UnknownNot Applicable

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

Spain200 participantsStarted 2020-06-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fetal cardiac sphericity index

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac diameters

Timeframe: 24 - 36+6 weeks of gestation

Fetal ventricular and atrial areas

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac ejection fraction

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac ejection volume

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac filling and ejection time fractions

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac debit

Timeframe: 24 - 36+6 weeks of gestation

Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)

Trial details

NCT IDNCT05670665

SponsorInstituto de Investigación Sanitaria Aragón

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-30

Contact for this trial

Cristina Paules, MD, PhD

650589500 cristinapaules@hotmail.com

View on ClinicalTrials.gov More Obstetric Labor, Premature trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fetal cardiac sphericity index

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac diameters

Timeframe: 24 - 36+6 weeks of gestation

Fetal ventricular and atrial areas

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac ejection fraction

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac ejection volume

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac filling and ejection time fractions

Timeframe: 24 - 36+6 weeks of gestation

Fetal cardiac debit

Timeframe: 24 - 36+6 weeks of gestation

Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)