Clinical trial · Interventional
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial
NCT04778631CI-TRIAL-00097593PERISAFEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Device | — | UNRESOLVED |
| Heat therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Heat therapy
- description
- Local perineal heat therapy during active second stage of labor
- interventionNames
- Device: Heat therapy
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- Local perineal cryotherapy during the immediate postpartum period
- interventionNames
- Device: Cryotherapy
- type
- NO_INTERVENTION
- label
- Active second stage usual car
- description
- Standard obstetrical care and perineal protection during active second stage of labor
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDBlanc-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. PMID 42548151