NCT06986824 Perineal Massage Using A Pelvic Wand During Pregnancy
| NCT ID | NCT06986824 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-10-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Sarah Little, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06986824 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06986824 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06986824 currently recruiting?
Yes, NCT06986824 is actively recruiting participants. Contact the research team at elitman@bidmc.harvard.edu for enrollment information.
Where is the NCT06986824 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06986824 clinical trial?
NCT06986824 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Sarah Little, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 140 participants.