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New treatment option for Postpartum Pelvic Floor Function and Symptoms
Official title Postpartum pElvic Assisted Recovery With Leva
ClinicalTrials.gov ID: NCT06609317
What this study is testing
- What it's testing
- The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device. In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Spontaneous vaginal delivery within the last 4-8 weeks
- Age ≥ 18 years
- Ambulatory
- Willing and able to consent to participate.
- English speaking
You likely can't join if
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
See the full eligibility criteria
- Spontaneous vaginal delivery within the last 4-8 weeks
- Age ≥ 18 years
- Ambulatory
- Willing and able to consent to participate.
- English speaking
- Owns a smartphone
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.