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On Pregnancy After Losses - OPAL Study

NCT05167812 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1931

Last updated 2021-12-22

No results posted yet for this study

Summary

Rationale:

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.

Conditions

  • Recurrent Pregnancy Loss

Interventions

OTHER

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-02-01
Completion
2028-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05167812 on ClinicalTrials.gov