Отказ от ответственности: Этот сайт агрегирует общедоступные официальные данные FDA, ClinicalTrials.gov, PubMed и SEC EDGAR только для общей справки. Он не является медицинской консультацией, диагнозом, рекомендацией по лечению или инвестиционным советом.

Клиническое исследование

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

NCT: NCT07862660 · NOT_YET_RECRUITING

NCT IDNCT07862660
СтатусNOT_YET_RECRUITING
Дата начала2026-10-05
SponsorRegion Skane (OTHER)
First posted
Last updated

Краткое описание

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.

Официальный источник

Открыть на ClinicalTrials.gov →

Данные получены через API ClinicalTrials.gov. Актуальный статус смотрите в официальной записи.

↑