The Ministry of Science and Technology, Government of India, launched the first national programme to study the reasons for preterm births, in an effort to prevent neonatal deaths, as India accounts for 25 per cent of preterm babies globally.
Launched with the support of the Department of Biotechnology and named the Grand Challenge Programme, the first phase was started in 2014 and will span a period of five years. 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 Gurgaon (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.
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 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.