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Prospective Recurrent Pregnancy Loss Registry

NCT ID: NCT05989178

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-12

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Recurrent Pregnancy Loss

Keywords

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Recurrent pregnancy loss Unexplained Explained Miscarriage Live Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data Registry

Follow-up questionnaires sent every year for the 5 years following the patient's initial visit.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Bedaiwy

Principal Investigator, Professor and Head Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, University of British Columbia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed A. Bedaiwy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BC Women's Hospital & Health Centre

Locations

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BC Women's Hospital & Health Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mohamed A. Bedaiwy, MD, PhD

Role: CONTACT

Phone: 604-875-2000

Email: [email protected]

Facility Contacts

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Mohamed A. Bedaiwy, MD, PhD

Role: primary

Other Identifiers

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H21-01887

Identifier Type: -

Identifier Source: org_study_id