Development of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Labor and Childbirth, Labor (Obstetrics)--Complications, Hand Strength, Physical Conditioning, Human. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Primary outcome measures
- Mode of birth [Time frame: At the time of delivery.]
Secondary outcome measures (1)
- Breastfeeding maintenance. [Time frame: At 1 month and 6 months postpartum.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital de Tortosa Verge de la Cinta — Tortosa
Publications
- 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. PMID 36172399
- 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. PMID 39473746
- 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. PMID 29566956
- 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. PMID 19941552
- 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. PMID 33740006
Identifiers
NCT: NCT07635771 · 034/2026 · FFPI26/BI01