Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
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Purpose
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 |
|---|---|
|
Preeclampsia |
Drug: Aspirin and progesterone Drug: Aspirin and placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- reduction in the incidence of preeclampsia [ Time Frame: second and third trimester of pregnancy ] [ Designated as safety issue: No ]
- Delay in onset of preeclampsia [ Time Frame: second and third trimester of pregnancy ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | July 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Aspirin and placebo
|
Drug: Aspirin and placebo
Aspirin 81mg once daily and placebo
Other Name: Baseline
|
|
Experimental: 2
Aspirin and progesterone
|
Drug: Aspirin and progesterone
aspirin 81 mg once a day oral progesterone 200mg twice daily
Other Name: Experimental
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
- 18 to 45 years of age will be included.
Exclusion Criteria:
- Patients with chronic hypertension
- children (age < 17 years)
- Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
- patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.
Contacts and Locations| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| Principal Investigator: | John E Uckele, MD | William Beaumont Hospitals |
More Information
No publications provided
| Responsible Party: | John Uckele, Medical Doctor, William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00719537 History of Changes |
| Other Study ID Numbers: | 2008-054 |
| Study First Received: | July 17, 2008 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by William Beaumont Hospitals:
|
preeclampsia progesterone aspirin prevent |
sFlt-1 PlGF risk |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Aspirin Progesterone Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013