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临床试验/NCT01569737
NCT01569737已完成不适用

Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

HRA Pharma1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年11月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
1
主要终点
Number of Participants Who Experienced Assessed Pregnancy Outcomes

研究概览

简要总结

The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ella

干预措施: ella (Drug)

结局指标

主要结局

Number of Participants Who Experienced Assessed Pregnancy Outcomes

时间窗: up to 9 months after pregnancy diagnosis

Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications)

次要结局

未报告次要终点

研究者

发起方
HRA Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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