Impact of threatened preterm labor on fetal heart and metabolism
Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming
This study looks at how threatened preterm labor affects the heart and metabolism of babies before and after birth to see if there are any differences compared to babies who weren't exposed to it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto de Investigación Sanitaria Aragón Academic / other |
| Locations | 1 site (Zaragoza) |
| Trial ID | NCT05670665 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how threatened preterm labor (TPL) affects cardiac function and metabolic profiles in fetuses and infants. Researchers will evaluate the cardiovascular and metabolic programming associated with TPL by performing antenatal echocardiography, collecting cord blood, and conducting postnatal echocardiography at six months. The study will compare outcomes between those exposed to TPL and those who were not, focusing on cardiac remodeling and growth patterns. Participants will also complete questionnaires regarding diet and stress.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 18 or older with singleton pregnancies who understand Spanish.
Not a fit: Patients with multiple pregnancies, major fetal defects, or those experiencing iatrogenic preterm labor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term cardiovascular health of infants exposed to threatened preterm labor.
How similar studies have performed: While there have been studies on preterm labor, this specific focus on cardiovascular and metabolic programming in fetuses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zaragoza
- Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: Cristina Paules — IIS Aragon, Hospital Clinico Universitario Lozano Blesa
- Study coordinator: Cristina Paules, MD, PhD
- Email: cristinapaules@hotmail.com
- Phone: 650589500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.