Congenital Heart DiseasePURE-HEARTNCT06574386
Pregnancy in GUCH Patients
A study testing Neurodevelopmental assessment in people with Congenital Heart Disease and Pregnancy Related, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Heart Disease, Pregnancy Related, Infant Development
- What is being tested?
- Neurodevelopmental assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione universitaria policlinico Agostino Gemelli
Roma, 00168
Maria Grandinetti, maria.grandinetti@policlinicogemelli.it
About this study
Official title: Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
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?
Read the detailed description
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
- Congenital Heart Disease, Pregnancy Related, Infant Development, IUGR, Fetal Growth Restriction
- Being tested
- Neurodevelopmental assessment
- Keywords
- GUCH, Pregnancy
- Medical subject headings
- Heart Defects, Congenital, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessmentDiagnostic test
Neurodevelopmental assessment
| Study group | Role | What they receive |
|---|---|---|
| Childhood neurodevelopment | Experimental | Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment Receives: Diagnostic Test: Neurodevelopmental assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessment in the first, second and third trimester of pregnancy
Secondary outcomes (21)
Physical examination of the mother (BMI)
Physical examination will be evaluated by weight and height combination to report BMI in kg/m^2
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Systolic and diastolic blood pressure of the mother during pregnancy
Systolic an diastolic blood pressure will be evaluated in mmHg
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
NYHA class progression during pregnancy (NYHA functional class)
NYHA class will be evalueted by medical examination during pregnancy
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assessment of the mother (Electrocardiogram):
Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes).
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (Echocardiography)
Cardiologic assesment will be evaluated by the use of echocardiography (wall motion assessment and residual congenital heart disease),
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (24-hour Holter ECG)
Cardiologic assesment will be evaluated by the use of 24-hour Holter ECG (ventricular and atrial arrhythmic burden)
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (24-hour Holter BP)
Cardiologic assesment will be evaluated by the use of 24-hour Holter BP (degree of arterial hypertension).
Measured: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT)
Evaluated by abdominal adipose thickness index
Measured: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Assessment of foetal oxygenation
Foetal oxygenation will be evaluated by rterial doppler of uterine arteries, umbilical arteries and middle cerebral artery and venous doppler of the umbilical vein and ductus venosus
Measured: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Numbers of obstetric and maternal complications
Incidence of obstetric and maternal complications (maternal mortality, cardiac complications, hypertensive disorders, gestational diabetes, hepatosis, sepsis, placental abruption, thromboembolic events, postpartum haemorrhage, disseminated intravascular coagulation, need for further hospitalization; evaluation of mode of delivery)
Measured: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Cardiological evaluation of the fetus
Cardiological evaluation of the fetus will be evaluated by foetal cardiotocography
Measured: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Physical examination in newborns
Physical examination will be evaluated by weight and height combination to report BMI in kg/m^2
Measured: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth
Newborn's health and vital signs
Evaluated by Apgar score calculation
Measured: At birth
Fetal metabolic condition
Evaluated by umbilical artery blood gas analysis
Measured: At birth
Cardiologic assessment in newborns (Electrocardiogram)
Cardiologic assesment will be evaluated by the use of Electrocardiogram (PR, QRS, QTc intervals and ST segment changes).
Measured: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Cardiologic assesment in newborns (Echocardiography)
Cardiologic assesment will be evaluated by the use of echocardiography (will be examined cardiac anatomical assessment; functional evaluation with left ventricular diastolic function and systolic function (EF and FS); right ventricular function; global function (MPI), PFO, PDA, pulmonary artery pressure, cardiac output, and input)
Measured: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Neurological examination in newborns
Neurological evaluation will include cerebral ultrasound
Measured: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination)
Neurological examination according to the Hammersmith Neonatal Neurological Examination
Measured: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Physical growth in newborns (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: Performed at birth, three months, and twelve months of age.
Physical growth in newborns (head circumference in Cm)
It will be measured head circumference in centimeters
Measured: Performed at birth, three months, and twelve months of age.
Respiratory function in newborns
Performed pulmonary function tests and nitrogen washout.
Measured: Performed at birth, three months, and twelve months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Massetti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574386
- Sponsor's protocol ID
- 6487
- Acronym
- PURE-HEART
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term
- ClinicalTrials.gov ID
- NCT06574386
- Acronym / sponsor ID
- PURE-HEART / 6487
- Conditions
- Congenital Heart Disease, Pregnancy Related, Infant Development, IUGR, Fetal Growth Restriction
- Keywords
- GUCH, Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childhood neurodevelopment | Experimental | Diagnostic Test: Neurodevelopmental assessmentNewborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental assessmentNeurodevelopmental assessment | Diagnostic test | Childhood neurodevelopment |
Primary outcome
Neonatal outcomes in terms of weight and appropriate intrauterine development
Time frame: Assessment in the first, second and third trimester of pregnancy
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).
21 secondary outcomes
Physical examination of the mother (BMI)
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Systolic and diastolic blood pressure of the mother during pregnancy
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
NYHA class progression during pregnancy (NYHA functional class)
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assessment of the mother (Electrocardiogram):
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (Echocardiography)
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (24-hour Holter ECG)
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Cardiologic assesment of the mother (24-hour Holter BP)
Time frame: Assessment in the first, second and third trimester of pregnancy. Follow-up at 1 and 2 year from childbirth
Assessment of foetal growth and weight (Subcutaneous Adipose Thickness SCAT)
Time frame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Assessment of foetal oxygenation
Time frame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Numbers of obstetric and maternal complications
Time frame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Cardiological evaluation of the fetus
Time frame: Assessment in the first, second, third trimester of pregnancy, and at delivery. Follow-up at 1/2 years after delivery.
Physical examination in newborns
Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth
Newborn's health and vital signs
Time frame: At birth
Fetal metabolic condition
Time frame: At birth
Cardiologic assessment in newborns (Electrocardiogram)
Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Cardiologic assesment in newborns (Echocardiography)
Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Neurological examination in newborns
Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Neurodevelopmental assessment in newborns (Hammersmith Infant Neurological Examination)
Time frame: Performed at birth, three months, and twelve months of age. Follow-up at 1/2 years after birth.
Physical growth in newborns (BMI)
Time frame: Performed at birth, three months, and twelve months of age.
Physical growth in newborns (head circumference in Cm)
Time frame: Performed at birth, three months, and twelve months of age.
Respiratory function in newborns
Time frame: Performed at birth, three months, and twelve months of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Massetti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental assessment in people with Congenital Heart Disease and Pregnancy Related, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grandinetti Maria (+39 3478555745/ 0630154241, maria.grandinetti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal outcomes in terms of weight and appropriate intrauterine development (time frame: Assessment in the first, second and third trimester of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.