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A controlled intrauterine contraceptive device trial.

G Dennerstein, R Langley, M Zimmerman

The Medical Journal of Australia

|March 5, 1977

Summary

The Dalkon Shield intrauterine contraceptive device (IUCD) was superior to the Inhiband over 12 months. No significant differences were found between the Dalkon Shield and Lippes Loop in this contraceptive device comparison.

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Area of Science:

Reproductive Health
Medical Device Technology
Clinical Trials

Background:

Intrauterine contraceptive devices (IUCDs) are widely used for birth control.
Comparative studies are essential to determine the efficacy and safety of different IUCD models.
Previous assessments of IUCDs have varied in methodology and outcomes.

Purpose of the Study:

To prospectively compare the performance of three specific intrauterine contraceptive devices: the Lippes Loop, the Dalkon Shield, and the Inhiband.
To evaluate the comparative effectiveness and safety profiles of these IUCDs over a 12-month period.
To assess the suitability of the study methodology for future IUCD evaluations.

Main Methods:

Random allocation of patients to one of three IUCD groups: Lippes Loop, Dalkon Shield, or Inhiband.
Prospective follow-up of patients for 12 months post-insertion.
Statistical analysis to compare device performance based on predefined metrics (though specific metrics are not detailed in the abstract).

Main Results:

The Dalkon Shield demonstrated significantly superior performance compared to the Inhiband over the 12-month trial period.
No statistically significant differences in performance were observed between the Dalkon Shield and the Lippes Loop.
Similarly, no significant differences were found when comparing the Lippes Loop and the Inhiband within the trial's duration.

Conclusions:

The Dalkon Shield appears to be a more effective IUCD option than the Inhiband based on the study's findings.
The study methodology employed is recommended for future comparative assessments of intrauterine contraceptive devices.
Further research may be warranted to explore long-term outcomes and a broader range of IUCDs.

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