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)

June 3, 2026 updated by: Aloma Antolí Forner, Institut Investigacio Sanitaria Pere Virgili

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of birth
Time Frame: At the time of delivery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding maintenance.
Time Frame: At 1 month and 6 months postpartum.
Status of exclusive or partial breastfeeding.
At 1 month and 6 months postpartum.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of labor phases.
Time Frame: From the onset of dilation until birth.
Time in minutes for the dilation and pushing stages of labor.
From the onset of dilation until birth.
Success of labor induction.
Time Frame: During the hospital stay for delivery.
Proportion of induced labors that result in a vaginal birth.
During the hospital stay for delivery.
Prevalence of fear of childbirth (Tokophobia).
Time Frame: During the third trimester of pregnancy (baseline assessment).
Score obtained through the Wijma Delivery Expectancy/Experience Questionnaire (WDEQ-A).
During the third trimester of pregnancy (baseline assessment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Collaborators

Hospital de Tortosa Verge de la Cinta
Fundació Doctor Ferran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 034/2026
  • FFPI26/BI01 (Other Grant/Funding Number: Fundació Doctor Ferran)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will not be shared. The informed consent approved for this observational study does not include provisions for sharing individual participant data with external researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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