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Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05952583
Acronym
CONTRAST
Enrollment
274
Registered
2023-07-19
Start date
2023-02-17
Completion date
2028-03-01
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

sFGR, sIUGR, selective fetal growth restriction

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTUltrasound

Additional ultrasound measurements during pregnancy

Sponsors

Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
BCNatal Fetal Medicine Research Center
CollaboratorUNKNOWN
MOUNT SINAI HOSPITAL
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
Leiden University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite outcome2 yearsThe composite outcome consists of fetal single or double demise, including selective fetal reduction and/or an iatrogenic elective birth \< 32 weeks of gestational age because of fetal distress).

Secondary

MeasureTime frameDescription
Ultrasound parameters2 yearsExplanatory analysis of ultrasound parameters over course of sFGR pregnancy
Prenatal and postnatal attachment2 years
Post-traumatic stress2 years
PARCA-R evaluation2 years

Countries

Belgium, Canada, Netherlands, Spain, Sweden, United States

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026