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ISRCTN
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ISRCTN87220680
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ClinicalTrials.gov identifier
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Public title
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A randomised trial of interval insertion of the TCu380A and Levonorgestrel 20 mcg intrauterine device
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Scientific title
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Acronym
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N/A
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Serial number at source
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WHO/HRP ID 91908
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Study hypothesis
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Compare the clinical performance of two Intrauterine Devices (IUD).
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Brazil, Chile, China, Hungary, Mongolia, Philippines, Slovenia, Thailand, Tunisia
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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. 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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/12/1993
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Anticipated end date
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01/07/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3800
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Interventions
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TCu380A versus 20 mcg Levonorgestrel releasing IUD (Mirena).
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Primary outcome measure(s)
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1. Pregnancy rates at five years
2. Discontinuation reasons at five years
3. Overall continuation rates at five years
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
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Trial website
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Publications
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Contact name
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Dr
Tim
Farley
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Address
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World Health Organization
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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farleyt@who.int
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Sponsor
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UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
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Address
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World Health Organization
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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Sponsor website:
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http://www.who.int/reproductive-health/hrp/
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Date applied
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19/03/2004
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Last edited
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11/08/2008
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Date ISRCTN assigned
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01/04/2004
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