On Pregnancy After Losses - OPAL Study

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Dec 21, 2021

Keywords

ClinConnect Summary

The OPAL Study is a clinical trial aimed at helping couples who have experienced recurrent pregnancy loss (RPL), which means they have lost two or more pregnancies before the fetus could survive outside the womb. This study seeks to understand the chances of having a successful pregnancy in the future, especially for couples who have not been able to find a clear reason for their losses. By gathering information from both past and current couples dealing with RPL, the researchers hope to provide individualized predictions about the likelihood of having a healthy baby in the next three years and during future pregnancies.

To be eligible for this study, couples must have experienced at least two pregnancy losses in their current relationship and include women aged 42 years or younger. Participants can expect to provide information about their pregnancy history and will not face any direct risks from joining the study. While they may not receive immediate benefits from participating, the findings could lead to better support and care for couples facing similar challenges in the future. The study will collect data for up to five years to help improve understanding and management of recurrent pregnancy loss.

Gender

ALL

Eligibility criteria

• 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