Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- Change of perineal pain assessed by the VAS (<H24)
Study Overview
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.
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 :
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Active second stage usual car
Standard obstetrical care and perineal protection during active second stage of labor
Postpartum usual care
Standard immediate (<2 hours) postpartum care
Heat therapy
Local perineal heat therapy during active second stage of labor
Intervention: Heat therapy (Device)
Cryotherapy
Local perineal cryotherapy during the immediate postpartum period
Intervention: Cryotherapy (Device)
Outcomes
Primary Outcomes
Change of perineal pain assessed by the VAS (<H24)
Time Frame: 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 Outcomes
- Urinary incontinence assessed with the ICIQ-UI SF(At 2 months after delivery)
- Sexual function assessed with the FSFI(At 2 months after delivery)
- Rate of breastfeeding complications(At 2 months after delivery)
- Urinary incontinence assessed with the ICIQ-UI SF(At 2 months after delivery)
- Rate of perineal laceration(2 hours after delivery)
- Rate of episiotomy(2 hours after delivery)
- Perineal healing assessed by the REEDA scale(3 days after delivery)
- Change of perineal pain assessed by the VAS (<H96)(From delivery to 3 days after delivery)
- Consumptions of pain relief medications(3 days after delivery)
- Pain interference on daily functioning assessed by the BPI-SF(2 months after delivery)
- Perineal complication(At two months postpartum)
- Childbirth experience assessed by the QACE(3 days postpartum)
- Rate of exclusive breastfeeding(At 2 months after delivery)
- Anal incontinence assessed with the Wexner Score(At 2 months after delivery)
- Sexual function assessed with the FSFI(At 2 months after delivery)
- Rate of postpartum depression assessed by the EPDS(At 2 months after delivery)
- Rate of exclusive breastfeeding(At 3 days after delivery)