Progress report on a study of the cervical cap

This study was conducted for the purpose of gathering more information on the effectiveness and convenience of the cervical cap as a contraceptive method; currently womens groups can only obtain and prescribe caps in the US if they secure an investigational device exemption from the FDA and subsequently carry out a study such as this one. This study focuses mainly on user satisfaction the propensity of study participants to continue using the cap over a long period of time and the incidence of cap failure or pregnancy. 8 clinical centers in 2 states fitted 872 women with the cap. There was however a high rate of attrition; only 580 of them returned for the 1-month checkups 307 for the 6-month and 113 for the 12-month. The strongest predictors for satisfaction with the cap were confidence in the cap and ease of insertion. More sexually active women were marginally more satisfied with the cap as were younger women and previous users of the diaphragm. Experiences of dislodgement trouble inserting the cap and cramps lowered womens satisfaction. The most influential factor affecting length of cap use was the womans use of spermicide with the cap: spermicide use substantially decreased the likelihood of continuing cap use. Prior use of the diaphragm increased continuity. Higher satisfaction with the cap was related of course to longer use. The analysis of failure pregnancies reveals that cap dislodgement (reported by 31% of the women) more than tripled the risk of pregnancy. Prior births also increased the likelihood of pregnancy. Women who reported difficulties inserting or removing the cap were about 2.5 times less likely to become pregnant than those who reported no such trouble. Prior diaphragm users who wre not using spermicide with the cap showed the lowest pregnancy rates; the highest pregnancy rates were observed for current spermicide users who had never used a diaphragm. It appears that 1st-time users of a spermicide require special attention and instruction in its proper use with the cervical cap.