Prospective Recurrent Pregnancy Loss Registry

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05989178

Collaborator

(none)

3,000

Enrollment

Location

125.7

Anticipated Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Pregnancy Loss	Other: Data Registry

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Recurrent Pregnancy Loss (ProRPL) Registry

Actual Study Start Date :

Jul 12, 2022

Anticipated Primary Completion Date :

Dec 31, 2032

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

Live Birth [5 years]
Percent of patients with a live birth within 5 years after initial visit at the clinic.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 49 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

• All new and re-referred patients at the BC Women's Recurrent Pregnancy Loss Clinic with recurrent pregnancy loss, defined as ≥2 miscarriages or ≥1 miscarriage beyond 10 weeks gestation; therapeutic abortions, ectopic pregnancies, and molar pregnancies are excluded from the miscarriage count.