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Clinical Trials/NCT05854888
NCT05854888CompletedNot Applicable

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

Universidade do Porto1 site in 1 country800 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
800
Locations
1
Primary Endpoint
Intact Perineum

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The randomization envelope was opened by the midwife when the participant entered the second stage of labor and was destroyed thereafter. The allocation was only shown to the midwife and if necessary, the obstetrician. 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 were blinded to their allocation. After the placenta delivery, a blinded midwife not otherwise involved in the birth but trained, assessed the perineum (graded the perineal tears). The data about the variables included in the study were registered by the midwife responsible for the birth. Midwives who assess the primary outcomes and the principal investigator were blinded to the randomization.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

PeMWaC (Perineal Massage and Warm Compresses)

Experimental

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.

Intervention: Perineal Massage and Warm Compresses (PeMWaC) (Procedure)

Control group (Hands-on)

Active Comparator

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.

Intervention: Control Group (Hands-on) (Procedure)

Outcomes

Primary Outcomes

Intact Perineum

Time Frame: up to 10 minutes after childbirth

Absence of tissue separation at any site, without vaginal tears or any other degree of perineal trauma)

First-degree perineal tear

Time Frame: up to 10 minutes after childbirth

Skin and vaginal tear

Second-degree perineal tear

Time Frame: up to 10 minutes after childbirth

Skin and muscle tear (posterior compartment)

OASIS

Time Frame: up to 10 minutes after childbirth

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

OASIS + episiotomy

Time Frame: up to 10 minutes after childbirth

Third and fourth degree tear with episiotomy

Episiotomy

Time Frame: up to 10 minutes after childbirth

without spontaneous perineal trauma or vaginal tears

Episiotomy and second degree tear

Time Frame: up to 10 minutes after childbirth

Episiotomy and spontaneous skin and muscle tear

OASIS with/without episiotomy

Time Frame: up to 10 minutes after childbirth

with and without episiotomy

Vaginal tears

Time Frame: up to 10 minutes after childbirth

only vaginal tear

Episiotomy and first degree tear

Time Frame: up to 10 minutes after childbirth

Episiotomy with spontaneous skin tear

Anterior Compartment tears

Time Frame: up to 10 minutes after childbirth

Without episiotomy or any other degree of perineal trauma

Secondary Outcomes

  • Admission to Neonatal Intensive Unit Care(up to 2 hours after childbirth)
  • Pelvic Floor Dysfunction symptoms(24 hours, 3 months and 6 months after childbirth)
  • Apgar 5 minutes(5 minutes after childbirth)
  • Recommend an intervention allocated to a friend(24 hours after childbirth)
  • Maternal satisfaction with intervention(24 hours after childbirth)
  • Female Sexual Function Index score(24 hours, 3 months and 6 months after childbirth)
  • Maternal Pain(24 hours, 3 months and 6 months after childbirth)
  • Breastfeeding(24 hours, 3 months and 6 months after childbirth)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sílvia Leite Rodrigues

Principal Investigator

Universidade do Porto

Study Sites (1)

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