Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Pelvic Pain

Treatments: Device: Heat therapy; Device: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04778631

APHP210326

2020-A03399-30 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

Heat therapy

Experimental group

Description:

Local perineal heat therapy during active second stage of labor

Treatment:

Device: Heat therapy

Cryotherapy

Experimental group

Description:

Local perineal cryotherapy during the immediate postpartum period

Treatment:

Device: Cryotherapy

Active second stage usual car

No Intervention group

Description:

Standard obstetrical care and perineal protection during active second stage of labor

Postpartum usual care

No Intervention group

Description:

Standard immediate (\<2 hours) postpartum care