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

May 2, 2023 updated by: Sílvia Leite Rodrigues, Universidade do Porto

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
up to 10 minutes after childbirth
First-degree perineal tear
Time Frame: up to 10 minutes after childbirth
Skin and vaginal tear
up to 10 minutes after childbirth
Second-degree perineal tear
Time Frame: up to 10 minutes after childbirth
Skin and muscle tear (posterior compartment)
up to 10 minutes after childbirth
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
up to 10 minutes after childbirth
OASIS + episiotomy
Time Frame: up to 10 minutes after childbirth
Third and fourth degree tear with episiotomy
up to 10 minutes after childbirth
Episiotomy
Time Frame: up to 10 minutes after childbirth
without spontaneous perineal trauma or vaginal tears
up to 10 minutes after childbirth
Episiotomy and first degree tear
Time Frame: up to 10 minutes after childbirth
Episiotomy with spontaneous skin tear
up to 10 minutes after childbirth
Episiotomy and second degree tear
Time Frame: up to 10 minutes after childbirth
Episiotomy and spontaneous skin and muscle tear
up to 10 minutes after childbirth
OASIS with/without episiotomy
Time Frame: up to 10 minutes after childbirth
with and without episiotomy
up to 10 minutes after childbirth
Vaginal tears
Time Frame: up to 10 minutes after childbirth
only vaginal tear
up to 10 minutes after childbirth
Anterior Compartment tears
Time Frame: up to 10 minutes after childbirth
Without episiotomy or any other degree of perineal trauma
up to 10 minutes after childbirth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Admission to Neonatal Intensive Unit Care
Time Frame: up to 2 hours after childbirth
Admission to Neonatal Intensive Unit Care
up to 2 hours after childbirth
Apgar 5 minutes
Time Frame: 5 minutes after childbirth
Apgar Score at 5 minutes (0-10) higher scores mean better outcome
5 minutes after childbirth
Maternal satisfaction with intervention
Time Frame: 24 hours after childbirth
Question about maternal satisfaction with intervention
24 hours after childbirth
Recommend an intervention allocated to a friend
Time Frame: 24 hours after childbirth
Question about whether women would recommend the intervention they received to a friend
24 hours after childbirth
Female Sexual Function Index score
Time Frame: 24 hours, 3 months and 6 months after childbirth
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
Time Frame: 24 hours, 3 months and 6 months after childbirth
Pelvic Floor Distress Inventory (0-300) higher scores mean worse outcome
24 hours, 3 months and 6 months after childbirth
Maternal Pain
Time Frame: 24 hours, 3 months and 6 months after childbirth
Numerical Pain score (0-10) higher scores mean worse outcome
24 hours, 3 months and 6 months after childbirth
Breastfeeding
Time Frame: 24 hours, 3 months and 6 months after childbirth
Exclusive breastfeeding
24 hours, 3 months and 6 months after childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Porto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sílvia Rodrigues, PhD, Institute Biomedical Sciences Abel Salazar-University of Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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