Contraception Pregnancy and Childbirth Contraceptive management
Conditions
Interventions
Eligible participants requesting EC up to 120 hours after unprotected intercourse and desiring long-term contraception with IUD, were given TCu380A IUD and followed for 12 months, including follow-up
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Requesting emergency contraception within 120 hour of unprotected intercourse 2. Regular menstrual cycles (24 to 42 days with no more than 5 days variation) 3. Having at least one spontaneous cycle before current cycle after recent discontinued hormonal contraception, abortion or delivery 4. Desire to use IUD as long term contraceptive 5. Available for follow up in one month, three months and 12 months 6. Negative pregnancy test 7. Aged 18 - 44 years
Exclusion criteria
Exclusion criteria: 1. Suspected or confirmed pregnancy 2. Any episode of pelvic inflammatory disease (PID) or pelvic abscess in the 12 months preceding trial admission 3. Sexually transmitted infection (STI) within the past six months 4. Any evidence of STI in clinical or laboratory examination during screening 5. Multiple sexual partners 6. Known or suspected genital tract malignancy 7. Cervical or uterine malformations 8. Vaginal bleeding of unknown aetiology 9. Multiple uterine fibroids associated with previous menstrual anomalies 10. Clinical or laboratory evidence of anaemia (haemoglobin less than 9 g/l) 11. Unsure about the date of their last menstrual period (LMP needed for pregnancy risk assessment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of the TCu380A in parous and nulliparous Chinese women | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effects of the TCu380A in parous and nulliparous Chinese women 2. Complications (such as upper genital tract infection) in the women who have IUD insertion for the purpose of emergency contraception 3. Continuation rate at one year of use | — |
Countries
China
Outcome results
None listed