EPI-NO: Yes or No?
Epi-No is a trademarked medical device/intervention manufactured by the German company Tescana (German for ‘gentle technology’) that is used for two purposes. The first is to strengthen weak and damaged pelvic floor and vaginal muscles that were likely damaged by vaginal birth in the first place. [It is impossible to repair the permanent damage. It is only possible to strengthen what remains and it is likely Epi-No is an effective tool for that in the sense that the user would get feedback on squeeze strength]. The second is (depending on what you read) either to ‘reduce risks of tearing and episiotomy during vaginal birth’ or to ‘help avoid tearing, pelvic organ prolapse and incontinence caused by vaginal birth’. There is no end to glowing testimonials about the device by those who profit from the manufacture, distribution, sale and care provider use of Epi-No. This is never something to be taken seriously. I could find no credible evidence to back any of the claims. There is stuff called ‘research’ but nothing credible. Some of the claims, beyond those already mentioned, are:
1) reduces anxiety and enhances your self-confidence about delivery
2) simple to use and easier than perineal massage (which is the same principle as Epi–No but you do it with your hands or have someone else do it to you)
3) reduces the pain relief required
4) aids in sexual satisfaction post-partum
5) reduces the length of second stage
6) increases neonatal APGAR scores
Epi-No costs from 50 to 90 Euros, $77 to $140 CDN and $69 to $125 US as of March 2014, depending on where you buy it. Epi-No consists of a pressure gauge, a manual bulb for inflating the device and a silicon balloon. Two or three weeks before the due date a woman is to insert the balloon ½ (or 2/3 or ¾) of the way into her vagina, inflate to the point of ‘comfortable’ stretch and hold that for 10 to 15 minutes each day. Every day she is to repeat these instructions until she reaches 10 cm, which is the generally accepted circumference of an average baby’s head. The darned thing has a reputation for popping out of the vagina and women are instructed to hold a rolled up towel in front of their vagina and keep their thighs closed during the hold period. Or have their partner hold it in. Women are instructed to relax during this time period. Sheesh. Since it is a foreign object it must be cleaned thoroughly between uses to ensure infection does not result. Epi-No mimics the outward pressure on the lower portion of the vagina during birth. It does not mimic the downward forces exerted as the baby descends.
European authorities have approved this device. The US FDA has not. Health Canada has approved it with a ‘Medical Device License’. It is not hard to get European approval. All you have to do is produce studies that show the damage caused by the device is not more dangerous than the possible damage caused by the original condition. In other words, the manufacturer would only need to prove that this device doesn’t cause any damage to women or neonates that would not be caused by vaginal birth. Considering the serious and common maternal and neonatal morbidities associated with vaginal births this European approval isn’t worth much. Health Canada’s approval of it with a Medical Device License amounts to the same thing as the European approval. The FDA is a very different beast. It requires that medical devices be proven safe (same definition as the Europeans and Canadians) AND effective. The problem is that credible evidence of Epi-No’s effectiveness does not exist. Anecdotal stories are not credible evidence. The manufacturer would have to prove that primiparous women using Epi-No either do not sustain the short AND long term damage associated with vaginal births OR that they have a real statistically significant reduced risk of this, when compared to primiparous women who birth vaginally and do not use Epi-No. If a credible study proved that Epi-No use was associated with no difference OR if it showed that it compounded the damage caused by first births and resulted in worse morbidity the manufacturer would be out of business. I think you can see that anything beyond ‘testimonials’ is not in the best interest of anyone profiting from Epi-No. This lack of credible evidence is certainly what we have seen in the two decades that have passed since Tescana put the device on the market.
Before I delve too much further into whether Epi-No has a hope of working we need to understand some facts about vaginal birth. Generally first births are longer and harder than second or subsequent births. First vaginal births cause 80-85% of a woman’s permanent life time damage to her vagina, pelvic floor, pelvic connective tissue and pelvic nerves. This permanent damage results in less resistance in subsequent births. If Epi-No is effective it would be because it causes the permanent damage associated with first births during pregnancy. The actual first birth would either cause no further damage or, just as likely, it would compound the damage already inflicted by Epi-No. [This would be the case if any tearing resulted with birth after Epi-No use] It is important to remember that short term and long term maternal morbidity happens when connective tissue, muscles and nerves are stretched beyond their capacity to stretch. During crowning the ‘ring of fire’ is the result of this capacity being exceeded [this is also what Epi-No is meant to mimic]. Tearing is what happens when the capacity to stretch is grossly exceeded. Permanent damage will occur whether the capacity to stretch is either exceeded or grossly exceeded.
