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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18 years or older

Low-to-moderate risk pregnancy

Singleton pregnancy

Third trimester of pregnancy (>28 gestational weeks)

Disqualifiers

Medical contraindication for light physical activity

Severe cardio-respiratory or musculoskeletal pathology

Elective cesarean section

Severe fetal malformations

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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).

Time frame
At the time of delivery.

Secondary outcomes

1

Breastfeeding maintenance.

Status of exclusive or partial breastfeeding.

Time frame
At 1 month and 6 months postpartum.

Other outcomes

1

Duration of labor phases.

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

Time frame
From the onset of dilation until birth.
2

Success of labor induction.

Proportion of induced labors that result in a vaginal birth.

Time frame
During the hospital stay for delivery.
3

Prevalence of fear of childbirth (Tokophobia).

Score obtained through the Wijma Delivery Expectancy/Experience Questionnaire (WDEQ-A).

Time frame
During the third trimester of pregnancy (baseline assessment).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Investigacio Sanitaria Pere Virgili

Lead sponsor

Fundació Doctor Ferran

Collaborator

Hospital de Tortosa Verge de la Cinta

Collaborator