BridgeMD
Compares treatment options for Pelvic Pain
Official title Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
ClinicalTrials.gov ID: NCT06921174
What this study is testing
- What it's testing
- GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Women aged 18 years or older.
- Residing in the Region of Murcia.
- Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
- Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
- Have not received any prior treatment for this condition.
You likely can't join if
- Presence of severe conditions such as:
- Excessive postpartum hemorrhage
- Serious infections
- Respiratory or circulatory complications
- Neurological disorders requiring intensive medical intervention
- Currently under pharmacological treatment for pelvic pain.
See the full eligibility criteria
- Women aged 18 years or older.
- Residing in the Region of Murcia.
- Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
- Presenting postpartum perineal pain, coded in ICD-11 as GA34.01.
- Have not received any prior treatment for this condition.
- Presence of severe conditions such as:
- Excessive postpartum hemorrhage
- Serious infections
- Respiratory or circulatory complications
- Neurological disorders requiring intensive medical intervention
- Currently under pharmacological treatment for pelvic pain.
- Active vaginal infections.
- Expressed refusal to participate or inability to comply with study procedures.
- Women with episiotomy may participate only if there were no complications such as severe infection or hemorrhage following the procedure. Willingness to participate and to follow the study protocol. Exclusion Criteria...
The study team makes the final eligibility decision.
Where it's taking place
- Murcia, Murcia, Spain
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 Murcia, Murcia, Spain. 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.