Recruiting

Observational Study

Sponsor:

Leiden University Medical Center

Code:

NCT05952583

Conditions

Twin; Pregnancy, Affecting Fetus or Newborn

Fetal Growth Retardation

Twin Monochorionic Diamniotic Placenta

Twin Diseases

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Study Details

Brief summary:

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 ID

NCT05952583

Start date

Feb 17, 2023

Status verified date

Apr, 2024

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

274 participants

Anticipated

Interventions and Outcome Measures

Arms

sFGR cohort

Monochorionic diamniotic twin pregnancies complicated by sFGR (diagnosed before 28 weeks of gestational age)

Interventions

Ultrasound

Additional ultrasound measurements during pregnancy

Primary outcome measure

  • Composite outcome [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, ON M5G 1X5

More Information

Sponsor

Leiden University Medical Center

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Keywords

  • sFGR
  • sIUGR
  • selective fetal growth restriction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Leiden University Medical Center on 2024-04-15.