Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pelvic Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Perineal lesions are common during vaginal delivery: 52% of women giving birth in France experience perineal lesions and 20% an episiotomy. Obstetrical anal sphincter injuries (OASIS) are the most feared due to the risk of anal incontinence, but they concerned a minority of women (0.8%). For most of...
Perineal lesions are common during vaginal delivery: 52% of women giving birth in France experience perineal lesions and 20% an episiotomy. Obstetrical anal sphincter injuries (OASIS) are the most feared due to the risk of anal incontinence, but they concerned a minority of women (0.8%). For most of the women with simple lesions of the perineum, the primary consequence is pain. This moderate to severe perineal pain affects between 40% and 95% of women and peaks in intensity the day after childbirth. This pain might be disabling, impair the mobility, the establishment of breastfeeding, the mother-infant bond, alter the emotional state and overall might affect the quality of life of mothers. Thermotherapy provides a minimally invasive and inexpensive alternative to limit perineal pain in postpartum, thanks to the effects of local heating or cooling application to the perineum : Heat therapy with warm compresses, to protect the perineum during active second stage of labor and reduce the degree of perineal injury : the application promotes vasodilation and extensibility of tissues; Cryotherapy with instant cold pack, to prevent the onset of pain in the immediate postpartum period: the application limits the development of oedema or hematoma. Midwives frequently use thermotherapy with heat or cold. However, these practices cannot be recommended due to a lack of data. Moreover, the potentially synergic effect of consecutive application of heat and cold therapy into the perineum during active second stage of labor and immediate postpartum period has never been evaluated. We hypothesize that thermotherapy during childbirth may reduce postpartum perineal pain.
Tracking Information
- NCT #
- NCT04778631
- Collaborators
- Fondation Apicil
- PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris
- Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- Study Director: Anne CHANTRY, RM & PhD Assistance publique - Hôpitaux de Paris / INSERM