The diaphragm is a barrier method of birth control.[3] It is moderately effective, with a one-year failure rate of around 12% with typical use.[4] It is placed over the cervix with spermicide before sex and left in place for at least six hours after sex.[5][6] Fitting by a healthcare provider is generally required.[5]
Before inserting or removing a diaphragm, one's hands should be washed[10] to avoid introducing harmful bacteria into the vaginal canal.
The rim of a diaphragm is squeezed into an oval or arc shape for insertion. A water-based lubricant (usually spermicide) may be applied to the rim of the diaphragm to aid insertion. One teaspoon (5 mL) of spermicide may be placed in the dome of the diaphragm before insertion, or with an applicator after insertion.[11]
The diaphragm must be inserted sometime before sexual intercourse, and remain in the vagina for 6 to 8 hours after a man's last ejaculation.[12] For multiple acts of intercourse, it is recommended that an additional 5 mL of spermicide be inserted into the vagina (not into the dome—the seal of the diaphragm should not be broken) before each act. Upon removal, a diaphragm should be cleansed with mild soap and warm water before storage. The diaphragm must be removed for cleaning at least once every 24 hours[11] and can be re-inserted immediately.
Oil-based products should not be used with latex diaphragms. Lubricants or vaginal medications that contain oil will cause the latex to rapidly degrade and greatly increases the chances of the diaphragm breaking or tearing.[12]
Natural latex rubber will degrade over time. Depending on usage and storage conditions, a latex diaphragm should be replaced every one to three years.[13][14] Silicone diaphragms may last much longer—up to ten years.
Effectiveness
The effectiveness of diaphragms, as of most forms of contraception, can be assessed two ways: method effectiveness and actual effectiveness. The method effectiveness is the proportion of couples correctly and consistently using the method who do not become pregnant. Actual effectiveness is the proportion of couples who intended that method as their sole form of birth control and do not become pregnant; it includes couples who sometimes use the method incorrectly, or sometimes not at all. Rates are generally presented for the first year of use. Most commonly the Pearl Index is used to calculate effectiveness rates, but some studies use decrement tables.
For all forms of contraception, actual effectiveness is lower than method effectiveness, due to several factors:
mistakes on the part of those providing instructions on how to use the method
mistakes on the part of the method's users
conscious user non-compliance with method
For instance, someone using a diaphragm might be fitted incorrectly by a health care provider, or by mistake remove the diaphragm too soon after intercourse, or simply choose to have intercourse without placing the diaphragm.
Contraceptive Technology reports that the method failure rate of the diaphragm with spermicide is 6% per year.[15]
The actual pregnancy rates among diaphragm users vary depending on the population being studied, with yearly rates of 10%[16] to 39%[17] being reported.
Unlike some other cervical barriers, the effectiveness of the diaphragm is the same for women who have given birth as for those who have not.[18]
Advantages
The diaphragm does not interfere with a woman's menstrual cycle, therefore, no reversal or waiting time is necessary if contraception is no longer wanted or needed.
The diaphragm only has to be used during intercourse. Many women, especially those who have sex less frequently, prefer barrier contraception such as the diaphragm over methods that require some action every day.[10]
Like all cervical barriers, diaphragms may be inserted several hours before use, allowing uninterrupted foreplay and intercourse. Most couples find that neither partner can feel the diaphragm during intercourse.
The diaphragm is less expensive than many other methods of contraception.[11]
Sexually transmitted infections
There is some evidence that the cells in the cervix are particularly susceptible to certain sexually transmitted infections (STIs). Cervical barriers such as diaphragms may offer some protection against these infections.[14] However, research conducted to test whether the diaphragm offers protection from HIV found that women provided with both male condoms and a diaphragm experienced the same rate of HIV infection as women provided with male condoms alone.[19]
Because pelvic inflammatory disease (PID) is caused by certain STIs, diaphragms may lower the risk of PID.[20] Cervical barriers may also protect against human papillomavirus (HPV), the virus that causes cervical cancer, although the protection appears to be due to the spermicide used with diaphragms and not the barrier itself.[21]
Diaphragms are also considered a good candidate as a delivery method for microbicides (preparations that, used vaginally, protect against STIs) that are currently in development.[14]
Side effects
Women (or their partners) who are allergic to latex should not use a latex diaphragm.
