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To see the effect of influenza vaccination in pregnant women and their newborn against influenza illness.

Effect Of Influenza Vaccine On Maternal And Fetal Outcomes - An Open Label Randomised Control Trail. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078484
Enrollment
156
Registered
2024-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O985- Other viral diseases complicatingpregnancy, childbirth and the puerperium

Interventions

Intervention1: Influenza vaccine: Single shot of Inactivated Tetravalent Influenza vaccine(SH 24) will be administered in pregnant females and the maternal and fetal outcome wil be studied related t

Sponsors

Aiims patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Females with a singleton pregnancy; 2-Atleast 18 years of age; willing to participate. 3-In between 13 weeks to 36 weeks of pregnancy. 4-Without serious medical conditions (i.e., cancers, rheumatoid arthritis, major psychiatric illnesses) or obstetrical complications (i.e., full placenta previa or diagnosed birth defects); 5-Who had not yet received the influenza vaccination during this pregnancy

Exclusion criteria

Exclusion criteria: 1-Women who are already been vaccinated with influenza vaccine. 2-Women were excluded if they had already participated in an influenza study before. 3-Did not intend to deliver their child in the study area 4-Women allergic to any vaccine component.

Design outcomes

Primary

MeasureTime frame
a)mean gestational age delivery b) birth weight of baby c) no. of episodes of URTI in pregnant femalesTimepoint: antenatal , perinatal and postnatal period

Secondary

MeasureTime frame
a)Cases of URTI in pregnant ladies b) Lost of wagesTimepoint: antenatal , perinatal and postnatal period

Countries

India

Contacts

Public ContactDr Mukta Agarwwal

AIIMS PATNA

drmuktaa@aiimspatna.org9661215080

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026