Obstetrics Clinical Trials

Condition:

• Obstetrics

Key Inclusion Criteria:

• Pregnant women who have been scheduled for a genetic counseling, chorionic villus sampling (CVS), amniocentesis, ultrasound and/or for clinical reasons
• Offspring of the pregnant women who have participated in this study
• Biological father of the offspring that is the product of current pregnancy

Summary:

This study focuses on pregnant patients. The purpose of the Prenatal Repository is to gather tissue samples and data to investigate causes of pregnancy complications, such as delivering a premature or small baby and developing diabetes or hypertension during pregnancy. By collecting this information, researchers can explore the possibility of developing new methods of prenatal diagnosis that may be completed earlier or less invasively to identify women at risk. Additionally, samples and clinical information collected as part of this repository may be used to support future research that aims to further scientific knowledge about prenatal development.

Researchers will ask to include participants' babies (by obtaining information from the babies' medical records) and attempt to enroll the biological father of the babies. The biological fathers willing to participate will be contacted through the mother.

Condition:

• Prenatal diagnosis

Key Inclusion Criteria:

• Female who is at least 8 weeks pregnant and no more than 26 weeks gestation
• At least 18 years old
• At increased risk for fetal chromosomal abnormalities (abnormalities of the fetus)

Summary:

This study focuses on patients who will undergo chorionic villus sampling (CVS) or amniocentesis (amnio) and who are at increased risk for having fetal aneuploidy (chromosomal abnormalities in the fetus). The study is designed to evaluate the investigational use of an in vitro diagnostic test called SEQureDx Trisomy 21. Researchers will compare SEQureDx Trisomy 21 to existing tests in order to learn more about the detection of fetal aneuploidy. CVS or amnio procedures are both invasive procedures and can carry an increased risk of complications. Researchers are conducting this study to help develop a new, noninvasive test.

Condition:

• Adverse pregnancy outcome and cardiovascular health

Key Inclusion Criteria:

• Women who experience an adverse pregnancy outcome including gestational diabetes, hypertension, preeclampsia, preterm delivery and/or growth-restricted newborn
• Women who are at least 18 years old

Summary:

This study focuses on women who have experienced an adverse pregnancy outcome (complications during pregnancy), including hypertension, gestational diabetes, small-for-gestation-age baby and/or preterm delivery, because they all have an increased risk of developing later cardiovascular disease, including heart attacks and strokes. The purpose of the study is to determine if early cardiovascular screening and evaluation can help these women reduce their long-term risk of developing heart disease. The registry will allow researchers to track the course of potential cardiovascular problems in women with adverse pregnancy outcomes to ultimately identify women who need intervention to help prevent cardiovascular disease, as well as study the association between adverse pregnancy outcomes, mental health and cardiovascular health.

Data will be collected from medical records, and participants will be asked to complete mental health questionnaires, among other research procedures.

Condition

Childbirth, COVID-19  

Participants Requirements

• Individuals who gave birth during the COVID-19 pandemic and are enrolled in the CORALE study
  

Summary

The purpose of this study is to learn how COVID-19 (coronavirus) has impacted the childbirth experience. The study focuses on individuals who gave birth during the COVID-19 pandemic and are enrolled in the Coronavirus Risk Associations and Longitudinal Evaluation (CORALE) Study.