Perineal massage with a pelvic wand in late pregnancy
A Pilot Study To Assess The Effect Of Antepartum Perineal Massage Using A Pelvic Wand On Labor Agency And Pelvic Health
This study will try a pelvic wand for pregnant adults in late pregnancy to see if regular perineal massage changes how much control they feel during labor and birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06986824 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized 1:1 study at Beth Israel Deaconess Medical Center comparing a pelvic wand plus standardized instruction to usual verbal education about manual perineal massage. Participants randomized to the wand arm receive the Intimate Rose™ device, a short instructional video, and are asked to perform massage at least three times weekly for 10 minutes from enrollment until hospital admission for birth. The control arm receives standard verbal education and will be given the device after delivery. The study will measure how use of the device and antepartum massage affect participants' birth experience, particularly their sense of self-control, and will collect delivery and postpartum pelvic outcomes as secondary data.
Who should consider this trial
Good fit: Adults aged 18 or older who are pregnant at 32–36 weeks, prefer English, and plan to give birth at Beth Israel Deaconess Medical Center are eligible if they have no contraindication to vaginal birth.
Not a fit: Patients planning a scheduled cesarean, with contraindications to vaginal birth, active genital herpes, fetal anomalies requiring cesarean, or those unable or unwilling to perform regular antepartum massage are unlikely to benefit.
Why it matters
Potential benefit: If successful, using a pelvic wand could increase patients' sense of control during labor and may help reduce perineal trauma and postpartum pelvic symptoms.
How similar studies have performed: Previous clinician-directed and patient-directed perineal massage studies have shown inconsistent reductions in severe obstetric laceration, and a lack of standardized protocols means the device-based standardized approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Little, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Ethan Litman, MD
- Email: elitman@bidmc.harvard.edu
- Phone: 617-667-2636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.