Intervention Review

Cervical cap versus diaphragm for contraception

  1. Maria F Gallo2,
  2. David A Grimes1,*,
  3. Kenneth F Schulz3,
  4. Laureen M Lopez1

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 20 JAN 2010

Assessed as up-to-date: 27 AUG 2009

DOI: 10.1002/14651858.CD003551

Database Title

Additional Information

How to Cite

Gallo MF, Grimes DA, Schulz KF, Lopez LM. Cervical cap versus diaphragm for contraception. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD003551. DOI: 10.1002/14651858.CD003551.

Author Information

  1. 1

    Family Health International, Behavioral and Biomedical Research, Research Triangle Park, North Carolina, USA

  2. 2

    Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, Georgia, USA

  3. 3

    Family Health International, Quantitative Sciences, Research Triangle Park, North Carolina, USA

*David A Grimes, Behavioral and Biomedical Research, Family Health International, PO Box 13950, Research Triangle Park, North Carolina, NC 27709, USA. dgrimes@fhi.org.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 JAN 2010

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

The cervical cap and the diaphragm are vaginal barrier contraceptive methods that prevent pregnancy by covering the cervix. The two devices also act as a reservoir for spermicide. The cervical cap is smaller and can remain in place longer than the diaphragm. The Prentif cap and the FemCap have been compared to the diaphragm in randomized controlled trials.

Objectives

To compare the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm.

Search methods

We searched MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS for randomized controlled trials of cervical caps. We wrote to manufacturers and investigators for information about other published or unpublished trials.

Selection criteria

All randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion.

Data collection and analysis

Articles identified for inclusion were independently abstracted by two reviewers. Data were entered into RevMan, and a second reviewer verified the data entered. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Outcomes were calculated as Peto odds ratios (OR) with 95% confidence intervals (CI). Life-table and Kaplan-Meier cumulative rate ratios for selected measures are presented.

Main results

The curves for the life-table cumulative pregnancy rates for the Prentif cap and the diaphragm did not differ. However, the Kaplan-Meier six-month cumulative pregnancy rates for the FemCap and the diaphragm were not clinically equivalent. The Prentif cap had more Class I to Class III cervical cytologic conversions than the diaphragm (OR 2.31; 95% CI 1.04 to 5.11). The FemCap trial did not find differences in Papanicolaou smear results between the groups. Fewer Prentif cap users had vaginal ulcerations or lacerations (OR 0.31; 95% CI 0.14 to 0.71) than diaphragm users. Fewer FemCap users had blood in the device (OR 2.29; 95% CI 1.27 to 4.14), but more had urinary tract infections (OR 0.59; 95% CI 0.39 to 0.95). In the FemCap trial, similar proportions of women reported liking their device. However, FemCap users were less likely to use the device alone after the trial (OR 0.47; 95% CI 0.31 to 0.71) or recommend it to a friend (OR 0.48; 95% CI 0.29 to 0.81).

Authors' conclusions

The Prentif cap was as effective as its comparison diaphragm in preventing pregnancy, but the FemCap was not. Both cervical caps appear to be medically safe.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Cervical cap versus diaphragm for birth control

The cervical cap and the diaphragm are small, rubber devices that women put in their vagina (birth canal) and place over their cervix. Both devices block sperm and help prevent pregnancy. Also, both hold a chemical that kills sperm. Birth control with these methods can be stopped at any time and can be used without involving the partner. The cervical cap is smaller than the diaphragm and can be left in place longer. The cervical cap can be worn up to 72 hours, and the diaphragm can be used up to 30 hours. In this review, we compared the cervical cap with the diaphragm for how well it worked for birth control. We also looked at its safety and whether women stopped using it early.

We did a computer search for studies of cervical caps. We wrote to manufacturers and researchers for information about other trials. We included randomized controlled trials that compared a cervical cap with a diaphragm.

We found two trials that compared the cervical cap with the diaphragm. Two types of cervical caps were studied: the Prentif cap and the FemCap. The Prentif cap prevented pregnancy as well as the diaphragm, but the FemCap did not. Women who used the Prentif cap had more abnormal changes in the cervix than diaphragm users. The FemCap users did not have more abnormal changes than the diaphragm users. Many women from both groups dropped out early from the two trials. Similar numbers of FemCap users and diaphragm users reported liking their assigned method.

