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临床试验/NCT06625866
NCT06625866尚未招募不适用

Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study

Universidad Panamericana0 个研究点目标入组 2 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2
主要终点
Number of episiotomies performed

研究概览

简要总结

This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.

排除标准

  • Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.

结局指标

主要结局

Number of episiotomies performed

时间窗: During spontaneous or assisted vaginal delivery

Number of episiotomies performed among patients having a vaginal delivery. Episiotomy: surgical incision made in the perineum during childbirth to enlarge the vaginal opening and facilitate the delivery. There are two main types of episiotomies, classified based on the direction of the incision: Median (the incision is made straight down from the vaginal opening towards the anus) and mediolateral (the incision is made at an angle \[usually 45 degrees\] from the vaginal opening towards the side, away from the anus).

次要结局

  • Episiotomy indication documented in the medical record(During spontaneous or assisted vaginal delivery)
  • Number of assisted vaginal deliveries(At the time of vaginal delivery)
  • Blood loss at the time of delivery(Within the first hour after spontaneous or assisted vaginal delivery)
  • Number of perineal and cervical lacerations (composite outcome)(At the time of spontaneous or assisted vaginal delivery)
  • Rate of transfusion of blood products (composite outcome)(Administered in the first 24 hours after delivery)
  • Hematocrit after delivery(Within 24 hours after delivery)
  • Pain management after delivery(Administered in the first 24 hours after vaginal delivery)
  • Patient satisfaction with the inpatient care received during and after vaginal delivery(Within the first 24 hours after delivery.)
  • Rate of surgical site infection(In the first 6 weeks after vaginal delivery)
  • Rate of NICU Admission(In the first 24 hours after delivery.)
  • Rate of surgical site dehiscence(In the first 6 weeks after vaginal delivery)
  • Five-minute Apgar(Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery)
  • Rate of Neonatal death(Within the first 28 days of life)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario I. Lumbreras-Marquez, MD, MMSc

Professor, Public Health and Epidemiology Department

Universidad Panamericana

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