Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain (PERISAFE)
Study Details
Study Description
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 evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 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 :
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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;
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Heat therapy Local perineal heat therapy during active second stage of labor |
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.
Other Names:
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| Experimental: Cryotherapy Local perineal cryotherapy during the immediate postpartum period |
Device: Cryotherapy
Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.
Other Names:
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| No Intervention: Active second stage usual car Standard obstetrical care and perineal protection during active second stage of labor |
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| No Intervention: Postpartum usual care Standard immediate (<2 hours) postpartum care |
Outcome Measures
Primary Outcome Measures
- Change of perineal pain assessed by the VAS (<H24) [From 2 to 24 hours after delivery]
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.
Secondary Outcome Measures
- Rate of perineal laceration [2 hours after delivery]
1st, 2nd, 3rd and 4th (OASIS) degree perineal lacerations
- Rate of episiotomy [2 hours after delivery]
episiotomy
- Perineal healing assessed by the REEDA scale [3 days after delivery]
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.
- Change of perineal pain assessed by the VAS (<H96) [From delivery to 3 days after delivery]
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.
- Consumptions of pain relief medications [3 days after delivery]
Number and type of pain relief medications consumed: paracetamol, nonsteroidal anti-inflammatory drugs, opioids, nefopam
- Pain interference on daily functioning assessed by the BPI-SF [2 months after delivery]
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.
- Perineal complication [At two months postpartum]
Number of health care appointments (in or outpatient care) for perineal reason (general practitioner, midwife, obstetrician-gynaecologist …)
- Childbirth experience assessed by the QACE [3 days postpartum]
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.
- Rate of exclusive breastfeeding [At 3 days after delivery]
Breastfeeding as exclusive mode of infant feeding
- Rate of exclusive breastfeeding [At 2 months after delivery]
Breastfeeding as exclusive mode of infant feeding
- Rate of breastfeeding complications [At 2 months after delivery]
Breastfeeding complications reported by women : breast engorgement, mastitis, breast abscess
- Urinary incontinence assessed with the ICIQ-UI SF [At 2 months after delivery]
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.
- Anal incontinence assessed with the Wexner Score [At 2 months after delivery]
Anal incontinence assessed with the Wexner Score. Score ranges from 0 to 20, higher scores indicating higher anal incontinence.
- Sexual function assessed with the FSFI [At 2 months after delivery]
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).
- Rate of postpartum depression assessed by the EPDS [At 2 months after delivery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primiparous women or multiparous women without history of vaginal birth
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singleton fetus
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fetal cephalic presentation
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≥37 gestational weeks
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active labor (cervical dilatation ≥ 6 cm)
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living fetus
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major female Exclusion Criteria
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Abnormal fetal heart rate requiring hastening childbirth
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Fetal malformation, stillbirth
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History of female genital mutilation
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Women not understanding French
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Women with psychiatric condition
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Anonymous childbirth
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Minor female
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No affiliation to a social security scheme (beneficiary or assignee)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Louis Mourier Hospital | Colombes | France | 92700 | |
| 2 | Cochin Hospital | Paris | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Fondation Apicil
- PRIDE prize, Laboratoire Guigoz, Département Hopsitalo-universitaire Risques et Grossesse, Université de Paris
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
- Study Director: Anne CHANTRY, RM & PhD, Assistance publique - Hôpitaux de Paris / INSERM
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- En cours-
- 2020-A03399-30