Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy
2026年6月6日 更新者：Rania Mahmoud Ahmed Elkhalily、Sohag University
Comparative Study Between Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy
This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy.
研究概览
详细说明
Hysteroscopy is an operative procedure in which the gynaecologist directly examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix.
Misoprostol is a synthetic Prostaglandins (PGE1) analogue that has been found to be a safe and inexpensive agent for cervical ripening. It is one of the most studied cervical ripening agents used prior to hysteroscopy.
Evening primrose oil is derived from the seeds of the evening primrose (Oenothera biennis) plant. It is rich in the essential fatty acid gamma linolenic acid, a fatty acid that the body converts to a hormone like substance called prostaglandin E1.
研究类型
介入性
注册 (实际的)
230
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。
学习地点
-
-
-
Sohag、埃及、82511
- Sohag University
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age range from 18-65 years
- Patients need operative hysteroscopy
Exclusion Criteria:
- Pregnant women.
- Incompetent cervix.
- History of cervical operations like conization.
- Contraindications for both drugs (women with bleeding disorders, consumers of anticoagulants, schizophrenic individuals receiving phenothiazine, epileptics and those on medication for antihypertension).
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group I
Patients received evening Primorose Oil.
|
Patients received evening Primorose Oil.
|
|
实验性的：Group II
Patients received Misoprostol.
|
Patients received Misoprostol.
|
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 |
|---|---|---|
|
Assessment of cervical Ripening
大体时间：During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
Cervical ripening assessed by the interval between insertion of Hegar dilators size 3 and size 10, and by the size of the first Hegar dilator requiring forceful insertion.
|
During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cervical Bleeding
大体时间：During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
Occurrence of cervical bleeding during cervical entry was recorded.
|
During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
|
False Passage Formation
大体时间：During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
Occurrence of false passage during cervical instrumentation was recorded.
|
During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
|
Cervical Laceration
大体时间：During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
Occurrence of cervical laceration during cervical dilatation was recorded.
|
During operative hysteroscopy (2 hours after vaginal administration of the study medication)
|
|
Incidence of drug-related adverse effects
大体时间：Until completion of the procedure (Up to 2 hours)
|
Incidence of drug-related adverse effects such as the occurrence of nausea, vomiting, diarrhea, fever, and severe abdominal pain were recorded.
|
Until completion of the procedure (Up to 2 hours)
|
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。
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)
2024年11月12日
初级完成 (实际的)
2026年5月21日
研究完成 (实际的)
2026年5月21日
研究注册日期
首次提交
2026年6月6日
首先提交符合 QC 标准的
2026年6月6日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月6日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- Soh-Med-24-11--7PD
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
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.