Health Condition 1: O269- Pregnancy related conditions, unspecified
Conditions
Interventions
None listed
Sponsors
Abt Associates Inc through CDC Atlanta
Eligibility
Inclusion criteria
Inclusion criteria: • Aged >=18 years; • Pregnant as confirmed by urine pregnancy test and/or abdominal ultrasound; • Have an estimated date of delivery (EDD) based on LMP or ultrasound o that occurs at least 8 weeks after the anticipated start date of the influenza season for women enrolled prior to that date; o that occurs at least 8 weeks after enrollment for women enrolled after the anticipated start date of the influenza season; • Meet one of the following criteria: o have had an ultrasound at OR o currently at • Plan to remain in the study area for the duration of her pregnancy and for her delivery; • Be willing and able to be contacted twice weekly by telephone call, mobile phone text message, or home visit from enrollment through the end of pregnancy;
Exclusion criteria
Exclusion criteria: • Aged • Plans for delivery outside the study area; • Unable to give consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Relative risk of preterm birth (37 weeks gestation based on ultrasound performed at 28 weeks gestation) among women with versus those without real- time reverse transcription polymerase chain reaction (RT-PCR)confirmed influenza virus infection during pregnancy.Timepoint: upto 6 weeks postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Difference in mean birth weight among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed influenza virus infection during pregnancyTimepoint: upto 6 weeks postpartum;â?¢ Frequency of illness signs and symptoms and duration of measured fever 38.0 Celsius using study-provided thermometers among pregnant women with RT-PCR-confirmed influenza.Timepoint: upto 6 weeks postpartum;Difference in mean gestational age at delivery or end of pregnancy among women with versus those without RT-PCR-confirmed influenza virus infection during pregnancyTimepoint: upto 6 weeks postpartum;Episodes of RT-PCR-confirmed influenza per 10,000 pregnant women months of observation.Timepoint: upto 6 weeks postpartum | — |
Countries
India
Contacts
Public ContactDr Archana Patel
Lata Medical Research Foundation
Outcome results
None listed