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临床试验/NCT07478159
NCT07478159尚未招募不适用

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

Universitat Internacional de Catalunya0 个研究点目标入组 376 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
376
主要终点
Number of Participants with Non-Spontaneous Delivery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Number of Participants with Non-Spontaneous Delivery

时间窗: At childbirth

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

时间窗: At childbirth

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.

次要结局

  • 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)
  • Mean Oswestry Disability Index (ODI) Score(12 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pilar Pardos Aguilella

Assistant Professor of Physiotherapy, Faculty of Health Sciences, University of Zarago

Universitat Internacional de Catalunya

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