Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia of More Than 5 Years in Women Who Have Already Had a Pregnancy of More Than 6 Months With Childbirth at Brest University Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Evaluate diagnostic sensitivity and specificity of the self questionnaire
研究概览
简要总结
PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.
详细描述
This study will help to evaluate the specificity and sensitivity of the French translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at Brest University Hospital before year 2015.
First, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the Medical Registry Database (MRD) of Brest University maternity ward.
All pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis.
250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study.
Then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Women who gave birth after a pregnancy of more than 6 months at Brest University Hospital between January 2002 and December 2014
- •For the cases: with a pre-eclampsia diagnosis during pregnancy
- •For the controls: with no history of hypertensive disorder during pregnancy
排除标准
- •Women Under legal protection
- •Women unable to read French
- •Medical interruption of pregnancy
- •Pregnancy with a delivery before 6 months
- •Women who refused to participate in the study
结局指标
主要结局
Evaluate diagnostic sensitivity and specificity of the self questionnaire
时间窗: Inclusion ( Day 0)
Presence or not of a history pre-eclampsia according to responses to the questionnaire
次要结局
未报告次要终点