STEP Inpatient Study
Sleep & Tracking activity: Effects in Pregnancy
What is the STEP Inpatient Study?
The STEP study is also known as the Sleep and Tracking Activity: Effects in Pregnancy Study. The inpatient part of this study is observational and uses Fitbit trackers to collect detailed data during your time at the hospital. It will help researchers to understand how hospitalization impacts activity and sleep levels and whether any changes impact delivery outcomes in high risk pregnancies.
Why am I being asked to participate?
You are being asked to be in the study because you have been admitted to the antepartum service, are expected to remain inpatient for at least 48 hours after enrollment, and are at a high risk for preterm delivery.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review the consent form and HIPAA form.
Once you agree to participate and sign the consent form and the HIPAA form, we will ask you to complete a set of surveys about your past medical history, activity/sleep levels, and stress. You will also receive a Fitbit that must be worn at all times during your time inpatient. You will be asked to complete a daily survey about your pregnancy and sleep. Once per week, you will be asked to complete a survey about symptoms of stress.
Biologic samples including blood, urine, and vaginal swabs will be collected at enrollment. We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor. Samples of cord blood and placenta will be collected at delivery.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a $25 gift card at the time the Fitbit device is returned.
The STEP study is also known as the Sleep and Tracking Activity: Effects in Pregnancy Study. The inpatient part of this study is observational and uses Fitbit trackers to collect detailed data during your time at the hospital. It will help researchers to understand how hospitalization impacts activity and sleep levels and whether any changes impact delivery outcomes in high risk pregnancies.
Why am I being asked to participate?
You are being asked to be in the study because you have been admitted to the antepartum service, are expected to remain inpatient for at least 48 hours after enrollment, and are at a high risk for preterm delivery.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review the consent form and HIPAA form.
Once you agree to participate and sign the consent form and the HIPAA form, we will ask you to complete a set of surveys about your past medical history, activity/sleep levels, and stress. You will also receive a Fitbit that must be worn at all times during your time inpatient. You will be asked to complete a daily survey about your pregnancy and sleep. Once per week, you will be asked to complete a survey about symptoms of stress.
Biologic samples including blood, urine, and vaginal swabs will be collected at enrollment. We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor. Samples of cord blood and placenta will be collected at delivery.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a $25 gift card at the time the Fitbit device is returned.
