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

NCT04778631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

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.

DEVICE

Cryotherapy

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

Sponsors & Collaborators

  • Fondation Apicil

    collaborator OTHER

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

    collaborator UNKNOWN

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

    collaborator OTHER_GOV

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne CHANTRY, RM & PhD · Assistance publique - Hôpitaux de Paris / INSERM

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2023-12-10
Completion
2024-02-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778631 on ClinicalTrials.gov