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.

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. Additional information about how to give the injection is available in the 17P Project section of this website.

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 injected 17P with women with a short cervix as their only indicator. However, the research is not yet strong enough to suggest the use of the injectable 17P for this condition at this time. Vaginal suppository compounds of 17P may be promising for use with this population.

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 should 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.

Given that both MakenaTM, an FDA approved 17P product, and compounded 17P are available to patients, providers should be sure that women are informed about which product they are receiving.  Our online order form asks providers to affirm that they have informed their patient that she will be receiving a compounded form of 17P.

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.

 

What if my patient needs assistance in adhering to the treatment regimen?

Women who have Medicid and have a history of prior preterm birth may qualify for maternity care coordination services. These services are provided by local health departments and coordinated through Community Care of North Carolina local networks. To learn more click on this link. Please note the CCNC website is undergoing changes and will have updated information for contacting local networks in a few weeks.

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. Ther-RX Corporation as part of their FDA approval status, has commited to conducting a very large multi-national 17P study. This study is underway currently and will include over 1000 women.

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 do we store 17P?

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.

What is the shelf life of 17P?

A sealed vial of 17P has a shelf life of about 3 months. Once a vial is open it should be used within 30 days.

What is the status of FDA's Approval for the Use of 17P to Prevent Preterm Labor?

In 2011 the FDA approved a commercially available 17P drug known as MakenaTM for use in preventing recurring preterm birth. This product is carefully monitored by the FDA. For more information about MakenaTM please click here.

The FDA also issued a statement that it will not take enforcement action against pharmacies that compound 17P based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality or are not being compounded in accordance with appropriate standards for compounding sterile products. A recent study conducted by the FDA tested 17P produced by 16 different compounding pharmacies. They found all the samples to meet safety standards, although there were some impurities in some of the samples. The FDA does recommend use of the commercially available product, MakenaTM.