Interventions for Geriatric Urinary Incontinence: The Effect of Intrapartum Interventions on Pelvic Floor Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,992
- 试验地点
- 2
- 主要终点
- Stress urinary incontence (SUI) occurrence at 6 weeks postpartum
研究概览
简要总结
This study is a prospective, multicenter, randomized controlled trial. Baseline data will be collected from eligible subjects recruited during the third trimester of pregnancy. Participants will be randomized into three groups when cervical dilation reaches 2 cm based on delivery position: lithotomy position, upright position, and lateral position. During the second stage of labor, data regarding delivery positions, duration of each position, and other obstetric conditions will be recorded. Pelvic floor function assessments will be performed in the postpartum period to evaluate the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 20 to 40 years.
- •Singleton, cephalic presentation, full-term primipara.
- •Absence of cephalopelvic disproportion.
- •Estimated fetal weight (EFW) < 4000 g.
- •Intended vaginal delivery and scheduled for postpartum follow-up at our hospital.
- •Voluntary participation with provision of informed consent.
排除标准
- •Moderate or severe stress urinary incontinence prior to pregnancy.
- •Pelvic Organ Prolapse Quantification (POP-Q) stage ≥ III, or a history of treatment for pelvic floor dysfunction.
- •Uncontrolled systemic medical diseases, or a history of asthma, allergic rhinitis, and constipation prior to pregnancy.
- •Presence of contraindications to vaginal delivery.
- •Presence of contraindications to the Valsalva maneuver (e.g., severe cardiopulmonary diseases, cervical incompetence, etc.).
- •Withdrawal Criteria:
- •The patient's clinical condition becomes unsuitable for continued study participation and follow-up.
- •The subject requests to withdraw from the study.
研究组 & 干预措施
Lithotomy Position Group
Participants in the lithotomy position group were in the lithotomy position at the second stage of labor of delivery
干预措施: Lithotomy position (Behavioral)
Upright Position Group
Participants in the upright position group were in the upright position at the second stage of labor of delivery.
干预措施: Upright Position (Behavioral)
Lateral Position.
Participants in the lateral position group were in the lateral position at the second stage of labor of delivery.
干预措施: Lateral Position (Behavioral)
结局指标
主要结局
Stress urinary incontence (SUI) occurrence at 6 weeks postpartum
时间窗: at 6 (±2) weeks postpartum
Stress urinary incontence (SUI) occurrence at 6 weeks postpartum
时间窗: at 6 (±1) weeks postpartum
次要结局
未报告次要终点
研究者
Gao lei
Attending Physician
Peking University People's Hospital