Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain

Status Recruiting

Clinical 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Pelvic Pain

Clinical Trial Details

NCT number	NCT04778631
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Anne CHANTRY, RM & PhD
Phone	01 42 34 55 80
Email	anne.chantry@inserm.fr
Status	Recruiting
Phase	N/A
Start date	May 16, 2022
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03740932` - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed	`NCT04077801` - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Recruiting	`NCT03868137` - Multi-dose Ibuprofen Prophylaxis for IUD-insertion	N/A
Suspended	`NCT04069572` - Vibratory Stimulation for the Treatment of Chronic Pain	N/A
Completed	`NCT02923245` - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound	N/A
Completed	`NCT02547857` - Transvaginal Pelvic Ultrasound in the ED	N/A
Completed	`NCT01938092` - Vaginal Diazepam for the Treatment of Female Pelvic Pain	Phase 2
Active, not recruiting	`NCT01731470` - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)	N/A
Completed	`NCT01421641` - Tenaculum Pain Control Study	Phase 4
Completed	`NCT00034047` - Endometriosis : Traditional Medicine vs Hormone Therapy	Phase 1/Phase 2
Completed	`NCT05368155` - Chronic Pelvic Pain and Education Skills Training for Women Veterans	N/A
Completed	`NCT04179149` - Enriched Environments in Endometriosis	N/A
Not yet recruiting	`NCT05530681` - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth	N/A
Completed	`NCT04077775` - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed	`NCT03715777` - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain	Phase 3
Recruiting	`NCT05926752` - Photobiomodulation for Myofascial Pelvic Pain	N/A
Completed	`NCT02588885` - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention	N/A
Completed	`NCT02261740` - Program to Overcome Pelvic Pain With Yoga	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms