Perineal Massage Using A Pelvic Wand During Pregnancy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06986824
Phase
PHASE4
Status
Recruiting
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Conditions

  • Obstetric; Injury
  • Patient Empowerment
  • Pelvic Floor Disorders
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelvic wand — DEVICE
    Use of a pelvic wand to perform perineal massage

Study Details

There is limited research on the optimal strategy to reduce obstetric laceration, postpartum urinary retention, and postpartum pelvic pain. In systematic reviews, clinician-directed massage of the perineal muscles at the time of birth and patient directed massage of the perineal muscles in the third trimester to inconsistently reduce the incidence of severe obstetric laceration.1,2 However, there is significant heterogeneity of these studies is due in large part to the lack of a standardized protocols and unpredictability of clinician availability to perform perineal massage around the time of birth. The purpose of this study is to understand how perineal massage with a pelvic wand in late pregnancy and during labor influences one's sense of self-control over the labor process and birth experience.

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
Apr 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    The intervention arm will receive standard of care education about the benefits of perineal massage and receive instruction to perform the massage three times weekly. They will then watch a 2-minute video to demonstrate proper use and cleaning of the device to assist with antepartum perineal massage. Trained study personnel will also be available to answer questions on proper use, storage, and cleaning. Participants will be provided with the pelvic wand at enrollment and asked to use the device at least three times weekly for 10 minutes beginning at enrollment until their hospitalization for birth. This frequency and duration are what is recommended by pelvic floor physical therapists and is their standard of care.
  • No Intervention: Control
    The control arm will receive standard of care verbal education about the benefits of self-directed (or partner) manual perineal massage in the antepartum period and during the birthing process. They will be given the device after birth before hospital discharge.

Primary Outcome Measure

Mean score difference between the two arms on the Labor Agentry Scale [ Time Frame: During hospitalization (assessed up to 5 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-

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Beth Israel Deaconess Medical Center· Boston, MA

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