Selective fetal growth restriction in monoChOrioNic Twins - an inteRnAtional inveSTigation

Selective fetal growth restriction in monoChOrioNic Twins - an inteRnAtional inveSTigation - CONTRAST

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51577

Enrollment

Registered

2023-01-13

Start date

2023-03-13

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

neurologische ontwikkeling (t/m 2 jaar) van kinderen geboren uit een sFGR zwangerschap. Selective fetal growth restriction (sFGR)

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

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 (if applicable) >= 18 years and able to consent - Written informed consent of the pregnant woman (for the antenatal study) and of both parents (if applicable) for participation in the longitudinal follow-up)

Exclusion criteria

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

Measure	Time frame
Composite outcome on a pregnancy level, consisting of the occurrence of one of the following: - Fetal demise of one or both twins (including selective reduction), and/or: - Iatrogenic elective birth	—

Secondary

Measure	Time frame
For the full list, we kindly refer to chapter 5.1.2. and 5.1.3. Summary: - Ultrasound parameters (both standard and additional parameters) - Fetal MRI (brain development) - Antenatal characteristics - Maternal, paternal and fetal baseline characteristics - Analysis of sFGR (characteristics and management during pregnancy) - Characteristics of labour - Placental evaluation (macroscopic and microscopic) - Neonatal variables - Neurodevelopmental outcomes at 2 years of age - Psychological impact on parents	—

Measure

Time frame

For the full list, we kindly refer to chapter 5.1.2. and 5.1.3. Summary: - Ultrasound parameters (both standard and additional parameters) - Fetal MRI (brain development) - Antenatal characteristics - Maternal, paternal and fetal baseline characteristics - Analysis of sFGR (characteristics and management during pregnancy) - Characteristics of labour - Placental evaluation (macroscopic and microscopic) - Neonatal variables - Neurodevelopmental outcomes at 2 years of age - Psychological impact on parents

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Countries

Netherlands

Outcome results