Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)
- Conditions
- Obstetric Labor, Premature
- Interventions
- Other: Threatened preterm labor
- Registration Number
- NCT05670665
- Lead Sponsor
- Instituto de Investigación Sanitaria Aragón
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Singleton pregnancies.
- Study patients must be 18 years or older
- Good understanding of Spanish
- Multiple pregnancies
- Major fetal defects or anomalies
- Underlying process that can cause a preterm labour
- Iatrogenic preterm labour
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed Threatened preterm labor Singleton pregnancies that are admitted to hospital due to threatened preterm labor or preterm premature rupture of membranes.
- Primary Outcome Measures
Name Time Method Fetal cardiac ejection fraction 24 - 36+6 weeks of gestation Pulsed-Doppler
Fetal cardiac E/A ratios 24 - 36+6 weeks of gestation Pulsed-Doppler
Infant global cardiac longitudinal strain rate 6 months Using echocardiography in order to measure myocardial function
Fetal cardiac sphericity index 24 - 36+6 weeks of gestation 2-D mode
Fetal cardiac debit 24 - 36+6 weeks of gestation Pulsed-Doppler
Left ventricular ejection fraction 6 months 2D echochardiography
ProBNP, troponin and cystatin levels in cord blood Third stage of labor Electrochemiluminescence immunoassay
Infant cardiac strain rate imaging 6 months Using echocardiography in order to measure myocardial function
Fetal cardiac diameters 24 - 36+6 weeks of gestation Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode
Fetal ventricular and atrial areas 24 - 36+6 weeks of gestation 2-D mode
Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE) 24 - 36+6 weeks of gestation M-mode
Fetal cardiac isovolumetric relaxation time 24 - 36+6 weeks of gestation Pulsed-Doppler
Estimated left ventricular myocardial mass 6 months 2D echochardiography
Left ventricular end-diastolic volume 6 months 2D echochardiography
Fetal cardiac ejection volume 24 - 36+6 weeks of gestation Pulsed-Doppler
Fetal cardiac filling and ejection time fractions 24 - 36+6 weeks of gestation Pulsed-Doppler
Fetal Doppler 24 - 36+6 weeks of gestation 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
Fetal growth 24 - 36+6 weeks of gestation Hadlock formula
Left ventricular muscle index 6 months 2D echochardiography
- Secondary Outcome Measures
Name Time Method Adherence to Mediterranean diet 24 - 36+6 weeks of gestation 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.
Maternal stress levels 24 - 36+6 weeks of gestation Perceived Stress Scale (PSS). Minimum score: 0. Maximum score: 40. We expect to find worse outcomes with higher scores.
Maternal anxiety levels 24 - 36+6 weeks of gestation State-Trait Anxiety Index (STAI). Minimum score: 20. Maximum score: 80. We expecto to find worse outcomes with higher scores.
Trial Locations
- Locations (1)
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain