17P is approved by FDA

Update:  The company providing this drug plans to make a huge profit, charging 14,900 % of what it cost previously through compounding pharmacies.  There is no justification for this besides gouging and taking advantage of people who need it the most.  We cannot support March of Dimes due to their conflict of interest because they have received a lot of funding from the company KV  Pharmaceuticals.  They are clearly not putting people ahead of money.

FDA approval of 17P (March of Dimes - News Moms Need)

The first-ever drug known to prevent some preterm births won market approval today from the Food and Drug Administration. “For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life,” said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. “Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone.”

The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation. The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.
Prior to today’s approval of Makena™, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.

A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.

This makes the treatment much more accessible and we hope that private production doesn't mean it will be expensive.  Something that can prevent any preterm births will save millions of health care dollars.

An update:  It appears that the manufacturers intend to charge an exorbitant amount for Makena which, when compounded, was costing about $10 a dose so even those without insurance or medicaid could afford it.  Now, even though the drug safety has already been determined and the company does not have to do all those expensive studies, they still plan to take advantage of the people and contribute to exploding health care costs.  Stay tuned...


Update 3/31/11:  Check out the FDA taking a stand against the high pricing and letting the compounding pharmacies know they can continue to produce this drug as previously (read low-cost).  Yay, FDA!  Read here.

Induction?

This is a week for lots of inductions and planned c-sections as people try to avoid Thanksgiving for the birth of their babies. But, before rushing in to this, it would be wise to consider the risks as well as the benefits (which of course are obvious!). Induction can be a positive experience with a good outcome if considered carefully and if you and the baby really are ready.

Some things to consider...

The March of Dimes says, "More than 70 percent of premature babies are born between 34 and 36 weeks gestation. These are called late-preterm births. Late-preterm babies account for most of the increase in the premature birth rate in this country. A 2008 study found that cesarean sections (c-sections) account for nearly all of the increase in U.S. singleton premature births, and this group had the largest increase in c-section deliveries."

What this means is that "late-preterm births" are the most preventable of all preterm deliveries. Much stress and risk can be avoided if the baby can go home with mom rather than going to a NICU (Newborn Intensive Care Unit). In addition to the emotional trauma, a special care nursery with its restrictions, wires, machines, treatments and feeding requirements associated with preterm babies can interfere with breastfeeding success and the health care costs skyrocket. We are very fortunate to have excellent NICU care, but a healthy, closer-to-term infant is ideal.

There is some confusion about why these preterm infants are preventable. If the induction is based on calculated dates, it would seem they would be at term. The problem arises that calculations have an error factor and can be off by a couple of weeks. Thus a "term" baby of 37 completed weeks gestation could actually be 35 weeks by physiological exam at birth. This happens often enough that the stats could be improved greatly by not delivering prior to 39 completed weeks' gestation, unless there is a serious medical concern with the mother or baby necessitating an early delivery. This would be in such cases as pre-eclampsia (where the blood pressure gets too high and can't be brought down with traditional means - bedrest and meds) or when the baby has a placenta or cord problem keeping it from receiving adequate nourishment.

There are other situations as well, but a few reasons that really aren't wise for an earlier delivery include:

• The doctor is going out of town
• The baby's grandmother is coming to town
• The mother is tired of being pregnant
• The mother is having lots of "false" labor and is uncomfortable
• The doctor said the baby will be healthy at this point (this is hard to ascertain)
• The ultrasound said my baby is too big (ultrasound exam estimates of weight in late pregnancy may be off by one whole pound)
• A friend/relative had a baby born early and was just fine
• Big babies run in the family

It is also dangerous to assume that induction assures a safe vaginal delivery. If your body is not ready for induction there is a higher than usual chance you could end up with a surgical delivery because once the membranes have been ruptured (often artificially in the case of labor induction), there is a risk of infection so the clock is ticking. Delivery is best accomplished within 24 hours or less. Risks of c-section include the usual surgical risks, anesthesia, a more difficult recovery, potential rupture of repaired incision, bladder or uterine injury, infection and postpartum depression related to complications and delayed return to activity, pain, etc. It can also affect your future childbearing plans as following deliveries mean either a VBAC delivery or repeat c-section (increasing risks with each).

