Maternal Musculoskeletal Factors of the Hip, Lumbopelvic, Abdominal and Pelvic Floor Regions and Their Association With Mode of Delivery and Postpartum Pelvic Floor Dysfunction

NCT07478159 | Not Yet Recruiting

• 1 other identifier: PI25/235
• Study Type: observational
• Target: 376
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational cohort study aims to investigate the association between maternal musculoskeletal factors of the hip, lumbopelvic, abdominal, and pelvic floor regions and childbirth outcomes, as well as their consequences on pelvic floor function during the postpartum period. A total of 376 pregnant women will be recruited at 36 weeks of gestation and followed until 12 weeks postpartum. Musculoskeletal assessments will include hip range of motion, lumbopelvic mobility, abdominal muscle function, and pelvic floor strength and morphology. Obstetric outcomes such as mode of delivery and perineal trauma will be recorded after childbirth. The study will analyze whether maternal musculoskeletal function during late pregnancy is associated with delivery mode and pelvic floor dysfunction in the postpartum period.

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Perineal Trauma; Pelvic Floor Dysfunction; Pregnancy; Puerperium

Keywords

Pelvic Floor Disorders; Obstetric Labor; Complications Perineal Trauma; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Non-Spontaneous Delivery

  Non-spontaneous delivery is defined as instrumental vaginal delivery (forceps, vacuum, or spatulas) or cesarean delivery performed during labor due to lack of progression or other obstetric indications. Vaginal delivery without instrumentation is classified as spontaneous vaginal delivery.

  At childbirth

• Number of Participants with Clinically Significant Perineal Trauma

  Clinically significant perineal trauma is defined as episiotomy or spontaneous perineal tear of grade II or higher according to the obstetric classification of perineal tears. This outcome will be assessed among women who undergo vaginal delivery.

  At childbirth

Secondary Outcomes (6)

• Mean Pelvic Floor Distress Inventory-20 (PFDI-20) Score

  12 weeks postpartum

• Mean International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score

  12 weeks postpartum

• Mean Fecal Incontinence Quality of Life Scale (FIQL) Score

  12 weeks postpartum

• Mean Female Sexual Function Index (FSFI) Score

  12 weeks postpartum

• Mean Pelvic Girdle Questionnaire (PGQ) Score

  12 weeks postpartum

Interventions

Maternal Musculoskeletal Assessment OTHER

Participants will undergo a comprehensive maternal musculoskeletal assessment during late pregnancy and postpartum follow-up. The evaluation will include measurements of hip range of motion and muscle length, lumbopelvic mobility and sacral inclination, lumbar spine mobility, ultrasound assessment of abdominal muscle thickness and inter-rectus distance, and pelvic floor evaluation including pelvic floor muscle strength, perineal body length, and transperineal ultrasound assessment of the puborectalis muscle. In addition, validated questionnaires will be used to assess lumbopelvic disability and pelvic floor-related symptoms. These assessments are performed for observational purposes only and no therapeutic intervention is assigned.

Also known as: Maternal musculoskeletal evaluation, Pelvic floor assessment, Lumbopelvic functional assessment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of pregnant women receiving prenatal care in primary healthcare centers of the Zaragoza II Health Sector (Zaragoza, Spain). Participants will be recruited during routine antenatal care visits at approximately 36 weeks of gestation. Women who meet the eligibility criteria and provide informed consent will undergo musculoskeletal assessment during late pregnancy and will be followed until 12 weeks postpartum.

You may qualify if:

• Pregnant women aged 18 years or older
• Singleton pregnancy
• Gestational age of 36 weeks at the time of the baseline assessment
• Receiving prenatal care in primary healthcare centers of Zaragoza (Spain)
• Ability to understand study procedures and provide written informed consent

You may not qualify if:

• Multiple pregnancy
• High-risk pregnancy conditions that may affect labor progression or maternal musculoskeletal assessment (e.g., severe obstetric complications requiring planned cesarean section)
• Previous pelvic floor surgery
• Neurological or musculoskeletal disorders affecting the lumbopelvic or pelvic floor region
• Inability to complete the assessment protocol or questionnaires

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pilar Pardos Agulella, PhD

CONTACT

690651998; ppardos@unizar.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy, Faculty of Health Sciences, University of Zarago

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03