Trial Outcomes & Findings for Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia (NCT NCT00719537)
NCT ID: NCT00719537
Last Updated: 2017-04-17
Results Overview
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
second and third trimester of pregnancy
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
Baseline characteristics by cohort
| Measure |
Aspirin and Placebo
n=2 Participants
Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
|
Aspirin and Progesterone
n=1 Participants
aspirin 81 mg once a day oral progesterone 200mg twice daily
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
1 participants
n=41 Participants
|
3 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: second and third trimester of pregnancyPopulation: 1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Outcome measures
| Measure |
Aspirin and Placebo
n=1 Participants
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
|
|---|---|---|
|
Incidence of Preeclampsia
|
0 Participants
|
—
|
Adverse Events
Aspirin and Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin and Progesterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place