Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jul 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a condition called selective fetal growth restriction (sFGR) in pregnancies with monochorionic diamniotic twins, meaning the twins share a placenta but have separate amniotic sacs. The goal is to better understand how this condition affects the babies and to improve the way doctors can predict outcomes for these pregnancies. Currently, there isn't a specific treatment for sFGR, so it’s really important to be able to predict if and when the babies might be at risk, which will help parents and doctors make informed decisions about care and monitoring.

To participate in this study, you must have a twin pregnancy where one baby is diagnosed with sFGR before the 28th week of pregnancy. Both parents need to be at least 18 years old and able to give consent for themselves and their babies. Participants can expect to be followed closely until the babies are two years old after birth, which will help researchers gather valuable information about the health and development of the children. This study is unique because it’s the first of its kind to look into these important questions on an international level, and it aims to provide clearer insights and support for families facing this challenging situation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • MCDA twin pregnancy
• • Diagnosis of sFGR before 28+0 weeks of GA (independent of Doppler flows)
• • Pregnant woman ≥ 18 years and able to consent
• • Partner (who has (future) parental responsibility - if applicable) ≥ 18 years and able to consent
• • Written informed consent of both parents (if applicable) for participation in the longitudinal follow-up until 2 years after birth)
• Exclusion Criteria:
• • The presence of lethal anomalies (one or both fetuses)
• • Multiple pregnancy higher order than twins;
• • TTTS/TAPS present at moment of sFGR diagnosis.