Pregnancy in GUCH Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2029-10-01

Brief Summary

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This study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns/children born from Grown-Up Congenital Heart (GUCH) mothers with follow-up at one year, extendable to two.

The main question it aims to answer is:

-Does maternal congenital heart disease affects outcomes of newborn?

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Detailed Description

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After being informed about the study and potential risks all patients giving written informed consent will undergo:

* Cardiological and obstetric evaluation in the first trimester of pregnancy;
* Cardiological and obstetric revaluation in the second trimester of pregnancy;
* Cardiological and obstetric revaluation in the third trimester of pregnancy;
* Cardiac and general neonatal evaluation at birth;
* 2-year follow-up: maternal and neonatal cardiology evaluation, childhood neurodevelopment evaluation

Conditions

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Congenital Heart Disease Pregnancy Related Infant Development IUGR Fetal Growth Restriction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Childhood neurodevelopment

Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment

Group Type EXPERIMENTAL

Neurodevelopmental assessment

Intervention Type DIAGNOSTIC_TEST

Neurodevelopmental assessment

Interventions

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Neurodevelopmental assessment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Congenital heart disease in natural history or undergoing corrective and/or palliative cardiothoracic surgery.
* Chronological age \> 18 years.
* Single pregnancy progressing normally at a gestational age of 14 weeks + 0.
* Correct pregnancy dating based on CRL as per ISUOG guidelines. (26)
* Normal results of non-invasive screening tests for foetal aneuploidies.
* Normal first-trimester ultrasound examination.
* Informed consent of the woman.

Exclusion Criteria

* Maternal chromosomal abnormalities.
* Maternal syndromic conditions.
* Spontaneous abortion.
* Vanishing Twin.
* High risk for chromosomal abnormalities on screening tests performed in the 1st Trimester (Combined Test/NIPT) or Major foetal structural anomalies identified during first-trimester ultrasound evaluation.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No