RECRUITING

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Quick Facts

Study Start:2023-02-17
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05952583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * MCDA twin pregnancy
  2. * Diagnosis of sFGR before 28+0 weeks of GA (independent of Doppler flows)
  3. * Pregnant woman ≥ 18 years and able to consent
  4. * Partner (who has (future) parental responsibility - if applicable) ≥ 18 years and able to consent
  5. * Written informed consent of both parents (if applicable) for participation in the longitudinal follow-up until 2 years after birth)
  1. * The presence of lethal anomalies (one or both fetuses)
  2. * Multiple pregnancy higher order than twins;
  3. * TTTS/TAPS present at moment of sFGR diagnosis.

Contacts and Locations

Study Contact

Anne Noll, MD
CONTACT
+32 16 34 47 50
a.t.r.noll@lumc.nl

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Leiden University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-17
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2023-02-17
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • sFGR
  • sIUGR
  • selective fetal growth restriction

Additional Relevant MeSH Terms

  • Twin; Pregnancy, Affecting Fetus or Newborn
  • Fetal Growth Retardation
  • Twin Monochorionic Diamniotic Placenta
  • Twin Diseases