Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

NCT05952583 | Recruiting DMC

• 1 other identifier: CONTR
• Study Type: observational
• Target: 274
• Locations: 6 countries
• Sites: 6

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

Keywords

sFGR; sIUGR; selective fetal growth restriction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ultrasound parameters

  2 years

• Prenatal and postnatal attachment

  2 years

• Post-traumatic stress

  2 years

• PARCA-R evaluation

  2 years

Study Arms (1)

sFGR cohort

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

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Additional ultrasound measurements during pregnancy

sFGR cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

MCDA pregnancies complicated by sFGR pregnancies that meet the inclusion criteria.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Karolinska University Hospital: collaborator
• BCNatal Fetal Medicine Research Center: collaborator
• MOUNT SINAI HOSPITAL: collaborator
• Boston Children's Hospital: collaborator

Study Sites (6)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, ON M5G 1X5, Canada

RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

BCNatal

Barcelona, 08028, Spain

RECRUITING

Karolinska University Hospital

Stockholm, 17164 Solna, Sweden

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Fetal Growth Retardation; Diseases in Twins

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Anne Noll, MD

CONTACT

+32 16 34 47 50; a.t.r.noll@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: February 17, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

BE (1); CA (1); US (1); ES (1); NL (1); SE (1)