Informations générales (source: ClinicalTrials.gov)
Radiofrequency Technic's Impact on Perineal Postpartum Pain
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
avril 2017
décembre 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Masreille - 13014 - Marseille - France | Florence Bretelle, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Patients who naturaly delivered with ou without instruments such as Suction cup,
spatulas, forceps
- Patients presenting perineal lesions
- Patients who naturaly delivered with ou without instruments such as Suction cup,
spatulas, forceps
- Patients presenting perineal lesions
- Patients who delivered through cesarean section