- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07635771
Development of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success. (MPM-PD)
Development of a Multidimensional Predictive Model of Dystocic Labor (MPM-PD): Pilot Study on the Association of Physical Condition and Psychosocial Factors With the Completion of Labor and the Success of Breastfeeding.
The goal of this observational study is to learn how a pregnant woman's physical fitness and emotional well-being can help predict the type of birth she will have (such as a natural vaginal birth versus a cesarean section or a birth requiring medical assistance). The study focuses on pregnant women in their third trimester (after 28 weeks of pregnancy).
The main questions the study aims to answer are:
- Can simple tests of physical strength and questions about emotions (like fear of childbirth) help health professionals predict if a birth might have complications or lack of progress?
- Do a woman's physical activity and confidence levels during pregnancy affect her ability to successfully breastfeed her baby for up to 6 months?
Participants will be asked to:
- Perform two simple physical tests during a clinic visit: a hand-grip test (dynamometry test) and a test to see how many times they can stand up from a chair in 30 seconds (Chair Stand Test, CST).
- Complete surveys about their daily physical activity (PPAQ-S), their feelings and fears regarding childbirth (WDEQ-A), and how confident they feel about handling the final stage of birth and the pushing phase (CBSEI-16).
- Answer brief follow-up phone calls one month and six months after the birth to talk about how breastfeeding is going.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aloma Antolí-Forner, Midwife (resident)
- Numéro de téléphone: 977519100
- E-mail: aantolif.ebre.ics@gencat.cat
Lieux d'étude
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Tarragona
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Tortosa, Tarragona, Espagne
- Recrutement
- Hospital de Tortosa Verge de la Cinta
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
The study population consists of pregnant women receiving prenatal care at the Hospital Universitari de Tortosa Verge de la Cinta (HUTVC).
The sample includes healthy volunteers in their third trimester of pregnancy (>28 weeks of gestation) with low-to-moderate obstetric risk. The population reflects a diverse group of expectant mothers who are able to perform simple physical functional tests and are interested in contributing to research on birth outcomes and breastfeeding. Participants are selected during their routine third-trimester prenatal visit at the HUTVC through non-probabilistic consecutive sampling until the required sample size of 420 participants is reached.
La description
Inclusion Criteria:
- Pregnant women aged 18 years or older
- Low-to-moderate risk pregnancy
- Singleton pregnancy
- Third trimester of pregnancy (>28 gestational weeks)
- Understanding of the official languages
- Acceptance and signing of the participant information sheet and informed consent form
- Availability of an electronic device to complete the forms
Exclusion Criteria:
- Medical contraindication for light physical activity
- Severe cardio-respiratory or musculoskeletal pathology
- Elective cesarean section
- Severe fetal malformations
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mode of birth
Délai: At the time of delivery.
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Classification of the birth outcome as either eutocic vaginal birth (spontaneous) or dystocic birth (including instrumental vaginal delivery or unplanned cesarean section).
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At the time of delivery.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Breastfeeding maintenance.
Délai: At 1 month and 6 months postpartum.
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Status of exclusive or partial breastfeeding.
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At 1 month and 6 months postpartum.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Duration of labor phases.
Délai: From the onset of dilation until birth.
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Time in minutes for the dilation and pushing stages of labor.
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From the onset of dilation until birth.
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Success of labor induction.
Délai: During the hospital stay for delivery.
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Proportion of induced labors that result in a vaginal birth.
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During the hospital stay for delivery.
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Prevalence of fear of childbirth (Tokophobia).
Délai: During the third trimester of pregnancy (baseline assessment).
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Score obtained through the Wijma Delivery Expectancy/Experience Questionnaire (WDEQ-A).
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During the third trimester of pregnancy (baseline assessment).
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Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Romero-Gallardo L, Roldan Reoyo O, Castro-Pinero J, May LE, Ocon-Hernandez O, Mottola MF, Aparicio VA, Soriano-Maldonado A. Assessment of physical fitness during pregnancy: validity and reliability of fitness tests, and relationship with maternal and neonatal health - a systematic review. BMJ Open Sport Exerc Med. 2022 Sep 23;8(3):e001318. doi: 10.1136/bmjsem-2022-001318. eCollection 2022.
- Erturk Celik G, Erturk Aksakal S, Engin Ustun Y. Impact of maternal muscle strength on cesarean delivery outcomes: a comparative study of nulliparous women. Turk J Med Sci. 2024 Jul 2;54(5):908-914. doi: 10.55730/1300-0144.5867. eCollection 2024.
- Oviedo-Caro MA, Bueno-Antequera J, Munguia-Izquierdo D. Transcultural adaptation and psychometric properties of Spanish version of Pregnancy Physical Activity Questionnaire: the PregnActive project. Gac Sanit. 2019 Jul-Aug;33(4):369-376. doi: 10.1016/j.gaceta.2017.12.004. Epub 2018 Mar 19.
- Cunqueiro MJ, Comeche MI, Docampo D. Childbirth Self-Efficacy Inventory: psychometric testing of the Spanish version. J Adv Nurs. 2009 Dec;65(12):2710-8. doi: 10.1111/j.1365-2648.2009.05161.x.
- Ortega-Cejas CM, Roldan-Merino J, Lluch-Canut T, Castrillo-Perez MI, Vicente-Hernandez MM, Jimenez-Barragan M, Biurrun-Garrido A, Farres-Tarafa M, Casas I, Cabrera-Jaime S. Reliability and validity study of the Spanish adaptation of the "Wijma Delivery Expectancy/Experience Questionnaire" (W-DEQ-A). PLoS One. 2021 Mar 19;16(3):e0248595. doi: 10.1371/journal.pone.0248595. eCollection 2021.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 034/2026
- FFPI26/BI01 (Autre subvention/numéro de financement: Fundació Doctor Ferran)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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