The Effect of a Pelvic Floor Training Program on Perineal Trauma During Birth: A Patient-Preference Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of Severe Perineal Trauma (Grade 3-4)
研究概览
简要总结
This study aims to determine whether a structured pelvic floor muscle training program during pregnancy can reduce perineal trauma during vaginal birth. Nulliparous pregnant women at 28 weeks of gestation or later were invited to participate. Women who chose to join the training program performed supervised pelvic floor exercises twice weekly and daily home exercises. Women who declined the program received standard antenatal care.
The study compared rates of severe perineal tears (third- or fourth-degree lacerations), episiotomy, the duration of the second stage of labor, postpartum urinary incontinence, and neonatal outcomes between the two groups. The goal of the study is to evaluate whether pelvic floor training can improve maternal and neonatal birth outcomes.
详细描述
This prospective, patient-preference controlled clinical trial was conducted to evaluate whether a structured antenatal pelvic floor muscle training (PFMT) program can reduce perineal trauma and improve maternal birth outcomes. Low-risk nulliparous pregnant women at 28 weeks of gestation or later were invited to participate. Women who chose to participate in the training program formed the intervention group, while those who declined received standard antenatal care and served as controls.
The intervention consisted of supervised PFMT sessions twice weekly, combined with a daily home-exercise program. Exercises followed a standardized protocol focusing on repeated maximal voluntary pelvic floor contractions with progressive increases in intensity. Adherence was monitored through attendance records and weekly follow-up.
The study assessed severe perineal trauma (third- or fourth-degree tears) as the primary outcome. Secondary outcomes included episiotomy rate, duration of the second stage of labor, postpartum urinary incontinence, and neonatal outcomes. All participants provided written informed consent, and the study was approved by the institutional ethics committee. The findings aim to inform whether structured PFMT should be incorporated into routine antenatal care to support maternal pelvic floor health and improve labor outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors who evaluated perineal trauma and neonatal outcomes were blinded to the participants' group assignments. All other study personnel and participants were aware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous pregnant women aged 18 to 36 years
- •Singleton pregnancy
- •Gestational age of 28 weeks or greater at enrollment
- •Low-risk pregnancy without known obstetric complications
- •Planning a vaginal delivery
- •Able and willing to participate in supervised exercise sessions
排除标准
- •Multiple gestation
- •Placenta previa or other contraindications to vaginal birth
- •Preeclampsia or gestational hypertension
- •Diabetes requiring medication
- •History of pelvic floor or urogenital surgery
- •Neurological disorders affecting continence or pelvic floor function
- •Inability to attend regular training sessions
- •Refusal to provide informed consent
结局指标
主要结局
Incidence of Severe Perineal Trauma (Grade 3-4)
时间窗: At delivery
Severe perineal trauma is defined as third- or fourth-degree obstetric anal sphincter injuries (OASIS). Diagnosis is made by the attending clinician immediately after delivery using standard perineal examination and classification procedures.
次要结局
未报告次要终点
研究者
Mehmet Incebıyik
Assistant Professor of Obstetrics and Gynecology
Harran University