About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Maternal Musculoskeletal Assessment
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
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