Obstetric Labor, Premature Clinical Trial
— SHsOfficial title:
Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico Universitario Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Sanitaria Aragón | Instituto de Salud Carlos III |
Spain,
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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