Unplanned Pregnancy Prevention
Conditions
Interventions
Copper IUD Group: 70 women, will be inserted copper IUD immediate postpartum. Women are assessed at 45, 90 days and then 1 year.
SIU Levonogestrel group:70 women, levonogestrel-releasing system will
Device
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 43 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 43 years; gestational age at delivery greater than or equal to 37 weeks; hemoglobin major than 8.0 during prenatal care; desire to use IUD as contraceptive method; immediate Postpartum of single gestation
Exclusion criteria
Exclusion criteria: Diagnosis or suspicion of ovular infection; diagnosis of any other infection (anywhere); active STD (sexually transmitted disease); uterine malformation (bicorn, septate);uterine myomatosis that deforms the cavity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cooper IUD or Levonogestrel IUS expulsion rate: assessed by transvaginal ultrasound. IUDs and non-uterine devices will be considered to be expelled during echographic evaluation of returns. | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstrual pattern: interval between menses, days of bleeding, and amount of menstrual bleeding measured in a period of 90 days prior to the date of the interview. The pattern described by the World Health Organization will be used where the menstrual pattern is classified in: 1) amenorrhea: no bleeding during the period taken as reference 2) infrequent bleeding: less than 3 episodes of bleeding 3) frequent bleeding: more than 5 episodes of bleeding 4) irregular bleeding: between 3 and 5 episodes of bleeding with less than 3 intervals without bleeding in the period of 14 days or more 5) prolonged bleeding: 1 or more episodes of bleeding lasting 14 days or more 6) none of the above: menstrual pattern "abnormal" ;Accumulated continuation rate: number of women that continues uses IUD after 1 year;Endometrial thickness: in mm evaluated by transvaginal ultrasonography;Satisfaction with the method through 3 questions answered through Likert scale: 1) Are you satisfied with the IUD you use? 1 to 10 2) Do you prefer to continue using this device? 1 to 10 3) Would you recommend this IUD to others? 1 to 10;Reason for acceptance: descriptive, open variable that will be regrouped after data collection; Cumulative pregnancy rate: number of women who became pregnant using the device in 1 year;Accumulated rate of removals for pain, bleeding, personal reasons or other medical reasons; Uterine perforation rate: describes the doctor who inserted the device | — |
Countries
Brazil
Contacts
Public ContactCassia ;Fernanda Juliato;Surita
Universidade Estadual de Campinas;Universidade Estadual de Campinas
Outcome results
None listed