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Frequently Asked Questions (FAQs) Applying to Early Signs of Pregnancy or Pre-Conception.

Preterm Birth (PTB)

What is preterm birth?

Premature or preterm birth is when your baby is born early, before 37 weeks of pregnancy. A baby needs about 39-40 weeks to develop before it is born.

Why is understanding your risk factors for PTB important?

The more you understand about your risks for preterm delivery, the easier it is to take meaningful steps to improve both your own and your baby’s health throughout your pregnancy. When these risks are detected during early signs of pregnancy (or pre-conception), you maximize the time available to work with your healthcare provider to make changes that may lead to better outcomes.

What is the difference between preterm birth and preterm delivery?

PTB (Preterm Birth) refers to a baby being born before their expected due date. PTD (Preterm Delivery) refers to the mom having the baby before the expected due date. Sometimes these terms are used interchangeably.

What are standard of care definitions?

Standard of care is a diagnostic and treatment process that a doctor should follow for a certain type of patient, illness, or clinical circumstance. In the case of pregnancy, the standard of care for determining whether you are at risk for preterm delivery has been focused on your history of prior preterm delivery. If you are pregnant for the first time, there has not been a clear standard of care for health care providers to determine what your risk level is for having your baby early.

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PopNatal Preterm Birth Risk Assessment

What is PopNatal?

PopNatal is a convenient, digital health tool that can help you understand your risk for a premature delivery. It is based on questions about yourself, your medical and pregnancy history as well as other potential risk factors. The PopNatal assessment is completed on-line (on your mobile device or computer), and can be taken at home or in a doctor’s office. It is simple, accurate and actionable.

Who should get a PopNatal assessment?

Any woman who is intending to become pregnant, or has early signs of pregnancy, may benefit from PopNatal.

What are the benefits of PopNatal?

PopNatal identifies nearly 10-times more women who may be at risk for preterm birth than the current standard of care. Knowing the chances of having a preterm birth helps you and your health care provider guide the next steps in your pregnancy care. PopNatal is secure and private, and does not require blood or any other patient samples.

Can I access PopNatal on my cell phone?
Yes, you can access PopNatal on any smartphone, tablet or laptop, at your convenience.
How do I request to take PopNatal?

You can access PopNatal by registering here. It is convenient and simple. Just follow the prompts, and it will take you through the assessment process.

How long does it take?
The assessment takes about 15 minutes for most women.
How is PopNatal different from other preterm birth risk tests?

Most other tests intended to predict PTB require invasive sampling (blood draw or pelvic exam) and are not available for use until the second half of pregnancy. PopNatal is unique because it does not require any samples (blood or otherwise) and can be taken during early signs of pregnancy, or even pre-conception when you are planning a pregnancy.

Is PopNatal approved by the FDA?
PopNatal is classified as a Non-Device Clinical Decision Support Tool. We’ve worked with regulatory agencies to ensure that we are in compliance with the appropriate FDA guidelines.
How does PopNatal work with my doctor or healthcare provider?

Please be sure to work with a qualified provider for your prenatal care. PopNatal is intended to be used with your health care professionals’ standard practices, and should not replace their clinical judgement when caring for your pregnancy.

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Understanding PopNatal Results

How do I get my results?

Results are sent directly to your healthcare provider. It is important for you to work with her/him to discuss the findings and determine next steps for your pregnancy care plan. You may request a copy of your results from your healthcare provider.

How long does it take to get results?

Results are sent to your doctor’s office within 72 hours of taking the test.

What will the results tell me about my pregnancy?

The results will let you know whether you are at a high or low risk for preterm birth. Some negative outcomes associated with preterm birth may be preventable, especially during early signs of pregnancy.

What does a HIGH-RISK result mean?

A HIGH-RISK PopNatal result means you are 4 times more at risk for preterm delivery than a woman with a LOW-RISK PopNatal result. This does not necessarily mean you will have your baby early, nor is it a predictor of how early you will deliver, but it indicates the presence of risk factors in your PopNatal assessment that have been shown to elevate risk.

If my test results show as HIGH-RISK, are there things I’ll be able to do to improve my chances for a healthier delivery?

The identification of at-risk pregnancies discovered during early signs of pregnancy allows for targeted interventions, such as enhanced pregnancy care to treat ongoing medical issues, tracking of your symptoms, behavioral changes, and much more. You and your healthcare provider may choose to create an individualized care plan after receiving the results of your PopNatal assessment.

What does a LOW-RISK result mean?

A LOW-RISK result score means that there is a 96% chance that you will not have a premature birth. Some women with a low-risk result may still deliver prematurely. As you get further into pregnancy, your healthcare provider may choose to utilize additional tests to determine your risk of preterm birth based on your symptoms (contractions, bleeding, or short cervix, among others).

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PopNatal Insights

What is PopNatal Insights?

PopNatal Insights is a report that summarizes evidence-based guidelines tailored to your medical history. The Insights report is based on your answers to the PopNatal assessment. PopNatal Insights is currently in a trial phase and the reporting will soon be available to your healthcare provider at the same time as the PopNatal result.

What are the benefits of PopNatal Insights?

PopNatal Insights uses evidence-based guidelines to provide a roadmap to optimizing care for your pregnancy. The Insights report is intended to be used by your healthcare provider as part of creating an individualized care plan for your pregnancy from early signs of pregnancy. If you choose to use PopNatal in the preconception period, the Insights report highlights risk factors to be addressed to optimize your future pregnancy.

Is PopNatal Insights approved by the FDA?

PopNatal Insights is classified as a Non-Device Clinical Decision Support Tool. We’ve worked with regulatory agencies to ensure that we are in compliance with the appropriate FDA guidelines.

How does PopNatal Insights work with my doctor or healthcare provider?

PopNatal Insights is intended to inform your health care provider’s management of your pregnancy, and should not replace their clinical judgement when caring for your pregnancy.

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Costs and Billing

Does my insurance cover PopNatal?

At this time, we are offering PopNatal at an affordable out-of-pocket price.

How much does PopNatal cost?

PopNatal is available for $99 and can be obtained by registering and beginning the process here.

How do I pay my bill?

You can pay for PopNatal with a credit card in the Orders section of the Patient Portal.

Does Nixxi have a financial assistance program?

Nixxi will be starting a financial assistance program in the near future.

Is PopNatal covered by HSA and FSA?

PopNatal is eligible to be covered by HSA and FSA funds.

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Where Can I Learn More?

If you wish to learn more about PopNatal, contact us or email info@nixxhealth.com