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Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00719537
Recruitment Status : Terminated (inability to find qualifying participants)
First Posted : July 21, 2008
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE July 17, 2008
First Posted Date  ICMJE July 21, 2008
Results First Submitted Date  ICMJE November 2, 2016
Results First Posted Date  ICMJE April 17, 2017
Last Update Posted Date April 17, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
Incidence of Preeclampsia [ Time Frame: second and third trimester of pregnancy ]
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
reduction in the incidence of preeclampsia [ Time Frame: second and third trimester of pregnancy ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
Delay in onset of preeclampsia [ Time Frame: second and third trimester of pregnancy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
Official Title  ICMJE Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial
Brief Summary This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
Detailed Description

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. Human Leukocytes Antigen-G (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preeclampsia
Intervention  ICMJE
  • Drug: Aspirin
    Aspirin 81 mg once a day
  • Drug: Placebo Oral Tablet
    Placebo 1 tab Daily
  • Drug: Progesterone
    Oral Progesterone 200 mg Twice Daily
Study Arms  ICMJE
  • Placebo Comparator: Aspirin plus Placebo Oral Tablet
    Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
    Interventions:
    • Drug: Aspirin
    • Drug: Placebo Oral Tablet
  • Active Comparator: Aspirin plus Progesterone
    Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
    Interventions:
    • Drug: Aspirin
    • Drug: Progesterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 26, 2011)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2008)
100
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00719537
Other Study ID Numbers  ICMJE 2008-054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No study data is available, will not be shared.
Responsible Party John Uckele, William Beaumont Hospitals
Study Sponsor  ICMJE John Uckele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John E Uckele, MD William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP