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DBT’s march to stall pre-term birth

Rapid Fire

  • Pre-Term Birth Programme (PTB) envisages multidisciplinary research effort to predict & diagnose PTB
  • Early findings from cohort study involving 1000 mothers indicates Indoor pollution is associated with early birth, early shortening of the cervix is a risk factor for PTB
  • 5500 pregnant women to be enrolled over next 2-3 years
  • Seeks to understand the epidemiology of PTB, its genetic and environmental interactions and changes in the vaginal microbial landscape
  • The final goal is to develop therapeutic agents against PTB
  • The therapeutic agents will help in categorization of pre-term birth phenotypes & develop effective algorithm for diagnosis & timing of intervention.

The Pre-term birth programme launched with the support of the Department of Biotechnology envisages a multidisciplinary research effort to predict and diagnose pre-term birth by enhancing the knowledge of patho-physiological mechanisms.

Early findings from ongoing pregnancy cohort study involving 1000 mothers indicates Indoor pollution is associated with early birth, early shortening of the cervix is a risk factor for preterm birth and has identified 3 distinct microbial community in the maternal vagina. Five thousand five hundred pregnant women will be enrolled in the cohort over next 2-3 years. This will help infuse new scientific thinking for innovative applications in preterm birth and fetal growth restriction.

The programme seeks to understand the epidemiology of PTB, its genetic & environmental interactions and changes in the vaginal microbial landscape.

Journey with the cohort
Pregnant women coming to the antenatal clinic of GHG are approached by the study nurses to ascertain their eligibility to participate in the study. Expectant mothers of less than 20 weeks gestation are eligible (if they were willing to participate in the study and give their written consent for it) as determined by a ‘dating’ ultrasound and who are willing to come to GHG for follow-up on antenatal visits.

Information related to maternal age and nutritional factors, socio-demographic details, psychosocial stress, past and present pregnancy details, medical history and other co-morbidities are obtained and recorded in structured and pre-tested case recording forms (CRF). The enrolled participants are followed up at pre-defined periods during the course of the pregnancy.

All factors at birth including details on labour, gestation, anthropometry of the baby are recorded. Collection of biological samples (maternal blood, stool, urine, high vaginal fluid, saliva) is done in pre-packed collection kits and labelled with a unique identification code (UIC) for each participant to ensure their confidentiality. This code is scanned at each step, from collection to immediate processing, temporary storage, transportation, and till final storage. Serial ultrasounds are done to assess the gestational age, fetal growth, cervical length, placental position, size, echogenicity and vascular flow.

This programme stratifies women early in pregnancy into various levels of risk of PTB, identifying simple and better prediction tools that recognise the optimal time of prediction and clinical intervention, along with developing additional strategies to identify the presence of unusual microbes in these women that could serve as biomarkers for PTB. This will further help identify therapies to prevent PTB and subsequently reduce infant and maternal mortality rates. The Translational Health Science and Technology Institute (THSTI) in Faridabad is the main coordinator of the programme. The General Hospital Gurugram (GHG) in the National Capital Region (NCR) is the main study site. The other study site is Safdarjung Hospital (SJH), New Delhi, where the study participants get referred for further management, if their medical condition so demands. The cohort study aims to enroll 8,000 women early in their pregnancy and serially follow them through their pregnancy till childbirth and 42 days (6 weeks) post-partum. The cohort was initiated in August 2015. Till date, 1108 women have been enrolled and the total number of babies born stands at 318.

This cohort will also serve as a platform for wider and larger research programmes. Investigators, who may or may not belong to the initial phases of this programme, will be encouraged to develop additional research questions through discussions using a trans-disciplinary approach. The clinical, imaging data and biospecimens longitudinally collected on enrolled women and the child will serve as resource for such studies.

Targeting improvement
Pre-term birth causes around 300,000 neo-natal deaths in India annually and is the single largest cause of neonatal deaths annually. India contributes to the highest number of preterm births and deaths annually. Despite substantive efforts to introduce new therapies for prevention, the problem persists and contributes significantly to neonatal mortality and morbidity.

The total cost of the first inter-institutional program on maternal infant health and spontaneous pre-term birth sciences in India funded by the Department under Grand Challenge Programme is Rs 48.85 crore for a period of 5 years.

It is expected that the clinically relevant research outputs from the study will aid characterization of biological, clinical and epidemiological risk factors to achieve appropriate risk stratification of mothers who may deliver before term. These in turn would provide a basis for discovery of novel therapeutic agents & determine appropriate timing for their clinical application. Together, it would strengthen the commitment of the Department of Biotechnology to health equity, contributing significantly to reduction in infant and maternal mortality.
It will also help in categorization of pre-term birth phenotypes and develop effective algorithm for diagnosis and timing of intervention.

The final goal for the Rs 48.85 crore (Rs 4.8 billion), project, of course, is to develop therapeutic agents against this scourge.

It is expected that the clinically relevant research outputs from the study will aid characterisation of the biological, clinical and epidemiological risk factors to help assess whether a mother is under high or low risk of delivering before term (achieve appropriate risk stratification of mothers).

These in turn would provide a basis for discovery of novel therapeutic agents and determine appropriate timing for their clinical application.

The inter-institutional profile of the programme is clear from the fact that it involves the

  • Paediatric Biology Centre, which will be the main coordinator of the programme and will be responsible for establishing and managing the cohort
  • Translational Health Science and Technology Institute (THSTI), Gurugram, an autonomous institute of DBT
  • Centre for Human Microbial Ecology
  • Regional Centre for Biotechnology (RCB), Gurugram
  • National Institute of Biomedical Genomics (NIBMG), Kalyani, West Bengal, and
  • Clinical Development Services Agency, an extramural unit of THSTI