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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
The main questions it aims to answer are:
The study's main tasks are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Only pregnant women are elegible for this study
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Paules, MD, PhD | Contact | 650589500 | cristinapaules@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Paules | IIS Aragon, Hospital Clinico Universitario Lozano Blesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39581725 | Derived | 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. |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Whole blood from umbilical cord
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 |
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 |