Cervix; Open Clinical Trial
Official title:
Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: Randomized and Quadruple Blind Clinical Trial.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05339399 -
4 Versus 6 cm Active Phase of Labour
|