My essay to this point has no doubt separated women reading it into two main camps. The first is the ‘Are you flippin kidding me?! No way would I agree to this. I’ll take my chances (and it is a big chance with a first baby) with an episiotomy or tearing OR sign me up for an unlabored cesarean’, in which case there is no pelvic floor or vaginal (and environs) damage from the birthing process. The second group are those who are willing to do anything they can to achieve a vaginal birth instead of a cesarean and are terrified of tearing and an episiotomy (and who the heck isn’t). Both schools of thought are intelligent and valid. I think I have provided enough information for those in the first group in the absence of the required credible evidence. You will have already headed for the exit. Until I have any credible evidence on the efficacy of Epi-No I can’t provide anything more to those women in the second group. I can tell you that various studies have been done that arrive at conflicting conclusions. The ones I’ve seen used small sample sizes, dubious statistical power to recognize significant differences between groups of women who have used Epi-No and control groups who have not and the claims of blinded researchers are rather weak. As an example, in one study involving 4 German hospitals 1, those responsible for overseeing the results were ‘asked’ not to tell the midwives attending births which women had used Epi-No and which ones had not (they called this single blind). Call me skeptical but that sounds unlikely when they all work at the same hospitals and know each other. Forbidden gossip is the kind most likely to spread most rapidly amongst humans. It is also unlikely the midwives couldn’t tell on their own. The women with the stretched out and bruised vaginas are going to be the ones who used Epi-No. They would look different from those few first time women who have naturally large vaginas and from the majority of first time women who had no damage and small, tight vaginas. [The latter group has a far higher incidence of obstetrical lacerations than the group with naturally large vaginas in any situation] In this same study involving only 135 women* who used Epi-No, the researchers concluded that the episiotomy rate in the group who used Epi-No was 42% and 50.5% in the control group. No mention was made of different care provider preferences which make a huge difference in episiotomy rates. They also concluded that the rate of intact perineums (labial tears and anterior lacerations did not matter to them and were higher in the Epi-No group) with Epi-No was 37.4% versus 25.7% in the control group. In the same study they also conclude that there was no significant difference between the two groups regarding incidence of perineal tears, duration of second stage, use of pain relief or incidence of vaginal infection. Other studies (no more credible than this German study) support the last conclusion. There was no difference in 6 month post-partum bladder neck mobility (measured by introital sonography - which is a vaginal ultrasound probe), incidence of occult (not visually apparent) anal sphincter trauma (as measured by endoanal sonography – which is same said probe in the rectum), anal pressure at rest or during squeezing as well as maximum pelvic floor contraction strength. This is the closest I could come to finding out that long term damage would be the same whether you used Epi-No or if you didn’t.
There was higher epidural use in the group who used Epi-No and the rate of the more severe 3rd and 4th degree obstetrical lacerations was higher in the Epi-No group. Problems with the Epi-No were listed as bleeding (8.2%), pain (8.9%) and contractions (1.5%). In addition, 8 patients cancelled their participation with Epi-No after ‘up to 20 days of training’. This is consistent with the dropout rate I hear about with women who are initially motivated to use Epi-No. The safety of device use was studied in an even smaller subsection of Epi-No and control group babies. [n=83 in the Epi-No group and n=79 in the control group] The majority of those neonates had APGAR scores over 7 at 5 minutes regardless of what study group their mothers were in. There was no mention of the rate of reconstructive genital tract surgery required for mothers after birth for either group.
No study I could find compares long term damage between the two groups so there is no information on rates of pelvic organ prolapse, urinary and anal incontinence, sexual satisfaction for both partners or the incidence of gynecological surgery to correct damage associated with vaginal births (which is a 10 billion dollar + industry in the US alone).
You, in the second group, unfortunately, have to make your decision on whether to try Epi-No based on your gut instinct, your tolerance for interventions and your personal preferences.
