NCT04360564

Brief Summary

This will be a retrospective observational cohort study utilizing the data from the British Columbia Perinatal Data Registry (BCPDR). The BCPDR is a provincially inclusive database that aggregates obstetrics and neonatal variables from all attended births in British Columbia. The primary objective of this study is to evaluate and contrast the average time interval from the first to second birth for patients with recurrent pregnancy loss compared to healthy controls. Secondarily, the investigators will calculate the cumulative live birth rate in the cohort of women with recurrent pregnancy loss who were \</= 35 at age of first birth and delivered between the years 2000-2010. Finally, the investigators will compare the incidence of adverse perinatal outcomes for those with recurrent pregnancy loss and those without. The results of this study will be valuable for clinicians and patients as it will provide information for prognosis counselling. This will also help those desiring more than one child with long term family planning.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

3.6 years

First QC Date

April 15, 2020

Last Update Submit

May 25, 2023

Conditions

Abortion, SpontaneousAbortion, HabitualBirth IntervalsPregnancy LossPregnancy Complications

Keywords

recurrent pregnancy losstime to live birthlive birth rateperinatal outcomes

Outcome Measures

Primary Outcomes (1)

  • Time between first birth and second birth

    Time interval in Weeks

    Time between first birth and second birth during 2000-2020

Secondary Outcomes (2)

  • Live birth rate

    10 years after first live birth

  • Obstetrical outcomes

    Live births during 2000-2020

Study Arms (4)

Recurrent pregnancy loss

All women with \>/=2 pregnancy loss before 20 weeks gestational age

Other: Recurrent pregnancy loss

Primary recurrent pregnancy loss

Primary RPL is defined by those with \>/=2 pregnancy loss before 20 weeks gestational age before the first birth

Other: Recurrent pregnancy loss

Secondary recurrent pregnancy loss

Secondary RPL is defined by those with \>/=2 pregnancy loss before 20 weeks gestational age occurring after the first birth

Other: Recurrent pregnancy loss

No history of recurrent pregnancy loss

Those with 0 or 1 previous spontaneous pregnancy loss.

Interventions

Recurrent pregnancy lossOTHER

As described before.

Primary recurrent pregnancy lossRecurrent pregnancy lossSecondary recurrent pregnancy loss

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those included in a provincially inclusive database that aggregates obstetrics and neonatal variables from all attended births in British Columbia from 2000-2018

You may qualify if:

  • \>/= 2 live births
  • Livebirths occurring 2000-2020

You may not qualify if:

  • Incomplete records
  • Women with multiple gestations (at 1st or 2nd births)
  • Stillbirths

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital & Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

  • Cho K, Fayek B, Liu YD, Albert A, Wiesenthal E, Dobrer S, AbdelHafez FF, Lisonkova S, Bedaiwy MA. A history of recurrent pregnancy loss is associated with increased perinatal complications, but not necessarily a longer birth interval: a population study spanning 18 years. Hum Reprod. 2024 May 2;39(5):1105-1116. doi: 10.1093/humrep/deae029.

    PMID: 38390658DERIVED

MeSH Terms

Conditions

Abortion, SpontaneousAbortion, HabitualPregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mohamed A. Bedaiwy, FACOG, FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mohamed Bedaiwy, Professor in the Division of Reproductive Endocrinology & Infertility

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 24, 2020

Study Start

May 13, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)