Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preeclampsia
Intervention: Aspirin and progesterone (Drug); Aspirin and placebo (Drug)
Phase: N/A
Status: Terminated
Sponsored by: John Uckele Official(s) and/or principal investigator(s): John E Uckele, MD, Principal Investigator, Affiliation: William Beaumont Hospitals
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: reduction in the incidence of preeclampsia
Secondary outcome: Delay in onset of preeclampsia
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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.
Locations and Contacts
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Additional Information
Starting date: July 2008
Last updated: January 16, 2013
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