Radiofrequency Technic's Impact on Perineal Postpartum Pain

NCT03172286 | Unknown

• 2 other identifiers: 2016-432016-A01499-42
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Delivery; Injury

Outcome Measures

Primary Outcomes (1)

• Pain score using analogical pain scale

  Pain score will be assessed before and after the radiofrequencing cession

  30 minutes

Study Arms (2)

Patient treated with fake radiofrequencer

ACTIVE COMPARATOR

Device: Radiofrequencer

Patient treated with radiofrequencer

EXPERIMENTAL

Device: Radiofrequencer

Interventions

Radiofrequencer DEVICE

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

Patient treated with fake radiofrequencer; Patient treated with radiofrequencer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who naturaly delivered with ou without instruments such as Suction cup, spatulas, forceps
• Patients presenting perineal lesions

You may not qualify if:

• Patients who delivered through cesarean section

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Masreille

Marseille, 13014, France

RECRUITING

Related Publications (1)

• Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.

  PMID: 32339169 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Florence Bretelle, MD

CONTACT

+33491964525; frlorence.bretelle@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind study

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: June 1, 2017
• Study Start: April 10, 2017
• Primary Completion: April 1, 2018
• Study Completion: December 31, 2018
• Last Updated: June 1, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)