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Misoprostol for Cervical Priming Before Office Hysteroscopy

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03276000
Enrollment
100
Registered
2017-09-08
Start date
2017-10-01
Completion date
2018-03-01
Last updated
2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Misoprostol Allergy

Keywords

Misoprostol ,office hysteroscopy

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.

Interventions

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.

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 acceptabilityThe VAS will be applied immediately after the procedure ended.according to a 10-point VAS

Secondary

MeasureTime frameDescription
Bleedingduring the procedure.Bleeding during and after the procedure.
Procedure timeit will be reported immediately after the process endedProcedure time from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity.
Ease of cervical entry by hysteroscopyThe 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.

Countries

Egypt

Contacts

Primary ContactSarah M Hassan, lecturer
saramohamed7880@yahoo.com01003733671

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026