Misoprostol Administration Before Operative Hysteroscopy

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

Detailed Description
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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.

Official Title
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A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy

Conditions
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Endometrial Disorder

Intervention / Treatment
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* Drug: Oral misoprostol
* Drug: Sublingual misoprostol
* Drug: Vaginal misoprostol
* Drug: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral misoprostol<br>The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery. | Drug: Oral misoprostol<br>* Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation<br>* Other names: two tablets of Cytotec (200 μg);|
| Experimental: Sublingual misoprostol<br>The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery. | Drug: Sublingual misoprostol<br>* Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation<br>* Other names: two tablets of Cytotec (200 μg);|
| Experimental: Vaginal misoprostol<br>The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery. | Drug: Vaginal misoprostol<br>* Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation<br>* Other names: two tablets of Cytotec (200 μg);|
| Experimental: Control<br>The no-misoprostol group did not administer the medication of misoprostol before the procedure | Drug: Control<br>* The control group was not given any cervical priming agents or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the preoperative cervical width | The primary outcome measure was the preoperative cervical width at the time of operation. The cervical width was assessed by performing cervical dilation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width. | just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| misoprostol-associated side effects |  | before the procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, misoprostol