An epidemiological study of women as of 24 weeks of pregnancy, and their infants up to 1 year of age, to describe maternal, fetal and neonatal outcomes, pregnancy-related and neonatal/infant events of interest and the occurrence in neonates/infants of RSV LRTI.

Not Applicable

• Registration Number: CTRI/2019/02/017514
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Pregnant women (mothers):

1 Healthy pregnant women 18-40 years of age who are >= 24 0/7 weeks GA at screening and < 28 0/7 weeks GA at Visit 1, as established by ultrasound

examination and/or last menstrual period (LMP) date

2 Women whose pregnancy is considered low risk, based on medical history, obstetric history, and clinical findings during the current pregnancy

3 Women who had no significant findings (such as abnormal fetal morphology, amniotic fluid levels, placenta, or umbilical cord) observed during a Level 2 ultrasound (fetal morphology assessment).

4 HIV uninfected women who have been tested within the past year and have documented HIV negative test results.

5 Individuals who gave written or witnessed/thumb printed informed consent after the study had been explained according to local regulatory requirements. Informed consent for study participation of the mother should be obtained from the mother or the mother and father, as applicable by local law, prior to performance of any study specific procedures;

6 Individuals (mother or mother and father) who, at the time of their informed consent, express willingness to enroll their infant in the study at the time of birth.

7 Individuals who consent to have cord blood collected at delivery for the purpose of the study;

8 Individuals who plan to reside in the study area for at least one year after delivery.

9 Individuals who are in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;

10 Individuals who, in the opinion of the investigator can and will comprehend and comply with all study procedures (e.g., return for study follow-up visits, be contactable and available on a regular basis for surveillance).

Infants:

1 Infants live-born to enrolled women that resulted from the enrolled pregnancy.

2 Written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infantâ??s mother and/or father, as applicable by local law, or LAR within 10 days of birth.

Exclusion Criteria

Pregnant women (mothers):

1 Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication

Gestational hypertension

Gestational diabetes uncontrolled by diet and exercise

Pre-eclampsia or eclampsia

Multiple pregnancy

Intrauterine growth restriction

Placenta previa

Polyhydramnios

Oligohydramnios

2 Individuals participating in any concurrent clinical trial during the current pregnancy

3 Individuals pregnant with a fetus with a confirmed or suspected major congenital anomaly at the time of enrolment

Infants:

1 Child in care

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Pregnancy outcomes. These include: <br/ ><br>-Live birth with no congenital anomalies <br/ ><br>-Live birth with congenital anomalies <br/ ><br>-Fetal death/still birth (loss at or after 22 weeks of gestation) with no congenital anomalies <br/ ><br>-Fetal death/still birth (loss at or after 22 weeks of gestation) with congenital anomalies <br/ ><br>-Elective/therapeutic termination with no congenital anomaliesTimepoint: 1 Pregnancy outcomes. These include: <br/ ><br>-Live birth with no congenital anomalies <br/ ><br>-Live birth with congenital anomalies <br/ ><br>-Fetal death/still birth (loss at or after 22 weeks of gestation) with no congenital anomalies <br/ ><br>-Fetal death/still birth (loss at or after 22 weeks of gestation) with congenital anomalies <br/ ><br>-Elective/therapeutic termination with no congenital anomalies

Secondary Outcome Measures

Name	Time	Method
1 Pregnancy outcomes (as defined in primary endpoints) for each GAIA level of diagnostic certainty <br/ ><br>Timepoint: Where applicable and feasible;2 Occurrence of pregnancy related events of interest (as defined in primary endpoints) for each GAIA level of diagnostic certainty (where applicable and feasible) <br/ ><br>Timepoint: Visit 1 through Visit 6;3 Occurrence of neonatal events of interest(as defined in primary endpoints) for each GAIA level of diagnostic certainty (where applicable and feasible) <br/ ><br>Timepoint: Birth through 28 days of age;4 Maternal RSV-A neutralizing antibody titerTimepoint: At delivery;5 Titers of RSV-A neutralizing antibodiesTimepoint: Cord blood;6 Occurrence of RSV-LRTITimepoint: Birth up to 1 year of age;7 Occurrence RSV hospitalizationTimepoint: Birth up to 1 year of age