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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy |
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| group B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| office hysteroscopy | Procedure | 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. |
| 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. |
| 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. |
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Inclusion criteria:
Exclusion criteria:
Contraindicating the use of prostaglandins such as:-
Contraindication to office hysteroscopy such as:-
Neurological disorders affecting the evaluation of pain.
Previous cervical surgery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah M Hassan, lecturer | Contact | 01003733671 | saramohamed7880@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Ainiy Hospital | Recruiting | Cairo | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20728083 | Background | Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21. | |
| 23701149 | Background |
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|
| 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. |
| Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1. |
| 21575939 | Background | El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14. |