Pregnant While On The Pill

Photo by Lew57

Becoming pregnant, while on the Pill, with twins. Twice! And you thought you had a bad day:

Proud mother Carly O'Brien has beaten odds of 11.3 million to one to give birth to two sets of twins - despite being on the contraceptive pill.

The 22-year-old and her partner John Grant, 28, were amazed when she gave birth to her first set of twins Brandon and Daisy.

Now, two years on, Carly has stunned experts by giving birth to another miracle set of twins - Dylan and Lilly.

...

Carly, from Portsmouth, Hants, had been using the contraceptive pill since she was 17 and never imagined she could get pregnant while using it.

She and John, who installs air conditioning units, had been together for only a year and having children had not crossed their minds.

But when Carly missed a period and started being sick, she may be pregnant.

A pregnancy test confirmed it but it wasn't until her 12 week scan she discovered she was carrying twins.

...

New mum Carly was overjoyed with her two children and, certain she did not want any more, she opted for a stronger contraceptive pill, which had to be taken twice a day.

But, just 18 months later, when Carly missed a period she couldn't believe the supposedly impossible had happened again.

A six-week scan revealed she was again carrying twins - beating odds of more than 11 million to one.

She said: 'I just couldn't believe it and didn't know how it could have happened to me again - especially as I was on a stronger pill.

Now, after the first pregnancy while on the Pill, what could Ms. O'Brien have done to lessen the chance of another contraceptive failure?

Option 1: Double-up.

While the simultaneous use of two methods of birth control, for example the Pill and a male condom, sounds great in theory, it can be problematic. A lot of couples, especially those in long-term, monogamous relationships, are not too keen on using a condom; the risk of noncompliance is quite high.

Option 2: Change Birth Control Methods

This is the one I would've advised. When you've already experienced a failure while taking the Pill, and with twins and no desire to become pregnant again it's time to move on to a more reliable birth control method.

For the Pill, the first year typical-use failure is ~8%.

Compare that with the typical-use failure for the most effective methods:

- Implants (Implanon) 0.05% and IUDs (Mirena, CuT) 0.2% and 0.8%, respectively

- Male sterilization 0.15%

- Depo-Provera 3%




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Implanon and Bleeding

Some facts about Implanon, the progestin-only [68 mg etonogestrel (3-keto-desogestrel)] single-rod implant device:

1. The contraceptive effect of Implanon is established within 24 hours after insertion; ovulation and fertility return within 1 month after the implant is removed.

2. The timing of insertion of Implanon is based on the patient’s menstrual cycle and current contraceptive method:

* For a woman who is not using a hormonal contraceptive, insertion should take place during the first 5 days of menses.

* For a woman who is actively using a cyclic hormonal contraceptive, the device should be inserted during the hormone-free interval.

* For a woman on a continuous hormonal contraceptive, Implanon can be inserted at any time.

* After pregnancy, the device can be inserted 3 or 4 weeks after delivery.

The Implanon rod can be removed at any time. It must be removed after 3 years of use.

The Implanon rod was originally studied in women who weighed no more than 130% of their ideal body weight. The effectiveness of Implanon in obese women has not been thoroughly assessed in a large population study.

3. Implanon is not associated with loss of bone mineral density (BMD).

What is the major side effect of Implanon?

Frequent or unpredictable bleeding (or both) is the major side effect of Implanon.

In one study of 324 women who used Implanon, continuation rates were 75%, 59%, and 47% at 1 year, 2 years, and 2 years-9 months, respectively. Of women who discontinued Implanon, 91% did so because of frequent or unpredictable bleeding or both. In another study, the continuation rate was 66% at 1 year.

Why the unpredictable bleeding?

Women using Implanon who have higher circulating estradiol levels and ovarian follicle activity may be at greater risk of abnormal patterns of bleeding.

Women using progestin contraceptives who have abnormal uterine bleeding have elevated levels of endometrial enzymes, such as matrix metalloproteinases and neutrophil elastase, that prevent epithelial tissue repair.

A possible solution

In a preliminary report, women with prolonged bleeding in association with Implanon were randomized to various treatment regimens, among which were doxycycline, 100 mg twice daily for 5 days, or placebo. Doxycycline treatment significantly reduced prolonged bleeding compared with placebo (4.8 days [95% confidence interval (CI), 3.9 to 5.8 days] versus 7.5 days [95% CI, 6.1 to 9.1 days], respectively).

Doxycycline may inhibit these [endometrial] enzyme systems and enhance repair of endometrial epithelial tissue. Whether doxycycline will become a widely used treatment for prolonged bleeding associated with Implanon remains to be determined in additional clinical trials.

Long-Term Reversible Birth Control

This should be emblazoned all over the place:

Reproductive-age women have varying contraceptive needs...[T]he method of contraception must be tailored to meet the needs of the individual.

Three long-term birth control methods (.pdf)--ParaGard (copper IUD), Mirena (progestin-releasing IUD), Implanon (contraceptive implant)--three case studies, and three experts. Read the whole thing.

FDA Approves Implanon

Finally:

Implanon, a single rod contraceptive implant that is highly effective for 3 years, has been approved in the United States, with a training and marketing plan designed to avoid some of the problems that plagued Norplant, the last implantable contraceptive available in this country.

About the size of a matchstick, Implanon is made of a soft polymer containing 68 mg of etonogestrel [a progestin] that is slowly released over 3 years at a rate of about 30 mcg/day. In a simple office-based procedure, the rod is inserted subdermally on the inner side of the upper arm and is 99% effective in preventing pregnancy, according to Organon, the manufacturer. Implanon works primarily by suppressing ovulation, but it also thickens cervical mucus, a secondary mechanism, according to Organon, which also markets NuvaRing, the vaginal ring that contains etonogestrel and estrogen.

Approved by the Food and Drug Administration in July, Implanon is the first long-term implantable contraceptive to become available in the United States since 2000 when Wyeth stopped marketing Norplant, the six-rod levonorgestrel implant. Since 1998, Implanon has been approved in more than 30 other countries, where it has been used by about 2.5 million women.

...

"We have been waiting for this for quite some time," Dr. Anita Nelson, professor of obstetrics and gynecology at the University of California, Los Angeles, said in an interview. The availability of a contraceptive with this degree of effectiveness and convenience, which takes about 1 minute to insert in a simple, office-based procedure and lasts for 3 years, should meet some of the unmet needs of women who find compliance a challenge even with monthly options such as vaginal rings.

Dr. Nelson expects that the product's gradual dissemination and the requirement that physicians be trained before they receive Implanon should avoid some of the problems that were associated with Norplant. When Norplant became available, there was "a fair amount of enthusiasm [for an implantable contraceptive] pent up for years" so it was widely prescribed soon after approval, and while training was available, it was not required to obtain the product, she said.

Dr. Andrew M. Kaunitz, professor and assistant chairman of the department of obstetrics and gynecology at the University of Florida Health Science Center, Jacksonville, said that the company's training requirements will lead to greater acceptance of the method by women and physicians, "because the clinicians providing the method will have the knowledge to appropriately counsel women and the skills to appropriately perform insertions."

The Implanon implant is longer, thicker, and slightly more rigid than the Norplant rods, and "because it's a single rod system, it's easier and quicker to insert, but more importantly, it's easy and quick to remove," Dr. Kaunitz said in an interview.

And note this, too:

They [Drs. Kaunitz and Nelson] both emphasized the importance of making sure women considering Implanon understand its impact on menstrual bleeding, as with other progestin-only methods. It is "almost unpredictably unpredictable," Dr. Nelson said, noting that in studies, no patterns of irregular bleeding were identified.

...

Bleeding irregularities were frequent and were the most common reason for choosing to discontinue the contraceptive, in 11% of women. About 4% of patients had implant site complications that included swelling, redness, hematoma, and pain. Nearly 2% had removal complications, which included implants that could not be palpated, a broken or damaged implant, slight migration, difficult localization, and formation of fibrosis, according to Organon.

...

Among heavier women, the failure rate of Norplant increased during the fifth year of use. Women weighing more than 30% above their ideal body weight were not included in Implanon trials, but Dr. Monroe said postmarketing data provided no clear evidence that failure was higher in overweight women. The label states that health care providers and patients should be aware that it is unknown whether effectiveness is lower in women over 30% above their ideal body weight.

Skip Your Period and Period Control Options

Good AP article on the available options for period control, as well as some coming attractions.

Among the existing methods:

- Seasonale: 30 μg of estrogen (ethinyl estradiol, or EE)/150 μg of progestin (levonorgestrel), taken continuously for 84 days, followed by 1 week off.

- Ortho Evra patch: 0.75 mg estrogen (EE)/ 6.00 mg progestin (norelgestromin) [20 μg estrogen/150 μg progestin per day], one patch per week for 8 or 12 weeks in a row, followed by 1 week off.

- NuvaRing vaginal ring: 2.7 mg estrogen (EE)/11.7 mg progestin (etonogestrel) [15 μg estrogen/120 μg progestin per day], one ring in place for 3 weeks at a time, for 6 or 12 weeks total in a row, followed by 1 week off. [Alternatively, one ring can be left in place for 4 weeks at a time.]

- Depo-Provera [and Depo-subQ provera 104] shot: 150 mg progestin (medroxyprogesterone acetate) [104 mg progestin], one injection four times a year.

One more existing brand worth mentioning is Loestrin 24 Fe. The innovation here is the shortened placebo interval--one estrogen/progestin pill taken for 24 days, followed by one iron-containing placebo pill taken for 4 days. [Of course, if you're already taking the Pill, and you want a shorter placebo interval, you can use your existing brand to do that. Just take 4 placebo pills, instead of the usual 7, followed by a new pack.]

And some newer developments:

- Seasonique: 30 μg of estrogen [EE]/150 μg of progestin [levonorgestrel]), and 10 μg EE, one estrogen/progestin pill taken continuously for 84 days, followed by one estrogen-only pill for 7 days; no placebo interval.

- Lybrel: 20 μg ethinyl estradiol/90 μg levonorgestrel, one estrogen/progestin pill taken daily with no placebo intervals.

- Implanon*: 68 mg progestin (etonogestrel) [~40 μg progestin per day], one-rod implant lasting up to 3 years.

*Just like so many other methods before it (Mirena, Depo-Provera), Implanon has been available for over a decade outside the U.S.. This pretty much insures Implanon's status as a "cutting edge" method over here.

NuvaRing News

Good news for NuvaRing users. A small study found that ring use is well tolerated and may have a beneficial effect on vaginal health:

The ring was well tolerated; the few genital symptoms reported were generally scored as mild and their incidence was similar to that reported with OC [oral contraceptive] use, with the exception of vaginal wetness.

Increased vaginal wetness was reported with 2.74-fold incidence...in ring users compared with those using OCs (ring, 63% vs OCs, 43%). "Women who reported more vaginal wetness did not differ on laboratory findings from women who did not report this symptom," the authors note.

Laboratory findings showed that the concentration of Lactobacillus colony-forming units positive for hydrogen peroxide (H2O2) also significantly increased during ring use....

The researcher's conclusion:

"This study provides some reassurance that an increase in vaginal wetness reported by a woman using the combination vaginal ring most likely does not represent pathology," the authors write, adding that increased H2O2-producing Lactobacillus concentrations may even indicate a favorable effect on vaginal health by preventing viral and bacterial infections.

A 1992 study also found that using a vaginal ring continuously (up to two months) didn't cause unfavorable changes in the vagina.

This is important information for women who use the ring for menstrual management. Why? Because when you use the ring to skip the fake period, you use a continuous regimen--the ring remains in place for months at a time. In other words, you insert the ring into the vagina and leave it in for either 3 or 4 weeks (twenty-eight days). After that, you remove it and throw it out. Then you replace the old ring, immediately, with a new one. There is no ring-free week between the old and the new ring. You continue to do this for 2-3 months. At the end of that interval you stop using the ring for 7 days (you'll have the fake period during these 7 ring-free days).

In an ongoing extended-wear study, women have been using the vaginal ring (replacing it every 3 weeks) continuously for six weeks, twelve weeks, and twelve months. Preliminary results should be available by the end of the year.*

*Aarts JM, Miller L. Design of an open-label, randomized, multicenter trial of continuous regimens with NuvaRing. Obstet Gynecol. 2003;101(45):145.

Implants and Intrauterine Devices (IUDs)

Two very good questions: is Norplant still available, and what about IUDs?

Implants

What is an implant?

An implant is one of the six types of hormonal methods of birth control. Implants come in the form of one/several small plastic rods, or a capsule which are inserted under the skin (of the arm, usually).

Each rod has a small amount of only one hormone, a progestin.

