Skip to main content

Table 3 Site-specific methods, the Pregnancy and Influenza Multinational Epidemiologic Study

From: The Pregnancy and Influenza Multinational Epidemiologic (PRIME) study: a prospective cohort study of the impact of influenza during pregnancy among women in middle-income countries

 

Bangkok, Thailand

Lima, Peru

Nagpur, India

Recruitment and enrollment

 Enrollment period, year 1 (epidemiologic weeks)

20–32

11–22

19–30

 Additional eligibility requirements

Ability to speak and understand Thai

None

Resident of urban Nagpur,

Access to mobile phone

 Recruitment setting

Antenatal care clinic

Antenatal care clinc,

Preventive care medicine clinic

Antenatal care clinic

 Method of identifying potentially eligible women

Review of medical record and antenatal clinic cards

Staff maintain list of all women seen in the clinics each day

Staff maintain list of all women seen in the clinics each day

 Method of sampling women for recruitment

None, attempt to approach all women

Sample every 3rd woman during high patient volume periods, otherwise, attempt to approach all women

None, attempt to approach all women

Gestational age dating by ultrasound

 Personnel primarily responsible for performing ultrasound

Hospital ultrasonographers trained on gestational age dating SOP

Hospital ultrasonographers trained on gestational age dating SOP

Private ultrasonographers hired for study and trained on gestational age dating SOP

Surveillance for ILS

 Primary method of contact with participants

Telephone calls

Telephone calls

Telephone calls,

Home visits

 Additional methods used by participants to report illness

Telephone calls to study nurses

Telephone calls or text messaging application to study staff

Telephone hotline to study staff

Customized electronic application

 Method of nasal swab collection

Participant self-collection

Study staff collection

Study staff collection

End of pregnancy or delivery

 Methods of identifying end of pregnancy or delivery

Surveillance contacts,

Medical records flagged so hospital staff recognize study participants at delivery and can communicate with study team

Surveillance contacts, Review of labor room records

Surveillance contacts,

Telephone hotline for participants and family to call

Medical records flagged so hospital staff recognize study participants at delivery and can communicate with study team

Review of labor room records

 Primary location of deliveries

Hospital

Hospital

Hospital

 Birthweights, personnel primarily responsible for collection

Delivery nurses trained on birthweight collection SOP

Delivery nurses trained on birthweight collection SOP

Delivery nurse midwives and study staff trained on birthweight collection SOP

Chart abstraction data sources

Delivery hospitalization records

Antenatal clinic records

Delivery hospitalization records

Antenatal clinic records

National prenatal care card

Delivery hospitalization records

Antenatal clinic records

Influenza vaccine verification sources

Hospital records

National prenatal care card

Hospital records

Hospital records

Antenatal clinic records

Immunization cards

Additional substudy activities

 Serology specimen collection for serology substudy

Yes

Yes

No

 Testing nasal swabs for other respiratory viruses

Yes (hMPV, RSV)

No

No

  1. SOP Standard operating procedures, hMPV human metapneumovirus, RSV respiratory syncytial virus