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

Pelvic Pain Clinical Trial

— PERISAFE  

Official title:

Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778631
• Other study ID #: En cours-
• Secondary ID: 2020-A03399-30
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: June 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anne CHANTRY, RM & PhD
• Phone: 01 42 34 55 80
• Email: anne.chantry[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
France	Louis Mourier Hospital	Colombes
France	Cochin Hospital	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation Apicil, Institut National de la Santé Et de la Recherche Médicale, France, PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of perineal pain assessed by the VAS (<H24)	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	Rate of perineal laceration	1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations	2 hours after delivery
Secondary	Rate of episiotomy	episiotomy	2 hours after delivery
Secondary	Perineal healing assessed by the REEDA scale	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
Secondary	Change of perineal pain assessed by the VAS (<H96)	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
Secondary	Consumptions of pain relief medications	Number and type of pain relief medications consumed: paracetamol, nonsteroidal anti-inflammatory drugs, opioids, nefopam	3 days after delivery
Secondary	Pain interference on daily functioning assessed by the BPI-SF	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
Secondary	Perineal complication	Number of health care appointments (in or outpatient care) for perineal reason (general practitioner, midwife, obstetrician-gynaecologist …)	At two months postpartum
Secondary	Childbirth experience assessed by the QACE	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
Secondary	Rate of exclusive breastfeeding	Breastfeeding as exclusive mode of infant feeding	At 3 days after delivery
Secondary	Rate of exclusive breastfeeding	Breastfeeding as exclusive mode of infant feeding	At 2 months after delivery
Secondary	Rate of breastfeeding complications	Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess	At 2 months after delivery
Secondary	Urinary incontinence assessed with the ICIQ-UI SF	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
Secondary	Anal incontinence assessed with the Wexner Score	Anal incontinence assessed with the Wexner Score. Score ranges from 0 to 20, higher scores indicating higher anal incontinence.	At 2 months after delivery
Secondary	Sexual function assessed with the FSFI	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
Secondary	Rate of postpartum depression assessed by the EPDS	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