Trial Outcomes & Findings for Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion (NCT NCT02277249)
NCT ID: NCT02277249
Last Updated: 2017-01-13
Results Overview
Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
At time of study (immediate)
Results posted on
2017-01-13
Participant Flow
Participant milestones
| Measure |
Transvaginal Digoxin
Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
Transabdominal Digoxin
Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion
Baseline characteristics by cohort
| Measure |
Transvaginal Digoxin
n=30 Participants
Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
Transabdominal Digoxin
n=30 Participants
Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.8 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
26.6 Years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.7 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Gender
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gestational Age
|
21.5 Weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
21.4 Weeks
STANDARD_DEVIATION 1.6 • n=7 Participants
|
21.4 Weeks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Parity
|
0.8 Births
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.87 Births
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.83 Births
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Body Mass Index
|
27.4 Kilograms/meters squared
STANDARD_DEVIATION 5.0 • n=5 Participants
|
26.7 Kilograms/meters squared
STANDARD_DEVIATION 4.8 • n=7 Participants
|
27.1 Kilograms/meters squared
STANDARD_DEVIATION 4.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: At time of study (immediate)Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection)
Outcome measures
| Measure |
Transvaginal Digoxin
n=30 Participants
Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
Transabdominal Digoxin
n=30 Participants
Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
|---|---|---|
|
Patient Discomfort With Digoxin Injection (Pain Score)
|
2.21 Units on a scale
Standard Deviation 1.33
|
1.88 Units on a scale
Standard Deviation 1.54
|
Adverse Events
Transvaginal Digoxin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transabdominal Digoxin
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
Clinical Instructor - Department of Obstetrics and Gynecology
University of California, Los Angeles
Phone: 3107942257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place