Skip to main content
OpenTrials
Completed

NCT Number: NCT04778631

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Louis Mourier Hospital, Colombes, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Warm compresses

Cryotherapy

Device

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

Other names: Perineal instant coldpack

Primary outcomes

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

    Time frame: From 2 to 24 hours after delivery

    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.

Secondary outcomes

  1. Rate of perineal laceration

    Time frame: 2 hours after delivery

    1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations

  2. Rate of episiotomy

    Time frame: 2 hours after delivery

    episiotomy

  3. Perineal healing assessed by the REEDA scale

    Time frame: 3 days after delivery

    Evaluation of perineal healing with the REEDA (redness, oedema, ecchymosis, discharge and approximation of the wound edges) scale: values from 0 to 15, higher scores meaning a worse perineal healing.

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

    Time frame: From delivery to 3 days after delivery

    Area under the curve of several repeated self-reports measure of perineal pain on an 11-point visual analogue scale (VAS) from 0 to 10.

  5. Consumptions of pain relief medications

    Time frame: 3 days after delivery

    Number and type of pain relief medications consumed: paracetamol, nonsteroidal anti-inflammatory drugs, opioids, nefopam

  6. Pain interference on daily functioning assessed by the BPI-SF

    Time frame: 2 months after delivery

    Pain interference on daily functioning assessed by the Brief pain inventory-short form scale (BPI-SF), 7 items from the subscale 23, each item independently scored from 0 to 10, higher score meaning higher pain interference on daily functioning.

  7. Perineal complication

    Time frame: At two months postpartum

    Number of health care appointments (in or outpatient care) for perineal reason (general practitioner, midwife, obstetrician-gynaecologist …)

  8. Childbirth experience assessed by the QACE

    Time frame: 3 days postpartum

    Childbirth experience assessed by the Short version of the Questionnaire for Assessing the Childbirth Experience (QACE). Scores for the 13 items range from 1-4 with higher scores indicating a more negative childbirth experience.

  9. Rate of exclusive breastfeeding

    Time frame: At 3 days after delivery

    Breastfeeding as exclusive mode of infant feeding

  10. Rate of exclusive breastfeeding

    Time frame: At 2 months after delivery

    Breastfeeding as exclusive mode of infant feeding

  11. Rate of breastfeeding complications

    Time frame: At 2 months after delivery

    Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess

  12. Urinary incontinence assessed with the ICIQ-UI SF

    Time frame: At 2 months after delivery

    Urinary incontinence assessed with the ICIQ - UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form). Score ranges from 0 to 21, higher scores indicating higher urinary incontinence.

  13. Anal incontinence assessed with the Wexner Score

    Time frame: At 2 months after delivery

    Anal incontinence assessed with the Wexner Score. Score ranges from 0 to 20, higher scores indicating higher anal incontinence.

  14. Sexual function assessed with the FSFI

    Time frame: At 2 months after delivery

    Sexual function assessed by 4 items of the satisfaction et pain subscales of the FSFI (Female Sexual Function Index). Higher score for satisfaction (from 1 to 5) means higher satisfaction. Higher scores for pain items means higher pain (from 1 to 5).

  15. Rate of postpartum depression assessed by the EPDS

    Time frame: At 2 months after delivery

    Postpartum depression assessed with the Edinburgh postnatal depression scale (EPDS). Score ranges from 0 to 30, higher scores meaning more depressive symptoms. Postpartum depression will be defined by a score greater than 12.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial

Acronym: PERISAFE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 3, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.