Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming

Conditions
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Obstetric Labor, Premature

Intervention / Treatment
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* Other: Threatened preterm labor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-exposed<br>Low-risk, singleton pregnancies. | |
| Exposed<br>Singleton pregnancies that are admitted to hospital due to threatened preterm labor or preterm premature rupture of membranes. | Other: Threatened preterm labor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal cardiac sphericity index | 2-D mode | 24 - 36+6 weeks of gestation | 
| Fetal cardiac diameters | Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode | 24 - 36+6 weeks of gestation | 
| Fetal ventricular and atrial areas | 2-D mode | 24 - 36+6 weeks of gestation | 
| Fetal cardiac ejection fraction | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| Fetal cardiac ejection volume | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| Fetal cardiac filling and ejection time fractions | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| Fetal cardiac debit | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE) | M-mode | 24 - 36+6 weeks of gestation | 
| Fetal cardiac E/A ratios | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| Fetal cardiac isovolumetric relaxation time | Pulsed-Doppler | 24 - 36+6 weeks of gestation | 
| 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 | 
| Fetal growth | Hadlock formula | 24 - 36+6 weeks of gestation | 
| ProBNP, troponin and cystatin levels in cord blood | Electrochemiluminescence immunoassay | Third stage of labor | 
| Estimated left ventricular myocardial mass | 2D echochardiography | 6 months | 
| Left ventricular muscle index | 2D echochardiography | 6 months | 
| Left ventricular end-diastolic volume | 2D echochardiography | 6 months | 
| Left ventricular ejection fraction | 2D echochardiography | 6 months | 
| Infant global cardiac longitudinal strain rate | Using echocardiography in order to measure myocardial function | 6 months | 
| Infant cardiac strain rate imaging | Using echocardiography in order to measure myocardial function | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Threatened preterm labor, Prematurity, Cardiac remodelling, Cardiac function