A clinical study of using copper intrauterine devices (IUDs) in emergency contraception
| ISRCTN | ISRCTN24843309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24843309 |
| Secondary identifying numbers | A15046/96506 |
- Submission date
- 14/01/2010
- Registration date
- 19/01/2010
- Last edited
- 19/01/2010
- 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 Shangchun Wu
Scientific
Scientific
National Research Institute for Family Planning
12 Da Hui Si, Hai Dian Qu
Beijing
100081
China
Study information
| Study design | Prospective multicentre efficacy trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Copper intrauterine contraception for emergency contraception: a prospective multicentre study |
| Study objectives | The TCu380A IUD is highly effective as an emergency contraceptive. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Efficacy of the TCu380A in parous and nulliparous Chinese women |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/1997 |
| Completion date | 15/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2000 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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) |
| Date of first enrolment | 01/07/1997 |
| Date of final enrolment | 15/01/2000 |
Locations
Countries of recruitment
- China
Study participating centre
National Research Institute for Family Planning
Beijing
100081
China
100081
China
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva
CH-1211
Switzerland
| info@who.int | |
| Website | http://www.who.int/en/ |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
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 |
