The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 737
- 试验地点
- 1
- 主要终点
- Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears
时间窗: Within two hours post-delivery
Neonatal outcomes: umbilical cord pH
时间窗: within 5 minutes of delivery
Neonatal outcomes: Apgar score
时间窗: within 5 minutes of birth
Apgar score ≥ 7 at 5 minutes.
次要结局
- Parity(Baseline)
- Ethnicity(Baseline)
- Fetal malpositions during labor(Throughout the entire course of labor)
- Maternal positions assumed during the expulsive phase(During the full duration of the second stage of labor)
- Duration of the second stage of labor(During the full duration of the second stage of labor)
- Birth with occiput in sacral rotation(periprocedural)
- Presence of limb association(periprocedural)
- Time from head to shoulders delivery(From the delivery of the fetal head until the completion of birth)
- Birth occurring with the same contraction as the head (single contraction)(From the delivery of the fetal head until the completion of birth.)
- Type of assistance provided (Hands-on / Hands-off)(Periprocedural)
- Use of a birthing pool during the expulsive phase or water birth(During active labor and the second stage)
- Use of lubricants during delivery(During the full duration of the second stage of labor)
- Application of warm perineal compresses during the expulsive phase(During the full duration of the second stage of labor)
- Maternal pushing technique and type of assistance provided by the operator(During the full duration of the second stage of labor)