Trial Outcomes & Findings for Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion (NCT NCT05099991)
NCT ID: NCT05099991
Last Updated: 2024-04-18
Results Overview
Time to speculum in to speculum out
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Up to approximately 30 minutes
Results posted on
2024-04-18
Participant Flow
Participant milestones
| Measure |
Dilapan-S
Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age.
|
Foley Balloon
Foley balloon inserted for cervical preparation and filled to 30mL of water or saline.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
Received Allocated Intervention
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Baseline characteristics by cohort
| Measure |
Dilapan-S
n=16 Participants
Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age.
|
Foley Balloon
n=16 Participants
Foley balloon inserted for cervical preparation and filled to 30mL of water or saline.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 3.9 • n=99 Participants
|
32.7 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
34.1 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Indian
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Korean
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Vietnamese
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Hispanic/Latin Origin
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 30 minutesTime to speculum in to speculum out
Outcome measures
| Measure |
Dilapan-S
n=16 Participants
Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age.
|
Foley Balloon
n=16 Participants
Foley balloon inserted for cervical preparation and filled to 30mL of water or saline.
|
|---|---|---|
|
Procedure Time
|
22.4 minutes
Standard Deviation 12.8
|
22.6 minutes
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Beginning of the procedure (approximately 5 seconds to assess)Measure the cervical dilation after removal of the Foley balloon or Dilapan-S
Outcome measures
| Measure |
Dilapan-S
n=16 Participants
Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age.
|
Foley Balloon
n=16 Participants
Foley balloon inserted for cervical preparation and filled to 30mL of water or saline.
|
|---|---|---|
|
Cervical Dilation
<1 cm
|
0 Participants
|
2 Participants
|
|
Cervical Dilation
1 cm
|
0 Participants
|
4 Participants
|
|
Cervical Dilation
2 cm
|
4 Participants
|
3 Participants
|
|
Cervical Dilation
3 cm
|
6 Participants
|
2 Participants
|
|
Cervical Dilation
≥ 4 cm
|
6 Participants
|
5 Participants
|
Adverse Events
Dilapan-S
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Foley Balloon
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dilapan-S
n=16 participants at risk
Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age.
|
Foley Balloon
n=16 participants at risk
Foley balloon inserted for cervical preparation and filled to 30mL of water or saline.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hemorrhage from atony
|
0.00%
0/16 • Up to 48 hours
|
6.2%
1/16 • Up to 48 hours
|
|
Injury, poisoning and procedural complications
Cervical abrasion
|
12.5%
2/16 • Up to 48 hours
|
6.2%
1/16 • Up to 48 hours
|
|
Injury, poisoning and procedural complications
Cervical laceration
|
6.2%
1/16 • Up to 48 hours
|
0.00%
0/16 • Up to 48 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place