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A multi-center randomized controlled trial of post-market monitoring for safety of three intrauterine devices

"Study on establishing approaches to assess the safety of contraceptive devices", A key project of "The Tenth Five-Year Plan" on Scientific and Technologic Research in China

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-06000003
Enrollment
Unknown
Registered
2006-08-02
Start date
2005-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproduction health

Interventions

Group 2:Copper intrauterine device TCu380A (28mm, 30mm and 32mm)
Group 3:Yuan Gong Copper intrauterine device: type Yuan Gong-365, contain Indometacin 20mg
Group 1:Multiload Copper intrauterine device (MLCu375)

Sponsors

Jiangsu Institute of Planned Parenthood Research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Married women of childbearing age who have had one child and were voluntary to use intrauterine devices (IUDs) to contracept in a long term without any contraindication.

Exclusion criteria

Exclusion criteria: Woman with any of the following conditions will be excluded: pregnancy, edeitis, irregular menses or epimenorrhagia in the last three months, inner-port of cervix was excessively loose, or with severe laceration or severe stenosis, uterine prolapse greater than II degree, Genital malformations, uterine cavity smaller than 5.5 cm or larger than 9 cm, post-abortion with bad uterine contraction, heavy hemorrhage, residual pregnancy organ or infection, sever acute or chronic systemic disease in postpartum or post-caesarean section, allergic history for Copper, lochia not been cleared over 42 days after abortion or perineum wound not recovered, genital tumour, anaemia (Hb<90g/L), ectopic pregnancy history.

Design outcomes

Primary

MeasureTime frame
Severe adverse events rate;

Secondary

MeasureTime frame
Bleeding, pain, infection, copper hypersensitivity;continuation rate of IUD, withdrawing rate of IUD, pregnancy rate, ectopic pregnancy rate, expulsion;

Countries

China

Contacts

Public ContactLi Ying
fply@public1.ptt.js.cn+86 25 86576001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026