The context of increased nuchal translucency thickness early in pregnancy

The context of increased nuchal translucency thickness early in pregnancy - NEK-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55184

Enrollment

Registered

2021-04-15

Start date

2021-05-26

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

first trimester nuchal translucency

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Maternal age

Design outcomes

Primary

Measure	Time frame
The incidence of chromosomal anomalies detected prenatally and after birth, in fetuses with normalized NT and fetuses with persistent increased NT	—

Secondary

Measure	Time frame
The incidence of structural anomalies, perinatal loss and composite abnormal outcome (defined as diagnosed chromosomal anomalies, single gene disorders, structural anomalies, perinatal loss or deceased during follow-up period), 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. In specific we will regard also perinatal outcomes as: number of terminations of pregnancy, stillbirths, mean gestational age at birth, birthweight and APGAR-scores.	—

Measure

Time frame

The incidence of structural anomalies, perinatal loss and composite abnormal outcome (defined as diagnosed chromosomal anomalies, single gene disorders, structural anomalies, perinatal loss or deceased during follow-up period), 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. In specific we will regard also perinatal outcomes as: number of terminations of pregnancy, stillbirths, mean gestational age at birth, birthweight and APGAR-scores.

—

Countries

Netherlands

Outcome results