Progesterone May Reduce Premature Births

"The evidence of this treatment's effectiveness was so dramatic, the research was stopped early," said the study's lead researcher, Dr. Paul Meis of Wake Forest University Baptist Medical Center.

Progesterone is naturally produced by the ovaries. It softens the uterus lining into a spongy bed that holds a fertilized egg.

Weekly injections of the hormone reduced the chance of premature births by 34 percent in the 306 high-risk women who received the therapy, the study reported. An additional 153 women were injected with a placebo. All the women had previously given birth prematurely, the single biggest indication of risk.

The study was carried out at the 19 centers that comprise the Maternal Fetal Medicine Units Network under the National Institutes of Health (news - web sites). Meis unveiled the results in San Francisco at the annual meeting of the Society for Maternal-Fetal Medicine.

"The results are so good that it's surprising," said Dr. Fredric Frigoletto, chief of obstetrics at Massachusetts General Hospital in Boston. "No intervention that we have ever applied has had any measurable effect. This is very good news."

Doctors have prescribed progesterone for years to help infertile and menopausal women.

Meis said progesterone had been previously toyed with as a preventive treatment for premature births in the 1960s and 1970s, but no one has completed a serious study on the subject.

"I think it's going to awaken people to an old idea that kind of slipped away," said Dr. Alan DeCherney, chair of the Obstetrics and Gynecology department at the University of California, Los Angeles.

Dr. Emile Papiernik, a French obstetrician, conducted a tiny progesterone study in 1970 that showed promise. But he said he couldn't interest any pharmaceutical companies or government agencies to fund a more comprehensive experiment.

"This has been sitting on the pharmacist's shelf for more than 30 years," Papiernik said.

In 2001, about 476,000 babies were born too soon in the United States — a 27 percent increase since 1981, according to the March of Dimes. One in eight babies was born before the 37th week of pregnancy, which is considered full term.

"The problem is huge," said Dr. Nancy S. Green, a New York City pediatrician and medical director of the March of Dimes. Last week she announced the organization's $75 million, five-year program to reduce premature births.

Babies born prematurely are at increased risk for neurological, hearing and behavioral problems. The average hospital charge in 2000 for a premature baby was $58,000, compared with $4,300 for a typical newborn, according to the March of Dimes.

Some of the increase in premature births can be attributed to more older women giving birth and the explosion of obesity in the country, Green said. But fully half of premature births have no known cause, Green said.

The March of Dimes said black women give birth prematurely at disproportionately high rates: 17.5 percent of all births to black women last year were premature, compared with the national average of 11.9 percent.

Frigoletto said that high rate has been studied extensively — but no definitive, scientific conclusions have been drawn.

In Meis' study, 59 percent of the women were black. The researchers concluded that race didn't influence the hormone's effectiveness.

"I think it really will attract a lot of interest," Meis said of the study. "This is the first fairly effective treatment for pre-term births."

Rare Exceptions

There are several rare exceptions.

Less than 1% of patients do not absorb progesterone well through the skin, and must either be injected with progesterone or take progesterone orally.

I personally do not like oral progsterone. This is because 90% of oral progesterone is metabolized by the liver. So a 60 mg/day topical dose of progesterone is equivalent to a 600 mg/day oral dose of progesterone. And what do these 90% metabolites do? No one knows for sure. But I do know that women get very sleepy. I can remember one women on oral progesterone that took 400 mg of oral progesterone, and then went to Wal-Mart. She was so sleepy that she could not drive home. She had to call her husband and have him come to pick her up.

There is also another rare case. Out of 8,000 patients, I have had 3 patients that I believed developed anti-bodies against progesterone. These patients tend to be very allergic patients. They may also have Hashimoto's thyroiditis. Beer, MD that recently passed away in 2007, documented antibodies against progesterone by using subcutaneous injections of progesterone and observing an allergie wheal.

For these extremely allergic patients, it is no problem. Just take progesterone throughout the entire pregnancy. However, again, you must be extrememely careful to take progesterone cream throughout the entire pregnancy. Twice per day is better since progesterone levels go up and down in about 7 hours after an application. If you forget one day to use the progesterone cream, this will generate a miscarriage.

