Investigation of selective fetal growth restriction in monochorionic twins
Official title: Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Run by Leiden University Medical Center · NCT05952583 · Data updated 2026-11-12
This study is trying to find better ways to understand and manage growth problems in one twin of monochorionic twins during pregnancy, while also checking how these issues affect the twins' development later on.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 274 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Status | Recruiting |
| Started | February 17, 2023 |
| Main results expected | March 1, 2025 |
| Study ends | March 1, 2028 |
| Registry record updated | April 15, 2024 |
| Trial ID | NCT05952583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women with monochorionic diamniotic twin pregnancies diagnosed with sFGR before 28 weeks of gestation.
✕Probably not a fit
Patients with lethal anomalies in one or both fetuses or those with higher-order multiple pregnancies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to improve the diagnostic management and understanding of selective fetal growth restriction (sFGR) in monochorionic diamniotic twin pregnancies. It focuses on identifying predictors of fetal deterioration and enhancing the current classification system based on umbilical artery flow patterns. The study will also involve extensive histological examinations of the placenta and assess neurodevelopment outcomes of affected twins at two years of age. By addressing these challenges, the study seeks to provide better counseling and management strategies for parents during pregnancy.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of fetal outcomes and better management of pregnancies affected by selective fetal growth restriction.
How similar studies have gone: While the approach to improving diagnostic management of sFGR is novel, similar studies have shown promise in enhancing outcome prediction in twin pregnancies.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting -
Universitaire Ziekenhuizen Leuven
Leuven, Belgium Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
Leiden University Medical Center
Leiden, South Holland, Netherlands Recruiting -
BCNatal
Barcelona, Spain Recruiting -
Karolinska University Hospital
Stockholm, Sweden Not yet recruiting
Study contacts
- Study coordinator: Anne Noll, MD
- Email: a.t.r.noll@lumc.nl
- Phone: +32 16 34 47 50
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.