Abortion, Second Trimester
Conditions
Brief summary
The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
Interventions
DEVICESingle Foley Balloon
Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure
DEVICEDilapan-S
Dilapan S will be placed through the cervix on the day prior to the procedure
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound * able to provide informed consent and comply with study protocol * English or Spanish-speaking * candidate for outpatient cervical preparation
Exclusion criteria
* Anyone with an allergy to misoprostol, mifepristone or any study medication * premature rupture of membranes * intrauterine fetal demise * placenta previa * suspected abnormal placentation * evidence of infection at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Up to approximately 30 minutes | Time to speculum in to speculum out |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Dilation | Beginning of the procedure (approximately 5 seconds to assess) | Measure the cervical dilation after removal of the Foley balloon or Dilapan-S |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dilapan-S Dilapan-S for cervical preparation, number determined by a standard protocol based on gestational age. | 16 |
| Foley Balloon Foley balloon inserted for cervical preparation and filled to 30mL of water or saline. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Dilapan-S | Foley Balloon | Total |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 3.9 | 32.7 years STANDARD_DEVIATION 7 | 34.1 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian or Indian | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Chinese | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Korean | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mexican | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other Hispanic/Latin Origin | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Vietnamese | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment United States | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 3 / 16 | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Procedure Time
Time to speculum in to speculum out
Time frame: Up to approximately 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dilapan-S | Procedure Time | 22.4 minutes | Standard Deviation 12.8 |
| Foley Balloon | Procedure Time | 22.6 minutes | Standard Deviation 8.9 |
95% CI: [-7.8, 8.2]
Secondary
Cervical Dilation
Measure the cervical dilation after removal of the Foley balloon or Dilapan-S
Time frame: Beginning of the procedure (approximately 5 seconds to assess)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dilapan-S | Cervical Dilation | ≥ 4 cm | 6 Participants |
| Dilapan-S | Cervical Dilation | <1 cm | 0 Participants |
| Dilapan-S | Cervical Dilation | 1 cm | 0 Participants |
| Dilapan-S | Cervical Dilation | 2 cm | 4 Participants |
| Dilapan-S | Cervical Dilation | 3 cm | 6 Participants |
| Foley Balloon | Cervical Dilation | 3 cm | 2 Participants |
| Foley Balloon | Cervical Dilation | 2 cm | 3 Participants |
| Foley Balloon | Cervical Dilation | <1 cm | 2 Participants |
| Foley Balloon | Cervical Dilation | ≥ 4 cm | 5 Participants |
| Foley Balloon | Cervical Dilation | 1 cm | 4 Participants |
p-value: 0.07Fisher Exact