Active — Not RecruitingNot Applicable

Prospective Randomized Trial On Episiorrhaphy

Italy100 participantsStarted 2025-06-01

Plain-language summary

An episiotomy refers to the incision of the perineum performed to increase the space of the vaginal opening to facilitate the birth of the newborn. Subsequently, the incision is closed by aligning the tissues without cutaneous and vascular alterations. Although a systematic review and metanalysis demonstrated that sutures coated with triclosan, a purified antimicrobial, prevent surgical site infections, there is no evidence in the literature regarding the use of antibacterial sutures for perineal plane compared to standard ones. Therefore, the goal of this clinical trial is to compare the outcomes of incisions performed with standard Vicryl 2/0 sutures and antibacterial Vicryl Plus 2/0 sutures. The study involves women giving birth at the Vittore Buzzi Children's Hospital, for whom an incision is necessary at the time of delivery. Participants will be evaluated at 48 hours (at the time of the hospital discharge visit), 40 days (at the postpartum visit), and 6 months (by phone interview) after delivery. In particular, the aim of this study is to assess whether: * antibacterial Vicryl Plus 2/0 sutures reduce pain after delivery; * antibacterial Vicryl Plus 2/0 sutures improve the overall wound healing rate, avoid sexual, urinary or bowel disorders and the need for additional pharmacological, surgical, or physiotherapeutic interventions (in case of suboptimal wound healing). This study also aims to validate a new ASEPSIS ( Additional Treatment, Serous exudate, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria and Stay) score for the evaluation of healing outcomes of episiotomies. This is a double-blind, parallel-group randomized controlled trial. After obtaining informed consent, participants are randomly assigned either to the experimental group or the control group. Participants do not know the group they belong to, as the researchers; only the healthcare professional performing the suture knows it.

Who can participate

Age range

18 Years – 40 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: * pregnant women at term (more than 37 weeks); * age between 18 and 40 years; * women who give consent to participate in the study; * women who give birth during the recruitment period; * women for whom an episiotomy is necessary at the time of delivery. Exclusion Criteria: * age lower than 18 years and more than 40 years; * gestational age lower than 37 weeks; * diabetes mellitus or gestational diabetes; * African and South-East Asian ethnicities; * cigarette smoking; * BMI higher than 30; * anemia; * lack of consent to participate; * complicated episiotomy and/or presence of other spontaneous perineal lacerations; * women lost to follow-up or who have undergone non-gynecological perineal interventions during the follow-up period.

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

Pain evaluation

Timeframe: 48 hours, 40 days and six months postpartum.

Trial details

NCT IDNCT07045285

SponsorASST Fatebenefratelli Sacco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

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