New Contraception Options

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Given that approximately half of all pregnancies in the United States every year are unplanned, birth control is an important consideration for all sexually active women at risk of becoming pregnant. In the case of women with diabetes, however, precision in family planning is even more crucial because of the effect of high blood glucose on the developing fetus.

“There’s a very close correlation between blood sugar level and the incidence of birth defects in the offspring of women with diabetes,” says Jo M. Kendrick, MSN a clinical instructor at the University of Tennessee Graduate School of Medicine’s Department of Obstetrics and Gynecology and author of Diabetes in Pregnancy (a guide for nurses). According to Kendrick, “Anytime you have a[n HbA1c] level of 7% or greater, there’s an increased risk of birth defects in the offspring or, as it rises even higher, an increased risk of miscarriage.” The HbA1c, or glycosylated hemoglobin, test gives an indication of average blood glucose control over the previous 2–3 months. People who don’t have diabetes generally have an HbA1c level between 4% and 6%.

Because of these risks, women with diabetes are advised to bring their blood glucose levels as close to normal as possible before attempting to conceive. In addition, any woman with diabetes who is considering having a baby should have a physical exam and a laboratory assessment to look for any evidence of vascular (blood vessel) disease, since pregnancy can put a great deal of stress on the vascular system. Having eyes and kidney function assessed is another important part of preconception care for women with diabetes.

According to Kendrick, “We very strongly encourage women to get an eye exam to make sure that they don’t have any retinopathy, an EKG [electrocardiogram] if they’ve had diabetes for more than 10 years [to check for heart disease], and a 24-hour urine test to assess renal function.” A psychosocial evaluation is also recommended. “Pregnancy in women with either Type 1 or Type 2 diabetes can be very stressful, not only because of the demands of pregnancy, but also because of the additional demands of diabetes control” says Kendrick.

All women considering pregnancy — with diabetes or without — should start taking a daily prenatal vitamin supplement that includes 400 micrograms of folic acid before conception occurs. This level of folic acid intake has been shown to help prevent the types of birth defects called neural tube defects.

For women who do not wish to become pregnant, reliable birth control is a must. “I certainly think that some methods are better than others, but that’s a decision that a woman and her partner should make in conjunction with a health-care provider,” Kendrick says. “I wouldn’t encourage natural family planning if a woman’s glycemic control weren’t excellent, and I’d be concerned about methods with a higher failure rate, such as barrier methods. But if a woman is maintaining good glycemic control and she prefers these methods, there’s no reason why she shouldn’t be able to use them.”

Kendrick is a proponent of methods that require infrequent administration, such as the NuvaRing, the Mirena intrauterine device, the Ortho Evra patch, and Depo-Provera contraceptive injections. “With all the other things that women have to think about when they have diabetes, contraception should be easy.” She also encourages women with diabetes to keep a current prescription for emergency birth control, as long as they do not have any special conditions, such as unexplained vaginal bleeding, that make the use of emergency contraception unsuitable.

Since 1998, a number of new birth control options have come on the market (although by mid-2004, some were being taken back off). The majority of these contain a hormonal component that prevents pregnancy by halting ovulation and by thickening cervical mucus, which makes it difficult for sperm to penetrate the uterus. The new methods differ from their predecessors in the means by which they deliver the hormones or, in the case of some of the latest oral contraceptives, in the way they affect a woman’s menstrual period. The side effects and possible complications are similar in most cases to those associated with other low-dose oral contraceptives: nausea, weight gain, fluid retention, breast tenderness, and headaches and, more seriously, blood clotting and hypertension. Hormonal methods should not be used by heavy smokers over the age of 35, because these women are at a higher risk of serious side effects. Women with diabetes must make sure their health-care provider is aware of their diabetes before taking any form of birth control.

To date, the best protection against sexually transmitted infections, short of abstinence, is still a latex condom used with each act of intercourse. However, condoms are not 100% reliable, and they are less effective at preventing transmission of viral infections such as herpes or genital warts that are passed from one person to another through skin-to-skin contact.

Seasonale

Unlike most oral contraceptives, which are taken for 21 days followed by seven days of placebo pills, Seasonale tablets are taken for 84 days (12 weeks) followed by seven days of placebo pills. This dosing regimen results in fewer menstrual periods (one every three months). The four yearly periods are no heavier or longer than the period of a woman taking a typical birth control pill and, in most cases, they are lighter than those experienced by women not taking oral contraceptives. Like conventional birth control pills, Seasonale is more than 99% effective when taken as directed. There is a higher incidence of irregular bleeding between periods with Seasonale than with conventional oral contraceptives, but such bleeding tends to decrease with time. It is still unclear what the long-term effects of absent periods may be, and there is some concern over the increased estrogen exposure from extra active pills. Women who have vascular complications are advised not to take Seasonale.

