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Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
This study is currently recruiting participants.
Verified by William Beaumont Hospitals, December 2008
Sponsored by: William Beaumont Hospitals
Information provided by: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00719537
  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

Drug Information available for: Progesterone Acetylsalicylic acid BaseLine
U.S. FDA Resources
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

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • reduction in the incidence of preeclampsia [ Time Frame: second and third trimester of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delay in onset of preeclampsia [ Time Frame: second and third trimester of pregnancy ] [ Designated as safety issue: No ]

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
1: Active Comparator
Aspirin and placebo
Drug: Aspirin and placebo
Aspirin 81mg once daily and placebo
2: Experimental
Aspirin and progesterone
Drug: Aspirin and progesterone
aspirin 81 mg once a day oral progesterone 200mg twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719537

Contacts
Contact: John E Uckele, MD 248-551-0610 John.Uckele@beaumont.edu
Contact: Evie Russell, RN 248-898-2068 Evie.Russell@beaumont.edu

Locations
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.            
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: John E Uckele, MD William Beaumont Hospitals
  More Information

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

Keywords provided by William Beaumont Hospitals:
preeclampsia
progesterone
aspirin
prevent
sFlt-1
PlGF
risk

Study placed in the following topic categories:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Progesterone
Aspirin
Eclampsia
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia
Hypertension

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 13, 2009