Misoprostol for Cervical Priming Before Office Hysteroscopy

Kasr El Aini Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Misoprostol Allergy

Treatments: Procedure: office hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03276000

12345

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group A

Active Comparator group

Description:

50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy

Treatment:

Procedure: office hysteroscopy

group B

Active Comparator group

Description:

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.

Treatment:

Procedure: office hysteroscopy