Investigation of selective fetal growth restriction in monochorionic twins
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Leiden University Medical Center · NCT05952583
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 |
|---|---|
| Enrollment | 274 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT05952583 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with monochorionic diamniotic twin pregnancies diagnosed with sFGR before 28 weeks of gestation.
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.
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 performed: While the approach to improving diagnostic management of sFGR is novel, similar studies have shown promise in enhancing outcome prediction in twin pregnancies.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Twin, Pregnancy, Affecting Fetus or Newborn, Fetal Growth Retardation, Twin Monochorionic Diamniotic Placenta, Twin Diseases, sFGR, sIUGR, selective fetal growth restriction