Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain sensation:
研究概览
简要总结
The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum
详细描述
Sample size calculation was done using the comparison of pain sensation represented through VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was 23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK
However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB.
The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.
The Patients will be allocated equally into 2 groups ( each group contain 50 patients)
Groups will be as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for diagnostic hysteroscopy for infertility or AUB.
- •Reproductive age >19 - 45yrs.
- •Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
排除标准
- •Contraindicating the use of prostaglandins such as:-
- •Cardiovascular disease
- •Severe bronchial asthma.
- •Hypertension.
- •Renal failure.
- •Known sensitivity to Prostaglandins
- •Contraindication to office hysteroscopy such as:-
- •Pelvic inflammatory disease.
- •Marked cervical stenosis.
- •Known cervical malignancy.
- •profuse uterine bleeding
- •Recent uterine perforation.
- •Neurological disorders affecting the evaluation of pain.
- •Previous cervical surgery.
研究组 & 干预措施
Group A
50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy
干预措施: office hysteroscopy (Procedure)
group B
50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina.
干预措施: office hysteroscopy (Procedure)
结局指标
主要结局
Pain sensation:
时间窗: The VAS will be applied immediately after the procedure ended.
the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
Patient acceptability
时间窗: The VAS will be applied immediately after the procedure ended.
according to a 10-point VAS
次要结局
- Bleeding(during the procedure.)
- Ease of cervical entry by hysteroscopy(The VAS will be applied immediately after the procedure ended.)
- Procedure time(it will be reported immediately after the process ended)
研究者
sarah mohamed hassan
lecturer of obstetrics and gynecology Cairo university
Kasr El Aini Hospital