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Trial record 72 of 252 for:    ASPIRIN AND low-dose aspirin

The Effects of Aspirin in Gestation and Reproduction (EAGeR)

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: NCT00467363
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : May 14, 2014
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Enrique Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Birth
Spontaneous Abortion
Interventions Drug: acetylsalicylic-acid (aspirin)
Dietary Supplement: Folic acid
Enrollment 1228
Recruitment Details Study participants were recruited using community-based advertisements and physician referral to four university medical centres in the US (2006–12).
Pre-assignment Details Out of the 1397 women with confirmed eligibility, consented, and expressed initial interest in the study, 60 (4.3%) chose to discontinue the enrolment process. An additional 109 (7.8%) tested positive for pregnancy at the baseline visit or became pregnant before their randomisation visit.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Period Title: Overall Study
Started 615 613
Completed 535 543
Not Completed 80 70
Reason Not Completed
Lost to Follow-up             80             70
Arm/Group Title Aspirin Placebo Total
Hide Arm/Group Description

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Total of all reporting groups
Overall Number of Baseline Participants 615 613 1228
Hide Baseline Analysis Population Description
All women who consented and underwent randomization were included in baseline analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 615 participants 613 participants 1228 participants
28.8  (4.9) 28.7  (4.7) 28.7  (4.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 615 participants 613 participants 1228 participants
Female
615
 100.0%
613
 100.0%
1228
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 615 participants 613 participants 1228 participants
White 576 586 1162
Non-White 39 27 66
1.Primary Outcome
Title Live Birth
Hide Description Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .
Time Frame after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: livebirths
309 286
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0984
Comments Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p<0.05.
Method Fisher Exact
Comments No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.98 to 1.22
Estimation Comments [Not Specified]
2.Secondary Outcome
Title hCG Recognized Pregnancy
Hide Description [Not Specified]
Time Frame within 8-weeks of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: pregnancy
394 363
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0165
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
1.02 to 1.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinically Recognized Pregnancy
Hide Description [Not Specified]
Time Frame 8-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: pregnancy
374 346
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0329
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
1.01 to 1.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Early Pregnancy Loss (EPL)
Hide Description Implantation failures
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 537 551
Measure Type: Number
Unit of Measure: pregnancy
28 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8902
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
.64 to 1.78
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pregnancy Losses Occurring Less Than 10 Weeks
Hide Description Includes preembryonic and embryonic losses (exclusive of implantation failures)
Time Frame less than 10-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 537 551
Measure Type: Number
Unit of Measure: pregnancy
56 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6869
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
.76 to 1.55
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Fetal Pregnancy Loss
Hide Description [Not Specified]
Time Frame until 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 537 551
Measure Type: Number
Unit of Measure: pregnancy
4 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .7530
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value .68
Confidence Interval (2-Sided) 95%
.19 to 2.41
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Stillbirth
Hide Description [Not Specified]
Time Frame 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 537 551
Measure Type: Number
Unit of Measure: participants
2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
.15 to 7.26
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Ectopic Pregnancy
Hide Description [Not Specified]
Time Frame within 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 537 551
Measure Type: Number
Unit of Measure: pregnancy
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
.21 to 5.06
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Molar Pregnancy
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: pregnancy
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
.21 to 5.06
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Preeclampsia
Hide Description [Not Specified]
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: participants
32 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .7943
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
.67 to 1.76
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Small for Gestational Age Infant
Hide Description birthweight
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Mean (Standard Deviation)
Unit of Measure: grams
3327  (521) 3315  (550)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .7802
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Preterm Birth
Hide Description [Not Specified]
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 535 543
Measure Type: Number
Unit of Measure: infants
22 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .2603
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value .72
Confidence Interval (2-Sided) 95%
.42 to 1.23
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Abnormal Fetal Testing
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this Outcome Measure.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Fetal Intolerance of Labor
Hide Description [Not Specified]
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this Outcome Measure.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Abruption
Hide Description Partial or complete abruption (ie, premature separation of the placenta)
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

Overall Number of Participants Analyzed 615 613
Measure Type: Number
Unit of Measure: participants
7 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.8 to 1.4
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description

81mg of low-dose aspirin plus 400micrograms of folic acid.

acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.

400micrograms of folic acid.

Folic acid: 400micrograms of folic acid.

All-Cause Mortality
Aspirin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/615 (1.14%)      5/613 (0.82%)    
Pregnancy, puerperium and perinatal conditions     
Transient Pulmonary Hypertension   1/615 (0.16%)  1 0/613 (0.00%)  0
Minor Birth Defects  [1]  4/615 (0.65%)  4 4/613 (0.65%)  4
Neonatal Death  [2]  2/615 (0.33%)  2 1/613 (0.16%)  1
Indicates events were collected by systematic assessment
[1]
No difference was seen in the proportion of minor birth defects between the groups (four in each group). Of the four birth defects in the low dose aspirin group, one was a cleft lip and three were ventricular septal defects.
[2]
Three cases of neonatal death occurred; of the two deaths in the lowdose aspirin group, one was due to cervical insufficiency and the other was attributed to chronic vaginal bleeding, chorioamnionitis, and preterm birth.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/615 (3.90%)      8/613 (1.31%)    
Pregnancy, puerperium and perinatal conditions     
Vaginal Bleeding   24/615 (3.90%)  8/613 (1.31%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Enrique Schisterman
Organization: NICHD
Phone: (301) 435-6893
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Enrique Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00467363     History of Changes
Other Study ID Numbers: EAGeR
First Submitted: April 27, 2007
First Posted: April 30, 2007
Results First Submitted: April 10, 2014
Results First Posted: May 14, 2014
Last Update Posted: February 3, 2017