Submitted by: Efriel Hazel Cruz 2018-10-30 00:00:00 Last Updated by: Efriel Hazel Cruz 2019-03-14 10:13:13 Export to PDF

A prospective epidemiological study of pregnancy outcomes and of events of interest in pregnant women, neonates and infants (PEPNI)

PHRR181106-001979

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207636 (EPI-RSV-008 BOD):A prospective epidemiological study of women between24-27 weeks of pregnancy to describe pregnancy outcomes and events of interest in the mother and neonate, as well as determine incidence in infants of RSV LRTI and RSV hospitalization

The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their newborns. The study will also determine incidence of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in the newborns during their first year of life.

Regime Classification Priority
2017 - 2022 Research to enhance and extend healthy lives Maternal, newborn and child health
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-06-24 30 2021-06-17 0000-00-00

Ongoing

Institution Classification Region LTO #
GlaxoSmithKline Philippines, Inc. Private Business NCR CDRR-NCR-S-3
Institution Amount Region
GlaxoSmithKline Philippines, Inc. N/A NCR
Name Expertise Affiliation
Grace Devota G. Go, MD Principal Investigator Mary Chiles General Hospital
Ricardo Manalastas Jr., MD Principal Investigator Philippine General Hospital
Raymond Sulay, MD Principal Investigator Perpetual Succour Hospital

Respiratory Syncytial Virus

Number of subjects with pregnancy outcomes [ Time Frame: From Day 1 up to Day 42 post delivery ] Pregnancy outcomes included: live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth (after 22 weeks of gestation) with no congenital anomalies, foetal death/still birth (after 22 weeks of gestation) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies. Number of subjects with pregnancy related events of interest [ Time Frame: From Day 1 up to Day 42 post- delivery ] Pregnancy related events of interest included: gestational diabetes, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and eclampsia, antenatal bleeding, dysfunctional labour, foetal growth restriction, non-reassuring foetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, postpartum haemorrhage, chorioamnionitis, oligohydramnios, polyhydramnios, and maternal death. Number of infant subjects with neonatal events of interest [ Time Frame: From birth through Day 28 of life. ] Neonatal events of interest included: small for gestational age, neonates with low birth weight including very low birth weight, large for gestational age, macrosomia, acute neonatal encephalopathy, respiratory distress, neonatal death, congenital microcephaly, congenital anomalies, neonatal infections, and preterm birth.

Number of subjects with pregnancy outcomes as defined for each Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) level of diagnostic certainty [ Time Frame: Up to 28 Days of life ] GAIA levels of diagnostic certainty (where applicable and feasible), for the following pregnancy outcomes: live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth (after 22 weeks of gestation) with no congenital anomalies, foetal death/still birth (after 22 weeks of gestation) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies. Number of subjects with pregnancy related events of interest for each GAIA level of diagnostic certainty [ Time Frame: From Day 1 up to Day 42 post-delivery ] Pregnancy related events of interest by GAIA level of diagnostic certainty (where applicable/feasible) range from Level 1 to Level 2 or 3: gestational diabetes, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and eclampsia, antenatal bleeding, dysfunctional labour, foetal growth restriction, non-reassuring foetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, postpartum haemorrhage, chorioamnionitis, oligohydramnios, polyhydramnios, and maternal death. Maternal respiratory syncytial virus type A (RSV-A) neutralizing antibody titer [ Time Frame: At delivery ] Maternal blood serum collected at delivery will be tested for RSV-A neutralizing antibody level and expressed as Geometric Mean Titer (GMTs). Titers of RSV-A neutralizing antibodies in cord blood. [ Time Frame: At delivery ] Cord blood sample serum collected at delivery will be tested for RSV A neutralizing antibody levels and expressed as Geometric Mean Titers (GMTs). Number of infant subjects with neonatal events of interest for each GAIA level of diagnostic certainty. [ Time Frame: From birth through Day 28 of life ] Neonatal events of interest by GAIA level of diagnostic certainty, range from Level 1 to Level 4 or 5: small for gestational age, neonates with low birth weight including very low birth weight, large for gestational age, macrosomia, acute neonatal encephalopathy, respiratory distress, neonatal death, congenital microcephaly, congenital anomalies, neonatal infections, and preterm birth. Number of infant subjects with lower respiratory tract infection (RSV-LRTI) [ Time Frame: From birth up to 1 year of age ] Number of LRTI cases, incidence rates and frequency of repeat occurrences of LRTI infections reported during the first year of life of infant subjects and will be classified as lower respiratory tract infection (LRTI), severe LRTI or very severe LRTI. Number of subjects with RSV hospitalizations. [ Time Frame: From birth up to 1 year of age ] Number of RSV hospitalizations, incidence rates and frequencies of repeat occurrences of RSV hospitalization will be recorded.

Pending

  • Argentina
  • Brazil
  • Colombia
  • India
  • Malaysia
  • Mexico
  • Philippines
  • South Africa
  • Thailand

Non-clinical Studies

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None

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24 Jun 2019

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