Diaphragms are associated with an increased risk of urinary tract infection (UTI)[22] Urinating before inserting the diaphragm, and also after intercourse, may reduce this risk.[10]
Toxic shock syndrome (TSS) occurs at a rate of 2.4 cases per 100,000 women using diaphragms, almost exclusively when the device is left in place longer than 24hours.[11]
The increase in risk of UTIs may be due to the diaphragm applying pressure to the urethra, especially if the diaphragm is too large, and causing irritation and preventing the bladder from emptying fully. However, the spermicide nonoxynol-9 is itself associated with increased risk of UTI, yeast infection, and bacterial vaginosis.[23] For this reason, some advocate use of lactic acid or lemon juice based spermicides, which might have fewer side effects.[24]
It has also been suggested that, for women who experience side effects from nonoxynol-9, it may be acceptable to use the diaphragm without any spermicide. One study found an actual pregnancy rate of 24% per year in women using the diaphragm without spermicide; however, all women in this study were given a 60mm diaphragm rather than being fitted by a clinician.[25] Other studies have been small and given conflicting results.[26][27] The current recommendation is still for all diaphragm users to use spermicide with the device.[28]
In the early 1920s, Marie Stopes claimed that when wearing a diaphragm, the vagina is stretched such that certain movements made by the woman for the benefit of the man were restricted by the diaphragm spring. In later years there was some discussion of this, with two authors supporting this concept and one opposed. One of them argued in the later 1920s-1930s that while the muscle movement by women is restricted it does not make all that much difference since most "women (in the 1920s) are not able to operate their pelvic muscles voluntarily to the best advantage" (during sex). However, Stopes anticipated this rebuttal, and in so many words classified it as a lame excuse.[29]
Types
Diaphragms are available in diameters of 50mm to 105mm (about 2–4inches). They are available in two different materials: latex and silicone. Diaphragms are also available with different types of springs in the rim.[30]
An arcing spring folds into an arc shape when the sides are compressed. This is the strongest type of rim available in a diaphragm, and may be used by women with any level of vaginal tone. Unlike other spring types, arcing springs may be used by women with mild cystocele, rectocele, or retroversion.[31] Arcing spring diaphragms may be easier to insert correctly than other spring types.[32]
A coil spring flattens into an oval shape when the sides are compressed. This rim is not as strong as the arcing spring, and may only be used by women with average or firm vaginal tone.[11] If an arcing spring diaphragm is uncomfortable for a woman or, during intercourse, her partner, a coil spring may prove more satisfactory. Unlike the arcing spring diaphragms, coil springs may be inserted with a device called an introducer.
A flat spring is much like a coil spring, but thinner. This type of rim may only be used by women with firm vaginal tone. Flat spring diaphragms may also be inserted with an introducer for women uncomfortable using their hands.[11] Ortho used to manufacture a flat-spring diaphragm called the Ortho White.[33] Reflexions also manufactured a flat-spring diaphragm up until 2014.[30][31]
There are a number of variations. The SILCS diaphragm is made of silicone, has an arcing spring, and a finger cup is molded on one end for easy removal. The Duet disposable diaphragm is made of dipped polyurethane, pre-filled with BufferGel (BufferGel is currently in clinical trials as a spermicide and microbicide).[30] Both the SILCS and Duet diaphragms come in only one size.
Diaphragms usually come in different sizes and require a fitting appointment with a health care professional to determine which size a woman should wear. Single size diaphragms that do not require fitting also exist.[34]
A correctly fitting diaphragm will cover the cervix and rest snugly against the pubic bone. A diaphragm that is too small might fit inside the vagina without covering the cervix, or might become dislodged from the cervix during intercourse or bowel movements.[11] It is also more likely that a woman's partner will feel the anterior rim of a diaphragm that is too small during intercourse. A diaphragm that is too large will place pressure on the urethra, preventing the bladder from emptying completely and increasing the risk of urinary tract infection.[11] A diaphragm that is too large may also cause a sore to develop on the vaginal wall.[35]
Diaphragms should be re-fitted after a weight change of 4.5kg (10lb) or more.[12] The traditional clinical guideline is that a decrease in weight may cause a woman to need a larger size, although the strength of this relationship has been questioned.[36]
Diaphragms should also be re-fitted after any pregnancy of 14 weeks or longer.[10] Full-term vaginal delivery especially will tend to increase the size diaphragm a woman needs, although the changes to the pelvic floor during pregnancy mean even women who experience second-trimester miscarriage, or deliver by C-section, should be refitted.
