INVESTIGATORS:

SHARE INDIA , MediCiti Institute of Medical Sciences.
Kalpana Betha, MD, Professor and Head of Department, OBY, MIMS
K. Govind Narsingrao MD, Professor and Head of Department, Community Health, MIMS
PS Reddy, MD, Chairman of SHARE INDIA

University of Pittsburgh Consultant:
Catherine L. Haggerty, PhD, MPH, Associate Professor and Director of the Reproductive, Perinatal and Pediatric Epidemiology Area of Emphasis University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, USA http://www.publichealth.pitt.edu/home/directory/catherine-l-haggerty

DESIGN PAPER:
Kusneniwar GN, Whelan RM, Betha K, Robertson JM, Ramidi PR, Balasubramanian K, Kamasamudram V, Haggerty CL, Bunker CH, Reddy PS. Cohort Profile: The Longitudinal Indian Family hEalth (LIFE) Pilot Study, Telangana State, India. International Journal of Epidemiology. 2017 Jun 1; 46(3):788-789j. PMID: 27649805. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5837391/

OBJECTIVES

1. The LIFE (Longitudinal Indian Family hEalth) study is being conducted in villages of Medchal Mandal, R.R.District, Telangana, India.This is a long-term research study that will examine socio-economic and environmental influences on children’s health and development in India.


2. The main aim of the study is to understand the link between the environmental conditions in which Indian women conceive, go through their pregnancy and give birth, and their physical and mental health during this period.


3. The LIFE Pilot is a prospective cohort study of Indian women followed through conception, pregnancy, and delivery, and the physical and mental health and development of their children.


4. The LIFE Pilot study is designed to identify the root causes of conditions excessively prevalent in India, including adverse pregnancy outcomes and childhood diseases and developmental disorders.


5. Since 2009, 1227 women aged between 15 and 35 years were recruited before conception or within 14 weeks of gestation. Women were followed through pregnancy, delivery, and postpartum. Follow-up of children is ongoing. Baseline data were collected from husbands of 642 women.


6. Anthropometric measurements, biological samples and detailed questionnaire data were collected during registration, the first and third trimesters, delivery and at 1 month postpartum. Anthropometric measurements and health questionnaire data are obtained for each child, and a developmental assessment is done at 1, 6, 12, 18, 24, 36, 48 and 60 months. At 36 months, each child is screened for development and mental health problems. Questionnaires are completed for pregnancy loss and death of children under 5 years old. The LIFE Biobank preserves over 6000 samples

EXPECTED OUTCOME

By linking multiple maternal and environmental factors to multiple health outcome measures, the LIFE study has the potential to pinpoint the root causes of many conditions that are excessively prevalent in India, including low birth weight, pre-term birth, other adverse pregnancy outcomes and diseases or development disorders of early childhood.

TO DISCUSS POTENTIAL COLLABORATION PLEASE CONTACT:

Dr. PS Reddy, psreddypittsburgh@gmail.com
Dr. K. Govind Narsingrao MD, drkgn2012@gmail.com
Kalpana Betha, MD, kalpanabasany@gmail.com
Catherine L. Haggerty, PhD, MPH, haggerty@pitt.edu

Principal Investigator:

1. Dr. Kusneniwar Govindrao N., Professor and Head, Department of Community Medicine, MIMS.

Co-Investigators:

1. Dr. K. Vijayaraghavan, Director Research, SHARE INDIA.
2. Dr. Kalpana Betha, Professor and Head, Department of I Obstetrics and Gynecology, MIMS.
3. Dr. Jammy Guru Rajesh, Associate Research Director, SHARE INDIA.

Funding source: GATI Limited.

Amount: Rs. 33 Lakhs (201 8-19).

Status of Field work from 1 st April, 2018 to 31 st March, 2019

Total Deliveries	10
Deliveries at MediCiti Hospital (MIMS)	8
Deliveries at Outside Hospitals	2
1st Trimester	0
3rd Trimester	8
PNC -1 month follow up	12
Child Follow -up visits (No. of questionnaires completed by age of the child)
6months	22
12months	24
18months	35
24months	46
36months	72
48months	98
60months	160
No of Children screened for mental health problems in the age group of 3-4 years	89
6-7years children follow up	396
No. of under five children deaths	0
8-16 years children follow up
96-98montfis follow up visit	99
WISC-IV scale (8 -11 years)	116
SMR scale	116

Principal Investigators:

1. Dr. Kalpana Betha, Professor and Head, Department of Obstetrics and Gynecology, MIMS.
2. Dr. Catherine L. Haggerty, Associate Professor, Department of Epidemiology, GSPH, University of Pittsburgh, PA, USA.

