Radiofrequency Technic's Impact on Perineal Postpartum Pain
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Marseille, Frankrig, 13014
- Rekruttering
- Assistance Publique Hôpitaux de Masreille
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Kontakt:
- Florence Bretelle, MD
- Telefonnummer: +33491964525
- E-mail: florence.bretelle@ap-hm.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Patient treated with fake radiofrequencer
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Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization
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Eksperimentel: Patient treated with radiofrequencer
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Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain score using analogical pain scale
Tidsramme: 30 minutes
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Pain score will be assessed before and after the radiofrequencing cession
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30 minutes
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2016-43
- 2016-A01499-42 (Anden identifikator: IDRCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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