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Clinical Trials in Sweden / NCT07862660
Starting soon Not applicable

Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial

NCT07862660 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2026-10-05
Last updated
2026-10-07

Condition(s) studied

Pelvic Floor DysfunctionPerineal LacerationWound DehiscenceAnal IncontinenceSexual Dysfunction and the Mode of DeliveriesPerineal InjuryPerineal InfectionPerineal PainPelvic Organ Prolapse (POP)Levator Ani Muscle Injury

Investigational drug(s) / intervention(s)

Perineal protection device, BabySlideStandard manual perineal support

Perineal protection device, BabySlide: The investigational device, BabySlide® is a CE-marked, soft perineal protection device designed to complement standard manual perineal support during vaginal birth. The device is inserted between the fetal head and the perineum at crowning and is intended to redistribute pressure with the aim of reducing tissue strain and risk of severe perineal trauma.

Standard manual perineal support: Standard manual perineal support during vaginal delivery according to routine clinical practice.

Study summary

The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in first-time mothers. The main questions it aims to answer are:

Does the use of BabySlide® reduce the risk of obstetric anal sphincter injury (OASI)? Does the use of BabySlide® reduce the risk of second-, third-, or fourth-degree perineal tears and/or episiotomy?

Researchers will compare women randomized to receive BabySlide® in addition to standard manual perineal support with women receiving standard manual perineal support alone to determine whether the device reduces perineal trauma during vaginal delivery.

Participants will:

be randomized during the late second stage of labour to either BabySlide® plus standard manual perineal support or standard manual perineal support alone; receive the allocated perineal protection method during vaginal delivery; have perineal outcomes assessed and documented after delivery; and complete follow-up assessments and questionnaires after delivery to evaluate recovery and pelvic floor symptoms.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women with no prior vaginal birth (including one previous cesarean section). Singleton, live fetus in cephalic presentation. Gestational age ≥34 weeks. Age ≥ 18 years. Planned vaginal birth. Exclusion Criteria: * Cesarean section before randomization. Water birth. Participation in another clinical trial with perineal tear as primary outcome.

Primary outcome measure(s)

  • Number of patients with OASI — Within 24 hours of delivery
    A binary outcome based on ICD-10 codes O70.2C-O70.2X or O70.3, and/or the corresponding surgical procedure code (MBC33)

Trial sites (1)

FacilityCityRegionStatus
Helsingborgs Lasarett Helsingborg Helsingborg

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Other trials for the same condition

The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation Recruiting
Treating Emergency Laparotomy Incisions With Negative Pressure Wound Therapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862660 on ClinicalTrials.gov ↗ ← All trials in Sweden