Last updated: 04/25/2024 09:10:31

Zanamivir 10 milligrams per milliliter (mg/ml) solution for infusion pregnancy registry

GSK study ID
208140
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Zanamivir 10 mg/ml solution for infusion pregnancy registry: an observational study of the safety of zanamivir 10 mg/ml solution for infusion exposure in pregnant women with complicated influenza and their offspring
Trial description: Pregnant women are a group at risk of increased influenza related morbidity and mortality. This multi-center, primarily prospective, observational study will evaluate pregnancy outcomes among women hospitalized with complicated influenza and exposed to intravenous (IV) zanamivir at any time during pregnancy. This study will be conducted in the European Union, United Kingdom (UK), Iceland and Norway. Zanamivir exposed pregnancies will be identified primarily by United Kingdom Obstetric Surveillance System (UKOSS) and International Obstetric Surveillance System (INOSS). The data will be collected from participant's medical record as part of usual care and data collection will be coordinated through study staff and the study contract research organization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Maternal deaths

Timeframe: Up to 42 days after end of pregnancy

Number of pregnant women with Live birth

Timeframe: Up to end of pregnancy

Number of participants with Spontaneous abortion (SAB)

Timeframe: Up to end of pregnancy

Number of participants with stillbirth

Timeframe: Up to end of pregnancy

Number of participants with Induced Abortion (IAB)

Timeframe: Up to end of pregnancy

Number of premature births

Timeframe: Up to end of pregnancy

Number of small gestational age (SGA) infants

Timeframe: At birth

Number of low birth weight (LBW) infants

Timeframe: At birth

Number of neonatal death

Timeframe: Up to 28 days after birth

Number of births with major congenital malformation (MCM)

Timeframe: Up to 3 months after birth

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Intravenous Zanamivir
    • Enrollment:
    0
    Primary completion date:
    2023-27-04
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Influenza, Human
    Product
    zanamivir
    Collaborators
    Not applicable
    Study date(s)
    February 2023 to April 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participants with sufficient evidence to confirm that exposure to IV zanamivir occurred at any time during pregnancy based on information from the reporter.
    • Participants with sufficient information to determine whether the pregnancy is prospectively or retrospectively recorded (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry).
    • Not Applicable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants with sufficient evidence to confirm that exposure to IV zanamivir occurred at any time during pregnancy based on information from the reporter.
    • Participants with sufficient information to determine whether the pregnancy is prospectively or retrospectively recorded (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry).
    • Date of enrolment into the registry.
    • Treating hospital contact information to allow for follow-up.
    • Women aged greater than 18 years at time of enrolment.
    Exclusion criteria:
    • Not Applicable.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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