Outcomes Following Pre-marking of Episiotomy Location
2021年10月13日 更新者：Sharon Davidesko MD
Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
研究概览
详细说明
Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.
Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.
Study type: prospective randomized-controlled trial
研究类型
介入性
注册 (预期的)
500
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sharon Davidesko, MD
- 电话号码：+972546837362
- 邮箱：shazadmoni85@gmail.com
学习地点
-
-
-
Be'er Sheva、以色列、84101
- 招聘中
- Soroka University Medical Center
-
接触：
- Sharon Davidesko, MD
- 电话号码：+972546837362
- 邮箱：shazadmoni85@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- women 18 years of age or older who present in active labour to our center and consent to participate in the study
Exclusion Criteria:
- women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pre-marked episiotomy location
Women in this group will undergo pre-marking of episiotomy location
|
A template marking the pre-determined correct location of episiotomy will be used to mark to women in the interventional group
|
|
无干预：No pre-marked episiotomy location
Women in this group will not undergo pre-marking of episiotomy location
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Extended laceration of the episiotomy
大体时间：Up to 1 hour following the episiotomy
|
Additional perineal tears originating from the original episiotomy, as described in the birth chart
|
Up to 1 hour following the episiotomy
|
|
Third- and fourth-degree perineal tears
大体时间：Up to 2 hours following the episiotomy
|
Perineal tears involving the anal sphincter in addition to the episiotomy, as documented in hospital records
|
Up to 2 hours following the episiotomy
|
|
Post-partum hemorrhage
大体时间：Up to 6 weeks following delivery
|
Early (<24 hours) or later (24 hours to 6 weeks) hemorrhage following delivery requiring physician intervention as documented in medical records
|
Up to 6 weeks following delivery
|
|
Blood transfusion requirement
大体时间：Up to 5 days following delivery
|
Any requirement for blood products following delivery as documented in the hospital discharge
|
Up to 5 days following delivery
|
|
Episiotomy site infection
大体时间：Up to 6 weeks following delivery
|
any documented infection of the episiotomy site treated in ambulatory or hospital setting, as recorded in medical records
|
Up to 6 weeks following delivery
|
|
Requirement of resuturing of episiotomy or evacuation of hematoma
大体时间：up to 6 weeks following delivery
|
Any additional surgical intervention required relating to the episiotomy, as recorded in medical records
|
up to 6 weeks following delivery
|
|
Long-term symptoms related to episiotomy
大体时间：Up to 5 years following delivery
|
Any symptoms including perineal pain, dyspareunia, urine incontinence or fecal incontinence as reported by women using a numerical scale or dichotomic scale where appropriate
|
Up to 5 years following delivery
|
|
Perineal tears in subsequent deliveries
大体时间：Up to 5 years following delivery
|
As recorded in hospital records
|
Up to 5 years following delivery
|
|
Surgical correction of episiotomy
大体时间：Up to 5 years following delivery
|
Any additional surgical procedures required for correction of episiotomy related symptoms as recorded in medical records
|
Up to 5 years following delivery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sharon Davidesko, MD、Soroka University Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年5月17日
初级完成 (预期的)
2025年9月24日
研究完成 (预期的)
2025年9月24日
研究注册日期
首次提交
2020年10月2日
首先提交符合 QC 标准的
2021年1月20日
首次发布 (实际的)
2021年1月22日
研究记录更新
最后更新发布 (实际的)
2021年10月21日
上次提交的符合 QC 标准的更新
2021年10月13日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
其他研究编号
- SOR-0089-20-CTIL
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
No data is to be shared with other researchers
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.