Misoprostol for Cervical Priming Before Office Hysteroscopy

Misoprostol Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276000
• Other study ID #: 12345
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 6, 2017
• Last updated: October 14, 2017
• Start date: October 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: October 2017
• Source: Kasr El Aini Hospital
• Contact: Sarah M Hassan, lecturer
• Phone: 01003733671
• Email: saramohamed7880[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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:

1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure.

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

Inclusion criteria:

1. Patients indicated for diagnostic hysteroscopy for infertility or AUB.

2. Reproductive age >19 - 45yrs.

3. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion criteria:

Contraindicating the use of prostaglandins such as:-

1. Cardiovascular disease

2. Severe bronchial asthma.

3. Hypertension.

4. Renal failure.

5. Known sensitivity to Prostaglandins

Contraindication to office hysteroscopy such as:-

1. Pelvic inflammatory disease.

2. Marked cervical stenosis.

3. Known cervical malignancy.

4. pregnancy

5. profuse uterine bleeding

6. Recent uterine perforation.

Neurological disorders affecting the evaluation of pain.

Previous cervical surgery.

Related Conditions & MeSH terms

• Misoprostol Allergy

Intervention

Procedure:
• office hysteroscopy
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.

Locations

Country	Name	City	State
Egypt	Kasr El Ainiy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

Sordia-Hernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Patient acceptability	according to a 10-point VAS	The VAS will be applied immediately after the procedure ended.
Secondary	Bleeding	Bleeding during and after the procedure.	during the procedure.
Secondary	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
Secondary	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.