Clinical trial NCT06986824: Perineal Massage Using A Pelvic Wand During Pregnancy
Official title: A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pregnancy Related
Pelvic Floor Disorders
Obstetric; Injury
Patient Empowerment
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized study with an intention-to-treat analysis with an intervention and control arm.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study Overview and Design This is a randomized controlled, single-center study to assess the effect of the Intimate RoseTM Pelvic Wand device (Figure 1) on the birth experience.

Methods Recruitment We will enroll eligible adult pregnant patients who plan to give birth at BIDMC.

Randomization After providing consent, we will randomize participants in a 1:1 ratio to the intervention or control arm.

Enrollment and Antepartum Period 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 avilable 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 begining at enrollment until their hospitilization for birth. This frequency and duration are what is recommended by pelvic floor physical therapists and is their standard of care.

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.

Participants will be told to call their primary obstetric provider if they experience any symptoms when using the device or doing manual massage.

Device Use on Labor \& Delivery The intervention arm will be asked to utilize the device every hour for at least 5 minutes. The participant will utilize the device until the second stage of labor (the onset of pushing), at which point the provider or bedside nurse can assist the participant in performing the perineal massage, which is the current standard of care on the BIDMC labor and delivery unit.

The control arm will perform perineal massage if they choose; there will be no research interaction with control arm participants on Labor and Delivery. We will give the device to the control arm participants after birth and before discharge in their postpartum room. As with the intervention group, they will be given the 2-minute video to demonstrate propoer use and cleaning, and they will be given an opportunity to ask questions.

Device Use During the Postpartum Period All participants will be asked to use the device at least three times weekly for 10 minutes after they receive clearance from their obstetric provider at their six-week postpartum visit. Study staff will call the participants to remind them on the instructions for use that were previously supplied. Participants will be asked to use the device until 12 weeks postpartum.

Participant Questionaries Participants will be asked to track their use of the device or manual massage and to complete the following questionnaires to assess their birth experience prior to hospital discharge and pelvic floor dysfunction and urinary dysfunction to be assessed at time of enrollment, 6 weeks postpartum, and 3 months postpartum.

* At enrollment and after consent: Pelvic Floor Distress Inventory 20 and Female Sexual Function Index
* During birth hospitalization: Labor Agentry Scale and Pelvic Floor Distress Inventory 20
* Six weeks postpartum: Pelvic Floor Distress Inventory 20
* 12 weeks postpartum: Labor Agentry Scale, Pelvic Floor Distress Inventory 20, Female Sexual Function Index

Eligibility criteria: 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).

Primary outcomes:
measure: Mean score difference between the two arms on the Labor Agentry Scale
timeFrame: During hospitalization (assessed up to 5 days)
Secondary outcomes:
measure: The average number of completed massage sessions prior to hospitalization
timeFrame: 6-8 weeks prior to birth event
measure: The average number of completed massage sessions during hospitalization
timeFrame: 24-48 hours
measure: The average number of completed massage sessions postpartum
timeFrame: 6 weeks post birth time point
measure: Number of patients with postpartum urinary symptoms
timeFrame: 12 weeks postpartum
measure: Number of patients with pelvic floor dysfunction in the postpartum period
timeFrame: 6 weeks postpartum and 12 week postpartum
measure: obstetric lacerations at time of delivery
timeFrame: During hospitalization (assessed up to 5 days)
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Sarah Little, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.