Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Number of live births
研究概览
简要总结
The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.
详细描述
NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.
In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.
Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.
Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.
Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least one dose of study drug administered in NT-03
- •Ongoing clinical pregnancy at Week 10 of gestation
- •Able and willing to enroll in NT-04
排除标准
- 未提供
结局指标
主要结局
Number of live births
时间窗: Within approximately 7 months after NT-03
次要结局
- Number of severe neonatal adverse events(Up to 4 weeks after birth)
- Number of stillbirths(Within approximately 7 months after study NT-03)
- Number of spontaneous abortions (miscarriages)(Within approximately 7 months after study NT-03)
- Number of congenital anomalies(Up to 4 weeks after birth)