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临床试验/NCT04948892
NCT04948892已完成不适用

Presence of the Father in the Operating Room During Hyperacute Cesarean Section in General Anesthesia

Sygehus Lillebaelt2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Father/partners experience

研究概览

简要总结

This study concerns cesarean sections, category 1, meaning those cases where the life of mother and/or fetus is in immedeate danger and the child must be delivered within 15 minutes from activating the cesarean section team. In most hospitals in Denmark, these cesarean sections are most often performed in general anesthesia and the mother is endotracheally intubated.

Previously in these situations, as the mother was rushed from the Labour Ward to the operation room (OR), her spouse/partner, would be placed outside the operating room (OR), and would stay there until the child had been delivered.

In Lillebaelt Hospital, Kolding, Denmark, the newborn-resuscitation table is placed inside the OR. The father would most often be allowed to enter the OR when the child was delivered and placed on the resuscitation table (no matter the status of the child).

However, during spring 2021, Lillebaelt Hospital Kolding updated the policy regarding the handling of the father/partner during cesarean section category 1. Now the father/partner is present in the OR during the whole procedure, including induction of general aesthesia, endotracheal intubation, performance of the cesarean section (drapings are positioned so that the father cannot see the operation field) and potential resuscitation efforts of the newborn.

In another hospital in the same region (Region of Southern Denmark), Aabenraa Hospital, the father is not present in the OR during the cesarean section. He waits in the labour ward.

The investigators therefore wish to investigate how the cesarean section category 1 is experienced by: the father/partner; the mother; the obstetrician; the anestesiologist; the midwife; the OR nurse; the anesthetic nurse, both in Kolding where the father/partner is present in the OR, and in Aabenraa, where the father/partner is not present in the OR during the cesarean sectio.

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
All
接受健康志愿者

入选标准

  • cesarean section category 1

排除标准

  • 未提供

结局指标

主要结局

Father/partners experience

时间窗: 1-2 days after the cesarean section combined with assessment of change from baseline in father/partners experience at 3 months after the cesarean sectio

Father/partners experience of being present or not in the OR during the hyperacute cesarean section category 1, described by questionnaire, semi-structured interview and PTSD-screening

次要结局

  • Mothers experience(1-2 days after the cesarean section)
  • Surgeons (obstetricians) experience(Up to 2 weeks after the cesarean section)
  • Anesthesiologists experience(Up to 2 weeks after the cesarean section)
  • Anesthetic nurses experience(Up to 2 weeks after the cesarean section)
  • Midwifes experience(Up to 2 weeks after the cesarean section)
  • OR nurses experience(Up to 2 weeks after the cesarean section)
  • Pediatricians experience(Up to 2 weeks after the cesarean section)

研究者

发起方
Sygehus Lillebaelt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helene Korvenius Nedergaard

MD, PhD

Sygehus Lillebaelt

研究点 (2)

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