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Perineal InjuryNCT07764068

Targeted Deep Pelvic Floor Muscle Physiotherapy Versus Antenatal Perineal Massage in Nulliparous Women

A study testing Targeted Deep Pelvic Floor Muscle Physiotherapy and Standard Antenatal Perineal Massage in people with Perineal Injury and Perineal Laceration, Tear, or Rupture During Delivery, run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Targeted Deep Pelvic Floor Muscle Physiotherapy and Standard Antenatal Perineal Massage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
19 Sep 2021to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Meir medical center

    Kfar Saba

Other trials in Israel

About this study

Official title: 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.

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.

Read the detailed description

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.

Being tested
Targeted Deep Pelvic Floor Muscle Physiotherapy, Standard Antenatal Perineal Massage
Keywords
PERINEAL TRAUMA, PELVIC FLOOR PHYSIOTHERAPY, ANTENATAL PERINEAL MASSAGE, PRIMIPAROUS, PERINEAL TEARS, EPISIOTOMY, SECOND STAGE OF DELIVRY, OPERATIVE DELIVERY
Medical subject headings
Lacerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted Deep Pelvic Floor Muscle PhysiotherapyProcedure or surgery

    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

  • Standard Antenatal Perineal MassageProcedure or surgery

    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

Study groups in NCT07764068
Study groupRoleWhat they receive
Targeted Deep Pelvic Floor Muscle PhysiotherapyExperimentalParticipants 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.
Receives: Procedure: Targeted Deep Pelvic Floor Muscle Physiotherapy
Standard Antenatal Perineal MassageActive comparatorParticipants received a standardized program of perineal (superficial) physical therapy, administered by an experienced pelvic floor physiotherapist, between 36-40 weeks of pregnancy. .
Receives: Procedure: Standard Antenatal Perineal Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of pernieal trauma

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

    Measured: at the time of delivery

Secondary outcomes (7)
  1. Duration of the second stage of labor

    Duration of the second stage of labor, measured from complete cervical dilatation to fetal delivery

    Measured: at the time of delivery

  2. Cesarean delivery due to arrest of descent

    Rate of cesarean delivery performed for arrest of fetal descent during labor.

    Measured: at the time of delivery

  3. Operative vaginal delivery

    at the time of delivery

    Measured: rate of operative vaginal delivery using forceps or vacuum extraction

  4. Postpartum perineal pain

    Perineal pain assessed using a Visual Analog Scale (VAS)

    Measured: Approximately 3 months postpartum and 6 months postpartum

  5. Dyspareunia

    Presence of dyspareunia assessed using the study follow-up questionnaire.

    Measured: Approximately 3 months postpartum and 6 months postpartum

  6. Urinary incontinence

    Presence of urinary incontinence assessed using the study follow-up questionnaire

    Measured: Approximately 3 months postpartum and 6 months postpartum

  7. Fecal or flatal incontinence

    Presence of fecal or flatal incontinence assessed using the study follow-up questionnaire.

    Measured: Approximately 3 months postpartum and 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start19 Sep 2021
  3. Primary completion26 Jun 2023
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07764068
Sponsor's protocol ID
MMC 0139-21
Other IDs
202123917
Status last verified
Aug 2026
First submitted
9 Aug 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Targeted Deep Pelvic Floor Muscle Physiotherapy and Standard Antenatal Perineal Massage in people with Perineal Injury and Perineal Laceration, Tear, or Rupture During Delivery, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of pernieal trauma (time frame: at the time of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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