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

NCT05670665 | Unknown

• 1 other identifier: Superhearts Study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor, Premature

Keywords

Threatened preterm labor; Prematurity; Cardiac remodelling; Cardiac function

Outcome Measures

Primary Outcomes (19)

• Fetal cardiac sphericity index

  2-D mode

  24 - 36+6 weeks of gestation

• Fetal cardiac diameters

  Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode

  24 - 36+6 weeks of gestation

• Fetal ventricular and atrial areas

  2-D mode

  24 - 36+6 weeks of gestation

• Fetal cardiac ejection fraction

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

• Fetal cardiac ejection volume

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

• Fetal cardiac filling and ejection time fractions

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

• Fetal cardiac debit

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

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

  M-mode

  24 - 36+6 weeks of gestation

• Fetal cardiac E/A ratios

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

• Fetal cardiac isovolumetric relaxation time

  Pulsed-Doppler

  24 - 36+6 weeks of gestation

• Fetal Doppler

  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

  24 - 36+6 weeks of gestation

• Fetal growth

  Hadlock formula

  24 - 36+6 weeks of gestation

• ProBNP, troponin and cystatin levels in cord blood

  Electrochemiluminescence immunoassay

  Third stage of labor

• Estimated left ventricular myocardial mass

  2D echochardiography

  6 months

• Left ventricular muscle index

  2D echochardiography

  6 months

• Left ventricular end-diastolic volume

  2D echochardiography

  6 months

• Left ventricular ejection fraction

  2D echochardiography

  6 months

• Infant global cardiac longitudinal strain rate

  Using echocardiography in order to measure myocardial function

  6 months

• Infant cardiac strain rate imaging

  Using echocardiography in order to measure myocardial function

  6 months

Secondary Outcomes (3)

• Adherence to Mediterranean diet

  24 - 36+6 weeks of gestation

• Maternal stress levels

  24 - 36+6 weeks of gestation

• Maternal anxiety levels

  24 - 36+6 weeks of gestation

Study Arms (2)

Non-exposed

Low-risk, singleton pregnancies.

Exposed

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

Other: Threatened preterm labor

Interventions

Threatened preterm labor OTHER

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.

Exposed

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women are elegible for this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Singleton pregnancies.
• Study patients must be 18 years or older
• Good understanding of Spanish

You may not qualify if:

• Multiple pregnancies
• Major fetal defects or anomalies
• Underlying process that can cause a preterm labour
• Iatrogenic preterm labour

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Related Publications (1)

• Abadia-Cuchi N, Clavero-Adell M, Gonzalez J, Medel-Martinez A, Fabre M, Ayerza-Casas A, Youssef L, Lerma-Irureta J, Maestro-Quibus P, Rodriguez-Calvo J, Ruiz-Martinez S, Lerma D, Schoolermer J, Oros D, Paules C. Impact of suspected preterm labour in foetal cardiovascular and metabolic programming: a prospective cohort study protocol. BMJ Open. 2024 Nov 24;14(11):e087430. doi: 10.1136/bmjopen-2024-087430.

  PMID: 39581725 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood from umbilical cord

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Cristina Paules

  IIS Aragon, Hospital Clinico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Paules, MD, PhD

CONTACT

650589500; cristinapaules@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: January 4, 2023
• Study Start: June 22, 2020
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

ES (1)