Misoprostol Administration Before Operative Hysteroscopy

CHA University

Status and phase: Completed; Phase 3

Conditions: Endometrial Disorder

Treatments: Drug: Control; Drug: Vaginal misoprostol; Drug: Sublingual misoprostol; Drug: Oral misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01805115

KNC13-005

Details and patient eligibility

About

The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.

Full description

The route of administration of misoprostol for cervical dilatation prior to operative hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is more effective and less harmful for cervical dilation prior to operative hysteroscopy in premenopausal women. Furthermore, there have been no studies comparing among oral, sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Symptomatic patients that were suspected as having intrauterine pathology, such as submucosal myoma, endometrial polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.

Inclusion criteria were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -

Exclusion criteria

Exclusion criteria included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

Oral misoprostol

Experimental group

Description:

The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery.

Treatment:

Drug: Oral misoprostol

Sublingual misoprostol

Experimental group

Description:

The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery.

Treatment:

Drug: Sublingual misoprostol

Vaginal misoprostol

Experimental group

Description:

The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery.

Treatment:

Drug: Vaginal misoprostol

Control

Experimental group

Description:

The no-misoprostol group did not administer the medication of misoprostol before the procedure

Treatment:

Drug: Control