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

ConditionsPelvic Floor Dysfunction Perineal Laceration Wound Dehiscence Anal Incontinence Sexual Dysfunction and the Mode of Deliveries Perineal Injury Perineal Infection Perineal Pain Pelvic Organ Prolapse (POP)Levator Ani Muscle Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorRegion Skane

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cesarean section before randomization. Water birth. Participation in another clinical trial with perineal tear as primary outcome.

Trial design

Design model

Parallel

Treatments tested in this trial

Perineal protection device, BabySlide
Device
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
Other intervention
Standard manual perineal support during vaginal delivery according to routine clinical practice.

Treatment groups

4,226 Participants

are divided into 2 treatment groups

Group A: Perineal protection device, BabySlideExperimental treatment 1 intervention

Group B: Standard manual perineal supportOther 1 intervention

Trial outcomes

Primary outcomes

Number of patients with OASI

A binary outcome based on ICD-10 codes O70.2C-O70.2X or O70.3, and/or the corresponding surgical procedure code (MBC33)

Time frame

Within 24 hours of delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Clinical Studies Sweden - Forum South

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: