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

NCT05854888 | Completed

• 1 other identifier: 201802476
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear Resulting From Childbirth

Keywords

Perineum

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Admission to Neonatal Intensive Unit Care

  up to 2 hours after childbirth

• Apgar 5 minutes

  5 minutes after childbirth

• Maternal satisfaction with intervention

  24 hours after childbirth

• Recommend an intervention allocated to a friend

  24 hours after childbirth

• Female Sexual Function Index score

  24 hours, 3 months and 6 months after childbirth

Study Arms (2)

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.

Procedure: Perineal Massage and Warm Compresses (PeMWaC)

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.

Procedure: Control Group (Hands-on)

Interventions

Perineal Massage and Warm Compresses (PeMWaC) PROCEDURE

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.

PeMWaC (Perineal Massage and Warm Compresses)

Control Group (Hands-on) PROCEDURE

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.

Control group (Hands-on)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy
• Meconial amniotic fluid
• Fetal distress
• Suspicion of fetal growth restriction
• Gestational hypertensive disorders

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Sílvia Rodrigues

Braga, 4715-304, Portugal

Location

Related Publications (1)

• Rodrigues S, Silva P, Borges AC, de Sousa NQ, Silva JN, Escuriet R. Effect of Perineal Massage and Warm Compresses Technique in Postpartum Pelvic Floor Dysfunction. A Secondary Analysis from a Randomised Controlled Trial. Reprod Sci. 2024 Apr;31(4):1006-1016. doi: 10.1007/s43032-023-01424-4. Epub 2023 Dec 14.

  PMID: 38097899 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sílvia Rodrigues, PhD

  Institute Biomedical Sciences Abel Salazar-University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 11, 2023
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 1, 2021
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: up to 3 years after completed the data collection
• Access Criteria: Will be shared with other researchers as long as they are involved in research projects

Locations

PT (1)