Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Condition
Twin; Pregnancy, Affecting Fetus or Newborn
Intervention / Treatment

-

Contacts and Locations

Boston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * The presence of lethal anomalies (one or both fetuses)
  • * Multiple pregnancy higher order than twins;
  • * TTTS/TAPS present at moment of sFGR diagnosis.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Leiden University Medical Center,

Study Record Dates

2028-03-01