ClinicalTrials.gg
RecruitingNCT07635771MPM-PDUpdated Jun 23, 2026

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

An observational study in Labor and Childbirth, Labor (Obstetrics)--Complications and Hand Strength, sponsored by Institut Investigacio Sanitaria Pere Virgili. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Primary conditionBreast FeedingRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Breast Feeding
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Breast Feeding.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Institut Investigacio Sanitaria Pere Virgili · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
420
Ages
18 Years and older
Sex
Female
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Study 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.
02

Conditions studied

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

Browse trials for

Keywords

  • Labor, Obstetric
  • Obstetric Labor Complications
  • Hand Strength
  • Dynamometry
  • Physical condition
  • Tocophobia
  • Self Efficacy
  • Breastfeeding
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In context

Breast Feeding Reclassified

1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.

This study's planned enrollment of 420 is above the median of 158 across 207 observational studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 39 studies on the registry; 18 are open to participants now.

Compared within Breast Feeding, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  • Availability of an electronic device to complete the forms

Exclusion criteria

Exclusion Criteria:

  • Medical for light physical activity
  • Severe cardio-respiratory or musculoskeletal pathology
  • Elective cesarean section
  • Severe fetal malformations
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
420 participants (estimated)
Patient registry
No
06

What researchers measure

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).

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 33740006 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's planned 12 months is below that.

Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2026
First posted
Jun 9, 2026
StartActual
Jun 10, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Dec 2027
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07635771
Lead sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Fundació Doctor Ferran, Hospital de Tortosa Verge de la Cinta
Responsible party
Aloma Antolí Forner (Midwife Resident, Institut Investigacio Sanitaria Pere Virgili) — Principal investigator
First posted
Jun 9, 2026
Start date
Jun 10, 2026
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Aloma Antolí-Forner, Midwife (resident)
Contact
aantolif.ebre.ics@gencat.cat
977519100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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