NCT05601375

Brief Summary

Comparison of prenatal and postnatal cardiac function assessed by echocardiography using pulsed wave Doppler, Tissue Doppler and speckle tracking (strain and strain rate) between foetuses/neonates with a structural heart disease, with an fetal growth restriction (FGR) and healthy fetuses/neonates.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

October 27, 2022

Last Update Submit

October 27, 2022

Conditions

Speckle TrackingFetus FetusNeonateStructural Heart DiseaseFetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Comparison of fetal systolic and diastolic function (strain and strain rate)

    3 years

Secondary Outcomes (1)

  • Technical feasibility of cardiac function measurements of fetal echocardiography using speckle tracking, pulsed waved Doppler and Tissue Doppler in fetuses with a structural heart disease.

    3 years

Study Arms (3)

Pregnancy with a healthy fetus

3 times echocardiography in pregnancy once echocardiography after birth

Other: Echocardiography

Pregnancy with a fetus with a structural heart disease

3 times echocardiography in pregnancy once echocardiography after birth

Other: Echocardiography

Pregnancy with a fetus with a fetal growth restriction

3 times echocardiography in pregnancy once echocardiography after birth

Other: Echocardiography

Interventions

EchocardiographyOTHER

Fetal echocardiography (ultrasound)

Pregnancy with a fetus with a fetal growth restrictionPregnancy with a fetus with a structural heart diseasePregnancy with a healthy fetus

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women, aged ≥16 years, with a singleton pregnancy with either a healthy fetus, a fetus with fetal growth restriction (defined as: weight and/or abdominal circumference p\<10, or deviating growth (weight and/or abdominal circumference) \> 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery) or a fetus with a structural heart disease.

You may qualify if:

  • Informed consent
  • Sufficient command of the Dutch language
  • A pregnancy with a fetus with a structural heart disease, or
  • A pregnancy with a fetus with an FGR (defined as: weight and/or abdominal circumference p\<10, or deviating growth (weight and/or abdominal circumference) \> 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery), or
  • A pregnancy with a healthy fetus (without any major fetal congenital abnormality)

You may not qualify if:

  • Multiple pregnancy
  • A pregnancy with known fetal genetic abnormality
  • A pregnancy with other major fetal congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3033 XD, Netherlands

RECRUITING

MeSH Terms

Conditions

Fetus-in-FetuFetal Growth Retardation

Condition Hierarchy (Ancestors)

Twins, ConjoinedAbnormalities, Severe TeratoidCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 1, 2022

Study Start

September 12, 2022

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

NL(1)