Bernstein G S, Kilzer L H, Coulson A H, Nakamura R M, Smith G C, Bernstein R, Frezieres R, Clark V A, Coan C
Contraception. 1982 Nov;26(5):443-56. doi: 10.1016/0010-7824(82)90143-3.
Prior to investigating the contraceptive efficacy of cervical caps, we undertook a preliminary study to evaluate potential side effects of these devices. Women who had not previously used a cap were randomly assigned to wear either a Vimule or Cavity Rim Cap (CRC) for as long as seven days. The Vimule cap caused lesions of the portio vaginalis ranging from erythematous impressions to abrasions and frank lacerations. There was variation in the degree of trauma depending, in part, on the size of the cap and duration of wear. Disruption of the epithelium occurred in eight of twelve Vimule users, but the lesions were sometimes difficult to see owing to their location. CRCs were worn by 20 women. This device sometimes left a "suction ring" on the cervix but did not disrupt the epithelium. Two of three long-term users of the Vimule cap who were also studied had unusual formations of the vaginal mucosa suggesting a proliferative reaction to chronic irritation. It is recommended that all women using a Vimule Cap be carefully re-examined and counseled about further use of the device according to the findings of the examination.
在研究宫颈帽的避孕效果之前，我们进行了一项初步研究，以评估这些器械的潜在副作用。以前未使用过宫颈帽的女性被随机分配佩戴Vimule宫颈帽或腔缘帽（CRC）长达7天。Vimule宫颈帽导致阴道部出现病变，从红斑压痕到擦伤和明显撕裂伤不等。创伤程度存在差异，部分取决于宫颈帽的大小和佩戴时间。12名佩戴Vimule宫颈帽的使用者中有8人出现上皮破坏，但由于病变位置的原因，有时难以看到。20名女性佩戴了CRC。该器械有时会在宫颈上留下“吸力环”，但不会破坏上皮。在接受研究的3名长期使用Vimule宫颈帽的使用者中，有2人出现阴道黏膜异常形成，提示对慢性刺激的增殖反应。建议根据检查结果，对所有使用Vimule宫颈帽的女性进行仔细复查，并就该器械的进一步使用提供咨询。
