Hands-on vs Hands-off Techniques in Perineal Protection
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Обзор
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
Подробное описание
Perineal trauma remains a frequent occurrence during vaginal childbirth, leading clinicians to adopt various protective strategies. The two primary approaches are the hands-on technique, characterized by active manual support of the perineum and fetal head, and the hands-off (or expectant) technique, which prioritizes spontaneous delivery without manual intervention.
The objective of this study is to compare these two methods by evaluating their impact on both maternal and neonatal health.
Study Endpoints
The research focuses on primary outcomes related to perineal integrity-ranging from an intact perineum to varying degrees of lacerations (1st through 4th degree)-and neonatal well-being, specifically monitoring umbilical cord pH and Apgar scores (≥ 7 at 5 minutes).
To ensure a comprehensive analysis, the study also accounts for several secondary variables that may influence these outcomes:
Maternal \& Clinical Factors: Parity, ethnicity, and the duration of the second stage of labor.
Delivery Dynamics: Fetal malpositions, presentation at birth (including occiput posterior/sacral rotation), limb associations, and the transition time from head to shoulder delivery.
Procedural Interventions: The specific pushing technique used, maternal positions during the expulsive phase, and the use of water (birthing pool or water birth).
Supportive Measures: The application of warm compresses, the use of lubricants, and the specific assistance provided by the healthcare operator during the final contraction.
Первичные конечные точки
- Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears [Срок оценки: Within two hours post-delivery]
- Neonatal outcomes: umbilical cord pH [Срок оценки: within 5 minutes of delivery]
- Neonatal outcomes: Apgar score [Срок оценки: within 5 minutes of birth]
Вторичные конечные точки (12)
- Parity [Срок оценки: Baseline]
- Ethnicity [Срок оценки: Baseline]
- Fetal malpositions during labor [Срок оценки: Throughout the entire course of labor]
- Maternal positions assumed during the expulsive phase [Срок оценки: During the full duration of the second stage of labor]
- Duration of the second stage of labor [Срок оценки: During the full duration of the second stage of labor]
- Birth with occiput in sacral rotation [Срок оценки: periprocedural]
- Presence of limb association [Срок оценки: periprocedural]
- Time from head to shoulders delivery [Срок оценки: From the delivery of the fetal head until the completion of birth]
- Birth occurring with the same contraction as the head (single contraction) [Срок оценки: From the delivery of the fetal head until the completion of birth.]
- Type of assistance provided (Hands-on / Hands-off) [Срок оценки: Periprocedural]
- Use of a birthing pool during the expulsive phase or water birth [Срок оценки: During active labor and the second stage]
- Use of lubricants during delivery [Срок оценки: During the full duration of the second stage of labor]
Критерии участия
Criteri di inclusione:
- Donne incinte nullipare o multipare
- Gravidanza a termine
- Feto nella presentazione cefalica
- Consegna eutocic (spontanea)
- Uso di ossitocina
- Uso di analgesici
Criteri di esclusione:
- Parto prematuro: prematuro tardivo -Disagio fetale acuto durante la fase di espulsione-
- Consegna della gretta
- Distocia della spalla
- Parto chirurgico (uso del vuoto ostetrico, manovra di Kristeller, taglio cesareo) --Episiotomia
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Ospedale San Bortolo — Vicenza
Идентификаторы
NCT: NCT07492940 · MF 11 · Prot. n. 9674