the clinical records of women who delivered. ...

Toward earlier inclusion of pregnant and postpartum women in TB drug trials: consensus statements from an International Expert Panel

Post Date:

2016-01-04

Publication:

Clinical Infectious Diseases

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15–44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and...

Cost effectiveness of isoniazid preventive therapy for HIV-infected pregnant women in India

Post Date:

2016-01-01

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

Background: India has a high burden of active tuberculosis (TB) and human immunodeficiency virus (HIV) infection. Pregnancy increases the risks of developing TB in HIV-infected women. Isoniazid preventive therapy (IPT) reduces progression to TB, but may increase costs and hepatotoxicity. The...

Availability and distribution of safe abortion services in rural areas: a facility assessment study in Madhya Pradesh, India

Post Date:

2015-03-20

Countries:

Publication:

Global Health Action

Abstract Background: Unsafe abortion contributes to a significant portion of maternal mortality in India. Access to safe abortion care is known to reduce maternal mortality. Availability and distribution of abortion care facilities can influence women's access to these...

Factors associated with gestational diabetes in HIV+ and HIV- women in Pune, India

Post Date:

2020-03-09

Countries:

Clinical Sites:

Chebrolu P , Alexander M, Bhosale R, Naik S, Patil N, Gupta A, Mathad J. Factors associated with gestational diabetes in HIV+ and HIV- women in Pune, India. Presented at: CROI 2020. Boston, Massachusetts. March 8-11, 2020.

Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV

Post Date:

2020-03-09

Clinical Sites:

Theron G , Chakhtoura N, Montepiedra G, Aaron L, Jean-Phillipe P, Weinberg A, McCarthy K, Nematadzira T, Masheto G, Chipato T, Onyango-Makumbi C, Gupta A, the IMPAACTP1078 Team. Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV. Presented at: CROI 2020. Boston,...

Is there a connection between gestational diabetes and TB?

Post Date:

2019-11-02

Countries:

Clinical Sites:

Alexander M . Is there a connection between gestational diabetes and TB? Speaker. Confronting the crisis: emerging research in maternal-child TB Symposium.50th Union World Conference on Lung Health. Hyderabad, India. October 30-November 2, 2019.

Performance of QuantiFERON-TB Gold in Tube (QFT-GIT) and QuantiFERON-TB Gold Plus (QFT-Plus) for detection of Mycobacterium tuberculosis infection in pregnant women in India

Post Date:

2019-11-01

Countries:

Clinical Sites:

Kulkarni V , Bhosale R, Jain D, Deshpande P, Naik N, Alexander M, Patil N, Gupte N, Gupta A, Mathad J. Performance of QuantiFERON-TB Gold in Tube (QFT-GIT) and QuantiFERON-TB Gold Plus (QFT-Plus) for detection of Mycobacterium tuberculosis infection in pregnant women in India. Poster presentation...

Does treatment of infertile women with probable genital tuberculosis improve fertility outcome?

Post Date:

2019-11-01

Countries:

Clinical Sites:

Naik SN , Chandanwale A, Kadam D, Sambarey PW, Dhumal G, DeLuca A, Jain D, Gupta A, Bollinger R, Mave V. Does treatment of infertile women with probable genital tuberculosis improve fertility outcome? Poster presentation. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-...

Assessing TB-related knowledge and stigma and associated risk factors among pregnant women in low-resource settings of Pune, India

Post Date:

2019-10-30

Countries:

Clinical Sites:

Mehta S , Murrill M, Suryavanshi N, Bhosale R, Naik S, Patil N, Gupta A, Mathad J, Shivakoti R, Alexander M. Assessing TB-related knowledge and stigma and associated risk factors among pregnant women in low-resource settings of Pune, India. Poster presentation. 50th Union World Conference on Lung...

Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort

Post Date:

2019-10-30

Countries:

Clinical Sites:

Bhosale R , Graham H, Alexander M, Kinikar A, Khwaja S, Patil N, Gupta A, Mathad J, Shivakoti R. Association of latent TB infection in pregnancy with perinatal health outcomes in an Indian cohort. Poster presentation. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-November...

Pregnancy is associated with decreased serum isoniazid levels in women living with HIV

Post Date:

2019-03-07

Gausi K , Denti P, Weisner L, Wallis C, Onyango-Makumbi C, Chipato T, Theron G, Bradford S, Costello D, Browning R, Chakhtoura N, Weinberg A, Montepiedra G, Gupta A and the IMPAACT P1078 (TB APPRISE) Study Group Team. Pregnancy is associated with decreased serum isoniazid levels in women living...

The prevalence of perinatal depression and associated birth outcomes in Pune, India

Post Date:

2019-02-11

Countries:

Clinical Sites:

Grossman TB , Mathad JS, Suryavanshi N, Alexander M, Mave V, Bhosale R, Gupta A. The prevalence of perinatal depression and associated birth outcomes in Pune, India. Society for Maternal-Fetal Medicine 39th Annual Pregnancy Meeting. Las Vegas, NV. February 11-16, 2019.

Perinatal Depression among HIV and TB Infected and Uninfected Women in an Urban Slum in India: Prevalence and Associated Birth Outcomes

Post Date:

2018-10-04

Countries:

Clinical Sites:

Grossman TB , Bhosale R, Alexander M, Suryavanshi N, Mave V, Jain D, Patil NU, Gupta A, Mathad JS. Perinatal depression among HIV and TB infected and uninfected women in an urban slum in India: prevalence and associated birth outcomes. IDSA. ID Week 2018. San Francisco, CA. October 3-7, 2018.

High Prevalence of Dengue among Pregnant Women in India

Post Date:

2018-08-27

Countries:

Clinical Sites:

Alexander M, Naik S, Robinson M , Sapkal G, Deshpande P, Kulkarni V, Nimkar S, Sambarey P, Kinikar A, Mave V, Suryavanshi N, Gupte N, Bollinger R, Gupta A, Bharadwaj R, Mathad J. High Prevalence of Dengue among Pregnant Women in India. 2018 International Conference on Emerging Infectious Diseases...

Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster Randomized Trial

Post Date:

2018-07-24

Countries:

Clinical Sites:

Suryavanshi N, Kadam A, Hegde A, Sivalenka S, Kumar VS, McKenzie-White J, Kanade S, Gupta A, Bollinger RC, Shankar A, Gupte N, Mave V. Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster...

Importance of Diagnosis of TB Infection in Pregnant Women in India: Findings from a Cohort Study in Pune, India

Post Date:

2018-04-24

Countries:

Clinical Sites:

Mathad J. Importance of Diagnosis of TB Infection in Pregnant Women in India: Findings from a Cohort Study in Pune, India. Oral Presentation. Presented at Global Health Research Initiative’s Scientific Conference, Weill Cornell Medical College, April 24, 2018.

Randomized Trial of Safety of Isoniazid Preventive Therapy During or After Pregnancy

Post Date:

2018-03-07

Clinical Sites:

Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Onyango-Makumbi C, Chipate T, Masheto G, Shin K, Zimmer B, Sterling TR, Chakhtoura N, Jean-Philippe P, Weinberg A for the IMPAACT P1078/TB APPRISE Study Team. Randomized Trial of Safety of Isoniazid Preventive Therapy During or After Pregnancy...

Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth

Post Date:

2018-03-07

Countries:

Clinical Sites:

Shivakoti R , Gupte N, Kumar NP, Kulkarni V, Balasubramanian U, Bhosale R, Sambarey P, Kinikar A, Bharadwaj R, Patil S, Inamdar S, Suryavanshi N, Babu S, Bollinger R, Gupta A. Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth. CROI 2018. Boston, MA. 2018

Meet the Expert: Managing Tuberculosis in Pregnant Women and Newborns

Post Date:

2017-10-13

Gupta A. Meet the Expert: Managing Tuberculosis in Pregnant Women and Newborns. 48th Annual Union World Conference of Lung Health. Guadalajara, Mexico.

Impact of Immune Changes of Pregnancy and HIV Infection on Tuberculosis

Post Date:

2017-02-03

Countries:

Clinical Sites:

Mathad J, Alexander M , Bhosale R, Naik S, Shivakoti R, Mave V, Suryavanshi N, Gupte N, Kulkarni V, Pradan N, Patil N, Gupta A. Impact of Immune Changes of Pregnancy and HIV Infection on Tuberculosis. 6th Annual Regional Prospective Observational Research for Tuberculosis (RePORT) India Joint...

Pharmacokinetic Aspects of 3HP in Special Populations

Post Date:

2016-10-29

Mathad J. Pharmacokinetic Aspects of 3HP in Special Populations. 47th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease. Liverpool, England.

IMPAACT P1078: Background, Design and Baseline Data

Post Date:

2016-10-29

Countries:

Clinical Sites: