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Acidemias clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT02322177 Completed - Pregnancy Clinical Trials

Maternal Inborn Errors of Metabolism in Pregnancy: A Pregnancy Registry Protocol

Start date: December 19, 2014
Phase:
Study type: Observational

Background: - People with inborn errors of metabolism can t turn food into energy the right way. This can affect a person s growth and health. Researchers want to know how this condition affects a pregnant woman and her baby. Objectives: - To collect data from the medical records of women with an inborn error of metabolism. Also, to create a pregnancy registry of inborn errors of metabolism. Eligibility: - Women with an inborn error of metabolism who either: - have been pregnant in the past, - are currently pregnant, or - have recently talked with their doctor about becoming pregnant. Design: - This study will collect data only. No extra tests will be done. - Participants will be in the study for the length of their pregnancy and for 1 year after delivery. - Participants will answer questions about their family s health. - The participant s doctor will send their medical records to researchers. These may include data about: - Last health care visit before pregnancy - Blood, urine, ultrasound, or lab results during pregnancy - Delivery and recovery after delivery - Researchers will ask for the test(s) used to confirm pregnancy. - After the participant has her baby, researchers will ask for data about how the baby is doing. This may include when the baby is sitting, walking, talking, etc. - The data will be placed into a database. The database will not include the participant s name or identifying data.