Clinical trial NCT05989178: Prospective Recurrent Pregnancy Loss Registry
Official title: Prospective Recurrent Pregnancy Loss (ProRPL) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Pregnancy Loss
Keywords: Recurrent pregnancy loss
Unexplained
Explained
Miscarriage
Live Birth
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the BC Women's Recurrent Pregnancy Loss Clinic seen for recurrent pregnancy loss.

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.

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.

Eligibility criteria: Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Live Birth
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital & Health Centre
state: British Columbia
Study officials:
affiliation: BC Women's Hospital & Health Centre
name: Mohamed A. Bedaiwy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: