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
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 2.1 • n=5 Participants	32.8 years STANDARD_DEVIATION 6.2 • n=7 Participants	34.5 years STANDARD_DEVIATION 6.4 • n=5 Participants	34.2 years STANDARD_DEVIATION 1.04 • n=4 Participants
Gender Female	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	2 participants n=5 Participants	11 participants n=4 Participants
Gestational Age at Enrollment	10.86 weeks n=5 Participants	12.19 weeks n=7 Participants	11.64 weeks n=5 Participants	11.73 weeks n=4 Participants
Weight at Enrollment	61.7 kg n=5 Participants	65.5 kg n=7 Participants	59.5 kg n=5 Participants	63.4 kg n=4 Participants
BMI at Enrollment	22.8 kg/m2 n=5 Participants	26.3 kg/m2 n=7 Participants	22.6 kg/m2 n=5 Participants	24.7 kg/m2 n=4 Participants
Insurance Status Public	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Insurance Status Private	3 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	9 participants n=4 Participants

PRIMARY outcome

Timeframe: One measurement per trimester of pregnancy, up to 36 weeks

Goal 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 postpartum

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
Thromboembolic Events	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Enrollment through 6 weeks postpartum

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
Bleeding Events	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Enrollment through 6 weeks postpartum

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
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

Dr. Deirdre Lyell

Stanford University

Phone: 650-736-1191

Email: dlyell@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place