Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
Primary Purpose
Preeclampsia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Placebo Oral Tablet
Progesterone
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk
Eligibility 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.
Sites / Locations
- William Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Aspirin plus Placebo Oral Tablet
Aspirin plus Progesterone
Arm Description
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Outcomes
Primary Outcome Measures
Incidence of Preeclampsia
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00719537
Brief Title
Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
inability to find qualifying participants
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Uckele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin plus Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Arm Title
Aspirin plus Progesterone
Arm Type
Active Comparator
Arm Description
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 81 mg once a day
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo 1 tab Daily
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Oral Progesterone 200 mg Twice Daily
Primary Outcome Measure Information:
Title
Incidence of Preeclampsia
Description
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Time Frame
second and third trimester of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E Uckele, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No study data is available, will not be shared.
Learn more about this trial
Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
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