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

• Conditions: malfunctioning placenta.; Uteroplacental insufficiency; 10035129

• Registration Number: NL-OMON51959
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 300

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

Age <18 years;
Chromosomal abnormalities;
Fetal demise during pregnancy, not caused by uteroplacental insufficiency;
Termination of pregnancy;
Congenital anomalies;
Suspected/proven infections;
Pregnant women who are unable to reasonably assess their interests in
participating in the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in DV flow measured during the 13-week GUO between pregnancies<br /><br>complicated by UPI and pregnancies not complicated by UPI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Difference in uteroplacental Doppler parameters measured during the 13-week<br /><br>GUO between pregnancies complicated by UPI and pregnancies not complicated by<br /><br>UPI.<br /><br>(2) Explorative biomarker analyses in 13- and 32-week blood samples in<br /><br>pregnancies complicated by UPI and pregnancies not complicated by UPI. </p><br>