Recruiting

Perineal Massage

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06986824

Conditions

Pregnancy Related

Pelvic Floor Disorders

Obstetric; Injury

Patient Empowerment

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic wand

Study Details

Brief summary:

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.

Conditions

Pregnancy Related

Pelvic Floor Disorders

Obstetric; Injury

Patient Empowerment

Study ID

NCT06986824

Start date

Oct 1, 2025

Status verified date

Mar, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant
  • Plan to give birth at BIDMC
  • Age ≥18 years old
  • English language preference
  • 32-36 weeks 'gestation

Exclusion Criteria:

  • Contraindication to vaginal birth, active genital herpes infection, fetal anomaly requiring cesarean birth).

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Pelvic wand

Use of a pelvic wand to perform perineal massage

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 and Locations

Central contacts

Ethan Litman, MD

617-667-2636elitman@bidmc.harvard.edu

Ethan Litman, MD

617-667-2636

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-09.