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临床试验/NCT07764068
NCT07764068已完成不适用

Evaluation of the Effectiveness of Targeted Deep Pelvic Floor Muscle Physiotherapy Compared With Standard Antenatal Perineal Massage in Reducing the Rates of Cesarean Delivery, Operative Vaginal Delivery, and Vaginal Tears in Nulliparous Women.

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
incidence of pernieal trauma

研究概览

简要总结

This prospective randomized clinical trial evaluates whether targeted deep pelvic floor muscle physiotherapy is more effective than standard antenatal perineal massage in reducing perineal trauma among nulliparous women. The study compares the effects of these two antenatal interventions on the incidence of perineal trauma requiring suturing, including perineal tears and episiotomy, as well as other obstetric outcomes such as cesarean delivery, operative vaginal delivery, and the duration of the second stage of labor.

The study aims to determine whether targeted deep pelvic floor muscle physiotherapy reduces the incidence and severity of perineal trauma and improves obstetric outcomes compared with standard antenatal perineal massage.

Participants are randomly assigned to receive either targeted deep pelvic floor muscle physiotherapy or standard antenatal perineal massage beginning at 36 weeks of gestation. Obstetric outcomes are assessed at the time of delivery, and postpartum maternal outcomes are evaluated using standardized follow-up questionnaires at 3 and 6 months after childbirth.

详细描述

Perineal trauma is one of the most common complications of vaginal childbirth, occurring in up to 85% of vaginal deliveries.Perineal trauma may result in significant long-term maternal morbidity, including chronic pelvic pain, dyspareunia, urinary incontinence, fecal incontinence, and reduced quality of life. Postpartum dyspareunia remains a frequent complication after childbirth, with previous studies reporting persistent symptoms in a substantial proportion of women for up to 18 months after delivery. Obstetric interventions, including operative vaginal delivery and emergency cesarean delivery, have also been associated with an increased risk of long-term pelvic floor dysfunction and postpartum sexual pain.

The prevention of perineal trauma has therefore become an important objective in modern obstetric care. Numerous intrapartum interventions have been investigated, including warm compresses, maternal positioning, perineal support techniques, breathing exercises, lubricants, and perineal massage. Systematic reviews have demonstrated that some intrapartum interventions, particularly warm compresses and perineal massage during the second stage of labor, may reduce severe obstetric anal sphincter injuries (OASIS). Consequently, intrapartum perineal massage has been incorporated into routine clinical practice in many delivery units.

In contrast, evidence regarding antenatal perineal massage remains less convincing. Previous randomized studies and Cochrane reviews have reported little or no reduction in severe perineal tears following antenatal perineal massage, although modest reductions in episiotomy rates have been observed. These findings suggest that interventions directed exclusively at the superficial perineal tissues may not adequately address the biomechanical changes occurring during fetal descent through the birth canal.

Recent advances in pelvic floor imaging have improved understanding of the anatomical changes occurring during labor. Magnetic resonance imaging studies have demonstrated that fetal head descent is primarily associated with elongation and stretching of the deeper pelvic floor muscles, particularly the pubococcygeus and iliococcygeus muscles, while relatively little change occurs within the superficial components of the pelvic floor. Additional ultrasound studies have demonstrated associations between larger levator hiatus dimensions and more favorable labor outcomes, including shorter duration of the second stage of labor and lower rates of operative vaginal delivery. Furthermore, pelvic floor muscle physiotherapy has been shown to increase levator hiatus dimensions during Valsalva maneuver and improve pelvic floor muscle function in women with pelvic floor disorders. These findings provide the physiological rationale for targeting the deep pelvic floor musculature during pregnancy rather than focusing solely on superficial perineal tissues.

The central hypothesis of the present study is that targeted physiotherapy of the deep pelvic floor muscles before childbirth will improve tissue flexibility and neuromuscular function, facilitate fetal head descent during labor, shorten the second stage of labor, reduce operative vaginal delivery and cesarean delivery for arrest of descent, and ultimately decrease the incidence of perineal trauma compared with standard antenatal perineal massage.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy Nulliparous women planning to deliver at Meir Medical Center.
  • •Singleton pregnancy.
  • •Expected birth weight between 2,500 gr and 4,000 gr.
  • •Planned vaginal delivery.

排除标准

  • •Multiparous women.
  • •Non-vertex presentation (e.g., breech presentation).
  • •Multiple pregnancy.
  • •Suspected fetal macrosomia or fetal growth restriction (FGR/IUGR).
  • •Significant cervical dilatation or cervical shortening at enrollment.

研究组 & 干预措施

Targeted Deep Pelvic Floor Muscle Physiotherapy

Experimental

Participants received a standardized program of targeted deep pelvic floor muscle physiotherapy administered by an experienced pelvic floor physiotherapist between 36 to 40 weeks of pregnancy.

干预措施: Targeted Deep Pelvic Floor Muscle Physiotherapy (Procedure)

Standard Antenatal Perineal Massage

Active Comparator

Participants received a standardized program of perineal (superficial) physical therapy, administered by an experienced pelvic floor physiotherapist, between 36-40 weeks of pregnancy. .

干预措施: Standard Antenatal Perineal Massage (Procedure)

结局指标

主要结局

incidence of pernieal trauma

时间窗: at the time of delivery

perineal trauma according to sultan classification- first, second, third, forth degree perineal tears and episiotomy

次要结局

  • Postpartum perineal pain(Approximately 3 months postpartum and 6 months postpartum)
  • Urinary incontinence(Approximately 3 months postpartum and 6 months postpartum)
  • Fecal or flatal incontinence(Approximately 3 months postpartum and 6 months postpartum)
  • Duration of the second stage of labor(at the time of delivery)
  • Cesarean delivery due to arrest of descent(at the time of delivery)
  • Operative vaginal delivery(rate of operative vaginal delivery using forceps or vacuum extraction)
  • Dyspareunia(Approximately 3 months postpartum and 6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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