Vaginal tenting, an increase in the length of the vagina, occurs during arousal. This means that during intercourse, the diaphragm will not fit snugly against the pubic bone because it is carried higher up the vaginal canal by the movement of the cervix. If the diaphragm is inserted after arousal has begun, extra care must be taken to ensure the device is covering the cervix.[13]
A woman might be fitted with a different size diaphragm depending on where she is in her menstrual cycle. It is common for a woman to wear a larger diaphragm during menstruation. It has been speculated that a woman may be fitted with a larger size diaphragm when she is near ovulation.[37] The correct size for a woman is the largest size that she can wear comfortably throughout her cycle.
In the United States, diaphragms are available by prescription only. Many other countries do not require prescriptions.
Mechanism of action
The spring in the rim of the diaphragm forms a seal against the vaginal walls. The diaphragm covers the cervix, and physically prevents sperm from entering the uterus through the os.
Traditionally, the diaphragm has been used with spermicide, and it is widely believed the spermicide significantly increases the effectiveness of the diaphragm. Insufficient studies have been conducted to determine effectiveness without spermicide.[38][needs update]
It is widely taught that additional spermicide must be placed in the vagina if intercourse occurs more than six hours after insertion.[10][13] However, there has been very little research on how long spermicide remains active within the diaphragm. One study found that spermicidal jelly and creme used in a diaphragm retained its full spermicidal activity for twelve hours after placement of the diaphragm.[39]
It has long been recommended that the diaphragm be left in place for at least six or eight hours after intercourse. No studies have been done to determine the validity of this recommendation, however, and some medical professionals have suggested intervals of four hours[40] or even two hours[41] are sufficient to ensure efficacy. One manufacturer of contraceptive sponges recommends leaving the sponge in place for only two hours after intercourse.[42] However, such use of the diaphragm (removal before 6 hours post-intercourse) has never been formally studied, and cannot be recommended.
It has been suggested that diaphragms be dispensed as a one-size-fits-all device, providing all women with the most common size (70mm). However, only 33% of women fitted for a diaphragm are prescribed a 70mm size, and correct sizing of the diaphragm is widely considered necessary.[43]
History
Photo of Caya diaphragm
The idea of blocking the cervix to prevent pregnancy is thousands of years old. Various cultures have used cervix-shaped devices such as oiled paper cones or lemon halves, or have made sticky mixtures that include honey or cedarresin to be applied to the cervical opening.[44] However, the diaphragm—which stays in place because of the spring in its rim, rather than hooking over the cervix or being sticky—is of more recent origin.
An important precursor to the invention of the diaphragm was the rubber vulcanization process, patented by Charles Goodyear in 1844. In the 1880s, a German gynecologist, Wilhelm P. J. Mensinga, published the first description of a rubber contraceptive device with a spring molded into the rim. Mensinga wrote first under the pseudonym C. Hasse, and the Mensinga diaphragm was the only brand available for many decades.[45][46][47] In the United States, the physician Edward Bliss Foote designed and sold an early form of occlusive pessary under the name "womb veil" starting in the 1860s.[48]
American birth control activist Margaret Sanger fled to Europe in 1914 to escape prosecution under the Comstock laws, which prohibited sending contraceptive devices, or information about contraception, through the mail. Sanger learned about the diaphragm in the Netherlands and introduced the product to the United States when she returned in 1916. Sanger and her second husband, Noah Slee, illegally imported large quantities of the devices from Germany and the Netherlands. In 1925, Slee provided funding to Sanger's friend Herbert Simonds, who used the funds to found the first diaphragm manufacturing company in the U.S., the Holland-Rantos Company.[44][49]
Diaphragms played a role in overturning the federal Comstock Act. In 1932, Sanger arranged for a Japanese manufacturer to mail a package of diaphragms to a New York physician who supported Sanger's activism. U.S. customs confiscated the package, and Sanger helped file a lawsuit. In 1936, in the court case United States v. One Package of Japanese Pessaries, a federal appellate court ruled that the package could be delivered.[44]
Although in Europe, the cervical cap was more popular than the diaphragm, the diaphragm became one of the most widely used contraceptives in the United States. In 1940, one-third of all U.S. married couples used a diaphragm for contraception. The number of women using diaphragms dropped dramatically after the 1960s introduction of the intrauterine device and the combined oral contraceptive pill. In 1965, only 10% of U.S. married couples used a diaphragm for contraception.[47] That number has continued to fall, and in 2002 only 0.2% of American women were using a diaphragm as their primary method of contraception.[50]
In 2014 Janssen Pharmaceuticals announced the discontinuation of the Ortho-All Flex Diaphragm, making it very difficult for women in the US to have that option as a birth-control method.[51][52][unreliable source?]
