Assessment of pain, ease of insertion and clinical performance of three types of intrauterine devices (copper, Mirena® and Kyleena®) in adolescents
Phase 4
- Conditions
- Adolescent, insertion of intrauterine device
- Registration Number
- RBR-8rczn6p
- Lead Sponsor
- niversidade Estadual de Campinas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Women up to 19 years old who want contraception with an IUD, nuligest or with children.
Exclusion Criteria
Confirmed or suspected pregnancy. Sexually Transmitted Disease (STD) active. Pelvic inflammatory disease. Malformation of the uterus or intracavitary myoma that distorts the uterine cavity.Genital bleeding of an unknown nature. Previous surgery in the cervix.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method It is expected to find a very similar contraceptive performance between the three types of devices among adolescents with very low pregnancy rate (0.1/100 women/year).
- Secondary Outcome Measures
Name Time Method Assess pain during device insertion using the analogue pain scale, comparing the three types of device which will have the lowest score.;Assess the technical difficulty for inserting the device, according to the assessment of the professional who inserted it (easy, difficult, need to use candles, need to use misoprostol), comparing the three methods (Copper, Kyllena and Mirena).;Assess satisfaction with the method used, using a Likert scale, comparing the 3 methods, <br>which has the best score.