First trimester differences in ultrasound parameters between pregnancies complicated by uteroplacental insufficiency and uncomplicated pregnancies: an observational study.

First trimester differences in ultrasound parameters between pregnancies complicated by uteroplacental insufficiency and uncomplicated pregnancies: an observational study. - FIT-study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51959

Enrollment

300

Registered

2021-10-18

Start date

2021-12-01

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

malfunctioning placenta. Uteroplacental insufficiency

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnant women referred to the UMCG for an indicated 13-week advanced anomaly scan (that is in Dutch: geavanceerd ultrageluidsonderzoek, GUO) will be included. Indications for a 13-week GUO are: - A first degree relative of the fetus, two second degree relatives of the fetus or other, further relatives with a comparable abnormality in the same bloodline are eligible for a 13-week GUO if the abnormality is expected to be visible at the 13-week GUO, that is: anencephaly, abdominal wall defect, spina bifida, megacystis, certain limb defects, holoprosencephaly, body stalk anomaly, diaphragmatic hernia, some congenital heart defects or use of teratogenic medication of the mother which can cause visible abnormalities in the first trimester; - Monochorionic twin pregnancy or larger multiple pregnancy; - Women with a burdened obstetric history, that is: with previous abnormalities of the fetus/child, perinatal death or termination of pregnancy.

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
Difference in DV flow measured during the 13-week GUO between pregnancies complicated by UPI and pregnancies not complicated by UPI.	—

Secondary

Measure	Time frame
(1) Difference in uteroplacental Doppler parameters measured during the 13-week GUO between pregnancies complicated by UPI and pregnancies not complicated by UPI. (2) Explorative biomarker analyses in 13- and 32-week blood samples in pregnancies complicated by UPI and pregnancies not complicated by UPI.	—

Countries

Netherlands

Outcome results