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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NOT_YET_RECRUITING
1931 participants
OBSERVATIONAL
2022-02-01
2028-02-01
Brief Summary
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Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before the fetus reaches viability. It affects 1-3% of all fertile couples and despite extensive diagnostic work-up, in only around 30% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a normal, successful pregnancy is still high. So, in supporting couples with RPL, an important part of the clinical management of these couples is to provide couples with accurate prognoses for their next pregnancy. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors such that prognoses are individualized, and separating between the cumulative live birth rate and the chance that the next conception will lead to a live birth. In this project therefore we aim to make an individualized prognosis regarding the future chance of live birth and the chance of a healthy child. This could then lead to improved wellbeing and the ability of making future reproductive choices.
Objectives:
Primary objective: to predict the chance of a live birth within three years after intake in couples with unexplained RPL
Secondary objectives:
* to predict the chance of an ongoing pregnancy (\>12 weeks) in the next pregnancy in couples with unexplained RPL.
* to predict the chance of a complicated pregnancy in couples with unexplained RPL
* to predict the chance dynamically of a live birth given the outcome of a pregnancy after intake
* to predict the chance of above outcomes in couples with a known cause for RPL
Study design: A multicenter retrospective and prospective cohort study.
Study population:
Couples with females aged ≤42 years in both prospective and retrospective inclusion.
Retrospective inclusion: Couples with RPL who visited the RPL outpatient clinic in participating centers from 2006 until the start of this study.
Prospective inclusion: new couples with RPL who will visit the clinic from 2021 onwards.
Main study parameters/endpoints:
* Pregnancy outcomes since intake
* Time to pregnancy since intake
* Time between pregnancies since intake
* Pregnancy complications since intake
* All outcomes will be obtained up to a maximum of five years after intake
* Patient characteristics: cause for RPL, female age, male age, previous live birth, duration of RPL (since diagnosis)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participating in this study does not yield any risks. There could be a burden in case of retrospectively collecting data. Participating does not yield direct benefits for the subjects, however it may lead to future improvements of care for couples with RPL.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prospective cohort of couples with RPL
Observation of pregnancies after intake
Monitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss
Retrospective cohort op couples with RPL
Observation of pregnancies after intake
Monitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss
Interventions
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Observation of pregnancies after intake
Monitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss
Eligibility Criteria
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Inclusion Criteria
* RPL in the current relationship: defined as the loss of ≥ 2 preceding pregnancies. These pregnancy losses include:
* all pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology
* non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive urine or serum hCG
* both consecutive and non-consecutive pregnancy losses
* Dutch or English speaking couple
* Couples with females aged ≤42 years at intake
Exclusion Criteria
* Loss of \< 2 pregnancies in current relationship
18 Years
42 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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ayoussef
Drs. A. Youssef, Medical Doctor, Principal Investigator,
Central Contacts
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References
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Youssef A, van der Hoorn ML, van Eekelen R, van Geloven N, van Wely M, Smits MAJ, Mulders A, van Lith JM, Goddijn M, Lashley E. Development of the OPAL prediction model for prediction of live birth in couples with recurrent pregnancy loss: protocol for a prospective and retrospective cohort study in the Netherlands. BMJ Open. 2022 Sep 23;12(9):e062402. doi: 10.1136/bmjopen-2022-062402.
Other Identifiers
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P_2022
Identifier Type: -
Identifier Source: org_study_id