- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05167812
On Pregnancy After Losses - OPAL Study (OPAL)
On Pregnancy After Losses; Predicting Pregnancy Success in Couples With Recurrent Pregnancy Loss
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Angelos Youssef, MD
- Phone Number: +31715262896
- Email: a.youssef@lumc.nl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Couples that fulfill the following criteria are included (according to the ESHRE Recurrent Pregnancy Loss Guideline 2017):
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:
- Mental or legal incapability of either the male or female of the couple
- Loss of < 2 pregnancies in current relationship
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prospective cohort of couples with RPL
|
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
|
Monitoring pregnancies after intake at a dedicated recurrent pregnancy loss clinic to predict pregnancy success chances in couples with recurrent pregnancy loss
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live birth of RPL couples within three years assessed by ultrasound or hCG after intake at the RPL clinic
Time Frame: 3 - 5 years
|
3 - 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy outcomes since intake (miscarriage, ongoing pregnancy, live birth) assessed by ultrasound, hCG, or "take home baby"
Time Frame: 3 - 5 years
|
miscarriages are assessed via ultrasound or pregnancy tests (positive test later followed by negative test).
Ongoing pregnancy when ultrasound assessment is known but further follow up is missing, and live birth when pregnancy ends with the live birth of a child.
|
3 - 5 years
|
Time to pregnancy since intake measured in days
Time Frame: 3 - 5 years
|
Time that has passed since couple had an intake at the RPL clinic until first pregnancy, measured in days until the first day of the last menstruation of the first pregnancy after intake
|
3 - 5 years
|
Time between pregnancies since intake measured in days
Time Frame: 3 - 5 years
|
Time that has passed between each pregnancy a couple had since intake at the RPL clinic, measured in days between the end of the last pregnancy and until the first day of the last menstruation of the new pregnancy
|
3 - 5 years
|
Pregnancy complications since intake as registered by gynecologist or midwife
Time Frame: 3 - 5 years
|
All complications during pregnancy and during labor registered by caregiver (gynecologist or midwife) in all pregnancies after intake at the RPL clinic
|
3 - 5 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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