A Phase 3 interventional study of Misoprostol 200mcg Tab and Misoprostol 800mcg Tab in Cervix; Open, sponsored by Professor Fernando Figueira Integral Medicine Institute. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Professor Fernando Figueira Integral Medicine Institute · Phase 3, Interventional, and Supportive care
The medication misoprostol is used to facilitate the entry into the uterus of hysteroscopy surgery equipment and this research aims to compare the results of the use of this drug in two different doses trying to find the optimal one.
To perform this work we will use the misoprostol and will perform a questionnaire that will be asked during hospitalization, before, during and the 12hours after the surgery.
The patients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups getting misoprostol 200mcg or misoprostol 800mcg.
Background: Hysteroscopy represents a minimally invasive procedure that has been increasing its adoption in the treatment of many cervical canal and uterine cavity disorders. However, difficulties related to the introduction of the equipment through the cervix are frequent. Although several studies suggest advantages in the cervical preparation with misoprostol, reducing the resistance of the uterine cervix, systematic reviews are unison to indicate the need for clarification on the ideal dose.
Aim: Compare the intra and postoperative results of patients submitted to cervical dilatation for surgical hysteroscopy with previous use of misoprostol at doses of 200mcg or 800mcg for uterine cervix preparation at Recife school hospitals.
Methods: Randomized, quadruple-blind clinical trial with patients who underwent cervical dilatation prior to surgical hysteroscopy at Recife school hospitals, Pernambuco. Patients included will be allocated randomly into two groups. The first group will use misoprostol in the dosage of 200mcg and the second, will use the dosage of 800mcg. Administration, via the vaginal route, will occur 12 hours before performing the operative hysteroscopy. The following variables will be studied: cervical canal width, cervical length, degree of difficulty, duration and failure of cervical dilation, side effects, surgical complications and patient's satisfaction. For statistical analysis, chi-square tests of association, Fisher's exact and Mann-Whitney tests will be used to compare the groups, with an alpha error of less than 5% being considered significant.
Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and was submitted to and approved by the Professor Fernando Figueira Integral Medicine Institute Research Ethics Committee, beginning only after this approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form.
There are no conflicts of interest.
34 studies on the registry are indexed under Uterine Cervical Incompetence; 10 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 23 interventional studies indexed under Uterine Cervical Incompetence.
Browse Uterine Cervical Incompetence studies →Professor Fernando Figueira Integral Medicine Institute is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
In this group, the participants will receive 200mcg of misoprostol, single dose, via the vaginal route.
Drug: Misoprostol 200mcg Tab
In this group, the participants will receive 800mcg of misoprostol, single dose, via the vaginal route.
Drug: Misoprostol 800mcg Tab
In the misoprostol 200mcg group there will be one tablet of 200mcg and three identical tablets in shape, size and color without pharmacological properties. These four tablets will be single dose administered via vaginal route for each participant.
Also known as: synthetic prostaglandin
In the misoprostol 800mcg group there will be four tablets of 200mcg. These four tablets will be single dose administered via vaginal route for each participant.
Also known as: synthetic prostaglandin
Cervical canal width.
Maximum size of dilator that passes through the internal os without resistance.
Time frame: during the surgery
Time required to dilate the cervix to 9mm.
Time necessary to achieve cervical permeability up to 9mm by introducting the Hegar dilators through the internal os.
Time frame: during the surgery
Ease of cervical dilation.
The feeling of ease or difficulty reported by the surgeon while dilating the cervix. Evaluated by LIKERT scale. It varies from one to five, one meaning very difficult and five meaning very easy .
Time frame: during the surgery
Length of the cervix.
The distance between the external and the internal os measured in centimeters.
Time frame: during the surgery
Abandonment of the procedure due to cervical dilation failure.
Impossibility of perform operative hysteroscopy due to difficulty to achieve complete cervical dilation up to 9mm.
Time frame: during the surgery
Intraoperative complications.
Complications related to the difficulty of the dilate de cervical canal like uterine perforation, creation of false path, cervical tears and post-dilation bleeding.
Time frame: during the surgery
Side effects due to the use of the misoprostol.
Adverse effects as nausea, vomiting, diarrhea, fever, chills, abdominal pain or any other complaint resulting from the use of the medication.
Time frame: 24 hours
Pain intensity
The highest level of pain reported by the patient according the Visual Analog Scale evaluated at 3 moments: at the time of hospitalization, at the preoperative time (between medication administration and anesthesia onset) and at the postoperative time (12 hours after the procedure).
Time frame: 24 hours
Patient satisfaction degree.
The satisfaction with the medication, reported by the participant. Evaluated by LIKERT scale. It varies from one to five, one meaning less than satisfied and five meaning very satisfied with the drug.
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Uterine Cervical Incompetence→
Professor Fernando Figueira Integral Medicine Institute