* I had to laugh at the explanation for the low number of recruits. They had wanted to recruit 225 in both the study group and the control group (total of 450 primiparous women). This is what they needed to get a statistical significance that they termed meaningful [it wouldn’t have been]. They called the problem ‘delayed recruitment’. This is a euphemism for ‘we couldn’t talk enough women into using this and putting up with the invasive testing required for our study.’
1. Ruckhaberle et al, Australian and New Zealand Journal of Obstetrics and Gynecology, June 2009.
Question: Can pregnancy cause cancer?
Answer: Yes. Gestational trophoblastic disease is a term given to a number of pre-cancerous and cancerous conditions associated with fetal tissue and the placenta. The tumour is called a mole and the pregnancy called a molar pregnancy. These tumours can spread to other parts of the mother’s body.
A woman also has an increased risk of breast cancer during pregnancy and for several years after she gives birth.
Pregnancy also elevates your risk of thyroid cancer. Thyroid cancer is the second most commonly diagnosed pregnancy related cancer behind breast cancer. These differentiated thyroid cancers (DTC) occur in 14 out of 100,000 live births and there has been a 2.4 fold increase in thyroid cancer from 1973 to 2002. During pregnancy high levels of hormones such as estrogen and human chorionic gonadotropin create a favourable environment for these cancers.
These conditions also increase the risk of kidney cancer in childbearing women. There is a strong positive correlation between number of births and the risk of renal cell cancer in mothers. There is a 40% increase in kidney cancer in women who have had children versus those women who have never had children and the risk of renal cell cancer with each subsequent pregnancy rises by 15%. [Pregnancy and Risk of Renal Cell Cancer: A Population-Based Study in Sweden M. Lambe et al, British Journal of Cancer (2002) 86, 1425-1429]
Question: I am in counseling for postpartum trauma and I am really feeling pressured to forgive the sadists involved in my birth experience. It doesn’t feel right but I don’t know what to say to fight back.
Answer: Forgiveness therapy is the new fad in ‘positive psychology’ but, as you have very wisely ascertained on your own, it has distinct drawbacks and anti-feminist roots. Janice Arenofsky writes eloquently about this subject and I have reproduced her work entitled “Swept Up in Forgiveness” here. I also want you to know that you should not stay with a therapist that you feel isn’t helpful or who is doing more harm than good.
Question: My sister had a baby and now she has thyroid disease. She was never told that pregnancy could do that and is very angry about that. She needs drugs for the rest of her life and has to go for tests all the time but now hates doctors and doesn’t go all the time. Can you tell me more about that?
Answer: Postpartum thyroiditis (PPT) is quite common and your sister isn’t the only woman of childbearing age who wasn’t told about this risk. If you ask around you will find out that many, many women who have had children take life-long medication and undergo frequent life-long testing for thyroid problems. The risks of thyroid problems after childbirth have been known by the obstetrical community for decades. The near absence of informed consent about this issue is not because they lack the knowledge. The incidence of postpartum thyroiditis is about 10% and that figure rises to 25% if you have Type 1 diabetes. Postpartum thyroiditis typically bounces between hyperthyroidism (too much thyroid hormones) first and then becomes hypothyroidism (too little thyroid hormone) later. For some women with PPT the condition resolves in 12 to 18 months. For others the thyroid glands are too damaged by the imbalance or because the pregnancy has triggered an autoimmune disease and they develop permanent thyroid disease. Even for those women who have their postpartum disease resolve within 12 to 18 months periods of stress, subsequent pregnancies and menopause will trigger more thyroid problems.
The thyroid gland is a butterfly shaped gland that sits at the front of your neck and controls processes in every cell of the body. Symptoms of hypothyroidism include thin and brittle hair and nails, weight gain, feeling cold, fatigue, decreased heart rate, constipation, depression and poor exercise tolerance. Symptoms of hyperthyroidism include hair loss, weight loss, frequent bowel movements, menstrual irregularity, increased heart rate and palpitations, nervousness, shakes and tremors and excessive perspiration.
