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Trial record 18 of 148 for:    severe preeclampsia AND hypertensive disorders

Early Prevention of Preeclampsia Study (EPAPP)

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: NCT01547390
Recruitment Status : Terminated (Terminated after Aspirin was recommended by the USPTF to Prevent Preeclampsia.)
First Posted : March 7, 2012
Results First Posted : May 14, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Preeclampsia
Interventions Drug: Aspirin
Drug: placebo
Enrollment 104
Recruitment Details  
Pre-assignment Details Of 1470 women screened, 138 were screen positive, and 53 consented to participate in the study and were randomized. Ten women in the aspirin group and 13 in the placebo group dropped out of the study.
Arm/Group Title Placebo Aspirin
Hide Arm/Group Description Study subjects receiving placebo one tablet orally per day Study subjects receiving aspirin 81 mg one tablet orally per day.
Period Title: Overall Study
Started 27 26
Completed 14 16
Not Completed 13 10
Reason Not Completed
Withdrawal by Subject             10             7
termination of pregnancy             0             1
Lost to Follow-up             0             2
Adverse Event             3             0
Arm/Group Title Placebo Aspirin Total
Hide Arm/Group Description 1 capsule orally daily 81mg, 1 capsule orally daily Total of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
16
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 30 participants
31.6  (6.1) 30.0  (5.0) 30.8  (5.5)
[1]
Measure Description: Maternal age at enrolment as reported by the participant
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Sex Number Analyzed 14 participants 16 participants 30 participants
Female
14
 100.0%
16
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Black
11
  78.6%
4
  25.0%
15
  50.0%
White
3
  21.4%
1
   6.3%
4
  13.3%
Other
0
   0.0%
11
  68.8%
11
  36.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 16 participants 30 participants
14
 100.0%
16
 100.0%
30
 100.0%
1.Primary Outcome
Title Number of Participants With Preeclampsia
Hide Description Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).
Time Frame within 3 months prior to delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Aspirin
Hide Arm/Group Description:
1 capsule orally, daily
81mg, 1 capsule orally daily
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
3
  21.4%
3
  18.8%
2.Secondary Outcome
Title Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage
Hide Description

Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.

Statistical significance not reported due to the low recruitment and poor patient compliance.

Time Frame within 3 months of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Aspirin
Hide Arm/Group Description:
1 capsule orally, daily
81mg, 1 capsule orally daily
Overall Number of Participants Analyzed 14 16
Measure Type: Number
Unit of Measure: participants
Small for gestational age (IUGR) 1 1
Gestational hypertension 0 2
Early preeclampsia 1 1
Severe preeclampsia 3 3
Preterm birth 2 1
Stillbirth 0 0
Placental abruption 0 0
antepartum hemorrhage 0 0
neonatal death 0 0
NICU admission 0 2
miscarriage 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Aspirin
Hide Arm/Group Description 1 capsule orally, daily 81mg, 1 capsule orally daily
All-Cause Mortality
Placebo Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/14 (21.43%)      0/16 (0.00%)    
Skin and subcutaneous tissue disorders     
Rash or hive *  3/14 (21.43%)  3 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Study terminated due to poor enrollment after Aspirin was recommended by the US Preventive Task Force for the Prevention of Preeclampsia.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anthony Odibo
Organization: University of South Florida
Phone: 813-259-0828
EMail: aodibo@health.usf.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01547390     History of Changes
Other Study ID Numbers: 201112007
First Submitted: March 1, 2012
First Posted: March 7, 2012
Results First Submitted: January 29, 2018
Results First Posted: May 14, 2018
Last Update Posted: June 29, 2018