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
Source
Brief title
Condition
- Foetal complications
Health condition
Chromosomal anomalies. Congenital anomalies.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of chromosomal anomalies detected prenatally and after birth, in fetuses with normalized NT and fetuses with persistent increased NT.
Secondary outcome
The incidence of structural anomalies, perinatal loss and composite abnormal outcome compared in fetuses with normalized NT and fetuses with persistent increased NT. The proportion of fetuses in which the NT normalizes after 11 weeks of gestation. The incidence of congenital anomalies not detected by NIPT. The incidence of structural anomalies at the 13 weeks scan, 20 weeks scan and after birth. Pregnancy outcomes such as pregnancy loss before 24 weeks of gestation, intra-uterine death or neonatal death before hospital discharge.
Background summary
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.
Study objective
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.
Study design
Inclusion: 8-11 weeks of gestation Ultrasound and NT-measurement: 11-13 weeks of gestation Follow-up: 4 weeks postpartum
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9494 |
| CCMO | NL74879.018.21 |
| OMON | NL-OMON55184 |