Trial Outcomes & Findings for Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women (NCT NCT00614432)
NCT ID: NCT00614432
Last Updated: 2022-07-18
Results Overview
Quantitative blood loss using volume measurement and weight
Recruitment status
COMPLETED
Target enrollment
10 participants
Primary outcome timeframe
Post procedure
Results posted on
2022-07-18
Participant Flow
Participant milestones
| Measure |
Women Who Are Anticoagulated
Women who are anticoagulated having surgical abortion below 12 weeks gestation
|
Women Who Are Not Anticoagulated
Women who are not anticoagulated having surgical abortion less than 12 weeks gestation
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Baseline characteristics by cohort
| Measure |
Women Who Are Anticoagulated
n=4 Participants
Women who are anticoagulated.
|
Matched Case Controls
n=6 Participants
Matched case controls.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
23.2 years
STANDARD_DEVIATION 3.0 • n=107 Participants
|
25.1 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Post procedureQuantitative blood loss using volume measurement and weight
Outcome measures
| Measure |
Women Who Are Anticoagulated
n=4 Participants
Women who are anticoagulated.
|
Matched Case Controls
n=6 Participants
Matched case controls.
|
|---|---|---|
|
Volume of Intraoperative Blood Loss
|
91.5 milliliters
Standard Deviation 88.0
|
52.2 milliliters
Standard Deviation 48.0
|
Adverse Events
Women Who Are Anticoagulated
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Matched Case Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Women Who Are Anticoagulated
n=4 participants at risk
Women who are anticoagulated.
|
Matched Case Controls
n=6 participants at risk
Matched case controls.
|
|---|---|---|
|
Surgical and medical procedures
reaspiration
|
25.0%
1/4 • Number of events 1 • 1 month
|
0.00%
0/6 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place