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ISRCTN
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ISRCTN24843309
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ClinicalTrials.gov identifier
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Public title
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A clinical study of using copper intrauterine devices (IUDs) in emergency contraception
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Scientific title
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Copper intrauterine contraception for emergency contraception: a prospective multicentre study
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Acronym
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N/A
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Serial number at source
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A15046/96506
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Study hypothesis
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The TCu380A IUD is highly effective as an emergency contraceptive.
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Lay summary
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Ethics approval
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1. China: Institutional Review Board of National Research Institute for Family Planning approved on the 20th September 2005 (ref: A15046; Protocol: 96506)
2. WHO Secretariat Committee on Research Involving Human Subjects
All other centres will seek ethics approval before recruiting participants.
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Study design
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Prospective multicentre efficacy trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Contraception
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/07/1997
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Anticipated end date
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15/01/2000
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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2000
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Interventions
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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 visits 1 and 3 months after the IUD insertion.
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Primary outcome measure(s)
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Efficacy of the TCu380A in parous and nulliparous Chinese women
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Secondary outcome measure(s)
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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
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Sources of funding
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World Health Organization (WHO) (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Shangchun
Wu
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Address
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National Research Institute for Family Planning
12 Da Hui Si, Hai Dian Qu
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City/town
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Beijing
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Zip/Postcode
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100081
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Country
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China
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Sponsor
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World Health Organization (WHO) (Switzerland)
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Address
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20 Avenue Appia
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City/town
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Geneva
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Email
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info@who.int
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Sponsor website:
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http://www.who.int/en/
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Date applied
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14/01/2010
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Last edited
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19/01/2010
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Date ISRCTN assigned
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19/01/2010
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