Obstetric; Injury Pelvic FloorNCT07099690
Perineal Massage During Labor for the Prevention of Perineal Trauma
A study testing Perineal massage in people with Obstetric; Injury Pelvic Floor, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies. The study will test two hypotheses: Null hypothesis: Perineal massage during labor does not prevent perineal trauma. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric; Injury Pelvic Floor
- What is being tested?
- Perineal massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients currently in labor
- Gestational age between 37 and 42 weeks
- Fetus presenting in cephalic position
- No prior perineal massage performed during prenatal care
Who cannot join
- Patients who progress to cesarean delivery
- Diagnosis of HELLP syndrome
- Unstable vital signs of the laboring woman or fetus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Gabriela Stein, +5551997710248, gabrielaplentz.fisio@gmail.com
About this study
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
The study will test two hypotheses:
Null hypothesis: Perineal massage during labor does not prevent perineal trauma.
Alternative hypothesis: Perineal massage during labor helps prevent perineal trauma.
Participants will be randomly assigned to one of two groups:
Perineal massage group: Participants will receive perineal massage during labor.
Control group: Participants will receive the standard care provided by the labor and delivery unit.
A randomization process will be used to assign participants to each group.
- Conditions
- Obstetric; Injury Pelvic Floor
- Being tested
- Perineal massage
- Keywords
- Perineal trauma, Episiotomy, Perineal massage, Laceration
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal massageProcedure or surgery
Perineal massage will be performed during labor, either between or during contractions, regardless of the position chosen by the laboring woman.
The researcher, wearing gloves, will insert one or two fingers (index and middle) into the participant's vaginal canal and move them from side to side in a "U"-shaped motion, for approximately one second in each direction. Light downward pressure will be applied toward the rectum, according to the woman's tolerance, until relaxation of the massaged perineal muscles is observed.
A water-based lubricant will be used to facilitate the procedure. The massage will last no longer than 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Perineal Massage Group | Experimental | The perineal massage group will receive the intervention during labor. Receives: Procedure: Perineal massage |
| Control Group | No intervention | The control group will receive the standard care provided by the obstetric center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery
The presence and degree of perineal trauma will be assessed after delivery by the attending healthcare provider. Trauma will be classified by the presence of spontaneous perineal lacerations (graded I to IV) and/or performance of episiotomy.
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start2 Apr 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric; Injury Pelvic FloorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Plentz Stein, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099690
- Sponsor's protocol ID
- 2023-0514
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineal Massage During Labor for the Prevention of Perineal Trauma
- ClinicalTrials.gov ID
- NCT07099690
- Acronym / sponsor ID
- 2023-0514
- Conditions
- Obstetric; Injury Pelvic Floor
- Keywords
- Perineal trauma, Episiotomy, Perineal massage, Laceration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies.
The study will test two hypotheses:
Null hypothesis: Perineal massage during labor does not prevent perineal trauma.
Alternative hypothesis: Perineal massage during labor helps prevent perineal trauma.
Participants will be randomly assigned to one of two groups:
Perineal massage group: Participants will receive perineal massage during labor.
Control group: Participants will receive the standard care provided by the labor and delivery unit.
A randomization process will be used to assign participants to each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal Massage Group | Experimental | Procedure: Perineal massageThe perineal massage group will receive the intervention during labor. |
| Control Group | No intervention | –The control group will receive the standard care provided by the obstetric center. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients currently in labor
- Gestational age between 37 and 42 weeks
- Fetus presenting in cephalic position
- No prior perineal massage performed during prenatal care
Key exclusion criteria (3 listed)
- Patients who progress to cesarean delivery
- Diagnosis of HELLP syndrome
- Unstable vital signs of the laboring woman or fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal massagePerineal massage will be performed during labor, either between or during contractions, regardless of the position chosen by the laboring woman. The researcher, wearing gloves, will insert one or two fingers (index and middle) into the participant's vaginal canal and move them from side to side in a "U"-shaped motion, for approximately one second in each direction. Light downward pressure will be applied toward the rectum, according to the woman's tolerance, until relaxation of the massaged perineal muscles is observed. A water-based lubricant will be used to facilitate the procedure. The massage will last no longer than 5 minutes. | Procedure or surgery | Perineal Massage Group |
Primary outcome
Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery
Time frame: At the time of delivery
The presence and degree of perineal trauma will be assessed after delivery by the attending healthcare provider. Trauma will be classified by the presence of spontaneous perineal lacerations (graded I to IV) and/or performance of episiotomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal massage in people with Obstetric; Injury Pelvic Floor, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Plentz Stein (+55 51997710248, gabrielaplentz.fisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery (time frame: At the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.