Condition category
Pregnancy and Childbirth
Date applied
14/01/2010
Date assigned
19/01/2010
Last edited
19/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shangchun Wu

ORCID ID

Contact details

National Research Institute for Family Planning
12 Da Hui Si
Hai Dian Qu
Beijing
100081
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A15046/96506

Study information

Scientific title

Copper intrauterine contraception for emergency contraception: a prospective multicentre study

Acronym

Study hypothesis

The TCu380A IUD is highly effective as an emergency contraceptive.

Ethics approval

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.

Study design

Prospective multicentre efficacy trial

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/1997

Overall trial end date

15/01/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2000

Participant 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)

Recruitment start date

01/07/1997

Recruitment end date

15/01/2000

Locations

Countries of recruitment

China

Trial participating centre

National Research Institute for Family Planning
Beijing
100081
China

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva
CH-1211
Switzerland
info@who.int

Sponsor type

Research organisation

Website

http://www.who.int/en/

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes