Status:
COMPLETED
Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fondation Apicil
PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris
Conditions:
Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 evalu...
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 fea...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2024
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04778631
Start Date
May 16 2022
End Date
February 4 2024
Last Update
November 20 2025
Active Locations (2)
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1
Louis Mourier Hospital
Colombes, France, 92700
2
Cochin Hospital
Paris, France, 75014