The single-sized, silicone diaphragm was developed by PATH during the late 2000s. It was licensed to Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany, which began to market it as the Caya Diaphragm. The diaphragm was approved for contraception in Europe in 2013 and in the United States the following year.[53] Since then, Kessel has also developed a traditionally circular, multi-sized diaphragm made from the same materials that they released in Germany in 2020 under the name Singa.[54][55]
Society and culture
Economics
In the United Kingdom they cost the National Health Service less than £10 each.[56] In the United States they cost about US$15 to $75 and are the birth control method of 0.3% of women.[57] These costs do not include that of spermicide.[58]
Related Research Articles
The cervix or cervix uteri is the lower part of the uterus (womb) in the human female reproductive system. The cervix is usually 2 to 3 cm long and roughly cylindrical in shape, which changes during pregnancy. The narrow, central cervical canal runs along its entire length, connecting the uterine cavity and the lumen of the vagina. The opening into the uterus is called the internal os, and the opening into the vagina is called the external os. The lower part of the cervix, known as the vaginal portion of the cervix, bulges into the top of the vagina. The cervix has been documented anatomically since at least the time of Hippocrates, over 2,000 years ago.
Intrauterine device (IUD) with copper(shortly called CU-T), also known as intrauterine coil or copper coil, is a type of intrauterine device which contains copper. It is used for birth control and emergency contraception within five days of unprotected sex. It is one of the most effective forms of birth control with a one-year failure rate around 0.7%. The device is placed in the uterus and lasts up to twelve years. It may be used by women of all ages regardless of whether or not they have had children. Following removal, fertility quickly returns.
Fertility awareness (FA) refers to a set of practices used to determine the fertile and infertile phases of a woman's menstrual cycle. Fertility awareness methods may be used to avoid pregnancy, to achieve pregnancy, or as a way to monitor gynecological health.
Safe sex is sexual activity using methods or contraceptive devices to reduce the risk of transmitting or acquiring sexually transmitted infections (STIs), especially HIV. "Safe sex" is also sometimes referred to as safer sex or protected sex to indicate that some safe sex practices do not eliminate STI risks. It is also sometimes used colloquially to describe methods aimed at preventing pregnancy that may or may not also lower STI risks.
Cervicitis is inflammation of the uterine cervix. Cervicitis in women has many features in common with urethritis in men and many cases are caused by sexually transmitted infections. Non-infectious causes of cervicitis can include intrauterine devices, contraceptive diaphragms, and allergic reactions to spermicides or latex condoms. Cervicitis affects over half of all women during their adult life.
Nonoxynol-9, sometimes abbreviated as N-9, is an organic compound that is used as a surfactant. It is a member of the nonoxynol family of nonionic surfactants. N-9 and related compounds are ingredients in various cleaning and cosmetic products. It is widely used in contraceptives for its spermicidal properties.
Spermicide is a contraceptive substance that destroys sperm, inserted vaginally prior to intercourse to prevent pregnancy. As a contraceptive, spermicide may be used alone. However, the pregnancy rate experienced by couples using only spermicide is higher than that of couples using other methods. Usually, spermicides are combined with contraceptive barrier methods such as diaphragms, condoms, cervical caps, and sponges. Combined methods are believed to result in lower pregnancy rates than either method alone.
The cervical cap is a form of barrier contraception. A cervical cap fits over the cervix and blocks sperm from entering the uterus through the external orifice of the uterus, called the os.
Vaginal lubrication is a naturally produced fluid that lubricates vagina. Vaginal lubrication is always present, but production increases significantly near ovulation and during sexual arousal in anticipation of sexual intercourse. Vaginal dryness is the condition in which this lubrication is insufficient, and sometimes artificial lubricants are used to augment it. Without sufficient lubrication, sexual intercourse can be painful. The vaginal lining has no glands, and therefore the vagina must rely on other methods of lubrication. Plasma from vaginal walls due to vascular engorgement is considered to be the chief lubrication source, and the Bartholin's glands, located slightly below and to the left and right of the introitus, also secrete mucus to augment vaginal-wall secretions. Near ovulation, cervical mucus provides additional lubrication.
