Perineal Massage and Warm Compresses - RCT for Reduce Perineal Trauma During Labor

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of a combined perineal massage and warm compresses intervention on the perineum integrity during second stage of labor.

Detailed Description
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A single-centre, prospective, randomized controlled trial was conducted. Eligibility and informed consent to participate were checked once the woman was in established labor. Eligible participants were randomized at the second stage of labor. The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on).

Official Title
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Perineal Massage and Warm Compresses During Second Stage of Labor - Randomised Controlled Trial for Reduce Perineal Trauma

Conditions
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Perineal Tear Resulting From Childbirth

Intervention / Treatment
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* Procedure: Perineal Massage and Warm Compresses (PeMWaC)
* Procedure: Control Group (Hands-on)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with 18 years or older Between 37 and 41 weeks of pregnancy Expected spontaneous vaginal birth Fetus in the cephalic presentation Able to provide informed written consent Exclusion Criteria: Multiple pregnancy Meconial amniotic fluid Fetal distress Suspicion of fetal growth restriction Gestational hypertensive disorders

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study was a single-centre, prospective, randomized controlled trial. Eligibility and informed consent to participate were checked once the woman was in established labor. All participants signed an informed consent form and received a copy wherein the study was described in detail.Eligible participants were randomized at the second stage of labor.The trial intervention took place during the second stage of the spontaneous vaginal birth. Participants were randomized to one of the two groups, perineal massage and warm compresses on second stage of labor or control group (hands-on). The participants could adopt the birth position they preferred.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PeMWaC (Perineal Massage and Warm Compresses)<br>In the second stage of labor, the midwife performed a soft perineal massage between 3 o'clock and 9 o'clock positions (U-shaped reciprocating motion) wearing sterile gloves and lubricated their hand with sterile lubricant. The massage lasted 10 minutes and the degree of downward pressure by the thumb was determined according to mothers' response. Perineal massage was established on the II Hodge Plan, between maternal contractions and regardless of maternal position. The women could adopted the birthing position they prefer. The application of warm compresses was performed by the midwife between the III and IV Hodge plans, during pushing and regardless of the mother's position. A metal jug filled with warm water (between 45° and 59°C) was used to soak the compresses, which were squeezed out before being gently placed on the perineum during contractions. | Procedure: Perineal Massage and Warm Compresses (PeMWaC)<br>* Perineal Massage was performed in the II Hodge Plan, between maternal contractions and regardless of maternal position. Warm Compresses were applied by the midwife between Hodge plans III and IV, during pushing and regardless of maternal position.<br>|
| Active Comparator: Control group (Hands-on)<br>The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a U, exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum, while the non-dominant hand supported the infant's head, allowing external rotation and spontaneous birth of the shoulders. After both shoulders were removed, the midwife removed the dominant hand from the posterior perineum. | Procedure: Control Group (Hands-on)<br>* The midwife placed the index, middle, and little fingers of the non-dominant hand together on the child's occiput, with the palm facing the anterior region of the perineum, when the child's head was crowning. In this way, the expulsion was controlled, maintaining the flexion of the head. Simultaneously, the dominant hand was flattened and placed on the posterior region of the perineum, with the index finger and thumb, forming a U, exerting pressure on the posterior region of the perineum during the crowning process. During the birth of the shoulders and the rest of the body, the dominant hand was kept in place, protecting the posterior region of the perineum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intact Perineum | Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma) | up to 10 minutes after childbirth | 
| First-degree perineal tear | Skin and vaginal tear | up to 10 minutes after childbirth | 
| Second-degree perineal tear | Skin and muscle tear (posterior compartment) | up to 10 minutes after childbirth | 
| OASIS | Obstetric anal sphincter injuries (Third-degree tears (injury of anal sphincter) and Fourth-degree tears (Injury of anal sphincter and the anal canal or rectum) without episiotomy | up to 10 minutes after childbirth | 
| OASIS + episiotomy | Third and fourth degree tear with episiotomy | up to 10 minutes after childbirth | 
| Episiotomy | without spontaneous perineal trauma or vaginal tears | up to 10 minutes after childbirth | 
| Episiotomy and first degree tear | Episiotomy with spontaneous skin tear | up to 10 minutes after childbirth | 
| Episiotomy and second degree tear | Episiotomy and spontaneous skin and muscle tear | up to 10 minutes after childbirth | 
| OASIS with/without episiotomy | with and without episiotomy | up to 10 minutes after childbirth | 
| Vaginal tears | only vaginal tear | up to 10 minutes after childbirth | 
| Anterior Compartment tears | Without episiotomy or any other degree of perineal trauma | up to 10 minutes after childbirth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to Neonatal Intensive Unit Care | Admission to Neonatal Intensive Unit Care | up to 2 hours after childbirth | 
| Apgar 5 minutes | Apgar Score at 5 minutes (0-10) higher scores mean better outcome | 5 minutes after childbirth | 
| Maternal satisfaction with intervention | Question about maternal satisfaction with intervention | 24 hours after childbirth | 
| Recommend an intervention allocated to a friend | Question about whether women would recommend the intervention they received to a friend | 24 hours after childbirth | 
| Female Sexual Function Index score | Female Sexual Function Index score (2-36) higher scores mean better outcome | 24 hours, 3 months and 6 months after childbirth | 
| Pelvic Floor Dysfunction symptoms | Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome | 24 hours, 3 months and 6 months after childbirth | 
| Maternal Pain | Numerical Pain score (0-10) higher scores mean worse outcome | 24 hours, 3 months and 6 months after childbirth | 
| Breastfeeding | Exclusive breastfeeding | 24 hours, 3 months and 6 months after childbirth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perineum