A randomised trial of interval insertion of the TCu380A and Levonorgestrel 20 mcg intrauterine device
- Conditions
- ContraceptionPregnancy and Childbirth
- Registration Number
- ISRCTN87220680
- Lead Sponsor
- DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 3800
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pregnancy rates at five years<br>2. Discontinuation reasons at five years<br>3. Overall continuation rates at five years
- Secondary Outcome Measures
Name Time Method o secondary outcome measures