Obstetric Labor, Premature
Conditions
Keywords
Threatened preterm labor, Prematurity, Cardiac remodelling, Cardiac function
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.
Interventions
OTHERThreatened 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.
Sponsors
Instituto de Salud Carlos III
Instituto de Investigación Sanitaria Aragón
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant cardiac strain rate imaging | 6 months | Using echocardiography in order to measure myocardial function |
| Left ventricular end-diastolic volume | 6 months | 2D echochardiography |
| Left ventricular ejection fraction | 6 months | 2D echochardiography |
| Infant global cardiac longitudinal strain rate | 6 months | Using echocardiography in order to measure myocardial function |
| Fetal cardiac isovolumetric relaxation time | 24 - 36+6 weeks of gestation | Pulsed-Doppler |
| ProBNP, troponin and cystatin levels in cord blood | Third stage of labor | Electrochemiluminescence immunoassay |
| Fetal ventricular and atrial areas | 24 - 36+6 weeks of gestation | 2-D mode |
| 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 cardiac sphericity index | 24 - 36+6 weeks of gestation | 2-D mode |
| Fetal cardiac diameters | 24 - 36+6 weeks of gestation | Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode |
| Fetal cardiac ejection fraction | 24 - 36+6 weeks of gestation | Pulsed-Doppler |
| 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 cardiac debit | 24 - 36+6 weeks of gestation | Pulsed-Doppler |
| Fetal growth | 24 - 36+6 weeks of gestation | Hadlock formula |
| Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE) | 24 - 36+6 weeks of gestation | M-mode |
| Fetal cardiac E/A ratios | 24 - 36+6 weeks of gestation | Pulsed-Doppler |
| Estimated left ventricular myocardial mass | 6 months | 2D echochardiography |
| Left ventricular muscle index | 6 months | 2D echochardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactCristina Paules, MD, PhD
Outcome results
None listed