Pregnancy RelatedPhase 4NCT06986824
Perineal Massage Using A Pelvic Wand During Pregnancy
A Phase 4 study testing Pelvic wand in people with Pregnancy Related and Pelvic Floor Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Pelvic Floor Disorders, Obstetric; Injury
- What is being tested?
- Pelvic wand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant
- Plan to give birth at BIDMC
- Age ≥18 years old
- English language preference
- 32-36 weeks 'gestation
Who cannot join
- Contraindication to vaginal birth, active genital herpes infection, fetal anomaly requiring cesarean birth).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethan Litman, MD contact
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
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.
Read the 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
- Being tested
- Pelvic wand
- Medical subject headings
- Pelvic Floor Disorders, Wounds and Injuries, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic wandDevice
Use of a pelvic wand to perform perineal massage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During hospitalization (assessed up to 5 days)
Secondary outcomes (6)
The average number of completed massage sessions prior to hospitalization
The average number of completed massage sessions measured by analyzing diary responses between enrollment and admission to the hospital for birth
Measured: 6-8 weeks prior to birth event
The average number of completed massage sessions during hospitalization
The average number of completed massage sessions measured by analyzing diary responses during birth hospitalization.
Measured: 24-48 hours
The average number of completed massage sessions postpartum
The average number of completed massage sessions measured by analyzing diary responses in the postpartum period
Measured: 6 weeks post birth time point
Number of patients with postpartum urinary symptoms
Number of patients with postpartum urinary symptoms based on survey responses.
Measured: 12 weeks postpartum
Number of patients with pelvic floor dysfunction in the postpartum period
Number of patients with pelvic floor dysfunction based on survey responses using the Pelvic Floor Distress Inventory 20 Questionnaire (PFDI-20) Female Sexual Function Index (FSFI)
Measured: 6 weeks postpartum and 12 week postpartum
obstetric lacerations at time of delivery
The number of patients with obstetric lacerations at time of delivery
Measured: During hospitalization (assessed up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Oct 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized study with an intention-to-treat analysis with an intervention and control arm.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Litman, Beth Israel Deaconess Medical Center
- Investigators
- Sarah Little, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986824
- Sponsor's protocol ID
- 2025P000062
- Status last verified
- Mar 2026
- First submitted
- 14 May 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: De-identified data may be shared on a case by case basis
Publications
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.
PubMed 10711565Aasheim 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.
PubMed 28608597Hodnett 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.
PubMed 3671777
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
- ClinicalTrials.gov ID
- NCT06986824
- Acronym / sponsor ID
- 2025P000062
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized study with an intention-to-treat analysis with an intervention and control arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Pelvic wandThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant
- Plan to give birth at BIDMC
- Age ≥18 years old
- English language preference
- 32-36 weeks 'gestation
Key exclusion criteria (1 listed)
- Contraindication to vaginal birth, active genital herpes infection, fetal anomaly requiring cesarean birth).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic wandUse of a pelvic wand to perform perineal massage | Device | Intervention |
Primary outcome
Mean score difference between the two arms on the Labor Agentry Scale
Time frame: During hospitalization (assessed up to 5 days)
A clinically significant difference is defined as a mean score difference of 10 points
6 secondary outcomes
The average number of completed massage sessions prior to hospitalization
Time frame: 6-8 weeks prior to birth event
The average number of completed massage sessions during hospitalization
Time frame: 24-48 hours
The average number of completed massage sessions postpartum
Time frame: 6 weeks post birth time point
Number of patients with postpartum urinary symptoms
Time frame: 12 weeks postpartum
Number of patients with pelvic floor dysfunction in the postpartum period
Time frame: 6 weeks postpartum and 12 week postpartum
obstetric lacerations at time of delivery
Time frame: During hospitalization (assessed up to 5 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 10711565Eason 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.
- Background: PubMed 28608597Aasheim 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.
- Background: PubMed 3671777Hodnett 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.
- Individual participant dataSharing planned: Undecided. De-identified data may be shared on a case by case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ethan Litman, MD contact
Sarah Little, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pelvic wand in people with Pregnancy Related and Pelvic Floor Disorders, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ethan Litman, MD (617-667-2636, elitman@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score difference between the two arms on the Labor Agentry Scale (time frame: During hospitalization (assessed up to 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986824, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.