Yasmin

Yasmin contains a unique progestin, known as drospirenone, along with estrogen. Like other birth control pills, Yasmin is over 99% effective, but its special drug combination also cuts down on water retention and symptoms associated with premenstrual disorder, such as mood swings and weight gain. This form of birth control may not be the best choice for women with diabetes, however. Yasmin may increase potassium levels in some women, so it should be avoided by women who have kidney, liver, or adrenal disease. Women taking potassium-increasing drugs, including NSAIDs such as ibuprofen, potassium-sparing drugs, or potassium supplementation should also steer clear of this contraceptive. In addition, women taking ACE inhibitors, heparin, or angiotensin-II receptor antagonists such as irbesartan (brand name Avapro) or valsartan (brand name Diovan) should avoid taking Yasmin. This contraceptive is available by prescription and costs about $35 to $38 a month.

Emergency contraception

At this time, emergency contraception is available in the United States by prescription only, except in Washington, California, Alaska, New Mexico, and Hawaii, where it is available directly from a pharmacist. In May 2004, the Food and Drug Administration (FDA) voted against making the drugs available over the counter, citing concerns that women would be unable to properly use the drugs without a doctor’s supervision, as well as fears that increased availability would lead to risky sexual behavior among young people, although studies have shown this to be untrue. At the time of the FDA decision, there were two drugs available for emergency contraception: Plan B, a progestin-only pill, and Preven, an estrogen–progestin pill. However, Preven was later taken off the market.

Emergency contraception works by stopping or delaying ovulation, by preventing fertilization, and by keeping a fertilized egg from attaching to the uterus, but it will not end an existing pregnancy. Emergency contraception should be taken within 72 hours of unprotected intercourse — the sooner the better — and can decrease the likelihood of conception by as much as 89%. Plan B is available at pharmacies and family planning clinics with a prescription from a health-care provider. Because there is a risk of nausea and vomiting with Plan B, some doctors may also prescribe an antinausea medicine. Progestin-only contraceptives such as Plan B may cause a slight deterioration in glucose tolerance, so women with diabetes who have taken this contraceptive should be monitored by their health-care provider.

Ortho Evra patch

The first transdermal contraceptive, the Ortho Evra patch is worn for three weeks (each individual patch lasts a week) on the lower abdomen, buttock, or upper arm, where it delivers a continuous level of progestin and estrogen through the skin. Each three-week interval is followed by a patch-free week during which a woman has her period. The Ortho Evra patch is about 99% effective if used correctly. If a patch comes off before the week is over, a new patch should be applied as soon as possible for the remainder of the week. If more than 24 hours go by before a new patch can be applied, backup birth control must be used. This method is less effective in women who weigh more than 198 pounds and it should not be used by women with diabetes who have vascular complications. The Ortho Evra patch is available by prescription and costs about $30 a month.

NuvaRing

A novel concept in contraception, the NuvaRing is a flexible polymer ring worn in the vagina. It is approximately two inches in diameter and contains low levels of hormones. The ring is inserted by a woman on or before the fifth day of her period by pinching the sides of the ring together and gently pushing it into her vagina where it releases low levels of estrogen and progestin for 21 days. Because NuvaRing is not a barrier method, precise placement is not essential. Efficacy is compromised, however, if the ring slips out of the vagina and is not replaced within three hours, or if it is left in for more than four weeks or removed before the three weeks is up. In clinical testing, NuvaRing has shown to be 99% effective, the same as the pill. This method should not be used by women with diabetes who have kidney, eye, nerve, or vascular complications. NuvaRing is available by prescription and costs about $30 a month.

Mirena intrauterine device

Although they are very popular worldwide, intrauterine devices (IUDs) have had a bad reputation in the United States since the Dalkon Shield scare of the 1970’s. (This brand of IUD was linked to an increased risk of pelvic inflammatory disease, attributed to the wicking effect of the multifilamented string.) In spite of the negative associations caused by this episode, the risk of pelvic inflammatory disease related to IUDs is actually quite low, and they provide a highly effective, easily reversible birth control option for women who have had one or more children and who are in a monogamous relationship. The latest IUD to come on the market, Mirena, consists of a small, flexible, T-shaped plastic frame that releases small amounts of levonorgestrel, a type of progestin. This device does not contain estrogen, so it does not cause estrogen-related side effects and complications such as headaches and breast tenderness. Progestin-related side effects are kept to a minimum as well because all of the hormone released, about one-seventh of the amount released by birth control pills, goes directly to the uterine lining rather than through the bloodstream. There may be cramping and dizziness at the time of insertion, so it’s not a bad idea to take a painkiller such as ibuprofen prior to the office visit. There may be spotting or light bleeding between periods for the first three to six months, after which periods usually become lighter — in contrast to most IUDs, which tend to cause heavier periods. Mirena, which is over 99% effective, can stay in the uterus for up to five years, at which time a new Mirena can be inserted. The device costs about $475, plus the cost of insertion.

