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Radiofrequency Technic's Impact on Perineal Postpartum Pain

Radiofrequency Technic's Impact on Perineal Postpartum Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03172286
Enrollment
62
Registered
2017-06-01
Start date
2017-04-10
Completion date
2018-12-31
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery; Injury

Brief summary

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.

Interventions

DEVICERadiofrequencer

Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Double blind study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score using analogical pain scale30 minutesPain score will be assessed before and after the radiofrequencing cession

Countries

France

Contacts

Primary ContactFlorence Bretelle, MD
frlorence.bretelle@ap-hm.fr+33491964525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026