RecruitingNot Applicable

Perineal Massage During Labor for the Prevention of Perineal Trauma

Brazil466 participantsStarted 2024-04-02

Plain-language 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. 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients currently in labor * Gestational age between 37 and 42 weeks * Fetus presenting in cephalic position * No prior perineal massage performed during prenatal care Exclusion Criteria: * Patients who progress to cesarean delivery * Diagnosis of HELLP syndrome * Unstable vital signs of the laboring woman or fetus

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery

Timeframe: At the time of delivery

Trial details

NCT IDNCT07099690

SponsorFederal University of Rio Grande do Sul

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Gabriela Plentz Stein

+55 51997710248 gabrielaplentz.fisio@gmail.com

View on ClinicalTrials.gov More Obstetric; Injury Pelvic Floor trials