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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05670665
Other study ID # Superhearts Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 22, 2020
Est. completion date December 30, 2025

Study information

Verified date December 2022
Source Instituto de Investigación Sanitaria Aragón
Contact Cristina Paules, MD, PhD
Phone 650589500
Email cristinapaules@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about cardiac function and remodelling and metabolomic profiles in fetuses and infants who were exposed to a threatened preterm labor (TPL) during pregnancy.


Description:

The main questions it aims to answer are: - Evaluate the impact of threated preterm labour in cardiovascular and metabolic programming in fetal life and early infancy. - Describe prenatal and postnatal patterns of cardiac remodelling associated to threatened preterm labour. - Describe fetal growth patterns associated to threatened preterm labour. - Describe metabolomic profiles in umbilical cord blood associated to cardiovascular programming in fetuses exposed to threatened preterm labour. The study's main tasks are: - To perform an antenatal echocardiography of the exposed cohort is performed during the admission due to TPL or preterm spontaneous rupture of membranes (SRM). - All participants are asked to fill a diet and stress questionnaire. - To collect cord blood at the time of delivery. - To perform a postnatal echocardiography six months after birth. Researchers will compare fetuses and infants who were exposed to TPL to those who were not exposed to TPL during pregnancy to see if threre are any differences in cardiac function and remodelling.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Singleton pregnancies. - Study patients must be 18 years or older - Good understanding of Spanish Exclusion Criteria: - Multiple pregnancies - Major fetal defects or anomalies - Underlying process that can cause a preterm labour - Iatrogenic preterm labour

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Threatened preterm labor
Presence of uterine contractions and cervical shortening between 24+0 and 36+6 weeks of gestation and/or rupture of the membranes between 24+0 and 36+6 weeks of gestation.

Locations

Country Name City State
Spain Hospital Clinico Universitario Lozano Blesa Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Instituto de Investigación Sanitaria Aragón Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fetal cardiac sphericity index 2-D mode 24 - 36+6 weeks of gestation
Primary Fetal cardiac diameters Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode 24 - 36+6 weeks of gestation
Primary Fetal ventricular and atrial areas 2-D mode 24 - 36+6 weeks of gestation
Primary Fetal cardiac ejection fraction Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal cardiac ejection volume Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal cardiac filling and ejection time fractions Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal cardiac debit Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE) M-mode 24 - 36+6 weeks of gestation
Primary Fetal cardiac E/A ratios Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal cardiac isovolumetric relaxation time Pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal Doppler Measurement of umbilical artery pulsatility index (PI), medial cerebral artery PI and systolic peak (SP), ductus venosus PI, and mean uterine arteries PI using pulsed-Doppler 24 - 36+6 weeks of gestation
Primary Fetal growth Hadlock formula 24 - 36+6 weeks of gestation
Primary ProBNP, troponin and cystatin levels in cord blood Electrochemiluminescence immunoassay Third stage of labor
Primary Estimated left ventricular myocardial mass 2D echochardiography 6 months
Primary Left ventricular muscle index 2D echochardiography 6 months
Primary Left ventricular end-diastolic volume 2D echochardiography 6 months
Primary Left ventricular ejection fraction 2D echochardiography 6 months
Primary Infant global cardiac longitudinal strain rate Using echocardiography in order to measure myocardial function 6 months
Primary Infant cardiac strain rate imaging Using echocardiography in order to measure myocardial function 6 months
Secondary Adherence to Mediterranean diet Validated 14-item PREDIMED (Prevención con dieta mediterránea) questionnaire. Minimum value is 0. Maximum value is 14. We expect a better outcome the higher the score. 24 - 36+6 weeks of gestation
Secondary Maternal stress levels Perceived Stress Scale (PSS). Minimum score: 0. Maximum score: 40. We expect to find worse outcomes with higher scores. 24 - 36+6 weeks of gestation
Secondary Maternal anxiety levels State-Trait Anxiety Index (STAI). Minimum score: 20. Maximum score: 80. We expecto to find worse outcomes with higher scores. 24 - 36+6 weeks of gestation
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