DSIR Recognized | FWA Approved - FWA00012971

Why is this research being conducted?

PRIME study is the first study to evaluate perinatal outcomes in India. It will provide data on seasonal circulation of influenza viruses & strains, the effect on pregnant women and pregnancy related outcomes i.e. maternal morbidity, mortality, pregnancy losses, stillbirths, preterm, LBW etc. Knowledge, attitude and practices regarding the influenza, its effect and vaccination. Data generated from this study are intended to inform decisions by Ministries of Health in low- and middle-income countries about the introduction and expansion of influenza vaccination programs for pregnant women.

Who is conducting this research?

woman

Principal Investigator

Dr Archana Patel

Lata Medical Research Foundation, Nagpur, India

man

Co-Principal Investigator

Dr Prabir Kumar Das

Lata Medical Research Foundation, Nagpur, India

Centre for Disease Control (CDC) through Abt. Associates.

This prospective, longitudinal cohort study of pregnant women in low- and middle-income countries has three primary objectives:

  1. To Evaluate the effects of laboratory-confirmed influenza virus infection during pregnancy on pregnancy and perinatal outcomes.
  2. To Estimate the incidences of any acute respiratory illness (ARI), febrile ARI, and laboratory confirmed influenza during pregnancy.
  3. To Examine the clinical spectrum of illness due to influeza virus infection among pregnant women including duration and severity of illness.
  • Pregnant population is unique as pregnancy covers nearly a year during which new strains (antigenic drift) develop, no studies available on epidemiology of flu for this population and what proportions could potentially be protected.
  • Recruitment and training of study staff (5 research officers & 22 auxiliary nurse midwives).
  • Capacity building of laboratory.
  • Compliance to guidelines of H1N1 reporting.
  • Empanelment of sonologist for free antenatal USG for study participants.
  • Enrollment completed within time period of 12 weeks.
  • Use of tablets for active surveillance and real-time data collection.
  • Development of tracking app resulted in approx. 95% active surveillance.
  • Use of “Toll Free” numbers for ILS and end of pregnancy reporting.
  • Good rapport development with participants.
  • More than 95% compliance.
  • The study is being conducted in compliance with protocol & GCP guidelines.
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PRIME Home

Why is this research being conducted?

PRIME study is the first study to evaluate perinatal outcomes in India. It will provide data on seasonal circulation of influenza viruses & strains, the effect on pregnant women and pregnancy related outcomes i.e. maternal morbidity, mortality, pregnancy losses, stillbirths, preterm, LBW etc. Knowledge, attitude and practices regarding the influenza, its effect and vaccination. Data generated from this study are intended to inform decisions by Ministries of Health in low- and middle-income countries about the introduction and expansion of influenza vaccination programs for pregnant women.

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Team

Who is conducting this research?

woman

Principal Investigator

Dr Archana Patel

Lata Medical Research Foundation, Nagpur, India

man

Co-Principal Investigator

Dr Prabir Kumar Das

Lata Medical Research Foundation, Nagpur, India

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Sponsor

Centre for Disease Control (CDC) through Abt. Associates.

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Objectives

This prospective, longitudinal cohort study of pregnant women in low- and middle-income countries has three primary objectives:

  1. To Evaluate the effects of laboratory-confirmed influenza virus infection during pregnancy on pregnancy and perinatal outcomes.
  2. To Estimate the incidences of any acute respiratory illness (ARI), febrile ARI, and laboratory confirmed influenza during pregnancy.
  3. To Examine the clinical spectrum of illness due to influeza virus infection among pregnant women including duration and severity of illness.
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Salient Features
  • Pregnant population is unique as pregnancy covers nearly a year during which new strains (antigenic drift) develop, no studies available on epidemiology of flu for this population and what proportions could potentially be protected.
  • Recruitment and training of study staff (5 research officers & 22 auxiliary nurse midwives).
  • Capacity building of laboratory.
  • Compliance to guidelines of H1N1 reporting.
  • Empanelment of sonologist for free antenatal USG for study participants.
  • Enrollment completed within time period of 12 weeks.
  • Use of tablets for active surveillance and real-time data collection.
  • Development of tracking app resulted in approx. 95% active surveillance.
  • Use of “Toll Free” numbers for ILS and end of pregnancy reporting.
  • Good rapport development with participants.
  • More than 95% compliance.
  • The study is being conducted in compliance with protocol & GCP guidelines.
+
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