Clinical trial NCT04778631: Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)
Official title: Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Keywords: perineum
pelvic pain
acute pain
pain management
delivery
obstetric
labor stage
second
analgesia
obstetrical
postnatal care
heat therapy
cryotherapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2021-03-03
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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 (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.

Eligibility criteria: Inclusion Criteria:

* Primiparous women or multiparous women without history of vaginal birth
* singleton fetus
* fetal cephalic presentation
* ≥37 gestational weeks
* active labor (cervical dilatation ≥ 6 cm)
* living fetus
* major female Exclusion Criteria
* Abnormal fetal heart rate requiring hastening childbirth
* Fetal malformation, stillbirth
* History of female genital mutilation
* Women not understanding French
* Women with psychiatric condition
* Anonymous childbirth
* Minor female
* No affiliation to a social security scheme (beneficiary or assignee)

Primary outcomes:
measure: Change of perineal pain assessed by the VAS (<H24)
timeFrame: From 2 to 24 hours after delivery
Secondary outcomes:
measure: Rate of perineal laceration
timeFrame: 2 hours after delivery
measure: Rate of episiotomy
timeFrame: 2 hours after delivery
measure: Perineal healing assessed by the REEDA scale
timeFrame: 3 days after delivery
measure: Change of perineal pain assessed by the VAS (<H96)
timeFrame: From delivery to 3 days after delivery
measure: Consumptions of pain relief medications
timeFrame: 3 days after delivery
measure: Pain interference on daily functioning assessed by the BPI-SF
timeFrame: 2 months after delivery
measure: Perineal complication
timeFrame: At two months postpartum
measure: Childbirth experience assessed by the QACE
timeFrame: 3 days postpartum
measure: Rate of exclusive breastfeeding
timeFrame: At 3 days after delivery
measure: Rate of exclusive breastfeeding
timeFrame: At 2 months after delivery
measure: Rate of breastfeeding complications
timeFrame: At 2 months after delivery
measure: Urinary incontinence assessed with the ICIQ-UI SF
timeFrame: At 2 months after delivery
measure: Anal incontinence assessed with the Wexner Score
timeFrame: At 2 months after delivery
measure: Sexual function assessed with the FSFI
timeFrame: At 2 months after delivery
measure: Rate of postpartum depression assessed by the EPDS
timeFrame: At 2 months after delivery
Other outcomes:
Locations:
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance publique - Hôpitaux de Paris / INSERM
name: Anne CHANTRY, RM & PhD
role: STUDY_DIRECTOR
References: