ClinicalTrials.gg
CompletedNCT07764068Updated Aug 13, 2026

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

An interventional study of Targeted Deep Pelvic Floor Muscle Physiotherapy and Standard Antenatal Perineal Massage in Perineal Injury and Perineal Laceration, Tear, or Rupture During Delivery, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Sep 2021, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Perineal Injury
  • Perineal Laceration, Tear, or Rupture During Delivery

Browse trials for

Keywords

  • PERINEAL TRAUMA
  • PELVIC FLOOR PHYSIOTHERAPY
  • ANTENATAL PERINEAL MASSAGE
  • PRIMIPAROUS
  • PERINEAL TEARS
  • EPISIOTOMY
  • SECOND STAGE OF DELIVRY
  • OPERATIVE DELIVERY
03

In context

Lacerations

174 studies on the registry are indexed under Lacerations; 43 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 128 interventional studies indexed under Lacerations.

Browse Lacerations studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Targeted Deep Pelvic Floor Muscle Physiotherapy

    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.

    Procedure: Targeted Deep Pelvic Floor Muscle Physiotherapy

  • Active comparator
    Standard Antenatal Perineal Massage

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

    Procedure: Standard Antenatal Perineal Massage

Interventions

  • ProcedureTargeted Deep Pelvic Floor Muscle Physiotherapy

    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

  • ProcedureStandard Antenatal Perineal Massage

    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

06

What researchers measure

Primary outcomes

  1. incidence of pernieal trauma

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

    Time frame: at the time of delivery

Secondary outcomes

  1. Duration of the second stage of labor

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

    Time frame: 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.

    Time frame: at the time of delivery

  3. Operative vaginal delivery

    at the time of delivery

    Time frame: rate of operative vaginal delivery using forceps or vacuum extraction

  4. Postpartum perineal pain

    Perineal pain assessed using a Visual Analog Scale (VAS)

    Time frame: Approximately 3 months postpartum and 6 months postpartum

  5. Dyspareunia

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

    Time frame: Approximately 3 months postpartum and 6 months postpartum

  6. Urinary incontinence

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

    Time frame: 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.

    Time frame: Approximately 3 months postpartum and 6 months postpartum

07

Study locations

1 site
  • Meir medical center
    Kfar Saba, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Jun 2023, 21 months.

Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's 21 months is above that.

Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 13, 2026
StartActual
Sep 19, 2021
Primary completionActual
Jun 26, 2023
CompletionActual
Sep 1, 2025
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07764068
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Sep 19, 2021
Primary completion
Jun 26, 2023
Completion
Sep 1, 2025
Last update
Aug 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion