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临床试验 NCT07286188 针对Fibroids, Uterine，Fluid Deficit，Hysteroscopy / Methods目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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西北大学Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy IV期 40 随机化 双盲
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临床试验NCT07286188旨在研究治疗，主要针对Fibroids, Uterine，Fluid Deficit，Hysteroscopy / Methods。这是一项IV期 干预性研究试验，目前试验状态为招募中。试验始于2025年12月16日，计划招募40名患者。该研究由西北大学主导，预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月17日。
简要概括
The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are:
Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies?
Participants will be randomized to received 800 mcg of either rectal misoprostol prior to t...
显示更多详细描述
Misoprostol is a synthetic analogue of prostaglandin E1 originally developed for the prevention and treatment of NSAID-induced peptic ulcers. Over time, it has become widely used in obstetrics and gynecology due to its uterotonic properties. It is FDA-approved as part of the regimen, paired with mifepristone, for medical abortion and is commonly used off-label for cervical ripening, management of postpartum hemorrhag...显示更多
官方标题
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial
疾病
Fibroids, UterineFluid DeficitHysteroscopy / Methods出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- #STU00223642
NCT编号
实际开始日期
2025-12-16
最近更新发布
2025-12-17
预计完成日期
2026-12
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
招募中
关键词
fibroids
hysteroscopy
myomectomy
fluid deficit
misoprostol
hysteroscopy
myomectomy
fluid deficit
misoprostol
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Misoprostol (treatment aem) Patients will received 800 mcg of misoprostol per rectum prior to procedure. | Misoprostol Tabets 800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy. |
安慰剂对照Zeebo (Placebo arm) Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure. | 安慰剂 4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Fluid Deficit | Primary outcome is difference in fluid deficit at the conclusion of the hysteroscopic myomectomy | Immediately at the conclusion of the procedure. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Total fluid volume | Difference in total fluid volume used (in milliliters) between groups. | intraoperative |
Time | Difference in total procedure time (in minutes) between groups. | Intraop |
Reoperation | Frequency of repeat hysteroscopic myomectomy due to incomplete fibroid resection caused by early termination of the initial procedure | within 3 month post op |
Specimen weight | Total specimen weight | Immediately post op |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
女性
- Patients presenting for hysteroscopic myomectomy for uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
- Age ≥ 18 years and ≤ 50 years.
- Fibroids between 1-3cm in size
- Myomectomy using myosure or resectoscope devices
- Willing to have rectal misoprostol or placebo at time of procedure
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history.
- Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
- Can have had prior Cesarean delivery
- Pregnancy. All patients will be required to have a negative urine pregnancy test prior to surgery.
- Post-menopausal women.
- Patients with a history of gynecologic malignancy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known active inflammatory bowel disease involving the rectum or other significant anorectal conditions that may interfere with safe rectal administration of study medication.
西北大学研究责任方
Magdy Milad, MD, 主要研究者, Albert B Gerbie Professor, Northwestern University
研究中心联系人
联系人: Hannah Pope, MD, 3126946773, [email protected]
联系人: Juan Avitia, [email protected]
1 位于 1 个国家/地区的研究中心
Illinois
Northwestern, Chicago, Illinois, 60611, United States
Hannah Pope, MD, 联系人, 312-694-6773, [email protected]
Juan Avitia, 联系人, [email protected]
招募中