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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
115
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.
Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.
Louis Mourier Hospital
Colombes, France
Cochin Hospital
Paris, France
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.
Time frame: From 2 to 24 hours after delivery
Rate of perineal laceration
1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations
Time frame: 2 hours after delivery
Rate of episiotomy
episiotomy
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Time frame: 2 months after delivery
Perineal complication
Number of health care appointments (in or outpatient care) for perineal reason (general practitioner, midwife, obstetrician-gynaecologist …)
Time frame: 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.
Time frame: 3 days postpartum
Rate of exclusive breastfeeding
Breastfeeding as exclusive mode of infant feeding
Time frame: At 3 days after delivery
Rate of exclusive breastfeeding
Breastfeeding as exclusive mode of infant feeding
Time frame: At 2 months after delivery
Rate of breastfeeding complications
Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At 2 months after delivery