在终端用户参与下开发的单一尺寸子宫帽的避孕效果、安全性、贴合度及可接受性。

Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input.

作者信息

Schwartz Jill L, Weiner Debra H, Lai Jaim Jou, Frezieres Ron G, Creinin Mitchell D, Archer David F, Bradley Lynn, Barnhart Kurt T, Poindexter Alfred, Kilbourne-Brook Maggie, Callahan Marianne M, Mauck Christine K

机构信息

CONRAD, Eastern Virginia Medical School, Arlington, Virginia; FHI 360, Durham, North Carolina; the California Family Health Council, Los Angeles, California; the University of Pittsburgh, Pittsburgh, Pennsylvania; Johns Hopkins Community Physicians, Baltimore, Maryland; the University of Pennsylvania, Philadelphia, Pennsylvania; Baylor College of Medicine, Houston, Texas; and PATH, Seattle, Washington. Dr. Creinin is currently affiliated with the University of California, Davis, Sacramento, California.

出版信息

Obstet Gynecol. 2015 Apr;125(4):895-903. doi: 10.1097/AOG.0000000000000721.

DOI:10.1097/AOG.0000000000000721

PMID:25751199

Abstract

OBJECTIVE

To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel.

METHODS

We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels.

RESULTS

Most (439/450 [98%]) women could be fitted with the single-size diaphragm. A total of 421 of 450 (94%) provided follow-up. The 35 study pregnancies yielded 6-month Kaplan-Meier cumulative typical use pregnancy probabilities per 100 women with 95% confidence intervals (CIs) of 10.4 (6.9-14.0) for all users and 9.6 (5.5-13.6) and 12.5 (5.4-19.5) with acid-buffering gel and nonoxynol-9, respectively. Historical control analysis yielded a propensity score-adjusted estimate of this pregnancy probability for the single-size diaphragm of 11.3 compared with 10.7 per 100 women for the standard diaphragm ([rounded] difference 0.7, 95% CI -3.6 to 4.9). Approximately half (51%) reported at least one urogenital event but compared favorably to the standard diaphragm in historical control analysis. Most (282/342 [82%]) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm.

CONCLUSION

The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877.

摘要

目的

评估与避孕凝胶配合使用的单一尺寸阴道隔膜的避孕效果、安全性、可接受性及适配性。

方法

我们开展了一项多中心试验，450对夫妇使用单一尺寸阴道隔膜，其中300对随机分配使用酸缓冲凝胶，150对使用壬苯醇醚-9，使用时间至少为190天且历经六个月经周期。访视时间点为入组时以及月经周期1、3和6结束后。研究结局包括妊娠概率、安全性、可接受性及适配性。将妊娠和安全性情况与使用这些凝胶搭配标准阴道隔膜的历史对照组进行比较。

结果

大多数（439/450 [98%]）女性能够适配单一尺寸阴道隔膜。450名女性中有421名（94%）提供了随访数据。35例研究妊娠得出每100名女性6个月的Kaplan-Meier累积典型使用妊娠概率，所有使用者的95%置信区间（CI）为10.4（6.9 - 14.0），使用酸缓冲凝胶者为9.6（5.5 - 13.6），使用壬苯醇醚-9者为12.5（5.4 - 19.5）。历史对照分析得出单一尺寸阴道隔膜的该妊娠概率经倾向得分调整后的估计值为每100名女性11.3，而标准阴道隔膜为10.7（[四舍五入后]差值0.7，95% CI -3.6至4.9）。约半数（51%）报告至少发生了一次泌尿生殖系统事件，但在历史对照分析中与标准阴道隔膜相比情况较好。大多数（282/342 [82%]）喜欢该阴道隔膜。结果表明，如果由临床医生提供指导，94%（95% CI 92 - 96%）的女性能够插入、正确放置并取出阴道隔膜。