Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778631
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2021-01-24
Brief Title:
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain PERISAFE
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain a Multicenter Factorial Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERISAFE
Brief Summary:
Perineal pain is common after vaginal birth Thermotherapy might be effective to limit postpartum perineal pain thanks to the effects of local heating or cooling application This study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain
Detailed 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 08 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A03399-30 | OTHER | ID-RCB Number | None |