NCT03172286

Radiofrequency Technic's Impact on Perineal Postpartum Pain

Status unknown NA Last updated 1 June 2017

What this trial tests

NA trial testing Radiofrequencer in Delivery; Injury in 62 participants. Status unknown.

Timeline

10 April 2017

Primary endpoint
1 April 2018

31 December 2018

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	62
Start date	10 April 2017
Primary completion	1 April 2018
Estimated completion	31 December 2018
Sites	1 location across France

Drugs / interventions tested

• Radiofrequencer

Conditions studied

• Delivery; Injury — all drugs for Delivery; Injury →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, female only, with Delivery; Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study.
   Bretelle F, Fabre C, Golka M, Pauly V, et al · · 2020 · cited 16× · PMID 32339169 · DOI 10.1371/journal.pone.0231869