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Trial record 34 of 523 for:    aspirin AND prevention

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aspirin and Placebo Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
Aspirin and Progesterone aspirin 81 mg once a day oral progesterone 200mg twice daily

Participant Flow:   Overall Study
    Aspirin and Placebo   Aspirin and Progesterone
STARTED   2   1 
COMPLETED   1   0 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                0 
Lost to Follow-up                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aspirin and Placebo Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
Aspirin and Progesterone aspirin 81 mg once a day oral progesterone 200mg twice daily
Total Total of all reporting groups

Baseline Measures
   Aspirin and Placebo   Aspirin and Progesterone   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   1   3 
Age [1] 
[Units: Participants]
Count of 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] 18-50 years, female
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2 100.0%      1 100.0%      3 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   1   3 


  Outcome Measures

1.  Primary:   Incidence of Preeclampsia   [ Time Frame: second and third trimester of pregnancy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Uckele
Organization: William Beaumont Hospital
phone: 2485510610
e-mail: john.uckele@beaumont.edu



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