An Observational Study to Assess the Safety of Pertagen®, a Recombinant Acellular Pertussis Vaccine in Pregnant Women in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- 1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery.
研究概览
简要总结
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®.
Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.
详细描述
A CRF has been developed and will be used to collect safety information on pregnancy outcomes including the health status of infants at birth. The following definitions will be used for data collection
- The 2nd trimester of pregnancy is defined as gestational period between 13-26 weeks
- The 3rd trimester of pregnancy is defined as gestational period from 27 weeks to delivery.
- Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
- Preterm birth is defined as delivery of a baby at GA<37 weeks.
- Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
- Safety information of pregnancy and delivery outcome refers to health of women during pregnancy and childbirth (WHO 2024). The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia and heart disease (WHO 2024).
- A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
- A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.
To ensure the privacy and confidentiality of the collected data, strict adherence to all relevant data protection regulations will be followed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Data of pregnant women previously vaccinated with Pertagen® during second or third trimester of pregnancy and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® during pregnancy.
- •Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy
排除标准
- •1. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.
结局指标
主要结局
1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery.
时间窗: Safety profile of Pertagen® in pregnant women at delivery
* Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks. * Preterm birth is defined as delivery of a baby at GA\<37 weeks. * Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
次要结局
- 1 Number and percentage of healthy infants born to mothers who received Pertagen® during pregnancy. 2.2 Number and percentage of not healthy infants born to mothers who received Pertagen® during pregnancy(Safety profile of Pertagen® in infants born to mother who received Pertagen® at birth)