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Sponsored by: |
William Beaumont Hospitals |
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Information provided by: | William Beaumont Hospitals |
ClinicalTrials.gov Identifier: | NCT00719537 |
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.
Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. HLA-G is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.
In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.
Condition | Intervention |
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Preeclampsia |
Drug: Aspirin and progesterone Drug: Aspirin and placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Aspirin and placebo
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Drug: Aspirin and placebo
Aspirin 81mg once daily and placebo
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2: Experimental
Aspirin and progesterone
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Drug: Aspirin and progesterone
aspirin 81 mg once a day oral progesterone 200mg twice daily
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: John E Uckele, MD | 248-551-0610 | John.Uckele@beaumont.edu |
Contact: Evie Russell, RN | 248-898-2068 | Evie.Russell@beaumont.edu |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Contact: John E Uckele, M.D. 248-551-0610 John.Uckele@beaumont.edu | |
Contact: Evie Russell, R.N. 248-898-20368 evie.russell@beaumont.edu | |
Principal Investigator: John E Uckele, M.D. |
Principal Investigator: | John E Uckele, MD | William Beaumont Hospitals |
Responsible Party: | William Beaumont Hospital ( John E. Uckele, MD ) |
Study ID Numbers: | 2008-054 |
Study First Received: | July 17, 2008 |
Last Updated: | December 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00719537 |
Health Authority: | United States: Food and Drug Administration |
preeclampsia progesterone aspirin prevent |
sFlt-1 PlGF risk |
Hypertension, Pregnancy-Induced Pregnancy Complications Progesterone Aspirin Eclampsia |
Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Hypertension |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Hormones Pharmacologic Actions |
Fibrin Modulating Agents Analgesics, Non-Narcotic Sensory System Agents Progestins Therapeutic Uses Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |