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临床试验/NCT03368157
NCT03368157已完成不适用

PREG-MS: New England MS Pregnancy Prospective Cohort Study

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
The relationship between EDSS and pregnancy course

研究概览

简要总结

The purpose of the study is to develop a detailed pregnancy registry of patients with Multiple Sclerosis in the New England states. Women with a diagnosis of MS that are either pregnant or actively planning to become pregnant are eligible to participate.

The study will solely take place through phone interviews. One of the study coordinator at the Partners MS Center will contact the participant for an intake phone interview where general information about the individual, their pregnancy and their MS will be collected. Thereafter the coordinator will contact the participant every 3 months for 20 minutes follow up interviews. After birth, the coordinator will collect information on the growth and development of the participant's baby. Pediatric interviews will be conducted at 2, 4, 6, 9, 12, 18, 24, 36 months. Information from the participant's neurologist and obstetrician, as well as information from the baby's pediatrician, will be made available to the study staff at regular intervals throughout the duration of the study.

Through this study, the investigators hope to learn more about the effects of MS on pregnancy and pediatric development, and about the effects of pregnancy on the course of MS.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Diagnosis of Multiple Sclerosis;
  • Pregnant or actively planning to become pregnant.

排除标准

  • 未提供

结局指标

主要结局

The relationship between EDSS and pregnancy course

时间窗: 9 months

The investigators assessed the correlation between EDSS scores and the presence of pregnancy complications, or the lack thereof.

次要结局

  • The relationship between MS treatments and pregnancy course(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Houtchens

Assistant Professor of Neurology

Brigham and Women's Hospital

研究点 (1)

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