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Prospective Cohort Assessing Novel Biomarkers of Early Pregnancy

The purpose of this research is to take and store blood, urine samples from pregnant women diagnosed by a positive pregnancy test or by ultrasound imaging. The purpose of this study is to determine a better way to diagnose the location and/or viability (chance of survival) of a pregnancy, as compared to current clinical care. Many women are found to be pregnant by a hCG (human chorionic gonadotropin) test which detects a hormone that is indicative of pregnancy. However, in early pregnancy, it is often difficult to see the pregnancy by ultrasound, which is called a pregnancy of unknown location (PUL). In early pregnancy, doctors do many tests (including blood tests and ultrasounds) to try to determine how far along the pregnancy is, whether it is healthy, and most importantly whether the pregnancy is growing in the right place. The doctors running this research project are trying to see if there are substances (biomarkers) in the blood or urine of a pregnant woman that can tell whether the pregnancy is a normal, healthy pregnancy, an ectopic pregnancy, or if pregnancy is not viable (miscarriage). To do this, blood and/or urine samples are being collected from women who have a pregnancy of unknown location, an ectopic pregnancy, women who are having a miscarriage, and women with a healthy growing pregnancy. The study will then look at a pre- determined panel of biomarkers that have been shown to be elevated (higher) or decreased (lower) in different types of pregnancy to determine the effectiveness and accuracy of this test in earlier diagnosing the viability and location of early pregnancy.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Pregnancy diagnosed by a positive serum human chorionic gonadotropin (hCG) test
Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
Diagnosed ectopic pregnancy
Pain or bleeding or at risk for ectopic pregnancy
Women seeking confimation of a pregnancy with a urine or serum pregnancy test (less than 14 weeks)
Exclusion Criteria:
Not a Penn State Health Patient
Pregnancy & Infertility, Women's Health
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Hershey, PA