Fetal Growth Retardation Clinical Trial
— CONTRASTOfficial title:
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
NCT number | NCT05952583 |
Other study ID # | CONTR |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 17, 2023 |
Est. completion date | March 1, 2028 |
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.
Status | Recruiting |
Enrollment | 274 |
Est. completion date | March 1, 2028 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitaire Ziekenhuizen Leuven | Leuven | |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Spain | BCNatal | Barcelona | |
Sweden | Karolinska University Hospital | Stockholm | |
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | BCNatal Fetal Medicine Research Center, Boston Children's Hospital, Karolinska University Hospital, MOUNT SINAI HOSPITAL, Universitaire Ziekenhuizen KU Leuven |
United States, Belgium, Canada, Netherlands, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite outcome | The 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). | 2 years | |
Secondary | Ultrasound parameters | Explanatory analysis of ultrasound parameters over course of sFGR pregnancy | 2 years | |
Secondary | Prenatal and postnatal attachment | 2 years | ||
Secondary | Post-traumatic stress | 2 years | ||
Secondary | PARCA-R evaluation | 2 years |
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