Prospective Recurrent Pregnancy Loss (ProRPL) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Live Birth
研究概览
简要总结
The purpose of this Registry is to prospectively collect data of Recurrent Pregnancy Loss (RPL) patients attending the specialized care centre at the BC Women's Hospital, in order to evaluate investigation practices, treatment options, and outcomes for this patient population over time.
详细描述
The Recurrent Pregnancy Loss Program at the BC Women's Centre for Reproductive Health is the only tertiary care centre of its kind in British Columbia, and has provided specialized and comprehensive care to RPL patients for the past 15 years. Using a team-based collaborative model, the program provides point-of-care investigations, surgical treatment, clinical management, education, and grief counselling.
All RPL patients are asked to complete the intake questionnaire prior to their initial visit at the clinic. If the patient provides their consent to take part in research, their data will be copied from the clinical database to the research database. The questionnaire includes information regarding patient demographics, obstetric history, gynecological history, personal and medical history, family history and partner information. Additionally, data will also be collected from patient charts, follow-up questionnaires sent once a year for the next 5 years following the patient's initial visit, and medical records from fertility clinics and general practitioners when available.
The online data registry is housed in the Research Electronic Data Capture (REDCap) platform located at BC Children's Hospital (BCCH).
As an optional component of this study, patients invited to join the registry will also be presented with the option to register with the BCCH BioBank to store their tissue samples collected in the RPL clinic for clinical & diagnostic purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients seen at the BC Women's Recurrent Pregnancy Loss Clinic with recurrent pregnancy loss, defined as ≥2 pregnancy losses before 20 weeks of gestation.
排除标准
- •Patients at BC Women's Recurrent Pregnancy Loss Clinic seen for reasons other than recurrent pregnancy loss.
结局指标
主要结局
Live Birth
时间窗: 5 years
Percent of patients with a live birth within 5 years after initial visit at the clinic.
次要结局
未报告次要终点
研究者
Mohamed Bedaiwy
Principal Investigator, Professor and Head Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, University of British Columbia
University of British Columbia