Misoprostol for Cervical Priming Before Office Hysteroscopy

Study Overview
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Brief Summary
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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

Detailed Description
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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: Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.

Official Title
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Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.

Conditions
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Misoprostol Allergy

Intervention / Treatment
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* Procedure: office hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) Exclusion criteria: 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. pregnancy profuse uterine bleeding Recent uterine perforation. Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy | Procedure: office hysteroscopy<br>* A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.<br>|
| Active Comparator: group B<br>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. | Procedure: office hysteroscopy<br>* A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensation: | the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS). | The VAS will be applied immediately after the procedure ended. | 
| Patient acceptability | according to a 10-point VAS | The VAS will be applied immediately after the procedure ended. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Bleeding during and after the procedure. | during the procedure. | 
| Procedure time | Procedure time from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity. | it will be reported immediately after the process ended | 
| Ease of cervical entry by hysteroscopy | Ease of cervical entry by hysteroscopy to evaluate the uterine cavity according to a 10-point VAS. | The VAS will be applied immediately after the procedure ended. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Misoprostol ,office hysteroscopy