Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment (SKs)

Impact of Suspected Preterm Labour During Pregnancy on Cardiometabolic Profile and Neurodevelopment During Childhood: a Prospective Cohort Study Protocol.

Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years).

Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.

Study Overview

• Status: Completed
• Conditions: Preterm Labor

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Spain
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Cristina Paules

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Two cohorts of children at 6-8 years of age:

A. Exposed cohort: children whose mothers suffered a suspected preterm labour during pregnancy. They are subdivided into:

• Moderate-late preterm births (between 32 and 37 weeks of gestation)
• "False suspected preterm labour" (full-term births (> 37 weeks) after suffering a suspected preterm labour) B. Unexposed cohort: children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy.

Description

Inclusion Criteria:

• Singleton pregnancy
• Good understanding and sign of informed consent.

Exclusion Criteria:

• Multiple pregnancy
• Malformations
• Chromosomal diseases
• Prenatal infections

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
Exposed cohort: Children whose mothers suffered a suspected preterm labour during pregnancy.
Unexposed cohort; Children born at term (> 37 weeks) whose mothers did not suffer a suspected preterm labour during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of fat mass and total and regional lean mass		6-8 years
Body mass index and adiposity		6-8 years
Cardio-respiratory resistance	After fitting the safety harness, the test began when the participants were able to walk easily on the treadmill (Quasar Med 4.0, h/p/cosmos, Nußdorf, Germany). The protocol started with a speed of 2.4 km/h, increasing by 0.8 km/h every 2 min until the participants were unable to walk or reached a speed of 4.8 km/h. Then, the slope was increased by 4% every minute until exhaustion or up to a maximal slope of 24%. The respiratory gas exchange data were measured breath-by-breath using open-circuit spirometry (Oxycon Pro, Jaeger/Viasys Healthcare, Hoechberg, Germany). Maximal oxygen uptake (VO2max) values were averaged over consecutive 15 s periods.	6-8 years
Systolic and diastolic blood pressure		6-8 years
Left ventricle (LV) systolic and diastolic function	End-diastolic and end-systolic diameter, septum and posterior wall thickness, heart rate, ejection fraction (by Teicholz and biplane Simpson methods), mitral annulus S´ wave velocity (tissue doppler), mitral annulus E and A waves velocity (pulse-wave doppler), E´ and A´ waves velocity (tissue doppler), TEI index (tissue doppler) and LV strain and strain rate at three apical views (speckle tracking).	6-8 years
General intelligence index		6-8 years
Visual development test		6-8 years
Global index of problems		6-8 years
Index of emotional problems		6-8 years
Index of behavioral problems		6-8 years

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria Aragón
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Cristina Paules, IISAragon . Clini Hospital Zaragoza.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 8, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; preterm labor; prematurity; cardiovascular; metabolic; neurodevelopment
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: Superkids 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