Trial Outcomes & Findings for Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions (NCT NCT01011634)
NCT ID: NCT01011634
Last Updated: 2013-05-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
within 5 mins after procedure
Results posted on
2013-05-16
Participant Flow
Participant milestones
| Measure |
Moderate Sedation
|
Oral Medication
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions
Baseline characteristics by cohort
| Measure |
Moderate Sedation
n=9 Participants
|
Oral Medication
n=9 Participants
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
>= 18 years old
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 5 mins after procedurePopulation: Study was stopped due to low enrollment (7%). No data analysis performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 min after procedurePopulation: Study was stopped due to low enrollment (7%). No data analysis performed.
Outcome measures
Outcome data not reported
Adverse Events
Oral Medications
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Medications
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