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

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Colombes, France, 92700
        • Louis Mourier Hospital
      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Heat therapy
Local perineal heat therapy during active second stage of labor
Device: 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.
Other Names:
  • Warm compresses
Experimental: Cryotherapy
Local perineal cryotherapy during the immediate postpartum period
Device: Cryotherapy
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
No Intervention: Active second stage usual car
Standard obstetrical care and perineal protection during active second stage of labor
No Intervention: Postpartum usual care
Standard immediate (<2 hours) postpartum care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From 2 to 24 hours after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of perineal laceration
Time Frame: 2 hours after delivery
1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations
2 hours after delivery
Rate of episiotomy
Time Frame: 2 hours after delivery
episiotomy
2 hours after delivery
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.
3 days after delivery
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.
From delivery to 3 days after delivery
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
3 days after delivery
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.
2 months after delivery
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 …)
At two months postpartum
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.
3 days postpartum
Rate of exclusive breastfeeding
Time Frame: At 3 days after delivery
Breastfeeding as exclusive mode of infant feeding
At 3 days after delivery
Rate of exclusive breastfeeding
Time Frame: At 2 months after delivery
Breastfeeding as exclusive mode of infant feeding
At 2 months after delivery
Rate of breastfeeding complications
Time Frame: At 2 months after delivery
Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess
At 2 months after delivery
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.
At 2 months after delivery
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.
At 2 months after delivery
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).
At 2 months after delivery
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.
At 2 months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Fondation Apicil
URC-CIC Paris Descartes Necker Cochin
PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne CHANTRY, RM & PhD, Assistance publique - Hôpitaux de Paris / INSERM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP210326
  • 2020-A03399-30 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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