An observational study in Pelvic Floor Disorders, Urinary Incontinence and Perineal Trauma, sponsored by Universitat Internacional de Catalunya. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Universitat Internacional de Catalunya · Observational
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.
Childbirth represents a major biomechanical and physiological challenge for the maternal pelvic floor. During vaginal delivery, the pelvic floor muscles and connective tissues undergo substantial mechanical strain, which may result in perineal trauma and contribute to the development of pelvic floor disorders such as urinary incontinence, anal incontinence, pelvic organ prolapse, dyspareunia, and chronic pelvic pain during the postpartum period. Identifying modifiable factors that may influence childbirth outcomes is therefore essential for improving maternal health.
Recent biomechanical models of childbirth suggest that maternal musculoskeletal function may play a relevant role in the progression of labor and in the mechanical stress experienced by pelvic floor structures. Hip mobility, pelvic and lumbar movement, abdominal muscle activation, and pelvic floor muscle strength may influence pelvic biomechanics during labor, fetal descent, and the efficiency of maternal pushing efforts. However, the relationship between maternal musculoskeletal status during pregnancy and obstetric outcomes remains poorly understood.
The aim of this study is to analyze the association between maternal musculoskeletal factors of the hip, lumbopelvic, abdominal, and pelvic floor regions during late pregnancy and the characteristics of childbirth, as well as their potential impact on pelvic floor dysfunction during the postpartum period.
This study is designed as a prospective observational cohort study. Pregnant women will be recruited at 36 weeks of gestation from primary healthcare centers in Zaragoza (Spain). Participants will undergo three assessment time points: baseline evaluation at 36 weeks of gestation (T0), follow-up after childbirth to collect obstetric outcomes (T1), and a postpartum evaluation at 12 weeks after delivery (T2).
At baseline and postpartum follow-up, participants will undergo a comprehensive musculoskeletal assessment including hip range of motion and muscle length tests, lumbopelvic mobility and sacral inclination measurements, ultrasound assessment of abdominal muscles and inter-rectus distance, and pelvic floor evaluation including pelvic floor muscle strength, perineal body length, and transperineal ultrasound assessment of the puborectalis muscle. Self-reported questionnaires will also be used to assess lumbopelvic disability and pelvic floor-related symptoms.
Obstetric variables recorded after delivery will include mode of delivery, perineal trauma, obstetric interventions, labor characteristics, fetal weight, and maternal satisfaction with childbirth.
The primary obstetric outcome will be non-eutocic delivery, defined as instrumental delivery or cesarean section. The primary perineal outcome will be clinically significant perineal trauma, defined as episiotomy or spontaneous perineal tear of grade II or higher among women who experience vaginal delivery.
Statistical analyses will include descriptive statistics, bivariate comparisons between groups, and multivariable logistic regression models to evaluate the association between predefined musculoskeletal predictors and obstetric outcomes. Additional regression models will explore the relationship between prenatal musculoskeletal factors, childbirth characteristics, and pelvic floor dysfunction in the postpartum period.
The results of this study may contribute to identifying maternal musculoskeletal factors associated with childbirth outcomes and postpartum pelvic floor health, potentially supporting the development of preventive physiotherapy strategies during pregnancy.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 376 is above the median of 161 across 60 observational studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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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.
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Exclusion Criteria:
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: At childbirth
Mean Pelvic Floor Distress Inventory-20 (PFDI-20) Score
Pelvic floor dysfunction symptoms will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20), a validated questionnaire evaluating urinary, colorectal-anal, and pelvic organ prolapse symptoms. Scores range from 0 to 300, with higher scores indicating greater symptom severity and worse pelvic floor dysfunction.
Time frame: 12 weeks postpartum
Mean International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated questionnaire evaluating the frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity of urinary incontinence.
Time frame: 12 weeks postpartum
Mean Fecal Incontinence Quality of Life Scale (FIQL) Score
Anal incontinence-related quality of life will be assessed using the Fecal Incontinence Quality of Life Scale (FIQL), a validated questionnaire evaluating the impact of fecal incontinence on lifestyle, coping/behavior, depression/self-perception, and embarrassment. Scores range from 1 to 4, with higher scores indicating better quality of life and less impact of anal incontinence.
Time frame: 12 weeks postpartum
Mean Female Sexual Function Index (FSFI) Score
Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated questionnaire evaluating sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function.
Time frame: 12 weeks postpartum
Mean Pelvic Girdle Questionnaire (PGQ) Score
Lumbopelvic disability related to pelvic girdle pain will be assessed using the Pelvic Girdle Questionnaire (PGQ), a validated questionnaire measuring activity limitations and symptoms associated with pelvic girdle pain. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: 12 weeks postpartum
Mean Oswestry Disability Index (ODI) Score
Lumbopelvic disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring functional disability associated with low back pain. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: 12 weeks postpartum
No study locations are listed for this record.
Plan to share: Undecided — De-identified individual participant data underlying the results reported in publications derived from this study may be made available upon reasonable request to the principal investigator. Data sharing will be considered for researchers with a methodologically sound proposal and in accordance with institutional policies, ethical approval, and applicable data protection regulations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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