TY - JOUR
T1 - Development of the OPAL prediction model for prediction of live birth in couples with recurrent pregnancy loss
T2 - protocol for a prospective and retrospective cohort study in the Netherlands
AU - Youssef, Angelos
AU - van der Hoorn, Marie-Louise
AU - van Eekelen, Rik
AU - van Geloven, Nan
AU - van Wely, Madelon
AU - Smits, Myrthe A J
AU - Mulders, Annemarie
AU - van Lith, Jan Mm
AU - Goddijn, Mariëtte
AU - Lashley, Eileen
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/9/23
Y1 - 2022/9/23
N2 - INTRODUCTION: Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before 24 weeks gestation. Despite extensive diagnostic workup, in only 25%-40% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a successful pregnancy is still high. Prognostic counselling plays a significant role in supportive care. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors, and separation between cumulative live birth rate and the success chance in the next conception. In this project, we aim to make an individualised prognosis for the future chance of pregnancy success, which could lead to improved well-being and the ability managing reproductive choices.METHODS AND ANALYSIS: In this multicentre study, we will include both a prospective and a retrospective cohort of at least 931 and 1000 couples with RPL, respectively. Couples who have visited one of the three participating university hospitals in the Netherlands for intake are eligible for the study participation, with a follow-up duration of 5 years. General medical and obstetric history and reports of pregnancies after the initial consultation will be collected. Multiple imputation will be performed to cope for missing data. A Cox proportional hazards model for time to pregnancy will be developed to estimate the cumulative chance of a live birth within 3 years after intake. To dynamically estimate the chance of an ongoing pregnancy, given the outcome of earlier pregnancies after intake, a logistic regression model will be developed.ETHICS AND DISSEMINATION: The Medical Ethical Research Committee of the Leiden University Medical Center approved this study protocol (N22.025). There are no risks or burden associated with this study. Participant written informed consent is required for both cohorts. Findings will be published in peer-reviewed journals and presentations at international conferences.TRIAL REGISTRATION NUMBER: NCT05167812.
AB - INTRODUCTION: Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before 24 weeks gestation. Despite extensive diagnostic workup, in only 25%-40% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a successful pregnancy is still high. Prognostic counselling plays a significant role in supportive care. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors, and separation between cumulative live birth rate and the success chance in the next conception. In this project, we aim to make an individualised prognosis for the future chance of pregnancy success, which could lead to improved well-being and the ability managing reproductive choices.METHODS AND ANALYSIS: In this multicentre study, we will include both a prospective and a retrospective cohort of at least 931 and 1000 couples with RPL, respectively. Couples who have visited one of the three participating university hospitals in the Netherlands for intake are eligible for the study participation, with a follow-up duration of 5 years. General medical and obstetric history and reports of pregnancies after the initial consultation will be collected. Multiple imputation will be performed to cope for missing data. A Cox proportional hazards model for time to pregnancy will be developed to estimate the cumulative chance of a live birth within 3 years after intake. To dynamically estimate the chance of an ongoing pregnancy, given the outcome of earlier pregnancies after intake, a logistic regression model will be developed.ETHICS AND DISSEMINATION: The Medical Ethical Research Committee of the Leiden University Medical Center approved this study protocol (N22.025). There are no risks or burden associated with this study. Participant written informed consent is required for both cohorts. Findings will be published in peer-reviewed journals and presentations at international conferences.TRIAL REGISTRATION NUMBER: NCT05167812.
KW - EPIDEMIOLOGY
KW - Maternal medicine
KW - Reproductive medicine
UR - http://www.scopus.com/inward/record.url?scp=85138458660&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-062402
DO - https://doi.org/10.1136/bmjopen-2022-062402
M3 - Article
C2 - 36153018
SN - 2044-6055
VL - 12
SP - e062402
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e062402
ER -