Of note, in one study, one third of endocrinologists and OB/Gyns didn’t know the answers to some basic questions concerning postpartum thyroiditis. [Thyroid Disease and Pregnancy: Degrees of Knowledge Marie Rinaldi & Alex Stagnoro, THYROID Aug 2007 Vol 17, No. 8 747-753]. Here is another article you and your sister will be interested in. I am so sorry your sister was denied informed consent about this issue. Hopefully your question and my answer will provide informed consent to other women considering pregnancy. Spread the word to as many young women as you can.
Guidelines for Thyroid Disease & Pregnancy
American Thyroid Association Issues Guidelines for Pregnant Women
By Mary Shomon, About.com Guide
Updated January 28, 2009
In 2004, the American Thyroid Association issued a public health statement regarding hypothyroidism and pregnancy.
Endocrinologists have agreed for decades that overt hypothyroidism needs to be treated during pregnancy to prevent an adverse outcome for both mother and baby.
What is controversial, however, is the need for frequent testing during pregnancy, the likelihood of a need for increased thyroid hormone medication during pregnancy, and the risk of thyroid antibodies -- among other factors. Many physicians have differing opinions on these issues.
The American Thyroid Association (ATA)
statement claimed that there is a potential for an adverse outcome when a
mother has subclinical hypothyroidism -- where the T4 levels are normal, and
TSH is slightly elevated -- and when a mother has thyroid autoantibodies indicative
of autoimmune thyroid disease.
The bottom line? The ATA is now saying that even mild hypothyroidism can cause serious problems with the pregnancy, including premature birth or lower IQ in the baby.
This was a major departure, as until these guidelines were issued, recently, many endocrinologists insisted that thyroid antibodies and mild hypothyroidism had no impact on fertility, pregnancy, or the development of the baby.
According to the ATA Statement:
- Pregnant mothers with overt or subclinical hypothyroidism
are at an increased risk for premature delivery.
- Pregnant mothers with detectable thyroid autoantibodies and normal thyroid function are at an increased risk for miscarriage and for postpartum thyroid disease including thyroiditis, hyperthyroidism (Graves’ Disease) and also hypothyroidism.
- The offspring of mothers with thyroid hormone deficiency or thyroid stimulating hormone elevation during pregnancy may be at risk of mild impairment in their intellectual function and motor skills.
- Pregnant women being treated with thyroid hormone replacement often require a 30-50% increase in their thyroid hormone dose.
The ATA called for more extensive research into the nature
of these problems, as well as the need for expanded testing programs.
In the meantime, routine TSH screening is recommended for all women as a standard part of their first full OB visit. The ATA also called for testing before pregnancy and in early pregnancy of women who are at high risk for thyroid disease. Those at risk include those who have had previous thyroid problems, those with previous or existing autoimmune disease, and those with thyroid and autoimmune conditions in the family.
And, among those women who are already diagnosed with hypothyroidism, experts recommend more frequent testing during pregnancy to ensure that they are not subclinically hypothyroid, and to ensure a proper dosage is maintained.
What Should You Do?
While the ATA and endocrinologists debate which research is necessary in the bigger picture, women who are contemplating pregnancy have options to consider:
Women who are contemplating pregnancy -- even those without a personal or family history of thyroid or autoimmune disease -- should, as a precautionary measure, get a basic TSH test. This can be done through your doctor, or in many states, you can order your own tests.
Any woman who has a personal or family history of thyroid or autoimmune disease -- should have her thyroid tested prior to becoming pregnant, and again within the first weeks of early pregnancy. She should be tested throughout the pregnant as often as symptoms might indicate, but at least once a trimester.
Any woman with a diagnosed thyroid condition should have her thyroid tested prior to becoming pregnant, and again within the first several weeks of early pregnancy. She should be tested frequently throughout the pregnancy, including several times in the first trimester, and throughout the pregnancy as often as clinical signs and symptoms might indicate, but at least once in each of the second and third trimesters.
Women contemplating pregnancy should make sure they start taking a prenatal vitamin that includes not only folic acid, but iodine, before becoming pregnant, and continue taking that vitamin throughout pregnancy. (Note, however, that women taking a prenatal vitamin with iron will need to be careful about separating the vitamins from their thyroid hormone by at least 3-4 hours at minimum, or the iron may make the thyroid hormone less effective by interfering with absorption.)
1; 2; 3; 4;