A randomised trial of interval insertion of the TCu380A and Levonorgestrel 20 mcg intrauterine device

ISRCTN	ISRCTN87220680
DOI	https://doi.org/10.1186/ISRCTN87220680
Secondary identifying numbers	WHO/HRP ID 91908

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 11/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tim Farley
Scientific

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

Email	farleyt@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Compare the clinical performance of two Intrauterine Devices (IUD).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Contraception
Intervention	TCu380A versus 20 mcg Levonorgestrel releasing IUD (Mirena).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levonorgestrel
Primary outcome measure	1. Pregnancy rates at five years 2. Discontinuation reasons at five years 3. Overall continuation rates at five years
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/12/1993
Completion date	01/07/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	3800
Key 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
Key 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
Date of first enrolment	01/12/1993
Date of final enrolment	01/07/1997

Locations

Countries of recruitment

Brazil
Chile
China
Hungary
Mongolia
Philippines
Slovenia
Switzerland
Thailand
Tunisia

Study participating centre

World Health Organization

Geneva
CH-1211
Switzerland

Sponsor information

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

Website	http://www.who.int/reproductive-health/hrp/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan