Trial Outcomes & Findings for Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline (NCT NCT02115256)
NCT ID: NCT02115256
Last Updated: 2017-06-14
Results Overview
Number of participants that had successful version of the fetus into the vertex position.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
6 participants
Primary outcome timeframe
average of 1 hour
Results posted on
2017-06-14
Participant Flow
6 Participants were enrolled from 06/12/2014 to 05/12/2015.
Participant milestones
| Measure |
Intravenous Terbutaline
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intravenous Terbutaline
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline
Baseline characteristics by cohort
| Measure |
Intravenous Terbutaline
n=3 Participants
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
n=2 Participants
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 1 • n=5 Participants
|
36 years
STANDARD_DEVIATION 2 • n=7 Participants
|
34 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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: average of 1 hourNumber of participants that had successful version of the fetus into the vertex position.
Outcome measures
| Measure |
Intravenous Terbutaline
n=3 Participants
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
n=2 Participants
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Successful Version of the Fetus Into the Vertex Position
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average of 1 hourNumber of participants with hypotension
Outcome measures
| Measure |
Intravenous Terbutaline
n=3 Participants
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
n=2 Participants
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Hypotension
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: average of 1 hourNumber of participants that needed a cesarean delivery
Outcome measures
| Measure |
Intravenous Terbutaline
n=3 Participants
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
n=2 Participants
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Need for Cesarean Delivery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: average of 1 hourNumber of participants that had tachycardia
Outcome measures
| Measure |
Intravenous Terbutaline
n=3 Participants
0.25 mL of Intravenous Terbutaline
Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
|
Intravenous Nitroglycerine
n=2 Participants
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
|
|---|---|---|
|
Tachycardia
|
2 Participants
|
0 Participants
|
Adverse Events
Intravenous Terbutaline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Nitroglycerine
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. Yaakov Beilin
Icahn School of Medicine at Mount Sinai
Phone: 212-241-7467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place