The number of rods, and the amount and type of progestin depend on which brand of implant you use. The rods are inserted and removed by medical personnel. Used since 1983, implants are widely available worldwide, except in the United States. Unfortunately, in 2002 Norplant, the only implant available in the U.S., was withdrawn from the market. (Yet, another entire class of birth control methods unavailable to American women. These would be the same women that most of these methods are tested on to begin with, a "minor" detail of course. But I digress.)

The five implant brands are:

1. Norplant: this is the original 6-rod implant; it can be left in place for up to five years

2. Jadelle (Norplant II): this is a 2-rod implant; it can be left in place for up to five years

3. Implanon: this is a single-rod implant; it can be left in placed for up to three years

4. Nestorone: one type consists of a single rod that lasts up to two years, while another type is a small capsule that lasts for six months. The six-month system is available in Brazil under the brand name Elcometrine. It is used to treat endometriosis.

5. Uniplant: this is a single-rod, one year implant (not available commercially).

In general, if you've been using Norplant and you'd like to continue using an implant, the best alternative is one of the newer brands, like Implanon or Jadelle. Of course, just because implants aren't available here, doesn't mean you have to go without. You have two options. If you're planning to travel outside the country, for example to Europe (or anywhere else for that matter), you can have the implant inserted there. Or, you can ask your Ob/Gyn to order the implant directly from the manufacturer. Just make sure he/she is familiar with the method, and is willing to accommodate your needs (there's quite a bit of paperwork involved).

Moving on to intrauterine devices (IUDs), what is an IUD? It is a small device that is inserted inside the uterus, and it's classified as a separate class of birth control. However, there is some crossover: hormone-releasing IUDs can be grouped together with the hormonal methods of birth control. Many types and brands of IUDs are available. Er, that is if you happen to live outside the U.S. In the States, only two brands are available: ParaGard and Mirena. Let's review the main groups of IUDs, so you may better understand your options.

IUDs are non-medicated or medicated (copper- and hormone-releasing), and either framed or frameless.

The non-medicated (or inert) IUDs have an inert plastic frame. Most of the older brands are inert: Graefenberg, Ota rings (these were used in the 1920s), Lippes Loop, Dalkon Shield, Saf-T-Coil, Spring coil, Margulies coil, Majzlin spring, Szontagh, Dana-Super, etc. As a rule, inert IUDs can be left in place for decades.

The framed copper-releasing IUD consists of an inert plastic frame (usually in the shape of a "T", "Y", or a "7") to which copper wire is added. Some brands also have silver wire (the ones with "Ag" in their name). Many types of copper-releasing IUDs are available (by 1974 there were over 20 types available; many more have been developed since). These IUDs may be left in place for up to 10 years. Some of the older types (first generation) are: Copper 7 (Cu-7/Gravigard), TCu-200, Copper T, ML Cu-250, Tatum-T, etc. The major second-generation IUDs are the TCu-380A (ParaGard) and the newer, improved version TCu-380S (Gyne T Slimline), Nova T, and Multiload-375 (MLCu-375) standard and SL. Other brands include the Nova-T380, DanaCu, Superlux, and Ombrelle250. The newest types of copper-releasing IUDs are: Cu-Safe 300 (Flexi-T 300), Fincoid-350, and Sof-T.

In the U.S., only one type of copper-releasing IUD is available, an older brand, ParaGard.

The copper-releasing frameless IUD, as the name implies, doesn't have the rigid, or semiflexible plastic frame seen in the framed type. The frameless IUDs currently in use are GyneFix (scroll down for the picture) and GyneFix mini, which consist of six (four) small copper sleeves threaded on a suture string. The upper end of the thread has a knot which serves as an anchor. (The knot is anchored into the top area of the muscular wall of the uterus; this secures the device in place.) The frameless IUD may be left in place for up to 5 years.

Finally, the hormone-releasing IUD is one that releases a hormone (a progestin). The type available in the U.S. is an older, framed brand Mirena (it's been available in Europe for over a decade). Mirena may be left in place for up to five years. Two newer types of hormone-releasing IUDs soon to be available in Europe are the framed Femilis T (ten years life span), and the frameless FibroPlant (three years life span).

Obviously, each type and brand of implant and IUD has its advantages and disadvantages. In order to find the one that's best suited to your unique needs, make sure you go over the details of each group with your Ob/Gyn.