Actively Recruiting

Age: 18Years - 50Years
All Genders
NCT05952583

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

262 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

Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified. The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy. Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case. By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.

CONDITIONS

Official Title

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant with monochorionic diamniotic (MCDA) twins
  • Diagnosed with selective fetal growth restriction (sFGR) before 28 weeks of gestational age
  • Pregnant woman aged 18 years or older and able to give consent
  • Partner aged 18 years or older and able to give consent, if applicable
  • Written informed consent obtained from both parents if applicable for follow-up until 2 years after birth
Not Eligible

You will not qualify if you...

  • Presence of lethal anomalies in one or both fetuses
  • Multiple pregnancy beyond twins
  • Twin-to-twin transfusion syndrome (TTTS) or twin anemia-polycythemia sequence (TAPS) present at the time of sFGR diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

A

Anne Noll, MD

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here