Radiofrequency Technic's Impact on Perineal Postpartum Pain

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Delivery; Injury

Treatments: Device: Radiofrequencer

Study type: Interventional

Funder types: Other

Identifiers

NCT03172286

2016-43

2016-A01499-42 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Patient treated with fake radiofrequencer

Active Comparator group

Treatment:

Device: Radiofrequencer

Patient treated with radiofrequencer

Experimental group

Treatment:

Device: Radiofrequencer