A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,493
- 试验地点
- 41
- 主要终点
- Number of Maternal Subjects With Pregnancy Outcomes
研究概览
简要总结
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 new-borns. The study will also determine incidence of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in the new-borns during their first year of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women 18-45years of age who are ≥ 24 0/7 weeks GA at screening and ≤ 27 6/7 weeks GA at Visit 1, as established by ultrasound examination and/or last menstrual period (LMP) date
- •Women with pre-pregnancy body mass index (BMI) ≥18.5 and ≤ 39.9 kg/m
- •Women whose pregnancy is considered low risk, based on medical history, obstetric history, and clinical findings during the current pregnancy
- •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).
- •Human Immunodeficiency Virus (HIV) uninfected women who have been tested within the past year and have documented HIV negative test results.
- •Individuals who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements.
- •The informed consent given at screening should either include consent for both the mother's participation and participation of the infant after the infant's birth (if consistent with local regulations/guidelines), or consent for the mother's participation and expressed willingness to consider permitting the infant to take part after the infant has been born (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth).
- •Both mother and father should consent if local regulations/guidelines require it.
- •Individuals who consent to have cord blood collected at delivery for the purpose of the study;
- •Individuals who plan to reside in the study area for at least one year after delivery.
- •Individuals who are in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
- •Individuals who, in the opinion of the investigator can and will comprehend and comply with all study procedures
- •Infants who were in utero at the time maternal (and paternal, if required) informed consent was given, and who are live-born.
- •If local law requires it: Written or witnessed/thumb printed informed consent for study participation of the infant obtained from parent(s)/Legally Accepted Representative [LAR(s)] within 21 days of birth.
排除标准
- •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;
- •Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:
- •Known or suspected:
- •Syphilis infection,
- •Parvovirus B19,
- •Rubella infection,
- •primary herpes simplex infection,
- •primary cytomegalovirus infection,
- •varicella infection,
- •Zika infection,
- •Active tuberculosis infection,
- •Incompetent cervix or cerclage
- •Individuals who have any underlying condition or infection that would predispose them to increased risk for a serious obstetrical complication that is not mentioned above
- •Individuals who have behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study;
- •Individuals who have known or suspected impairment of the immune system, an active autoimmune disorder that is not well-controlled, or who are receiving systemic immunosuppressive therapy;
- •Individuals participating in any concurrent clinical trial during the current pregnancy;
- •Individuals pregnant with a fetus with a confirmed or suspected major congenital anomaly at the time of enrolment.
- •Child in care
结局指标
主要结局
Number of Maternal Subjects With Pregnancy Outcomes
时间窗: From Day 1 up to Day 42 post delivery
Pregnancy outcomes included: live birth with no congenital anomalies, live birth with congenital anomalies, fetal death/stillbirth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with no congenital anomalies, fetal death/still birth loss at or after 22 weeks of gestation (antepartum stillbirth, Intrapartum stillbirth) with congenital anomalies, elective/therapeutic termination with no congenital anomalies, elective/therapeutic termination with congenital anomalies.
Number of Maternal Subjects With Pregnancy Related Events of Interest
时间窗: From Day 1 up to Day 42 post-delivery
Pregnancy related events of interest included: maternal death, hypertensive disorders of pregnancy including gestational hypertension, pre-eclampsia and pre-eclampsia with severe features (including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, Caesarean scar pregnancy, uterine rupture), postpartum haemorrhage, fetal growth restriction, dysfunctional labor (first stage of labor, second stage of labor), gestational diabetes mellitus, non-reassuring fetal status, pathways to preterm birth including premature preterm rupture of membranes, preterm labour, and provider initiated preterm birth, chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy \[ICP\], acute fatty liver of pregnancy), and maternal sepsis.
Number of Infant Subjects With Neonatal Events of Interest
时间窗: From birth up to Day 28 post-birth
Neonatal events of interest included: small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally diagnosed, prenatally diagnosed), congenital anomalies \[CA\] (major external structural defects, internal structural defects, functional defects), neonatal death (neonatal death in a preterm live birth \[gestational age greater than or equal to (≥) 28 to less than (\<) 37 weeks\], neonatal death in a term live birth), neonatal infections, (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia, any other neonatal event considered by the investigator to be of concern (e.g. neurodevelopmental delay).
次要结局
- Number of Infant Subjects With Neonatal Events of Interest for Each GAIA Level of Diagnostic Certainty(From birth through Day 28 of life)
- Respiratory Syncytial Virus Type A (RSV-A) Neutralizing Antibody Titers in Maternal Blood(At delivery)
- Incidence Rates of Infant Subjects With RSV Hospitalizations(From birth up to 1 year of age)
- Number of Maternal Subjects With Pregnancy Related Events of Interest for Each Global Alignment of Immunization Safety Assessment (GAIA) Level of Diagnostic Certainty(From Day 1 up to Day 42 post-delivery)
- RSV-A Neutralizing Antibodies Titers in Cord Blood(At delivery)
- Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very Severe LRTI for Infant Subjects as Defined by the LRTI Case Definition(From birth up to 1 year of age)