Perineal Massage Using A Pelvic Wand During Pregnancy

NCT06986824 | Recruiting Phase 4 FDA Device

• 1 other identifier: 2025P000062
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean score difference between the two arms on the Labor Agentry Scale

  A clinically significant difference is defined as a mean score difference of 10 points

  During hospitalization (assessed up to 5 days)

Secondary Outcomes (6)

• The average number of completed massage sessions prior to hospitalization

  6-8 weeks prior to birth event

• The average number of completed massage sessions during hospitalization

  24-48 hours

• The average number of completed massage sessions postpartum

  6 weeks post birth time point

• Number of patients with postpartum urinary symptoms

  12 weeks postpartum

• Number of patients with pelvic floor dysfunction in the postpartum period

  6 weeks postpartum and 12 week postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: Pelvic wand

Control

NO INTERVENTION

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 DEVICE

Use of a pelvic wand to perform perineal massage

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• Eason E, Labrecque M, Wells G, Feldman P. Preventing perineal trauma during childbirth: a systematic review. Obstet Gynecol. 2000 Mar;95(3):464-71. doi: 10.1016/s0029-7844(99)00560-8.

  PMID: 10711565 BACKGROUND

• Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.

  PMID: 28608597 BACKGROUND

• Hodnett ED, Simmons-Tropea DA. The Labour Agentry Scale: psychometric properties of an instrument measuring control during childbirth. Res Nurs Health. 1987 Oct;10(5):301-10. doi: 10.1002/nur.4770100503.

  PMID: 3671777 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Wounds and Injuries; Patient Participation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sarah Little, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethan Litman, MD

CONTACT

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

Ethan Litman, MD

CONTACT

617-667-2636

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Obstetrics, Gynecology and Reproductive Biology

Model Details: This is a randomized study with an intention-to-treat analysis with an intervention and control arm.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 23, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)