Labor and ChildbirthMPM-PDNCT07635771
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 of Labor and Childbirth and Labor (Obstetrics)--Complications, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor and Childbirth, Labor (Obstetrics)--Complications, Hand Strength
- How many people
- 420 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Medical contraindication for light physical activity
- Severe cardio-respiratory or musculoskeletal pathology
- Elective cesarean section
- Severe fetal malformations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Tortosa Verge de la Cinta
Tortosa, Tarragona
About this study
Official 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.
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:
Read more
- 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, Labor (Obstetrics)--Complications, Hand Strength, Physical Conditioning, Human, Tocophobia, Self Efficacy
- Keywords
- Labor, Obstetric, Obstetric Labor Complications, Hand Strength, Dynamometry, Physical condition, Tocophobia, Self Efficacy, Breastfeeding
- Medical subject headings
- Motor Activity, Breast Feeding, Obstetric Labor Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the time of delivery.
Secondary outcomes (1)
Breastfeeding maintenance.
Status of exclusive or partial breastfeeding.
Measured: At 1 month and 6 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start10 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Labor and ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Doctor Ferran, Hospital de Tortosa Verge de la Cinta
- Responsible party
- Principal investigator, Aloma Antolí Forner, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635771
- Sponsor's protocol ID
- 034/2026
- Other IDs
- FFPI26/BI01
- Acronym
- MPM-PD
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36172399Erturk 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 39473746Oviedo-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 29566956Cunqueiro 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 19941552Ortega-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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07635771
- Acronym / sponsor ID
- MPM-PD / 034/2026
- Conditions
- Labor and Childbirth, Labor (Obstetrics)--Complications, Hand Strength, Physical Conditioning, Human, Tocophobia, Self Efficacy
- Keywords
- Labor, Obstetric, Obstetric Labor Complications, Hand Strength, Dynamometry, Physical condition, Tocophobia, Self Efficacy, Breastfeeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Fundació Doctor Ferran, Hospital de Tortosa Verge de la Cinta
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Medical contraindication for light physical activity
- Severe cardio-respiratory or musculoskeletal pathology
- Elective cesarean section
- Severe fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Breastfeeding maintenance.
Time frame: At 1 month and 6 months postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 36172399Romero-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.
- Background: PubMed 39473746Erturk 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.
- Background: PubMed 29566956Oviedo-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.
- Background: PubMed 19941552Cunqueiro 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.
- Background: PubMed 33740006Ortega-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor and Childbirth and Labor (Obstetrics)--Complications, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aloma Antolí-Forner, Midwife (resident) (977519100, aantolif.ebre.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of birth (time frame: At the time of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635771, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.