Assessment of pain, ease of insertion and clinical performance of three types of intrauterine devices (copper, Mirena® and Kyleena®) in adolescents

Assessment of pain, ease of insertion and clinical performance of three types of intrauterine devices (copper, Mirena® and Kyleena®) in adolescents: partially blind randomized study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-8rczn6p

Enrollment

Unknown

Registered

2021-10-15

Start date

2021-11-10

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, insertion of intrauterine device

Interventions

A questionnaire will be filled out with socioeconomic and gynecological information for all participants (318 in total), then the drawn IUD will be inserted, there will be 3 different groups, with 109

E07.190.250.510

Eligibility

Sex/Gender

Female

Age

No minimum to 19 Years

Inclusion criteria

Inclusion criteria: Women up to 19 years old who want contraception with an IUD, nuligest or with children.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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, which has the best score.	—

Measure

Time frame

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, which has the best score.

—

Countries

Brazil

Contacts

Public ContactLuis;Fabianny Bahamondes;de Oliveira

;

drluibahamondes@hotmail.com;fabianny_torres@hotmail.com+55-019-32892856;55 (82) 99982-5455

Outcome results

None listed

Source: REBEC (via WHO ICTRP)