Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up) (Thrive-IVF F/U)
Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
• None
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Follow-Up after dosing with NT100 Dose 1
|
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实验性的:Follow-Up after dosing with NT100 Dose 2
|
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安慰剂比较:Follow-Up after dosing with Placebo
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of live births
大体时间:Within approximately 7 months after NT-03
|
Within approximately 7 months after NT-03
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of stillbirths
大体时间:Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
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Number of spontaneous abortions (miscarriages)
大体时间:Within approximately 7 months after study NT-03
|
Within approximately 7 months after study NT-03
|
|
Number of congenital anomalies
大体时间:Up to 4 weeks after birth
|
Up to 4 weeks after birth
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Number of severe neonatal adverse events
大体时间:Up to 4 weeks after birth
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Up to 4 weeks after birth
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NT-04
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