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NCT Number: NCT07635771

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital de Tortosa Verge de la Cinta

Tortosa, Tarragona, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Breastfeeding maintenance.

    Time frame: At 1 month and 6 months postpartum.

    Status of exclusive or partial breastfeeding.

Other outcomes

  1. Duration of labor phases.

    Time frame: From the onset of dilation until birth.

    Time in minutes for the dilation and pushing stages of labor.

  2. Success of labor induction.

    Time frame: During the hospital stay for delivery.

    Proportion of induced labors that result in a vaginal birth.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aloma Antolí-Forner, Midwife (resident)

CONTACT

[email protected]

977519100

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

  • Fundació Doctor Ferran
  • Hospital de Tortosa Verge de la Cinta

Registry information

Official study 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.

Acronym: MPM-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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