This proposal aims to develop a logistic model incorporating maternal factors and inflammatory biomarkers during the first trimester of pregnancy to better predict preeclampsia and pregnancy outcomes. A prospective cohort study of 1,500 pregnant women in India will collect data on maternal risk factors and biomarker levels during the first trimester and follow the women through pregnancy to observe outcomes. The results will be analyzed using logistic regression to create a predictive model. This study hopes to improve early detection of preeclampsia through a multi-factorial approach combining traditional risk factors and novel biomarkers.

1. Pre-Proposal
1. Title of the proposed research project: Logistic Model incorporating Maternal
factors and Inflammatory Biomarkers during the first trimester of pregnancy
in the prediction of Pre-eclampsia and pregnancy outcomes
2. Rationale (up to 350 Words): Preeclampsia (PE) magnitude ranges from 5% to
7% of total deliveries leading to high maternal and foetal morbidity and
mortality. The long term complications are irreparably leading to life long
morbidity among women. Premature babies born are more prone to suffer
from near-fatal conditions. Because of these multiple and devasting
consequences of preeclampsia, there is an urgent need for its prevention
through early prediction and proper management
The aetiology of PE is complex and is not understood completely. Early
detection of pregnant women who are at risk of developing PE would lead to
arranging accessible quality care and preserving the precious lives of mother
and foetus. Though maternal factors are incriminated in the development of
PE, these factors alone may not be sufficient to predict it. Over the years,
biophysical and biochemical markers are identified as possible early
indicators of failures in the complex placentation process, which would
ultimately lead to preeclampsia. However, no single potential biomarker can
predict future PE accurately. Hence, it is suggested that a combination of
maternal factors and potential biomarkers will be able to predict the
development of PE accurately. Studies are underway to develop accessible
and useful PE early prediction methods. The objectives of this proposal are to
attempt the systematic review of the PE early detection biomarkers among the
Asian population. It is also envisaged to conduct biomarker analysis among
pregnant women and apply a logistic model to detect PE early.
3. Novelty/Innovation (up to 100 Words): The reported occurrence of PE among
Population living in Southeast Asian countries will be collected. This bench study
will involve a literature search and conducting a systematic review and meta-
analysis. The community-based component consists of recruiting pregnant women
during the first trimester and conducting a cohort follow-up for 12 months. These
women initially are evaluated for their potential biomarkers status SFLT/PGF,
Inhibin-A, PAPPA and Uterine artery Doppler velocity). Through a monthly
followup, these pregnant women are screened for the clinical signs and symptoms
of PE.
4. Project Description (up to 700 Words):
Describe study setting: The study will be carried out at Narayana Medical College,
Nellore, India
Study design: Prospective cohort study
Sampling strategy: Incidental sampling
Sample size: 1500 pregnant women attending the hospital during
the first trimester of pregnancy

2. Feasibility: This hospital being the only tertiary Maternal and Child health care centre
in this region, pregnant women prefer to avail services from this hospital.
Moreover, the Matruseva Pathakam, a social welfare scheme implementing at
NMC, is a boon to pregnant women.
Expected outcomes: Through bench research, Meta-Analysis and identification of
contributing risk factors essential for decision making.
The Cohort study outcomes are the development of classical Preeclampsia, type of
delivery, pregnancy outcome, fetal health status
Inter- department/inter- institutional collaborations: Department of Obstetrics and
Gynecology, Department of Biochemistry & Department of Community Medicine-
Narayana Medical College and Linkoping University, Malaysia
Timelines: 2 years
Budget: 75.00 lakhs
5. Strength of PI: The Principal Investigator is an experienced researcher. She is
a world-renowned Obstetrician. She is credited with more than 50 research
projects and quality publications.
Academic qualifications: M.D.
Nature of employment (permanent/ad- hoc); Permanent
Previous experience of handling research projects and the scienscientific contributions
made from these grants; enumerate ten recent publications (in Vancouver style):
Attached.
6. Institutional Support: Narayana Medical College will support the project and allow
the PI to utilise the infrastructure, equipment and wards and transport facility.