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Pelvic PainPERISAFENCT04778631

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

A study testing Heat therapy and Cryotherapy in people with Pelvic Pain, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pelvic Pain
What is being tested?
Heat therapy and Cryotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
2 sitesFrance
Study dates
16 May 2022to 4 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Louis Mourier Hospital

    Colombes, 92700

  • Cochin Hospital

    Paris, 75014

Other trials in France

About this study

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

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.

Read the 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
Being tested
Heat therapy, Cryotherapy
Keywords
perineum, pelvic pain, acute pain, pain management, delivery, obstetric, labor stage, second, analgesia, obstetrical, postnatal care, heat therapy, cryotherapy
Medical subject headings
Pelvic Pain, Acute Pain, Agnosia, Neoplasm Metastasis, Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heat therapyDevice

    Also called Warm compresses

    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.

  • CryotherapyDevice

    Also called Perineal instant coldpack

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

Study groups in NCT04778631
Study groupRoleWhat they receive
Heat therapyExperimentalLocal perineal heat therapy during active second stage of labor
Receives: Device: Heat therapy
CryotherapyExperimentalLocal perineal cryotherapy during the immediate postpartum period
Receives: Device: Cryotherapy
Active second stage usual carNo interventionStandard obstetrical care and perineal protection during active second stage of labor
Postpartum usual careNo interventionStandard immediate (<2 hours) postpartum care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 2 to 24 hours after delivery

Secondary outcomes (15)

  1. Rate of perineal laceration

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

    Measured: 2 hours after delivery

  2. Rate of episiotomy

    episiotomy

    Measured: 2 hours after delivery

  3. Perineal healing assessed by the REEDA scale

    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.

    Measured: 3 days after delivery

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

    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.

    Measured: From delivery to 3 days after delivery

  5. Consumptions of pain relief medications

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

    Measured: 3 days after delivery

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

    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.

    Measured: 2 months after delivery

  7. Perineal complication

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

    Measured: At two months postpartum

  8. Childbirth experience assessed by the QACE

    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.

    Measured: 3 days postpartum

  9. Rate of exclusive breastfeeding

    Breastfeeding as exclusive mode of infant feeding

    Measured: At 3 days after delivery

  10. Rate of exclusive breastfeeding

    Breastfeeding as exclusive mode of infant feeding

    Measured: At 2 months after delivery

  11. Rate of breastfeeding complications

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

    Measured: At 2 months after delivery

  12. Urinary incontinence assessed with the ICIQ-UI SF

    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.

    Measured: At 2 months after delivery

  13. Anal incontinence assessed with the Wexner Score

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

    Measured: At 2 months after delivery

  14. Sexual function assessed with the FSFI

    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).

    Measured: At 2 months after delivery

  15. Rate of postpartum depression assessed by the EPDS

    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.

    Measured: At 2 months after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start16 May 2022
  3. Primary completion10 Dec 2023
  4. Study completion4 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778631
Sponsor's protocol ID
APHP210326
Other IDs
2020-A03399-30
Acronym
PERISAFE
Status last verified
Oct 2025
First submitted
24 Jan 2021
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blanc-Petitjean P, Rollet C, Meunier G, Mandelbrot L, Le Ray C, Chantry AA. Thermotherapy for prevention of perineal pain after vaginal birth: Evaluation of warm compresses and cold packs using a factorial randomized controlled trial. Int J Gynaecol Obstet. 2026 Aug 3. doi: 10.1002/ijgo.71243. Online ahead of print.

    PubMed 42548151

Questions about this trial

What is this clinical trial studying?

A study testing Heat therapy and Cryotherapy in people with Pelvic Pain, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of perineal pain assessed by the VAS (<H24) (time frame: From 2 to 24 hours after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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