You may be a candidate for induction if:

• Your cervix is ready (soft, dilating and effaced) and the baby in low, correct position. A bishop's score is often used to predict readiness.
  
• You have completed 39 weeks or more of gestation with accurate date estimates by last menstrual period and/or early ultrasound dating. The closer you are to your due date, the higher the likelihood of a successful induction.
  
• You have discussed pros and cons of induction with your doctor or midwife, including how long induction will last before other interventions occur, such as c-section. There are a lot of 5:00 pm c-sections performed following early morning inductions - sometimes due to "failure to progress" which may just mean not enough time to progress yet. It is not unusual for labor to take 12-14 hours and the initial dilation can be slow, especially if the cervix is less favorable).
• You are OK with having an IV from the onset and for the duration of labor and delivery. Usually continuous monitoring is also required, thus restricting movement and mobility to a degree, possibly earlier than desired.
• You are able to be objective about what is best for you and your baby. It is easy when you are nearing nine months pregnancy to let your emotions make your decisions. Try to remember that even though each day feels like a week, adequate time in utero is critical to the health of your baby.
• You can be flexible since some procedures may be required that aren't part of your birth plan. However, you can have an unmedicated (limited or no anesthesia) birth even with induction if you want, particularly if you have prepared for that.
  

To improve your odds, talk frankly with your health care provider and be sure you know all your options, risks and benefits - including c-section delivery possibility before committing to a scheduled induction. Inductions can be good when all factors are considered and sometimes it is the best option for you and your baby's health and safety.

Tomorrow I will post a 16 minute video for your enjoyment, celebrating the first birthday of one late preterm baby. He is very healthy now but he got a rough start.

17 P Screening Statement for Pregnant Women

Have you had a baby born too early or too little?  There is a drug called 17-P that may lessen your chance of having this happen again.  17-P needs to be started between the fourth and sixth months of your pregnancy.  Call your doctor now to see if you should take 17-P (Alpha Hydroxyprogesterone Caproate). 

It is not indicated in all cases, but the best thing to do is ask if it might be the answer for you.

The exact mechanism by which progesterone prevents preterm birth is unknown although it is has been shown to decrease inflammation and blocks the effect of oxytocin on the myometrium, keeping the uterus from contracting. Studies to date have demonstrated that hydroxyprogesterone is not associated with congenital anomalies or other neonatal developmental problems.
An important feature of both recently reported studies is that enrollment was limited to singleton gestations in patients with a previous history of spontaneous preterm delivery. Studies to date have indicated that progesterone is not effective in preventing premature delivery in pregnancies at low risk for prematurity, multiple gestation, or in patients once preterm contractions have occurred.
Current candidates for progesterone should meet the following criteria:

• Singleton pregnancy
• Previous spontaneous preterm delivery (< 37 weeks gestation) of a single baby
  

A preferred use of progesterone is weekly intramuscular injections of 250 mg of 17-P starting at 16 weeks gestation and continuing to 36 weeks and 6 days.  (source)

Preterm Births - The magic of 40 weeks

According to the March of Dimes Utah gets a "C" grade in preterm births, which are on the rise throughout the country. There was only one "B" grade (Vermont) and no "A"s.

Late preterm birth (defined as 34-37 weeks) is on the rise in the U.S., now making up 71% of all preterm births. Many of these are preventable, but they are associated with increased problems.

In some cases this early delivery is a necessary prevention of problems. Pregnancy dating difficulty often results in elective induction or cesarean section births because these aren't always accurate, especially those estimates and ultrasounds done later in pregnancy. An early dating ultrasound in the first few weeks is considered most accurate and measurement of the mother's abdomen and by ultrasound are notoriously wrong.

