Development of a Multidimensional Predictive Model of Dystocic Labor. Association of Physical Condition and Psychosocial Factors With the Birth Process and Breastfeeding Success.

NCT07635771 | Not Yet Recruiting

• 2 other identifiers: 034/2026FFPI26/BI01
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Labor and Childbirth; Physical Conditioning, Human; Tocophobia; Self Efficacy; Hand Strength; Labor (Obstetrics)--Complications; Breastfeeding

Keywords

Labor, Obstetric; Obstetric Labor Complications; Hand Strength; Dynamometry; Physical condition; Tocophobia; Self Efficacy; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Mode of birth

  Classification of the birth outcome as either eutocic vaginal birth (spontaneous) or dystocic birth (including instrumental vaginal delivery or unplanned cesarean section).

  At the time of delivery.

Secondary Outcomes (1)

• Breastfeeding maintenance.

  At 1 month and 6 months postpartum.

Other Outcomes (3)

• Duration of labor phases.

  From the onset of dilation until birth.

• Success of labor induction.

  During the hospital stay for delivery.

• Prevalence of fear of childbirth (Tokophobia).

  During the third trimester of pregnancy (baseline assessment).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Medical contraindication for light physical activity
• Severe cardio-respiratory or musculoskeletal pathology
• Elective cesarean section
• Severe fetal malformations

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Fundació Doctor Ferran: collaborator
• Hospital de Tortosa Verge de la Cinta: collaborator

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Breast Feeding; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Behavior; Feeding Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Aloma Antolí-Forner, Midwife (resident)

CONTACT

977519100; aantolif.ebre.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife Resident

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share