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

• ClinicalTrials.gov Identifier: NCT04778631
• Recruitment Status: Not yet recruiting
• First Posted: March 3, 2021
• Last Update Posted: February 18, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: 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
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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
Pelvic Pain	Device: Heat therapy; Device: Cryotherapy	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial
• Estimated Study Start Date: March 2022
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: April 2023

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 Name: Warm compresses
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 Name: Perineal instant coldpack
No Intervention: Active second stage usual car; Standard obstetrical care and perineal protection during active second stage of labor
No Intervention: Postpartum usual care; Standard immediate (<2 hours) postpartum care

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Anne CHANTRY, RM & PhD; 01 42 34 55 80; anne.chantry@inserm.fr

Contact: Eric DUFOUR, PhD; 01 58 41 12 11; eric.dufour@aphp.fr

Locations

France

Louis Mourier Hospital

Colombes, France, 92700

Contact: Géraldine MEUNIER, RM & MSc 01.47.60.63.53 geraldine.meunier@aphp.fr

Cochin Hospital

Paris, France, 75014

Contact: Clémence LOSCUL, RM & MSc clemence.loscul@aphp.fr

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

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04778631
• Other Study ID Numbers: En cours-; 2020-A03399-30 ( Other Identifier: ID-RCB Number )
• First Posted: March 3, 2021
• Last Update Posted: February 18, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

perineum; pelvic pain; acute pain; pain management; delivery; obstetric; labor stage; second; analgesia; obstetrical; postnatal care; heat therapy; cryotherapy

Additional relevant MeSH terms:

Pelvic Pain; Pain; Neurologic Manifestations