MedTrace Logo

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

NCT07764068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-13

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

Targeted 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

PROCEDURE

Standard 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

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-19
Primary Completion
2023-06-26
Completion
2025-09-01

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764068 on ClinicalTrials.gov