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

NCT07764068 | Completed DMC

• 2 other identifiers: MMC 0139-21202123917
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• incidence of pernieal trauma

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

  at the time of delivery

Secondary Outcomes (7)

• 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

• Postpartum perineal pain

  Approximately 3 months postpartum and 6 months postpartum

• Dyspareunia

  Approximately 3 months postpartum and 6 months postpartum

Study Arms (2)

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.

Procedure: Targeted Deep Pelvic Floor Muscle Physiotherapy

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. .

Procedure: Standard Antenatal Perineal Massage

Interventions

Targeted Deep Pelvic Floor Muscle Physiotherapy PROCEDURE

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

Targeted Deep Pelvic Floor Muscle Physiotherapy

Standard Antenatal Perineal Massage PROCEDURE

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

Standard Antenatal Perineal Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: September 19, 2021
• Primary Completion: June 26, 2023
• Study Completion: September 1, 2025
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)