Pregnancy in GUCH Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Maternal chromosomal abnormalities.
Maternal syndromic conditions.
Spontaneous abortion.
Vanishing Twin.
Trial design
Design model
Single group
Treatments tested in this trial
Neurodevelopmental assessment
Diagnostic testNeurodevelopmental assessment
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Childhood neurodevelopmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neonatal outcomes in terms of weight and appropriate intrauterine development
Observation of neonatal outcome in terms of incidence of foetal growth restriction (FGR), defined as deviation from genetic potential with neonates classified as small for gestational age (SGA) or adequate for gestational age (AGA).
Time frame
Assessment in the first, second and third trimester of pregnancySecondary outcomes
1
Physical examination of the mother (BMI)
Physical examination will be evaluated by weight and height combination to report BMI in kg/m\^2
Time frame
Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth2
Systolic and diastolic blood pressure of the mother during pregnancy
Systolic an diastolic blood pressure will be evaluated in mmHg
Time frame
Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth3
NYHA class progression during pregnancy (NYHA functional class)
NYHA class will be evalueted by medical examination during pregnancy
Time frame
Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth4
Cardiologic assessment of the mother (Electrocardiogram):
Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes).
Time frame
Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirthSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: