Predicting outcomes in selective fetal growth restriction of monoChOrioNic Twins: an inteRnAtional observational cohort STudy protocol (CONTRAST study).
Anne Noll, Ali Javinani, Femke Slaghekke...
https://pubmed.ncbi.nlm.nih.gov/41734920Actively Recruiting
Age: 18Years - 50Years
All Genders
ID05952583
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Led by Leiden University Medical Center · Updated on 2024-04-15
274
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies, a condition that can lead to serious risks such as fetal deterioration, preterm birth, or loss of one or both fetuses. The current methods for diagnosing and predicting outcomes in sFGR have limitations, creating uncertainty for expectant parents. This international, multicenter, prospective cohort study aims to better understand the diagnostic challenges, underlying mechanisms, and impacts of sFGR, including its effects on brain development and parental mental health. The study involves monitoring pregnancies complicated by sFGR diagnosed before 28 weeks of gestation. Participants will undergo additional ultrasound measurements during pregnancy to assess potential predictors for fetal outcomes and to improve existing classification methods. Researchers will also perform detailed placental examinations after birth to explore microscopic abnormalities related to sFGR. The study includes a longitudinal follow-up of the children until two years of age to evaluate their neurodevelopment and the psychological impact on parents. Participants will be involved from diagnosis through the follow-up period, with assessments including ultrasounds, evaluations of parent-to-infant attachment, and mental health questionnaires. The primary outcome focuses on a composite measure assessed at two years. Secondary outcomes include ultrasound parameters, parental attachment, post-traumatic stress, and developmental evaluations. This comprehensive approach aims to improve counseling and management of pregnancies affected by sFGR, with total participation lasting until the child reaches two years of age.
CONDITIONS
Brief Title
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- MCDA twin pregnancy
- Diagnosis of selective fetal growth restriction before 28 weeks of gestation
- Pregnant woman aged 18 years or older and able to consent
- Partner aged 18 years or older and able to consent (if applicable)
- Written informed consent from both parents for participation in follow-up until 2 years after birth (if applicable)
You will not qualify if you...
- Presence of lethal anomalies in one or both fetuses
- Higher order multiple pregnancy beyond twins
- Twin-to-twin transfusion syndrome (TTTS) or twin anemia-polycythemia sequence (TAPS) present at time of sFGR diagnosis
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - From diagnosis before 28 weeks of gestation until birth
Participants undergo additional ultrasound measurements during pregnancy to improve diagnostic accuracy and outcome prediction for selective fetal growth restriction.
Multiple ultrasound visits during pregnancy
Long-term Monitoring
Duration - Up to 2 years after birth
Participants are followed up to evaluate neurodevelopment, parental mental health, and parent-to-infant attachment up to two years after birth.
Periodic follow-up visits up to 2 years
Trial Site Locations
Total: 6 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Actively Recruiting
3
Mount Sinai Hospital
Toronto, Ontario, Canada, ON M5G 1X5
Actively Recruiting
4
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
5
BCNatal
Barcelona, Spain, 08028
Actively Recruiting
6
Karolinska University Hospital
Stockholm, Sweden, 17164 Solna
Not Yet Recruiting
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Research Team
A
Anne Noll, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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