Clinical trial NCT05670665: Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)
Official title: Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstetric Labor, Premature
Keywords: Threatened preterm labor
Prematurity
Cardiac remodelling
Cardiac function
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-01-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exposed cohort: women older than 18 years-old who have a singleton pregnancy and who are admitted to our unit due to TPL or preterm SRM are offered to participate in the study. Non-exposed cohort: women older than 18 years-old who have a singleton pregnancy and who attend our low-risk antenatal clinic are selected randomly and offered to participate.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fetal cardiac sphericity index
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac diameters
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal ventricular and atrial areas
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac ejection fraction
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac ejection volume
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac filling and ejection time fractions
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac debit
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac E/A ratios
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal cardiac isovolumetric relaxation time
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal Doppler
timeFrame: 24 - 36+6 weeks of gestation
measure: Fetal growth
timeFrame: 24 - 36+6 weeks of gestation
measure: ProBNP, troponin and cystatin levels in cord blood
timeFrame: Third stage of labor
measure: Estimated left ventricular myocardial mass
timeFrame: 6 months
measure: Left ventricular muscle index
timeFrame: 6 months
measure: Left ventricular end-diastolic volume
timeFrame: 6 months
measure: Left ventricular ejection fraction
timeFrame: 6 months
measure: Infant global cardiac longitudinal strain rate
timeFrame: 6 months
measure: Infant cardiac strain rate imaging
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to Mediterranean diet
timeFrame: 24 - 36+6 weeks of gestation
measure: Maternal stress levels
timeFrame: 24 - 36+6 weeks of gestation
measure: Maternal anxiety levels
timeFrame: 24 - 36+6 weeks of gestation
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
affiliation: IIS Aragon, Hospital Clinico Universitario Lozano Blesa
name: Cristina Paules
role: PRINCIPAL_INVESTIGATOR
References: