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

Instituto de Investigación Sanitaria Aragón

Status: Enrolling

Conditions: Obstetric Labor, Premature

Treatments: Other: Threatened preterm labor

Study type: Observational

Funder types: Other

Identifiers

NCT05670665

Superhearts Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Non-exposed

Description:

Low-risk, singleton pregnancies.

Exposed

Description:

Singleton pregnancies that are admitted to hospital due to threatened preterm labor or preterm premature rupture of membranes.

Treatment:

Other: Threatened preterm labor