I had one patient, that was extremely allergic. She had Hashimoto's Thyroiditis and demonstrated allergies to many foods and topicals including lotions, detergents and shampoos. She had 2 previous miscarriages at 6-8 weeks. So I put her on a Progesterone cream with coconut oil. Right at 6-8 weeks she developed a rash to the progesterone cream with coconut oil. So I switched her to grapeseed oil and progesterone one week. And then the next week I would use progesterone and olive oil. I did this to prevent an allergy developing to the progesterone in the particular oil. The rash from the coconut oil disappeared. I told her that she was so allergic that she probably developed anti-bodies to progesterone itself. So I advised her to take a progesterone cream throughout the entire pregnancy. The pregancy was uneventful until week 38. The normal pregnancy is 40 weeks. However, at 38 weeks, unknown to me, her naturopath told her to stop the progesterone. I would NOT have done that. After stopping the progesterone cream, she delivered 40 hours later.

As soon as progesterone levels drop, the placenta may begin to peel off the side of the uterus. It is much better to continue to use the progesterone, and as 40 weeks approaches, the normal gestation time, let other hormones kick in to carry through the delivery.

Estrogen Dominance over 35

Progesterone cream was used by John Lee, MD to also help infertility after the age of 35 for women. Progesterone may be used to trigger ovulation, and get the woman to conceive.

Many times as women pass the age of 35, they have regular cycles, but they are making only estradiol and NOT progesterone. This is because after the age of 35, the follicles come up, do NOT ovulate and go back down. Normally, the follicle would pop out an egg, and then the used follicle becomes the corpus luteum. The corpus luteum then produces progesterone.

However, after the age of 35, the follicle comes up and then goes back down. No egg is released. No corpus luteum is produced. No progesterone is produced. After the age of 35, only estradiol is produced during most menstrual cycles. This ensures estrogen dominance.

In addition, many of the chemicals put on the skin just happen to mimic estrogen. This leads to your body thinking you have more estrogen.

Using Progesterone for Infertility

from "What Your Doctor May Not Tell You About Menopause" by John Lee, MD page 244.

"The use of natural progesterone can give women the power to enhance their fertility without a lot of expensive office visits and prescription hormones. It also flies in the face of mainstream medicine's approach to fertility, which doesn't trouble me since their success rate in acheiving conception is depressingly low. It's no wonder--they are precribing the wrong hormones! Synthetic estrogens and progestins generally cause more harm than they solve.

I believe that estrogen dominance from progesterone deficiency has casued a near epidemic of infertility among women in their midthirties. Excess estrogen seems to stimulate the ovaries to overproduce follicles, which, combined with delayed childbearing, results in an early burnout of the follicles. If you are having difficulty in conceiving, you may be able to use progesterone to your advantage.

I had a number of patients in my practice who had been unable to conceive. For two to four months, I had them use natural progesterone from days five to 26 in the cycle (stopping on day 26 to bring on menstruation). Using the progesterone prior to ovulation effectively supressed ovulation. After a few months of this, I had them stop progesterone use. If you still have follicles left, they seem to respond to a few months of suppression with enthusiasm, and the successful maturation and release of an egg. Some of my patients who had been trying to conceive for years had very good luck conceiving with this method. There are even a few children named after me!

On the other side of the coin is the fact that using progesterone prior to ovulation can supress ovulation. In a normal munstrual cycle, the release of progesterone by one ovary functions as a signal to the ovther ovary not to ovulate-- Nature's brilliant plan for avoiding multiple births. If your're using progesterone cream prior to ovulation, chances are good both ovaries will interpret its presence as a sign that the other ovary has ovulated, thus effectively suppressing ovulation.

If you decide to use progesterone while trying to conceive, be sure to begin using it only after you have ovulated each month. You can track your ovulation by taking your temperature each morning before you get out of bed. When you ovulate, the release of progesterone will cause a slight rise in body temperature. Once that has happedned, you can safely continue using the progesterone cream.

If you think you maybe pregnant and want the pregnancy, do NOT stop the progesterone until you have done a pregnancy test, as a sudden drop in progesterone levels would signal the body to shed the uterine lining, possibly inducing an abortion. While the urine pregnancy tests you can buy at a drugstore are reliable after day 28 of your cycle, a blood pregnancy test is reliable within several days of conception. (You usually do not need a doctor's prescription to get a blood pregnancy test at a local medical lab.) If it is positive and you want to remain pregnant, you should continure to use progesterone cream to prevent the scheduled menstrual shedding and to protect the developing fetus from early miscarriage. Progesterone should be continured at least until the third month of pregnancy, when the placenta becomes the major producer of progesterone, at which time you can GRADUALLY taper your progesterone supplementation. If blood progesterone levels remain good, you can discontinue it altogether. By the third trimester, the placenta will be making hundreds of times more progesterone than you would be getting with the cream alone."

