Frequently Asked Questions

Can you tell me more about the study drug?
The drug in this study is called hydroxyprogesterone caproate, also known as “17P”. 17P is a man-made progesterone that may help prevent preterm birth in some pregnant women who have already had a preterm birth. 17P has been tested for the prevention of early delivery in women with a single-baby pregnancy and who have a history of previous early single-baby delivery. However, an additional study to confirm its safety and benefit is needed.

Who qualifies for the study?
Qualified candidates for this study are over the age of 18, have a history of a previous preterm birth, are currently pregnant with a singleton pregnancy, or one baby, and meet other protocol specific inclusion criteria. Candidates will be medically screened and evaluated based on the criteria for this study via phone or on the website www.devotedtobabies.com prior to being referred to the study doctor.

Where are the study sites?
There will be approximately 1700 subjects enrolled in the United States, Canada and several other countries. For more information on the specific US study site locations, you can visit the “Participating Locations” tab on the study website at www.devotedtobabies.com or call toll-free at 877-707-4888.

When will I know if I qualify for this research study?
At the end of our pre-screening questionnaire, you will know if you have pre-qualified for this research study. An evaluation of your medical history and present condition will determine your final eligibility and whether this study is appropriate for you.

How long will the research study last?
If you choose to participate, your participation in this study may last for approximately 20 weeks depending upon how long you have been pregnant when you enter the study. Once your baby is born, you may be asked to have your child participate in a follow-up study. Your study doctor will be able to provide you with additional information regarding the follow up study.

Will I be able to discontinue participation in this clinical research study?
Taking part in this research study is strictly voluntary. You have the right to decline participation or to withdraw from this study at any point without affecting your medical care. You will not be penalized, and you and your baby won’t lose any benefits to which you might otherwise be entitled.

Should I still see my prenatal care doctor (OBGYN)?
You are encouraged to discuss your participation in any clinical research study with your prenatal care physician. The study doctor will typically be willing to share the results of your study progress.

Will my prenatal care doctor be kept informed of my progress and any test results?
The doctor at the study site will be able to answer that question for you.

What information will be furnished to my primary doctor?
The doctor at the study site will be able to answer that question for you.

What are the risks or benefits of participating in the study?
Prior to your participation in this study, you will be asked to read and sign an Informed Consent Form. This form and your study doctor will address the risks and benefits of participating in this research study.

Are there any alternative treatments that I should consider?
There may be other treatments available to you to help prevent preterm birth that your study doctor will explain to you, including the important risks and benefits.

Who is sponsoring the study?
The study sponsor is Hologic, Inc. located in Sunnyvale, CA.

Will there be a charge to me for participating in the study?
There will be no extra costs to you for participating in this study. The study drug (17P or placebo) will be provided to you at no charge.

Will I be reimbursed for travel or other expenses?
The doctor at the study site will be able to answer that question for you.

Who pays if I have a drug reaction that requires medical attention?
The doctor at the study site will be able to answer that question for you