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

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

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.

Study Overview

• Status: Completed
• Conditions: Perineal Tear Resulting From Childbirth
• Intervention / Treatment: Procedure: Perineal Massage and Warm Compresses (PeMWaC); Procedure: Control Group (Hands-on)

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4715-304
    • Sílvia Rodrigues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PeMWaC (Perineal Massage and Warm Compresses); 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); 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.
Active Comparator: Control group (Hands-on); 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Investigators: Principal Investigator: Sílvia Rodrigues, PhD, Institute Biomedical Sciences Abel Salazar-University of Porto

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Perineum
• Other Study ID Numbers: 201802476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: up to 3 years after completed the data collection
• IPD Sharing Access Criteria: Will be shared with other researchers as long as they are involved in research projects
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No