Obstetric Labor, PrematureSHsNCT05670665
Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)
An observational study of Obstetric Labor, Premature, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor, Premature
- What is being tested?
- Threatened preterm labor
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2020to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Singleton pregnancies.
- Study patients must be 18 years or older
- Good understanding of Spanish
Who cannot join
- Multiple pregnancies
- Major fetal defects or anomalies
- Underlying process that can cause a preterm labour
- Iatrogenic preterm labour
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Cristina Paules, Md, PhD, 650589500, cristinapaules@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstetric Labor, Premature
- Being tested
- Threatened preterm labor
- Keywords
- Threatened preterm labor, Prematurity, Cardiac remodelling, Cardiac function
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threatened preterm laborOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Threatened preterm labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal cardiac sphericity index
2-D mode
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac diameters
Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode
Measured: 24 - 36+6 weeks of gestation
Fetal ventricular and atrial areas
2-D mode
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac ejection fraction
Pulsed-Doppler
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac ejection volume
Pulsed-Doppler
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac filling and ejection time fractions
Pulsed-Doppler
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac debit
Pulsed-Doppler
Measured: 24 - 36+6 weeks of gestation
Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)
M-mode
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac E/A ratios
Pulsed-Doppler
Measured: 24 - 36+6 weeks of gestation
Fetal cardiac isovolumetric relaxation time
Pulsed-Doppler
Measured: 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
Measured: 24 - 36+6 weeks of gestation
Fetal growth
Hadlock formula
Measured: 24 - 36+6 weeks of gestation
ProBNP, troponin and cystatin levels in cord blood
Electrochemiluminescence immunoassay
Measured: Third stage of labor
Estimated left ventricular myocardial mass
2D echochardiography
Measured: 6 months
Left ventricular muscle index
2D echochardiography
Measured: 6 months
Left ventricular end-diastolic volume
2D echochardiography
Measured: 6 months
Left ventricular ejection fraction
2D echochardiography
Measured: 6 months
Infant global cardiac longitudinal strain rate
Using echocardiography in order to measure myocardial function
Measured: 6 months
Infant cardiac strain rate imaging
Using echocardiography in order to measure myocardial function
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 - 36+6 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start22 Jun 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Cristina Paules, Instituto de Investigación Sanitaria Aragón
- Investigators
- Cristina Paules, Principal investigator, IIS Aragon, Hospital Clinico Universitario Lozano Blesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670665
- Sponsor's protocol ID
- Superhearts Study
- Acronym
- SHs
- Status last verified
- Dec 2022
- First submitted
- 3 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39581725
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming
- ClinicalTrials.gov ID
- NCT05670665
- Acronym / sponsor ID
- SHs / Superhearts Study
- Conditions
- Obstetric Labor, Premature
- Keywords
- Threatened preterm labor, Prematurity, Cardiac remodelling, Cardiac function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-exposed | – | –Low-risk, singleton pregnancies. |
| Exposed | – | Other: Threatened preterm laborSingleton pregnancies that are admitted to hospital due to threatened preterm labor or preterm premature rupture of membranes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Singleton pregnancies.
- Study patients must be 18 years or older
- Good understanding of Spanish
Key exclusion criteria (4 listed)
- Multiple pregnancies
- Major fetal defects or anomalies
- Underlying process that can cause a preterm labour
- Iatrogenic preterm labour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threatened preterm laborPresence 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. | Other | Exposed |
Primary outcome
Fetal cardiac sphericity index
Time frame: 24 - 36+6 weeks of gestation
2-D mode
Fetal cardiac diameters
Time frame: 24 - 36+6 weeks of gestation
Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode
Fetal ventricular and atrial areas
Time frame: 24 - 36+6 weeks of gestation
2-D mode
Fetal cardiac ejection fraction
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac ejection volume
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac filling and ejection time fractions
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac debit
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)
Time frame: 24 - 36+6 weeks of gestation
M-mode
Fetal cardiac E/A ratios
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac isovolumetric relaxation time
Time frame: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal Doppler
Time frame: 24 - 36+6 weeks of gestation
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
Fetal growth
Time frame: 24 - 36+6 weeks of gestation
Hadlock formula
ProBNP, troponin and cystatin levels in cord blood
Time frame: Third stage of labor
Electrochemiluminescence immunoassay
Estimated left ventricular myocardial mass
Time frame: 6 months
2D echochardiography
Left ventricular muscle index
Time frame: 6 months
2D echochardiography
Left ventricular end-diastolic volume
Time frame: 6 months
2D echochardiography
Left ventricular ejection fraction
Time frame: 6 months
2D echochardiography
Infant global cardiac longitudinal strain rate
Time frame: 6 months
Using echocardiography in order to measure myocardial function
Infant cardiac strain rate imaging
Time frame: 6 months
Using echocardiography in order to measure myocardial function
3 secondary outcomes
Adherence to Mediterranean diet
Time frame: 24 - 36+6 weeks of gestation
Maternal stress levels
Time frame: 24 - 36+6 weeks of gestation
Maternal anxiety levels
Time frame: 24 - 36+6 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 39581725Abadia-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.
Related trials for Obstetric Labor, Premature
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Paules principal investigator
IIS Aragon, Hospital Clinico Universitario Lozano Blesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Labor, Premature, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Paules, MD, PhD (650589500, cristinapaules@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal cardiac sphericity index (time frame: 24 - 36+6 weeks of gestation). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.