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

ISRCTN	ISRCTN87220680
DOI	https://doi.org/10.1186/ISRCTN87220680
Protocol serial number	WHO/HRP ID 91908
Sponsor	UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Funder	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)

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

Dr Tim Farley
Scientific

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

Email	farleyt@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levonorgestrel
Primary outcome measure(s)	1. Pregnancy rates at five years 2. Discontinuation reasons at five years 3. Overall continuation rates at five years
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/07/1997

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

World Health Organization

Geneva
CH-1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan