Trial Outcomes & Findings for Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy. (NCT NCT00878826)
NCT ID: NCT00878826
Last Updated: 2016-12-16
Results Overview
Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
11 participants
Primary outcome timeframe
One measurement per trimester of pregnancy, up to 36 weeks
Results posted on
2016-12-16
Participant Flow
Subjects were enrolled from 11/2/09 to 1/13/11 in the Obstetric Clinic at Lucile Packard Children's Hospital.
There were no significant events.
Participant milestones
| Measure |
Enoxaparin 40 mg Per Day
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.
Baseline characteristics by cohort
| Measure |
Enoxaparin 40 mg Per Day
n=3 Participants
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
n=6 Participants
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
n=2 Participants
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
32.8 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
34.5 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
34.2 years
STANDARD_DEVIATION 1.04 • n=7 Participants
|
|
Gender
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
2 participants
n=206 Participants
|
11 participants
n=7 Participants
|
|
Gestational Age at Enrollment
|
10.86 weeks
n=99 Participants
|
12.19 weeks
n=107 Participants
|
11.64 weeks
n=206 Participants
|
11.73 weeks
n=7 Participants
|
|
Weight at Enrollment
|
61.7 kg
n=99 Participants
|
65.5 kg
n=107 Participants
|
59.5 kg
n=206 Participants
|
63.4 kg
n=7 Participants
|
|
BMI at Enrollment
|
22.8 kg/m2
n=99 Participants
|
26.3 kg/m2
n=107 Participants
|
22.6 kg/m2
n=206 Participants
|
24.7 kg/m2
n=7 Participants
|
|
Insurance Status
Public
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Insurance Status
Private
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
9 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: One measurement per trimester of pregnancy, up to 36 weeksGoal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.
Outcome measures
| Measure |
Enoxaparin 40 mg Per Day
n=3 Participants
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
n=6 Participants
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
n=2 Participants
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
|---|---|---|---|
|
Peak Anti-Xa Level
14-18 weeks gestation
|
0.35 u/ml
Standard Deviation 0.07
|
0.46 u/ml
Standard Deviation 0.27
|
0.57 u/ml
Standard Deviation 0.01
|
|
Peak Anti-Xa Level
24-28 weeks gestation
|
0.27 u/ml
Standard Deviation 0.1
|
0.34 u/ml
Standard Deviation 0.23
|
0.34 u/ml
Standard Deviation 0.1
|
|
Peak Anti-Xa Level
32-34 weeks gestation
|
0.22 u/ml
Standard Deviation 0
|
0.55 u/ml
Standard Deviation 0.23
|
0.56 u/ml
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Enrollment through 6 weeks postpartumOutcome measures
| Measure |
Enoxaparin 40 mg Per Day
n=3 Participants
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
n=6 Participants
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
n=2 Participants
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
|---|---|---|---|
|
Thromboembolic Events
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Enrollment through 6 weeks postpartumOutcome measures
| Measure |
Enoxaparin 40 mg Per Day
n=3 Participants
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
n=6 Participants
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
n=2 Participants
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
|---|---|---|---|
|
Bleeding Events
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Enrollment through 6 weeks postpartumOutcome measures
| Measure |
Enoxaparin 40 mg Per Day
n=3 Participants
40 mg Enoxaparin injection daily
|
Enoxaparin 1 mg Per kg Daily
n=6 Participants
1 mg/kg Enoxaparin injection daily
|
Enoxaparin 60 mg Per Day
n=2 Participants
60 mg Enoxaparin injection daily - Pre prescribed regimen
|
|---|---|---|---|
|
Side Effect - Bruising
|
1 participants
|
3 participants
|
0 participants
|
Adverse Events
Enoxaparin 40 mg Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enoxaparin 1 mg Per kg Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enoxaparin 60 mg Per Day
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