Preterm Birth (PTB)

GARBH-INI– interdisciplinary Group for Advanced Research on BirtH outcomes – DBT INdia Initiative (PTB)

Unique collaborative interdisciplinary program between research institutes (Translational Health Science and Technology Institute, National Institute of Biomedical Genomics, Kalyani; Regional Centre for Biotechnology, Delhi NCR, and district (Gurugram Civil Hospital (GCH), Haryana) and tertiary care hospitals (Safdarjung Hospital (SJH), Maulana Azad Medical College, New Delhi; Coordinated by Pediatric Biology Centre, THSTI).

Globally, preterm birth is a major public health problem. In India, annually about 13% (3.6 million of 27 million) of all babies born are preterm. About 300,000 of preterm babies die each year because of complications, contributing to 25% of the overall global preterm-related deaths. The adverse consequences of preterm birth (PTB) extend beyond early infancy with substantial consequences later in life. Effective solutions have not been possible because PTB is a complex syndrome with multiple etiologies that include interacting biological, psychosocial and environmental factors.

 

Risk stratification of women based on multidimensional risk factors assessed during pregnancy is critical for prevention of preterm birth. To address this, an interdisciplinary Group GARBH-INi has been established across DBT autonomous research institutes and hospitals. A cohort of pregnant women was started in May 2015 at the civil hospital in Gurugram, Haryana, India with the objectives to identify the clinical, epidemiological, genomic, epigenomic, proteomic and microbial correlates, discover molecular risk-markers by using an integrative omics approach, and generate a risk-prediction algorithm for preterm birth.

 

CDSA supported in setting up a co-ordination unit for site preparation, role-based training, and standardized processes to ensure efficient implementation/compliance. CDSA is ensuring the quality of this study by conducting the monitoring activities.

 

Project Title:Inter Institutional Program for Maternal, Neonatal and Infant Sciences- a translational approach to studying Pre-term birth

Project Status:
1. Primary site – Gurgaon civil Hospital (Participant enrolled here)
2. Referral site - Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
(referred here in case of any complications during pregnancy)
Study Sites:1. Primary site – Gurgaon civil Hospital (Participant enrolled here)
2. Referral site - Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
(referred here in case of any complications during pregnancy)
Quality Management data review status:1. Concurrent enrolment – till 4476

2. Ongoing outcome – till 3151

3. Ongoing follow up – till 3840

Achievements:
• Concurrent monitoring of the enrolment data

• Release of monitored data after query resolution on daily basis

• Escalation of critical quality issues to clinical team on weekly basis and their resolution

The Team

  • Dr. Shilpa Malik
  • Mr. Mantu Kumar
  • Ms. Niranjana