Today Sponge

Introduced in 1983, the Today Sponge was once the most popular over-the-counter female contraceptive choice. It was taken off the market in 1995 because of problems that were found at the factory where it was made, but the rights to the sponge were bought by another company, and the sponge was re-released in 2005. The Today Sponge, which is about 89% to 91% effective, consists of polyurethane foam with spermicidal nonoxynol-9. Once moistened and inserted into the vagina, where it works as a physical barrier to the cervix and as a sperm killer, the sponge protects against pregnancy for 24 hours even with repeated intercourse. It is currently available at some retail and online pharmacies and at www.thetodaystore.us for around $30 for a 12-pack. Women who are allergic to nonoxynol-9 should not use the Today Sponge. In addition, women who use barrier methods such as the sponge, a diaphragm, or a cervical cap are at an increased risk of urinary tract infections.

It should be noted that use of nonoxynol-9 has not been shown to reduce the risk of transmission of HIV. In fact, in some studies, it has been associated with a higher HIV infection rate.

Permanent birth control
Until fairly recently, permanent birth control for women — tubal ligation — required surgery and general anesthesia. The Essure system, however, requires no incision and can be put into place in as little as 35 minutes, and it requires only local anesthesia, intravenous sedation, or, in some cases, no anesthesia at all. The system consists of small metal and polyester-fiber coils that are threaded into a woman’s Fallopian tubes through the vaginal opening via catheter. Scar tissue eventually forms over the coils, blocking the Fallopian tubes so that fertilization cannot take place. The scarring process takes about three months, during which a backup birth control method must be used. Clinical studies have shown the Essure System to be 99.8% effective after two years (data for more than two years is not yet available). The method should be used only by women who are certain that they do not wish to have children (or more children). Although information is not available on the safety or effectiveness of reversal, it is clear that an attempt would require major abdominal surgery and would likely be ineffective. The Essure system itself costs $980, but there may be other, associated costs.

Natural family planning aid

The necklace-like CycleBeads were developed by the Institute for Reproductive Health at Georgetown University to be used in conjunction with the Standard Days Method, a natural family planning method that grants a fairly wide window for conception possibility. CycleBeads consist of a string of 32 color-coded beads that correspond with levels of fertility throughout a woman’s cycle, and a ring to keep track of the passing days. Since this method is more calendar than contraception, there are no side effects. It should be used only by women whose regular cycles are 26 to 32 days long, and who are willing to abstain from intercourse or use a reliable contraceptive during their fertile days. CycleBeads cost about $13 and are available at retailers and pharmacies, as well as online at www.cyclebeads.com.

Vasclip

Women are not the only ones for whom new methods of birth control are being developed. A small polymer mechanism known as Vasclip now offers men who desire permanent birth control an alternative to a vasectomy. This device, which is about the size of a grain of rice, locks around each vas deferens, the vessel that transports sperm from the testes to the urethra, thereby preventing the passage of sperm to the urethra and out of the body. The procedure to insert the Vasclip devices involves making a small incision in the scrotum to access the vas deferens and then positioning the clips. The entire process takes only about 15 minutes from start to finish, and because there is no cutting or cauterizing of the vas deferens, complications such as swelling and infection are generally reduced. After the procedure, a couple still must use a backup form of birth control until it is confirmed by a doctor that the man no longer has any sperm in his semen; as with a vasectomy, it is expected that the majority of men who undergo the procedure will achieve infertility within three months. Because the operation is considered permanent, only men who are sure they do not want any (or more) children should consider having it. (In the future, the company that makes Vasclip intends to conduct studies to explore the possibility of reversing the procedure.) The device generally costs $400 to $500, plus the cost for insertion, which varies.

Hormonal male birth control

Although they are a long way from being commercially available, there is a possibility of some hormone-based forms of male birth control in the future. The most promising method so far involves a combination of testosterone implants that are replaced every four or six months with injections of progestin every three months. This combination effectively turns off sperm production for the duration of its use, and is completely reversed within six to 12 months after the treatment is discontinued. In a recent study, 55 couples used this method as their only form of birth control for a year and no pregnancies resulted.

Expanding options

Choosing whether and when to have a baby is a major decision. Having a reliable method of birth control lets you make that decision when you’re ready. The growing number of contraceptive choices on the market should make it easier to find one that meets your needs. If you choose to use a method that requires a doctor’s prescription, make sure the prescribing doctor knows about your diabetes, how you treat it, any other medical conditions you may have, and any drugs you may take. Women with diabetes who feel they are ready to start a family or have another child should talk to their health-care provider about preconception planning to make sure they are ready physically as well as emotionally.

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