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

NCT ID: NCT04778631

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2024-02-04

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.

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Heat therapy

Local perineal heat therapy during active second stage of labor

Group Type: EXPERIMENTAL

Heat therapy

Intervention Type: DEVICE

Application of warm compresses, soaked in hot tap water (between 38° and 44 °C), to the perineum, at each contraction or pushing effort from the start of perineum distension until birth.

Cryotherapy

Local perineal cryotherapy during the immediate postpartum period

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: DEVICE

Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.

Active second stage usual car

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Postpartum usual care

Standard immediate (\<2 hours) postpartum care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Heat therapy

Application of warm compresses, soaked in hot tap water (between 38° and 44 °C), to the perineum, at each contraction or pushing effort from the start of perineum distension until birth.

Intervention Type: DEVICE

Cryotherapy

Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.

Intervention Type: DEVICE

Other Intervention Names

Warm compresses; Perineal instant coldpack

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondation Apicil

OTHER

Sponsor Role: collaborator

PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris

UNKNOWN

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne CHANTRY, RM & PhD

Role: STUDY_DIRECTOR

Assistance publique - Hôpitaux de Paris / INSERM

Locations

Louis Mourier Hospital

Colombes, , France

Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

2020-A03399-30

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210326

Identifier Type: -

Identifier Source: org_study_id