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

Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming

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.

Study Overview

• Status: Recruiting
• Conditions: Obstetric Labor, Premature
• Intervention / Treatment: Other: Threatened preterm labor

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Cristina Paules, Md, PhD; Phone Number: 650589500; Email: cristinapaules@hotmail.com

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa
    • Contact: Cristina Paules, Md, PhD; Phone Number: 650589500; Email: cristinapaules@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Mediterranean diet	Validated 14-item PREDIMED (Prevención con dieta mediterránea) questionnaire. Minimum value is 0. Maximum value is 14. We expect a better outcome the higher the score.	24 - 36+6 weeks of gestation
Maternal stress levels	Perceived Stress Scale (PSS). Minimum score: 0. Maximum score: 40. We expect to find worse outcomes with higher scores.	24 - 36+6 weeks of gestation
Maternal anxiety levels	State-Trait Anxiety Index (STAI). Minimum score: 20. Maximum score: 80. We expecto to find worse outcomes with higher scores.	24 - 36+6 weeks of gestation

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria Aragón
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Cristina Paules, IIS Aragon, Hospital Clinico Universitario Lozano Blesa

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: December 31, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 31, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac function; Prematurity; Threatened preterm labor; Cardiac remodelling
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature
• Other Study ID Numbers: Superhearts Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No