Meir medical center
Kfar Saba, Israel
NCT Number: NCT07764068
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Kfar Saba, Israel
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.
This is a prospective, randomized, parallel-group clinical trial conducted among nulliparous women planning vaginal delivery at Meir Medical Center. Eligible participants are recruited before 36 weeks' gestation and randomly assigned to one of two intervention groups.
The participants of the two interventional groups were randomly allocated into perineal massage (superficial muscles physical therapy) or pelvic floor (deep+ superficial muscles) physical therapy groups.
Each patient was scheduled to undergo three intervention sessions before delivery, scheduled at weeks 36, 38, and 39, unless labor developed earlier. In cases where delivery did not occur by week 40, additional treatment was administered to minimize the time gap between the last session and delivery. For women experiencing dyspareunia, additional treatment was provided at week 37 to address predicted heightened muscle tension and low soft tissue compliance.
All physiotherapy treatments and perineal massage (superficial muscles physical therapy) sessions were performed by the same experienced pelvic floor physiotherapist using a standardized treatment protocol, ensuring consistency throughout the study.
The perineal (superficial) physical therapy focuses on the superficial layer of the urogenital triangle and perineal area. Each procedure lasts about 15 minutes. The physical therapist performed a U-shaped perineal massage and bilateral myofascial release techniques for urogenital triangle muscles to release the perineal body.
The pelvic floor physical therapy: Each procedure lasted about 40 minutes. The pelvic floor physical therapy focused primarily on the deep muscle layer of the pelvic floor and sacrococcygeal mobility, in addition to the superficial layer of the urogenital triangle and perineal area. The physical therapist performed 15 minutes X 2 (on each side-lying position(, myofascial soft tissue mobilizations focused on the deep pelvic floor muscles: coccygeus, iliococcygeus, pubococcygeus, puborectalis, and obturator internus. In addition, mobilization of the coccyx (sacrococcygeal joint) was performed. Additionally, 10 minutes of U-shaped perineal massage and bilateral myofascial release techniques for urogenital triangle muscles to release the perineal body (similar to the perineal physical therapy group).
In the second phase of the study, a retrospective matching process was conducted using the hospital delivery database. The control group was selected from the birth registration records and aligned with study participants based on matching criteria, including the same day of delivery, the same week of birth, maternal age, BMI, and baby weight Each study participant was matched with two control cases
Data collection after birth : The data regarding the delivery was taken from the medical center "Camilion" system, including the mode of delivery, induction of labor, the duration of the second stage, epidural anesthesia, tears degree, episiotomy, and instrumental delivery.
Primary outcome measures:
Perineal trauma was categorized according to The Sultan classification of perineal trauma -including first-, second-, third-, and fourth-degree perineal tears and episiotomy.
Secondary outcomes include duration of the second stage of labor, cesarean delivery due to arrest of descent, operative vaginal delivery, postpartum perineal pain assessed using a visual analog scale (VAS), dyspareunia, return to sexual activity, urinary incontinence, and fecal or flatal incontinence. Postpartum follow-up assessments are performed at approximately three and six months after delivery using structured questionnaires.
This study is designed to determine whether a targeted physiotherapy program focusing on the deep pelvic floor muscles provides greater protection against perineal trauma and adverse obstetric outcomes than conventional antenatal perineal massage. The findings may contribute to the development of evidence-based antenatal strategies for the prevention of obstetric perineal injury in nulliparous women.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant was scheduled to undergo three intervention sessions before delivery, scheduled at weeks 36, 38, and 39, unless labor developed earlier. In cases where delivery did not occur by week 40, additional treatment was administered to minimize the time gap between the last session and delivery. For women experiencing dyspareunia, additional treatment was provided at week 37.
Each procedure lasted about 40 minutes. The pelvic floor physical therapy focused primarily on the deep muscle layer of the pelvic floor and sacrococcygeal mobility, in addition to the superficial layer of the urogenital triangle and perineal area
Each participant was scheduled to undergo three intervention sessions before delivery, scheduled at weeks 36, 38, and 39, unless labor developed earlier. In cases where delivery did not occur by week 40, additional treatment was administered to minimize the time gap between the last session and delivery. For women experiencing dyspareunia, additional treatment was provided at week 37. The perineal (superficial) physical therapy focuses on the superficial layer of the urogenital triangle and perineal area. Each procedure lasts about 15 minutes. The physical therapist performed a U-shaped perineal massage and bilateral myofascial release techniques for urogenital triangle muscles to release the perineal body
Time frame: at the time of delivery
perineal trauma according to sultan classification- first, second, third, forth degree perineal tears and episiotomy
Time frame: at the time of delivery
Duration of the second stage of labor, measured from complete cervical dilatation to fetal delivery
Time frame: at the time of delivery
Rate of cesarean delivery performed for arrest of fetal descent during labor.
Time frame: rate of operative vaginal delivery using forceps or vacuum extraction
at the time of delivery
Time frame: Approximately 3 months postpartum and 6 months postpartum
Perineal pain assessed using a Visual Analog Scale (VAS)
Time frame: Approximately 3 months postpartum and 6 months postpartum
Presence of dyspareunia assessed using the study follow-up questionnaire.
Time frame: Approximately 3 months postpartum and 6 months postpartum
Presence of urinary incontinence assessed using the study follow-up questionnaire
Time frame: Approximately 3 months postpartum and 6 months postpartum
Presence of fecal or flatal incontinence assessed using the study follow-up questionnaire.
Meir Medical Center
Other
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.
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