A pessary is a prosthetic device inserted into the vagina for structural and pharmaceutical purposes. It is most commonly used to treat stress urinary incontinence to stop urinary leakage and to treat pelvic organ prolapse to maintain the location of organs in the pelvic region. It can also be used to administer medications locally in the vagina or as a method of contraception.
The contraceptive sponge combines barrier and spermicidal methods to prevent conception. Sponges work in two ways. First, the sponge is inserted into the vagina, so it can cover the cervix and prevent any sperm from entering the uterus. Secondly, the sponge contains spermicide.
Vaginal rings are polymeric drug delivery devices designed to provide controlled release of drugs for intravaginal administration over extended periods of time. The ring is inserted into the vagina and provides contraception protection. Vaginal rings come in one size that fits most women.
There are many methods of birth control that vary in requirements, side effects, and effectiveness. As technology, education, and awareness about contraception has evolved, new contraception methods have been theorized and put in application. Although no method of birth control is ideal for every user, some methods remain more effective, affordable or intrusive than others. Outlined here are the different types of barrier methods, hormonal methods, various methods including spermicides, emergency contraceptives, and surgical methods and a comparison between them.
An internal condom is a barrier device that is used during sexual intercourse as a barrier contraceptive to reduce the probability of pregnancy or a sexually transmitted infection (STI). Meant as an alternative to the condom, it was invented by Danish MD Lasse Hessel and designed to be worn internally by the woman during vaginal sex to prevent exposure to semen or other body fluids. His invention was launched in Europe in 1990 and approved by the FDA for sale in the US in 1993. Its protection against STIs is inferior to that of male condoms. Internal condoms can be used by the receptive partner during anal sex.
Condom effectiveness is how effective condoms are at preventing STDs and pregnancy. Correctly using male condoms and other barriers like female condoms and dental dams, every time, can reduce the risk of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV) and viral hepatitis. They can also provide protection against other diseases that may be transmitted through sex like Zika and Ebola. Using male or female condoms correctly, every time, can also help prevent pregnancy.
Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unintended pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth control only became available in the 20th century. Planning, making available, and using human birth control is called family planning. Some cultures limit or discourage access to birth control because they consider it to be morally, religiously, or politically undesirable.
CONRAD is a non-profit organization scientific research organization that works to improve the reproductive health of women, especially in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development(USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. CONRAD is led by Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH).
Postcoital bleeding is bleeding from the vagina after sexual intercourse and may or may not be associated with pain. The bleeding can be from the uterus, cervix, vagina and other tissue or organs located near the vagina. Postcoital bleeding can be one of the first indications of cervical cancer. There are other reasons why vaginal bleeding may occur after intercourse. Some people will bleed after intercourse for the first time but others will not. The hymen may bleed if it is stretched since it is thin tissue. Other activities may have an effect on the vagina such as sports and tampon use. Postcoital bleeding may stop without treatment. In some instances, postcoital bleeding may resemble menstrual irregularities. Postcoital bleeding may occur throughout pregnancy. The presence of cervical polyps may result in postcoital bleeding during pregnancy because the tissue of the polyps is more easily damaged. Postcoital bleeding can be due to trauma after consensual and non-consensual sexual intercourse.
There are many types of contraceptive methods available in France. All contraceptives are obtained by medical prescription after a visit to the family planning, a gynecologist or a midwife. With the exception of emergency contraception that does not require a prescription and can be obtained directly in a pharmacy.
Cervical drug delivery is a route of carrying drugs into the body through the vagina and cervix. This is a form of localized drug delivery that prevents the drugs from impacting unintended areas of the body, which can lower side effects of toxic drugs such as chemotherapeutics. Cervical drug delivery has specific applications for a variety of female health issues: treatment of cervical cancer, pregnancy prevention, STD prevention, and STD treatment.
1 2 Trussell, James (2011). "Contraceptive efficacy"(PDF). In Hatcher, Robert A.; Trussell, James; Nelson, Anita L.; Cates, Willard Jr.; Kowal, Deborah; Policar, Michael S. (eds.). Contraceptive technology (20th reviseded.). New York: Ardent Media. pp.779–863. ISBN978-1-59708-004-0. ISSN0091-9721. OCLC781956734. Archived(PDF) from the original on 2013-11-12.
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