Misoprostol for Cervical Priming Before Office Hysteroscopy

Phase 2

• Conditions: Misoprostol Allergy
• Interventions: Procedure: office hysteroscopy

• Registration Number: NCT03276000
• Lead Sponsor: Kasr El Aini Hospital

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Status Verified: 2017-10
• Study Start: 2017-10-01
• Last Update Submitted: 2017-10-14
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	office hysteroscopy	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.
Group A	office hysteroscopy	50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Pain sensation:	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	The VAS will be applied immediately after the procedure ended.	according to a 10-point VAS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt