A clinical study of using copper intrauterine devices (IUDs) in emergency contraceptio

Completed

Conditions: Contraception
Pregnancy and Childbirth
Contraceptive management

Registration Number: ISRCTN24843309

Lead Sponsor: World Health Organization (WHO) (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 2000

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the TCu380A in parous and nulliparous Chinese women

Secondary Outcome Measures

Name	Time	Method
1. Side effects of the TCu380A in parous and nulliparous Chinese women<br>2. Complications (such as upper genital tract infection) in the women who have IUD insertion for the purpose of emergency contraception<br>3. Continuation rate at one year of use