PRIME Study

Not Applicable

Completed

• Conditions: Health Condition 1: O269- Pregnancy related conditions, unspecified

• Registration Number: CTRI/2018/04/012961
• Lead Sponsor: Abt Associates Inc through CDC Atlanta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5000

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

othat occurs at least 8 weeks after the anticipated start date of the influenza season for women enrolled prior to that date;

othat 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:

ohave had an ultrasound at <28 weeks gestation to establish her EDD at a facility where medical records are available for verification of ultrasound results;

OR

ocurrently at <28 weeks gestation based on her reported EDD or LMP and willing to undergo a trans-abdominal ultrasound for pregnancy dating as part of the study;

•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

•Aged <18 years;

•Plans for delivery outside the study area;

•Unable to give consent;

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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