Contraception Pregnancy and Childbirth Contraception
Conditions
Interventions
TCu380A versus 20 mcg Levonorgestrel releasing IUD (Mirena).
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age less than 40 and more than 16 years 2. Had at least one pregnancy of at least 20 weeks gestation or a foetus delivered weighing more than 500 g 3. Willing to participate and rely solely on the IUD as method of fertility regulation 4. Frequently exposed to risk of pregnancy 5. Ability to attend follow-up visits
Exclusion criteria
Exclusion criteria: 1. History of recurrent pelvic inflammatory disease (PID) 2. Pelvic abscess 3. Episode of PID in 12 months prior to admission 4. Valvular heart disease 5. History of sexually transmitted infections in past six months 6. Undiagnosed genital tract bleeding 7. Current cervical or vaginal infection 8. Congenital malformation of vagina, cervix or uterus 9. Known or suspected genital tract or breast malignancy 10. Multiple uterine fibroids associated with previous menstrual abnormalities 11. Less than six weeks since parturition or termination of pregnancy 12. Lactation of less than six months duration 13. Active liver disease 14. History of thrombosis or thromboembolic disease 15. Clinical or laboratory evidence of anaemia 16. History of ectopic pregnancy or hydatiform mole grand mal epilepsy receiving medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pregnancy rates at five years 2. Discontinuation reasons at five years 3. Overall continuation rates at five years | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Brazil, Chile, China, Hungary, Mongolia, Philippines, Slovenia, Thailand, Tunisia
Outcome results
None listed