Prospective Recurrent Pregnancy Loss Registry

Recurrent Pregnancy Loss Clinical Trial

Official title:

Prospective Recurrent Pregnancy Loss (ProRPL) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989178
• Other study ID #: H21-01887
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: August 2023
• Source: University of British Columbia
• Contact: Mohamed A. Bedaiwy, MD, PhD
• Phone: 604-875-2000
• Email: mohamed.bedaiwy[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Exclusion Criteria:

• Patients at BC Women's Recurrent Pregnancy Loss Clinic seen for reasons other than recurrent pregnancy loss.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Recurrent Pregnancy Loss

Intervention

Other:
• Data Registry
Follow-up questionnaires sent every year for the 5 years following the patient's initial visit.

Locations

Country	Name	City	State
Canada	BC Women's Hospital & Health Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth	Percent of patients with a live birth within 5 years after initial visit at the clinic.	5 years