Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Last updated: April 12, 2024
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Birth Defects

Treatment

Ultrasound

Clinical Study ID

NCT05952583
CONTR
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ableto consent
  • Written informed consent of both parents (if applicable) for participation in thelongitudinal follow-up until 2 years after birth)

Exclusion

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

Total Participants: 274
Treatment Group(s): 1
Primary Treatment: Ultrasound
Phase:
Study Start date:
February 17, 2023
Estimated Completion Date:
March 01, 2028

Study Description

Selective fetal growth restriction (sFGR) in monochorionic twins may negatively impact the pregnancy. There is a substantial risk of fetal deterioration resulting in (iatrogenic) preterm birth or even intrauterine demise of one, or both fetuses. There are important unresolved challenges on a diagnostic level and underlying pathophysiological mechanisms of sFGR 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 observed flow patterns may be volatile in nature. This hinders optimal diagnostic management and complicates outcome prediction as the survival outcome differs per umbilical artery flow type. Consequently, parents encounter a great deal of uncertainty during the pregnancy. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double demise.

By testing several predictors, the investigators are aiming to improve outcome prediction at the time of sFGR diagnosis. The investigators furthermore hypothesize that additional ultrasound parameters could be of benefit in making the current classification system more accurate and less variable. Extensive histological placental examinations will shine a light on microscopic abnormalities which can increase our knowledge of the pathophysiology. Examining neurodevelopment of sFGR twins at two years of age will additionally be of great value for our understanding of the impact of sFGR and contribute to adequate patient counselling. Our study will evaluate the impact of a sFGR pregnancy on parental mental health and parent-to-infant(s) attachment, which has not been carried out this extensively before.

Connect with a study center

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario ON M5G 1X5
    Canada

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, Zuid-Holland 2333 ZA
    Netherlands

    Active - Recruiting

  • BCNatal

    Barcelona, 08028
    Spain

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, 17164 Solna
    Sweden

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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