The healthiest babies with the lowest risks (even for the first year of life) are born between 39 and 41 weeks completed gestation. Anything earlier increases their odds for a myriad of problems including breathing difficulties, feeding problems and jaundice. These babies are also at increased risk for readmission to the hospital. Breastfeeding is often interrupted, sometimes resulting in a baby being deprived of the best nourishment out there at a time when they need it most. Many of these late preterm babies require NICU or special stay nursery care which can cost 10 times the charges in a normal, uncomplicated delivery at term.

As an example of what is happening during those last few weeks of gestation, the baby's brain at 35 weeks weighs only2/3 of what it will weigh at39-40 weeks. See more here.

ACOG (American College of Obstetrics and Gynecology) advises against any elective deliveries prior to that time without clear risks which must be circumvented such as maternal or fetal well-being (high blood pressure, pre-eclampsia, congenital malformations, cord or placental insufficiency, etc.) . Because of dating errors sometimes when we think we are dealing with a baby at 37 - 38 weeks, it could be that the baby is actually 35 - 36 weeks and behavior is like that of a preemie as opposed to a term baby.

Consequences of Late Preterm Delivery
• Temperature instability
• Hypoglycemia
• Breathing difficulties
• Feeding difficulties
• Jaundice
• Sepsis
• Increased neonatal and infant mortality
• Increased NICU use and readmission
• Increased cost

No pregnant woman enjoys the last few weeks of pregnancy and most would jump at the chance to deliver early if they feel the baby would be OK. And, in many cases, the baby is OK, but in far too many, the baby is not ready for life outside the womb. Cesarean delivery rates are also increased when an elective induction is performed because once the membranes are ruptured, infection risks necessitate delivery one way or another. The first c-section often determines future deliveries. This could mean increased risks because multiple c-sections and VBAC deliveries are both associated with more complications than vaginal deliveries. So this first one is a critical decision not to be entered into lightly, even when sorely tempted. Asking a pregnant woman if she wants to have the baby at her (or her doctor's) convenience is not the best way to make a decision with possible long-term adverse consequences.

The March of Dimes suggests asking hard but important questions.

If your doctor or CNM recommends delivery before 39 completed weeks, ask these questions about induction or elective c-section:

• Is there a problem with my health or the health of my baby that may make me need to have my baby early?
• Can I wait to have my baby until I'm closer to 40 weeks?
• Why do you need to induce my labor?
• How will you induce my labor?
• Will inducing labor increase the chance that I'll need to have a c-section?
• Why do I need to have a c-section (if applicable)?
• What problems can a c-section cause for me and my baby?
• Will I need to have a c-section in future pregnancies?
• If I want more children beyond one or two, how will a c-section now affect this?

Sometimes women mistakenly believe that c-sections are safer and they request this surgery. The truth is, risks are inherent in any birth, but c-sections are major surgeries and except when they are truly needed, the risk is greater than in normal vaginal deliveries. C-sections should be the rare exception when the benefits outweigh the risks. Unnecessary c-sections also contribute to the high cost of health care since they cost 2-3 times that of a vaginal delivery even without other complications resulting from the surgery. For a time it was believed that future problems with urinary stress incontinence might be prevented if a vaginal delivery is bypassed but this has not proven to be the case. This problem occurs in women who have never had children and in women with c-sections. The studies concluded that this should not be a consideration in deciding mode of delivery.

If you are the one pushing for an early delivery due to discomfort, false labor pain, family concerns, grandma coming to town, etc. try to keep perspective about what is most important. The convenience now could be completely consumed by the inconvenience, stress and worry that comes when the baby ends up in trouble because he/she was just not quite "done" yet. Even grandma will be happier with a healthy grandchild and baby's mom, even if it is a little bit inconvenient.

More thoughts on induction here.

Know the Signs of Preterm Labor

(You may want to pause the background music on the left sidebar so you can hear)



For info on Fetal Fibronectin (fFN) Testing to predict preterm labor - MOD Blog