Radiofrequency Technic's Impact on Perineal Postpartum Pain

Study Overview
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Brief Summary
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A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery. Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers. The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions. A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital. Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study. Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency. The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months. The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.

Official Title
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Radiofrequency Technic's Impact on Perineal Postpartum Pain

Conditions
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Delivery; Injury

Intervention / Treatment
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* Device: Radiofrequencer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps Patients presenting perineal lesions Exclusion Criteria: Patients who delivered through cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient treated with fake radiofrequencer<br> | Device: Radiofrequencer<br>* Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization<br>|
| Experimental: Patient treated with radiofrequencer<br> | Device: Radiofrequencer<br>* Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score using analogical pain scale | Pain score will be assessed before and after the radiofrequencing cession | 30 minutes |