What women are eligible for 17P treatment to reduce the risk of preterm birth recurrence?
Women who are pregnant with a singleton pregnancy and who have a history of a previous singleton spontaneous preterm birth between 200 and 366 weeks gestation are eligible.
Currently, the North Carolina 17P Project is making this medication available free of charge to eligible mothers who have Medicaid, are uninsured, or whose private insurer does not reimburse for the medication.
When should 17P be started?
Treatment should be initiated between 16 and 216 weeks gestation. In cases where a woman has begun her prenatal care late, injections may be started up to 236 weeks gestation.
Should 17P be given until 36 or 37 weeks?
In order to prevent late preterm birth, 17P should be administered until 366 weeks gestation.
What if a woman misses a week or more of injections?
While this is not a desirable situation, 17P should continue to be given on a weekly basis. The woman may need additional assistance and support in completing the full course. While the risk of delivery appears to increase with cessation of 17P, the benefit of partial therapy still outweighs the risk of no therapy.
How is the injection given? What are the side effects?
The majority of nurses who give this injection do so in the gluteus muscle, alternating sides each week. It may also be given in the anterior thigh. The shot is not unusually painful. It has been compared to Depo Provera injections with less medication but a thicker consistency. Patients can take Tylenol and/or soak in a warm tub if they are sore but this usually is not necessary.
How often should 17P be given?
Progesterone stays in the body for approximately one week. As such, the shot needs to be given approximately every seven days. The suggested range of days in between injections is 5 to 9 days. This range may be helpful when planning around holidays or delayed appointments.
Does 17P work in twin pregnancies?
No, 17P is not appropriate for use in women carrying multiples. One trial published in 1980 looked at the effect of 17P for twin pregnancies. There was no difference in the rate of preterm delivery compared to the placebo group. A more recent randomized clinical trial conducted by the Maternal Fetal Medicine Network also found no difference in the rate of preterm delivery.
Does 17P work for women with a short cervix?
Recent clinical trials have had some promising results as far as the effectiveness of 17P with women with a short cervix as their only indicator. However, the research is not yet strong enough to suggest the use of 17P for this condition at this time.
Can you use 17P for patients who have Herpes?
Yes, herpes is not a contraindication for the use of 17P. Administration of 17P should not alter the routine management of HSV during pregnancy.
Can you use 17P with patients who have Diabetes or Gestational Diabetes?
Yes, 17P is not contraindicated in diabetes. Routine management and screening for diabetes and should continue. It is possible that 17P will increase insulin requirements, but routine care will address this issue.
Does a patient need to sign a written consent form prior to receiving 17P?
No, 17P does not require a written consent form. The prescribing provider shoudl review all risks and benefits with the patient, as with any medical treatment. Some facilities have asked patients to sign a consent form or a patient contract to emphasize the importance of adhering to the weekly dosing regimen. Examples are available in the For Providers section of this site.
If I am keeping a vial in the clinic for a specific patient and she miscarries, can I use the remaining doses as my stock vial?
If this vial never leaves the control of your practice site, it may be used for multiple patients. Some practice sites choose to use only one vial at a time for multiple patients, so that only one vial is unsealed at a time. Be sure to check the expiration date regularly; the shelf life for 17P is 6 months.
Where can I access patient education materials?
There are a number of free materials for patients in English and Spanish about 17P. There are also several videos they can view. These items are posted on this website under For Providers and For Mothers. To order copies contact the project at cmih@med.unc.edu. The March of Dimes website has good information about 17P. Click here to download a copy.
Can 17P be used as a tocolytic?
No, 17P is intended only for the prevention of preterm delivery for women at risk. Six studies have shown various progestin regimens to be ineffective for the treatment of preterm labor and should not be used for tocolysis.
Is 17P safe for mothers?
There are minimal risks for mothers who take 17P to reduce their risk for recurring preterm birth. The most common problems are soreness, irritation, itching, bruising, swelling and pain that can occur at the injection site. More severe side effects may occur in rare circumstances.
Is 17P safe for the baby?
The randomized clinical trials of 17P did not find increased risks for birth defects for mothers taking 17P. The Maternal Fetal Medicine Unit network trial has followed the infants in their study for five years and found no differences in development of health problems. This medication is given in the second and third trimester of pregnancy, after much of organogenesis has occured.
How much does 17P cost?
Currently, 17P is available through compounding, mail-order pharmacies. Information about some vendors is available in the "other sources" section of this site. Prices can vary ranging from $150 to $300 for a full course. Orders placed via the mombaby website cost $15 for a single dose vial, $60 for a 5 dose vial and $90 for a 10 dose vial.
How do we bill for 17P?
Complete information about billing is avaiable in the 17P Billing section of this site. Still have questions? Contact Sarah Verbiest at 919-843-7865 or sarahv@med.unc.edu.
How do we store 17P?
The shelf life for 17P is 6 months. The medication can be kept at room temperature and does not need refrigeration. The drug is sensitive to light and should be stored in a dark area. The bottles in which it is dispensed are brown to protect the medication.
Are there suggestions for integrating this into clinical practice?
The UNC Obstetrical Program has developed an internal algorithm for the use of 17P. Please click here to review it. The upcoming 17P Practice Bulletin includes an algorithm for providers to use in help integrate 17P into their practice.
Do health insurance plans cover 17P? Which ones?
Currently in North Carolina, Aetna, United Healthcare and Blue Cross Blue Shield reimburse for this medication. The Division of Medical Assistance began covering 17P on April 1, 2007. Patients with private insurance should check with their carriers to be sure they understand about any particular forms or process they should use for reimbursement.
What is the status of FDA's Approval for the Use of 17P to Prevent Preterm Labor?
Progesterone has been used during pregnancy for decades. Based on clinical trial data, ACOG has endorsed the use of 17P to reduce the risk of recurring preterm birth among a specific population of pregnant women. Ther-Rx Corporation is now partnering on Gestiva (17P) with Hologic/Cytyc Corporation. Ther-Rx will be commercializing Gestiva (17P) upon its approval by the FDA. Hologic/Cytyc will continue to be involved in all aspects of the product's review by the FDA through its anticipated approval. In the fall of 2006, the FDA's advisory committee recommended 17P for full approval. Required animals sutdies were completed with favorable results. The FDA recently requested an additional study series, which is underway. They have suggested that approval of Gestiva will follow upon the enrollment of 85 women in this new study.
ONLINE VIDEO -VIEW NOW
The 17P Project has developed an 11 minute educational video about reducing the risk of recurring preterm birth. The video features comments from mothers who have taken 17P as well as detailed information from physicians about the use of this medication.
To view this video online, please click here. To view the video full screen on your computer click on the real player button. Having problems? Give us a call at 919-843-7865 or 919-843-7864.
To watch a short video clip about the FDA approval status, please click here.
