We hypothesize that the risk of any congenital abnormality in fetuses with an early increased NT that normalizes, will be lower than those with persistent increased NT after 11 weeks of gestation.
ID
Bron
Verkorte titel
Aandoening
- Foetale complicaties
Aandoening
Chromosomal anomalies. Congenital anomalies.
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of chromosomal anomalies detected prenatally and after birth, in fetuses with normalized NT and fetuses with persistent increased NT.
Achtergrond van het onderzoek
Rationale: Fetal Nuchal Translucency (NT) thickness is a reliable marker for chromosomal- and structural between 11 and 13+6 weeks. Little is known about its clinical relevance before 11 weeks of gestation. Objective: To estimate the relationship between nuchal translucency thickness early in pregnancy and chromosomal anomalies, structural anomalies, perinatal loss and composite abnormal outcome in fetuses with a NT measurement of ≥2.5mm and a crown rump length (CRL) <45mm. To compare fetuses with a normalized NT and fetuses with persistent increased NT after 11 weeks of gestation. Study design: Prospective cohort study. Study population: Women in the first trimester of pregnancy with a fetus with a NT measurement of ≥2.5mm and a CRL <45mm. Main study parameters: Incidence of chromosomal anomalies.
Doel van het onderzoek
We hypothesize that the risk of any congenital abnormality in fetuses with an early increased NT that normalizes, will be lower than those with persistent increased NT after 11 weeks of gestation.
Onderzoeksopzet
Inclusion: 8-11 weeks of gestation Ultrasound and NT-measurement: 11-13 weeks of gestation Follow-up: 4 weeks postpartum
Publiek
Wetenschappelijk
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Singleton or twin pregnancy 2. Ultrasound with viable fetus(es) with a CRL between 20-45mm AND 3. Nuchal translucency measurement =>2.5mm or increased NT with "eyeballing" 4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Maternal age <16 years 2. Insufficient knowlegde of English or Dutch language to comprehend the patient information and consent form 3. Cases of parents with recognized medical history for monogenetic disease or known carriers of a balanced translocation, deletion or duplication.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9494 |
| CCMO | NL74879.018.21 |
| OMON | NL-OMON55184 |