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Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Preeclampsia
Interventions Drug: Aspirin
Drug: Placebo Oral Tablet
Drug: Progesterone
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin and Placebo Aspirin and Progesterone
Hide Arm/Group Description Aspirin and placebo: Aspirin 81mg once daily and placebo once daily aspirin 81 mg once a day oral progesterone 200mg twice daily
Period Title: Overall Study
Started 2 1
Completed 1 0
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             1
Arm/Group Title Aspirin and Placebo Aspirin and Progesterone Total
Hide Arm/Group Description Aspirin and placebo: Aspirin 81mg once daily and placebo once daily aspirin 81 mg once a day oral progesterone 200mg twice daily Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: 18-50 years, female
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Incidence of Preeclampsia
Hide Description Number of Participants with preeclampsia in second and third trimester of pregnancy.
Time Frame second and third trimester of pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.
Arm/Group Title Aspirin and Placebo Aspirin and Progesterone
Hide Arm/Group Description:
Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
aspirin 81 mg once a day oral progesterone 200mg twice daily
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin and Placebo Aspirin and Progesterone
Hide Arm/Group Description Aspirin and placebo: Aspirin 81mg once daily and placebo Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily
All-Cause Mortality
Aspirin and Placebo Aspirin and Progesterone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin and Placebo Aspirin and Progesterone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Aspirin and Placebo Aspirin and Progesterone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Uckele
Organization: William Beaumont Hospital
Phone: 2485510610
EMail: john.uckele@beaumont.edu
Layout table for additonal information
Responsible Party: John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00719537     History of Changes
Other Study ID Numbers: 2008-054
First Submitted: July 17, 2008
First Posted: July 21, 2008
Results First Submitted: November 2, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017