Funding source: Fogarty International Center - NIH.

Amount: US $46,318 (2016-19).

Aims: To reduce the burden of poor pregnancy outcomes due to reproductive tract infections in India.

Objectives:
Determine the role of pre-pregnancy and prenatal vaginal infections with mollicutes including fastidious Mycoplasma genitalium and the newly differentiated Ureaplasma spp. termed U. urealyticum (UU) and U. parvum (UP) in Pre-Term Birth (PTB) and Spontaneous abortion (SAB). The study also aims to determine the relationships between vaginal infection with Mycoplasma genitalium, Ureaplasma urealyticum, Ureaplasma parvum, and adverse pregnancy outcomes, including spontaneous abortion and preterm birth. It also examines chorioamnionitis as a mediating factor between Mycoplasma genitalium or Ureaplasma infection and spontaneous preterm birth.

Status of the project
The project is studying 1 88 women who delivered preterm, 21 8 women who experienced spontaneous abortion and 436 control women who delivered at term in the LIFE study. RT PCR isolation of DNA was completed from 2000 samples. Seven probes were standardized. Completed PCR testing for 100 samples for Trichomonas and Mycoplasma genitalium.

Principal Investigators:

1. Dr. Kalpana Betha, Professor and Head, Department of Obstetrics and Gynecology, MIMS.
2. Dr. Catherine L. Haggerty, Associate Professor, Department of Epidemiology, GSPH, University of Pittsburgh, PA, USA.

Aims:
To characterize and compare the pre-pregnancy vaginal microbiota of:

a) pregnant women who subsequently experience a spontaneous abortion

b) women who subsequently deliver preterm, to a control group of women who deliver at term To characterize and compare the vaginal microbiota at labor and delivery among women who deliver preterm and a control group of women who deliver at term

Status of the project:
The project is studying 20 cases of women with spontaneous abortion, 20 cases of women who delivered preterm and 20 control women who delivered at term. Archived preconception vaginal samples were analyzed using broad range 16S rRNA gene PCR with sequencing. The interim report showed more sequence reads from Sneathia species, Megasphaera species and Atopobium vaginae than controls. Women who delivered at term had vaginal microbiota dominated by lactobacillus sp.

Principal Investigator:

1. Dr. Kalpana Betha, Professor and Head, Department of Obstetrics and Gynecology, MIMS. Co-Investigators:
2. Dr. Brandie N. Taylor, Associate Professor, School of Public Health, The Texas A&M University System, Texas, USA.
3. Dr. Catherine L. Haggerty, Associate Professor, Department of Epidemiology, GSPH, University of Pittsburgh, PA, USA.

Funding source: Partial support from Texas A&M University.

Amount: US $ 24,000 (2017-19).

Aims:
a) Determine if circulating pre-pregnancy and first trimester biomarkers of placental dysfunction (EGFL7, PIGF,sFLT-l, PP-13) are associated with SAB

b) Determine if circulating pre-pregnancy and early pregnancy DAMPs (HGBM-1, HSP70) and innate immune signaling biomarkers (Pentraxin-3) are associated with SAB

c) Determine if pre-pregnancy and early pregnancy circulating markers of oxidative stress (MDA,GDH) are associated with SAB

Objectives
Examine the relationship between early pregnancy serum markers of cellular damage, innate immune signaling, angiogenesis and preeclampsia subtypes.

Status of the project
The project is studying 50 cases of women who had spontaneous abortion and 100 control women who delivered at term. First pregnancies with

Principal Investigator:

1. Dr. Kalpana Betha, Professor and Head, Department of Obstetrics and Gynecology, MIMS.

Co-Investigator

1. Dr. Catherine L. Haggerty, Associate Professor, Department of Epidemiology, GSPH,University of Pittsburgh, PA, USA.

Funding source :NIH through University of Pittsburgh.

Amount: US $ 936,756.

Aims
To examine a broad range of preconception and prenatal serum biomarkers in the above Cardiovascular Disease (CVD) pathways in relation to the risk of Pre-Term Birth (PTB).

Objectives
Determine if preconception biomarkers: lipid, inflammatory/immune, glucose, blood pressure and vitamin D predict PTB. Examine longitudinal changes in the above biomarkers across pregnancy (preconception, first and third trimester and delivery) in relation to PTB. Examine shared pathways leading to pregnancy loss and PTB. Status of the project: Grant applied, approval is awaited.