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

NCT04778631 | Completed

• 2 other identifiers: APHP2103262020-A03399-30
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Pain

Keywords

perineum; pelvic pain; acute pain; pain management; delivery; obstetric; labor stage; second; analgesia; obstetrical; postnatal care; heat therapy; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Change of perineal pain assessed by the VAS (<H24)

  Perineal pain intensity, as a mean of several repeated self-reports measure of perineal pain (each 4 hours) on an 11-point visual analogue scale (VAS) from 0 to 10.

  From 2 to 24 hours after delivery

Secondary Outcomes (15)

• Rate of perineal laceration

  2 hours after delivery

• Rate of episiotomy

  2 hours after delivery

• Perineal healing assessed by the REEDA scale

  3 days after delivery

• Change of perineal pain assessed by the VAS (<H96)

  From delivery to 3 days after delivery

• Consumptions of pain relief medications

  3 days after delivery

Study Arms (4)

Heat therapy

EXPERIMENTAL

Local perineal heat therapy during active second stage of labor

Device: Heat therapy

Cryotherapy

EXPERIMENTAL

Local perineal cryotherapy during the immediate postpartum period

Device: Cryotherapy

Active second stage usual car

NO INTERVENTION

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

Postpartum usual care

NO INTERVENTION

Standard immediate (\<2 hours) postpartum care

Interventions

Heat therapy 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.

Also known as: Warm compresses

Heat therapy

Cryotherapy DEVICE

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

Also known as: Perineal instant coldpack

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation Apicil: collaborator
• PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Louis Mourier Hospital

Colombes, 92700, France

Location

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Pelvic Pain; Acute Pain; Agnosia; Neoplasm Metastasis; Hyperthermia

Interventions

Diathermy; Cryotherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Anne CHANTRY, RM & PhD

  Assistance publique - Hôpitaux de Paris / INSERM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: March 3, 2021
• Study Start: May 16, 2022
• Primary Completion: December 10, 2023
• Study Completion: February 4, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)