The context of increased nuchal translucency thickness early in pregnancy

Completed

Conditions: first trimester
10028920
nuchal translucency

Registration Number: NL-OMON55184

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 68

Inclusion Criteria

1. Singleton or twin pregnancies
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 year
2. Insufficient knowledge 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of chromosomal anomalies detected prenatally and after birth, in<br /><br>fetuses with normalized NT and fetuses with persistent increased NT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The incidence of structural anomalies, perinatal loss and composite abnormal<br /><br>outcome (defined as diagnosed chromosomal anomalies, single gene disorders,<br /><br>structural anomalies, perinatal loss or deceased during follow-up period),<br /><br>compared in fetuses with normalized NT and fetuses with persistent increased<br /><br>NT. The proportion of fetuses in which the NT normalizes after 11 weeks of<br /><br>gestation. The incidence of congenital anomalies not detected by NIPT. The<br /><br>incidence of structural anomalies at the 13 weeks scan, 20 weeks scan and after<br /><br>birth.<br /><br>Pregnancy outcomes such as pregnancy loss before 24 weeks of gestation,<br /><br>intra-uterine death or neonatal death before hospital discharge. In specific we<br /><br>will regard also perinatal outcomes as: number of terminations of pregnancy,<br /><br>stillbirths, mean gestational age at birth, birthweight and APGAR-scores.</p><br>