Recurrent Pregnancy LossNCT05989178
Prospective Recurrent Pregnancy Loss Registry
An observational study of Recurrent Pregnancy Loss, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Data Registry
- How many people
- 3,000 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2022to 31 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients at the BC Women's Recurrent Pregnancy Loss Clinic seen for recurrent pregnancy loss.
Who may be able to join
- 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.
Who cannot join
- Patients at BC Women's Recurrent Pregnancy Loss Clinic seen for reasons other than recurrent pregnancy loss.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Women's Hospital & Health Centre
Vancouver, British Columbia, V6H 3N1
Mohamed A. Bedaiwy, MD, PhD, 604-875-2000 ext. 4310, mohamed.bedaiwy@cw.bc.ca
About this study
Official title: Prospective Recurrent Pregnancy Loss (ProRPL) Registry
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.
Read the 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.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Data Registry
- Keywords
- Recurrent pregnancy loss, Unexplained, Explained, Miscarriage, Live Birth
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data RegistryOther
Follow-up questionnaires sent every year for the 5 years following the patient's initial visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Percent of patients with a live birth within 5 years after initial visit at the clinic.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Jul 2022
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bedaiwy, University of British Columbia
- Investigators
- Mohamed A. Bedaiwy, MD, PhD, Principal investigator, BC Women's Hospital & Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989178
- Sponsor's protocol ID
- H21-01887
- Status last verified
- Dec 2024
- First submitted
- 3 Aug 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Recurrent Pregnancy Loss (ProRPL) Registry
- ClinicalTrials.gov ID
- NCT05989178
- Acronym / sponsor ID
- H21-01887
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Recurrent pregnancy loss, Unexplained, Explained, Miscarriage, Live Birth
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients at the BC Women's Recurrent Pregnancy Loss Clinic seen for recurrent pregnancy loss.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients at BC Women's Recurrent Pregnancy Loss Clinic seen for reasons other than recurrent pregnancy loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data RegistryFollow-up questionnaires sent every year for the 5 years following the patient's initial visit. | Other | – |
Primary outcome
Live Birth
Time frame: 5 years
Percent of patients with a live birth within 5 years after initial visit at the clinic.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Recurrent Pregnancy Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Active, not recruitingObservational study
Fertility, Hypercoagulability, and Inflammation (FREYA) Registry
Thrombophilia
Recruiting
Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-Ab
Recurrent Pregnancy Loss, Euthyroid With Thyroid Antibodies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A. Bedaiwy, MD, PhD principal investigator
BC Women's Hospital & Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Bedaiwy, MD, PhD (604-875-2000 ext. 4310, mohamed.bedaiwy@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.