RPL: Interval to Live Birth and Adverse Perinatal Outcomes
NCT ID: NCT04360564
Last Updated: 2023-05-30
Study Results
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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UNKNOWN
140000 participants
OBSERVATIONAL
2020-05-13
2023-12-31
Brief Summary
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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.
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Detailed Description
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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. Since April 2000, there are up to 700, 000 births included in this database. The study population will be divided into 4 groups: those without RPL (control group), all patients with RPL, primary RPL, and secondary RPL. Within the RPL group, primary RPL is defined by those with \>/=2 pregnancy loss before 20 weeks gestational age before the first birth and the remaining patients will make up the secondary RPL group.
The following demographic variables will be requested: age at first delivery, age at second delivery, the average number of pregnancy loss before first birth, number of pregnancy loss before second birth, BMI at first delivery, BMI at second delivery, principle residence, use of in vitro fertilization to conceive, obstetrical status (number of pregnancies, term deliveries, preterm deliveries, miscarriages, and living children) at first and second birth, school years completed, smoking, at-risk alcohol use, preexisting hypertension, preexisting diabetes, psychiatric illnesses, the number of infant(s) born in first and second delivery, live birth/stillbirth. Primary outcome variables include the date (year, month, and day) of delivery for the first and second live births.
For our second objective, the investigators will analyze the cumulative live birth rate of a subgroup who is \</= 35 at age of first birth and first delivery recorded between the year 2000-2010. The investigators will assume that this cohort will be more likely to try for a second pregnancy rather than an older group. Furthermore, there will be 10 to 20 years of follow-up data from the year 2010. A Kaplan-meier curve will be constructed showing the cumulative live birth rate for patients with RPL, primary RPL, secondary RPL, and control group, controlling for age, BMI, city of residence, use of IVF, number of miscarriages, consecutive RPL, and school years completed.
Lastly, the medical and obstetric characteristics of the pregnancies resulting in live birth after the diagnosis of RPL will be analyzed between the 4 groups (primary RPL, secondary RPL, all RPL, control). The associations between the previous diagnosis of RPL and adverse perinatal outcomes will be determined using logistic regression analyses.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
RETROSPECTIVE
Study Groups
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Recurrent pregnancy loss
All women with \>/=2 pregnancy loss before 20 weeks gestational age
Recurrent pregnancy loss
As described before.
Primary recurrent pregnancy loss
Primary RPL is defined by those with \>/=2 pregnancy loss before 20 weeks gestational age before the first birth
Recurrent pregnancy loss
As described before.
Secondary recurrent pregnancy loss
Secondary RPL is defined by those with \>/=2 pregnancy loss before 20 weeks gestational age occurring after the first birth
Recurrent pregnancy loss
As described before.
No history of recurrent pregnancy loss
Those with 0 or 1 previous spontaneous pregnancy loss.
No interventions assigned to this group
Interventions
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Recurrent pregnancy loss
As described before.
Eligibility Criteria
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Inclusion Criteria
* Livebirths occurring 2000-2020
Exclusion Criteria
* Women with multiple gestations (at 1st or 2nd births)
* Stillbirths
FEMALE
Yes
Sponsors
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Children's & Women's Health Centre of British Columbia
OTHER
Responsible Party
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Dr. Mohamed Bedaiwy
Dr. Mohamed Bedaiwy, Professor in the Division of Reproductive Endocrinology & Infertility
Principal Investigators
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Mohamed A. Bedaiwy, FACOG, FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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BC Women's Hospital & Health Centre
Vancouver, British Columbia, Canada
Countries
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References
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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.
Other Identifiers
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1055
Identifier Type: -
Identifier Source: org_study_id
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