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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


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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.


Inclusion Criteria:

- pregnant patients with a previous history of preeclampsia in the immediate preceding


- 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


- 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

Page last updated: August 23, 2015

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