The effect of Diazepam on facilitating placement of devices during Tubal Ligation procedure
Not Applicable
- Conditions
- Tubal sterilizationE04.950.300.766
- Registration Number
- RBR-8vd2bp
- Lead Sponsor
- Hospital das Clínicas de Ribeirão Preto - HCRP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
82 women were recruited, after being evaluated in the Contraceptive Outpatient Clinic and released for such procedure, having fulfilled all the criteria of Law 9.263 (Law on Family Planning), 1996 (article 226 of the Federal Constitution).
Exclusion Criteria
Minimum age of 25 years and maximum of 45 years; women with an allergic reaction to the nickel component in the devices; women who are pregnant or in the immediate puerperal period; chronic use of medications that could interfere with the pain threshold; uterine malformation; single or bilateral anterior tubal ligation or surgery; signs and or symptoms of vaginal or cervical infection;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate in patients submitted to tubal sterilization by hysteroscopy if the use of diazepam prior to the procedure facilitates its insertion or not, through the evaluation of the inserting physician in an easy, difficult variable or if there was a failure in the placement of the devices through the Chi-Square test and divided into three categories: 0 for easy placement, 1 for difficult placement, and therefore for resistance, and 2 for those in which placement failed. We also assessed the agreement between the two sides of the tubas and the ease of insertion of the devices through Kappa, in order to exclude the bias of the same patient having different evaluations between the two sides.
- Secondary Outcome Measures
Name Time Method To evaluate the effect of the use of diazepam in patients submitted to tubal sterilization by hysteroscopy:<br>1. In pain reported by the patient immediately after insertion performed by the International Association for the Study of Pain (IASP)<br>2. At the time of insertion performed by wall-mounted stopwatch in the procedure room <br>