Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia - Full Text View

Sponsor:	William Beaumont Hospitals
Information provided by (Responsible Party):	John Uckele, 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

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

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Progesterone BaseLine

U.S. FDA Resources

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 ]

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:	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

Locations

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

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:	September 30, 2011
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 February 12, 2012