The above Excerpt was from John Lee, MD.

Progesterone cream may be used to maintain a healthy pregnancy along with avoiding the chemicals on the skin that cause the unhealthy pregnancy. Again anything put on the skin is 10 times the oral dose. Make sure to work with your health care practitioner or health care professional while using progesterone cream in pregancy.

Where to Apply

Apply the progesterone cream to the skin anywhere where the circulation is good. Do not use where any lotion, perfume, or cosmetic is applied. You may apply it on the leg, the arm, the back, inner thigh and the chest. The topical progesterone cream is absorbed into the subcutaneous fat, and then slowly released into the blood stream where it is carried on the Red Blood Cell membranes and the chylomicrons (normal microscopic fat bubbles in the blood).

Rotate sites when applying Progestelle. If you just use one site, then the subcutaneous fat will saturate and you will not be able to absorb any more progesterone. For instance, if you keep doing right arm, right arm and right arm day after day, then you will not be able to absorb any more.

When you first try Progestelle, use only one drop at first so that if you have an allergy you will not get a big reaction. Usually, this is a reaction to the coconut oil, and NOT the progesterone. We do have other oils available.

Suggested Use

Use Progesterone Cream on days 12-26. Day 1 is the first day of your period. Use 20-40 mg/day of topical Natural Progesterone. Usually, you need 40 mg/day for the first 2-3 months, and then 20 mg/day for maintenance. However, there are some patients that are really good about their avoidance list and don't need to take progesterone after several months. Infrequently, some patients need to take progesterone for 6 months to 1 year to complete their menstrual period health.

If you have in increase in pain, bleeding, or discomfort, stop the progesterone cream immediately. Then, cut out all xenoestrogens and phytoestrogens according to the information that comes with the product. After cutting out all xenoestrogens and phytoestrogens for about 1-2 months, try the progesterone cream again.

The use of synthetic prescription birth control pills or synthetic prescription brand name hormones is not recommended. Synthetic prescription progestins will block Natural Progesterone. It is suggested that you use a condom without spermicide.

Increase in bloating, breast tenderness, and migraine headaches with the use of progesterone cream indicates the presence of some xenoestrogen (fake estrogen) or phytoestrogen.

Estrogen dominance will depress and decrease the activity of the thyroid receptor and will make you appear to be hypothyroid. Taking progesterone and cutting out xenoestrogens and phytoestrogens will revive the thyroid receptor back to normal and you will need less thyroid hormone. Make sure to work with your physician or health care professionally to decrease the thyroid dose. Hair should become fuller and the fat on the stomache and hips less.

Every woman absorbs, metabolizes and reacts to progesterone differently. So you may titrate the dose to what your body likes. Your job is to find the least amount of Progesterone Cream that you need to get the desired effect.

A woman usually makes about 20-40 mg/day during the luteal phase of her menstrual cycle. During one day of third trimester pregnancy, her body makes 400 mg/day of progesterone. So you can see that progesterone is quite safe. And there is a wide therapeutic range of progesterone that is effective and safe.

Interactions

Birth Control Pills

Birth Control Pills may contain a synthetic progestin that blocks the Natural Progesterone. So Birth Control Pills cannot be used with Natural Progesterone. Progesterone is NOT recommended for birth control.

Thyroid

Estrogen Dominance (too much estrogen usually from xenoestrogens and phytoestrogens) causes thyroid receptor desensitivity. In other words, you become less sensitive to thyroid hormone. Thyroid tests are usually normal or below normal. However, the estrogen dominant patient looks hypothyroid. Hypothyroid patients have thinning hair, low temperature, and develop fat on the hips and belly. After 4-6 months of getting rid of xenoestrogens and phytoestrogens, and taking progesterone the thyroid receptor perks up usually and becomes normal. As a result, hypothyroid symptoms decrease and you become normal. Also IF you are taking thyroid supplements, these thyroid supplements should be slowly tapered off working with your doctor.

Before or After Ovulation

Progesterone taken before ovulation will fool the body into thinking it is pregnant, and the ovaries will not ovulate. In essence, the progesterone is saving your eggs for the future. However, progesterone taken after ovulation may encourage conception. Progesterone encourages a nice "nest" lining for the embryo to implant. You should work with your health care practitioner when using progesterone during pregnancy and lactation.