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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pelvic Pain

Intervention / Treatment
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* Device: Heat therapy
* Device: Cryotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat therapy<br>Local perineal heat therapy during active second stage of labor | Device: Heat therapy<br>* 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.<br>* Other names: Warm compresses;|
| Experimental: Cryotherapy<br>Local perineal cryotherapy during the immediate postpartum period | Device: Cryotherapy<br>* Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.<br>* Other names: Perineal instant coldpack;|
| No Intervention: Active second stage usual car<br>Standard obstetrical care and perineal protection during active second stage of labor | |
| No Intervention: Postpartum usual care<br>Standard immediate (<2 hours) postpartum care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perineal laceration | 1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations | 2 hours after delivery | 
| Rate of episiotomy | episiotomy | 2 hours after delivery | 
| 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 | 
| 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 | 
| Consumptions of pain relief medications | Number and type of pain relief medications consumed: paracetamol, nonsteroidal anti-inflammatory drugs, opioids, nefopam | 3 days after delivery | 
| 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 | 
| Perineal complication | Number of health care appointments (in or outpatient care) for perineal reason (general practitioner, midwife, obstetrician-gynaecologist …) | At two months postpartum | 
| 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 | 
| Rate of exclusive breastfeeding | Breastfeeding as exclusive mode of infant feeding | At 3 days after delivery | 
| Rate of exclusive breastfeeding | Breastfeeding as exclusive mode of infant feeding | At 2 months after delivery | 
| Rate of breastfeeding complications | Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess | At 2 months after delivery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second, analgesia, obstetrical, postnatal care, heat therapy, cryotherapy, perineum, pelvic pain, acute pain, pain management, delivery, obstetric, labor stage