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Failed intrauterine device contraception and limb reduction deformities: a case-control study.

Three recent case reports have suggested an association between failed intrauterine device (IUD) contraception and limb reduction deformities in the resulting offspring. To clarify further the purported teratogenic role of the IUD in the etiology of these defects, we conducted a case-control study of 96 mothers who had given birth to infants with limb defects. Interview data about IUD exposure at conception among these mothers were compared with interview data from 2 sets of controls: (1) 915 mothers of infants with other major defects and (2) a subset of the first group consisting of 169 mothers with chromosomally defective infants. No significant increase in the incidence of IUD use was found for cases when compared with either control group. Estimates of the relative risk were 1.28 (95% confidence limits [CL]of 0.29 to 5.67) and 1.78 (95% CL of 0.25 to 12.82) when the first and second groups of controls were used, respectively. These risk figures were not significantly different from 1.0. The evidence accumulated thus far militates against a teratogenic role for the IUD.

Clinical Trials as Topic↗

New female intravaginal barrier contraceptive device. Preliminary clinical trial.

The Fem Cap, a silicone rubber cervical cap, is shaped like a sailor's hat. While its dome covers the cervix, its rim fits snugly into the vaginal fornices, and its brim adheres and conforms to the vaginal walls. A spermicidal material is applied to the cap, then it is positioned over the cervix by hand or with a special applicator. The device is removed by hand up to 48 hours after insertion, but no sooner than eight hours after intercourse. Women chosen for the trial had contraindications to or were dissatisfied with the currently available contraceptive methods. Each woman was fitted with a cap of suitable size and instructed in its use. She was then asked to note any side effects and the dates of her menses in a diary. One-hundred-twenty-one women were enrolled in the study. Five became pregnant. Of those, two reported dislodgment of the cap during intercourse; the other three admitted to non-use of the cap on several occasions. This device has proven so far to be safe, effective and acceptable to women and men. It has several advantages over the currently available barrier contraceptive devices. The silicone rubber material from which it is made is non-allergenic, durable and easy to clean. Its design fits the anatomy and accommodates physiological changes. The Fem Cap is easy to insert and remove; an applicator facilitates insertion for some women. Instruction for use of the device requires short time from the health care provider.

Adolescent↗