The Prentif cap worked as well as the diaphragm to prevent pregnancy. The FemCap did not prevent pregnancy as well as the diaphragm. Both cervical caps appear to be medically safe.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

子宮頸帽(cerical cap)和子宮隔膜(diaphragm)的避孕效果

子宮頸帽和子宮隔膜都是一種置於陰道內的避孕器,利用屏蔽子宮頸的方式,來達到避孕之目的.這兩種避孕器都可內含殺精劑.子宮頸帽因體積較小,故比子宮隔膜更不易位移.有一些隨機試驗對於兩種子宮頸帽(Prentif cap及FemCap)與子宮隔膜做了比較.

目標

比較子宮頸帽和子宮隔膜對於避孕的效果,安全性,停止使用率以及接受度

搜尋策略

我們在MEDLINE, POPLINE, CENTRAL, EMBASE, 以及LILACS上搜尋有關子宮頸帽的隨機試驗,並且去函製造廠商及相關學者以獲取其他已發表或未發表的相關研究報告.

選擇標準

任何有關子宮頸帽和子宮隔膜之比較，不限語言的隨機對照試驗皆納入研究。

資料收集與分析

被選入的研究報告皆由兩位檢閱人獨立摘其精要。資料皆輸入RevMan軟體，且由第二位檢閱人檢查輸入的資料。評估項目包括兩種避孕方式的效力、安全性、停止使用率以及接受度。最後的數據以Peto odds ratios (OR)配合95%信賴區間(CI)來計算。上述的評估項目則以生命表(Lifetable)以及KaplanMeier 累積率比值來表現。

主要結論

在生命表中, Prentif cap或子宮隔膜的累積懷孕率的曲線並無差異.但是以KaplanMeier法分析6個月的累積懷孕率, FemCap與子宮隔膜則不相等.使用Prentif cap者較使用子宮隔膜者有更多子宮頸第一級(class I)至第三級(class III)的細胞變化(OR 2.31; 95% CI 1.04 – 5.11).至於在FemCap與子宮隔膜組中,子宮頸抹片的結果則未出現差異.使用Prentif cap者相比於使用子宮隔膜者,較少有陰道潰瘍或撕裂傷(OR 0.31; 95% CI 0.14 – 0.71).使用FemCap者較不會有血液殘留在此避孕裝置上(OR 2.29; 95% CI 1.27 – 4.14),但是出現泌尿道感染的情形較多(OR 0.59; 95% CI 0.39 – 0.95).在FemCap試驗中,喜歡FemCap或子宮隔膜的受試婦女比例差不多,但是FemCap的使用者傾向於試驗結束後不會再單獨使用FemCap(OR 0.47; 95% CI 0.31 – 0.71)或向朋友推薦OR 0.48; 95% CI 0.29 – 0.81).

作者結論

Prentif cap的避孕效果和子宮隔膜相當,但FemCap的避孕效果就較差.兩種子宮頸帽都是安全的.

翻譯人

本摘要由臺灣大學附設醫院陳怡伶翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

比較子宮頸帽和子宮隔膜的避孕效果:子宮頸帽和子宮隔膜都是小的,橡膠製的避孕裝置,可供婦女將之置入陰道(產道)以屏蔽子宮頸.兩種裝置都可阻擋精子進入子宮以達到避孕之效果.兩種避孕裝置也都可內含化學物以殺死精子.使用這兩種裝置避孕可隨時停止使用且不會影響性伴侶.子宮頸帽體積較小因此較子宮隔膜更能置於陰道久些.子宮頸帽可使用長達72小時,而子宮隔膜可使用30小時.在這篇回顧中,我們比較了子宮頸帽和子宮隔膜的避孕效果,並且探究了兩種裝置的安全性以及受試婦女的繼續使用意願.我們利用電腦搜尋有關子宮頸帽的研究.我們也去函製造廠商以及相關學者以獲得其他相關研究的資訊.我們蒐羅了有關子宮頸帽與子宮隔膜比較的研究文獻.我們找到了兩篇有關子宮頸帽與子宮隔膜比較的臨床試驗,其中包含了兩種子宮頸帽:Prentif cap及FemCap. Prentif cap 的避孕效果和子宮隔膜相當,但FemCap則否.使用Prentif cap者,與使用子宮隔膜者相比,其子宮頸出現異常變化的情形較多.使用FemCap者,較使用子宮隔膜者,其子宮頸出現異常變化的情形則無差異.在兩個試驗中皆有許多受試婦女提早退出試驗.喜歡FemCap者和喜歡子宮隔膜的數目相當. Prentif cap的避孕效果和子宮隔膜相同. FemCap的避孕效果則遜於子宮隔膜.兩種子宮頸帽都是安全的.

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