Trial Outcomes & Findings for The Effects of Aspirin in Gestation and Reproduction (NCT NCT00467363)

Results Overview

Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1228 participants

Primary outcome timeframe

after delivery

Results posted on

2017-02-03

Participant Flow

Study participants were recruited using community-based advertisements and physician referral to four university medical centres in the US (2006-12).

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.

Participant milestones

Participant milestones
Measure	Aspirin 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Overall Study STARTED	615	613
Overall Study COMPLETED	535	543
Overall Study NOT COMPLETED	80	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Aspirin 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Overall Study Lost to Follow-up	80	70

Baseline Characteristics

The Effects of Aspirin in Gestation and Reproduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=615 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=613 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.	Total n=1228 Participants Total of all reporting groups
Age, Continuous	28.8 years STANDARD_DEVIATION 4.9 • n=5 Participants	28.7 years STANDARD_DEVIATION 4.7 • n=7 Participants	28.7 years STANDARD_DEVIATION 4.8 • n=5 Participants
Gender Female	615 Participants n=5 Participants	613 Participants n=7 Participants	1228 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	576 participants n=5 Participants	586 participants n=7 Participants	1162 participants n=5 Participants
Race/Ethnicity, Customized Non-White	39 participants n=5 Participants	27 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: after delivery

Population: Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).

Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Live Birth	309 livebirths	286 livebirths

SECONDARY outcome

Timeframe: within 8-weeks of gestation

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
hCG Recognized Pregnancy	394 pregnancy	363 pregnancy

SECONDARY outcome

Timeframe: 8-weeks

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Clinically Recognized Pregnancy	374 pregnancy	346 pregnancy

SECONDARY outcome

Timeframe: 8 weeks

Implantation failures

Outcome measures

Outcome measures
Measure	Aspirin n=537 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=551 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Early Pregnancy Loss (EPL)	28 pregnancy	27 pregnancy

SECONDARY outcome

Timeframe: less than 10-weeks

Includes preembryonic and embryonic losses (exclusive of implantation failures)

Outcome measures

Outcome measures
Measure	Aspirin n=537 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=551 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Pregnancy Losses Occurring Less Than 10 Weeks	56 pregnancy	53 pregnancy

SECONDARY outcome

Timeframe: until 40 weeks

Outcome measures

Outcome measures
Measure	Aspirin n=537 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=551 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Fetal Pregnancy Loss	4 pregnancy	6 pregnancy

SECONDARY outcome

Timeframe: 40 weeks

Outcome measures

Outcome measures
Measure	Aspirin n=537 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=551 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Stillbirth	2 participants	2 participants

SECONDARY outcome

Timeframe: within 6 weeks

Outcome measures

Outcome measures
Measure	Aspirin n=537 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=551 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Ectopic Pregnancy	3 pregnancy	3 pregnancy

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Molar Pregnancy	0 pregnancy	0 pregnancy

SECONDARY outcome

Timeframe: until delivery

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Preeclampsia	32 participants	30 participants

SECONDARY outcome

Timeframe: until delivery

birthweight

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Small for Gestational Age Infant	3327 grams Standard Deviation 521	3315 grams Standard Deviation 550

SECONDARY outcome

Timeframe: until delivery

Outcome measures

Outcome measures
Measure	Aspirin n=535 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=543 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Preterm Birth	22 infants	31 infants

SECONDARY outcome

Timeframe: 8 weeks

Population: No data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until delivery

Population: No data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: until delivery

Partial or complete abruption (ie, premature separation of the placenta)

Outcome measures

Outcome measures
Measure	Aspirin n=615 Participants 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=613 Participants 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Abruption	7 participants	5 participants

Adverse Events

Aspirin

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aspirin n=615 participants at risk 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=613 participants at risk 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Pregnancy, puerperium and perinatal conditions Transient Pulmonary Hypertension	0.16% 1/615 • Number of events 1	0.00% 0/613
Pregnancy, puerperium and perinatal conditions Minor Birth Defects	0.65% 4/615 • Number of events 4	0.65% 4/613 • Number of events 4
Pregnancy, puerperium and perinatal conditions Neonatal Death	0.33% 2/615 • Number of events 2	0.16% 1/613 • Number of events 1

Other adverse events

Other adverse events
Measure	Aspirin n=615 participants at risk 81mg of low-dose aspirin plus 400micrograms of folic acid. acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid.	Placebo n=613 participants at risk 400micrograms of folic acid. Folic acid: 400micrograms of folic acid.
Pregnancy, puerperium and perinatal conditions Vaginal Bleeding	3.9% 24/615	1.3% 8/613

Additional Information

Dr Enrique Schisterman

NICHD

Phone: (301) 435-6893

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place