Cervical Preparation
Conditions
Brief summary
This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction. Hypothesis: Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference. Primary objective: Determine differences in procedure times Secondary objectives: Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
Interventions
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnancy between fourteen and eighteen weeks gestation * Request for elective abortion and certainty of decision to proceed
Exclusion criteria
* Incarceration * Minor status (women younger than eighteen years) * Allergy to Dilapan or laminaria * Inability to speak and understand Spanish or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Day of procedure | Procedure time to complete early second-trimester dilation and evacuation (D&E) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Experienced Complications or Need for Additional Dilation | Day of procedure | Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria |
Countries
United States
Participant flow
Recruitment details
Women were recruited for the study at the Women's Options Center at San Francisco General Hospital (SFGH) between October 2008 and February 2010. SFGH is San Francisco's county hospital and serves a diverse and mostly uninsured population.
Pre-assignment details
Of 72 eligible and enrolled participants, 3 did not receive an abortion (2 in the Same-day Dilapan-S group, and 1 in the Overnight laminaria group).
Participants by arm
| Arm | Count |
|---|---|
| Laminaria laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten. | 35 |
| Dilapan-S For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion. | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Laminaria | Dilapan-S | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 32 Participants | 66 Participants |
| Age Continuous | 24 years STANDARD_DEVIATION 7 | 27 years STANDARD_DEVIATION 6 | 26 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 35 participants | 34 participants | 69 participants |
| Sex: Female, Male Female | 35 Participants | 34 Participants | 69 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 | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
Procedure Time
Procedure time to complete early second-trimester dilation and evacuation (D&E)
Time frame: Day of procedure
Population: All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overnight Laminaria | Procedure Time | 5.9 minutes | Standard Error 2.9 |
| Dilapan-S | Procedure Time | 8.1 minutes | Standard Error 5.5 |
Comparison: Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.97.5% CI: [-0.3, 4.5]t-test, 2 sided
Secondary
Participants Who Experienced Complications or Need for Additional Dilation
Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
Time frame: Day of procedure
Population: All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overnight Laminaria | Participants Who Experienced Complications or Need for Additional Dilation | Reaspiration | 2 participants |
| Overnight Laminaria | Participants Who Experienced Complications or Need for Additional Dilation | Additional dilation | 8 participants |
| Overnight Laminaria | Participants Who Experienced Complications or Need for Additional Dilation | Cervical laceration | 1 participants |
| Overnight Laminaria | Participants Who Experienced Complications or Need for Additional Dilation | Bleeding requiring uterotonics | 10 participants |
| Dilapan-S | Participants Who Experienced Complications or Need for Additional Dilation | Bleeding requiring uterotonics | 7 participants |
| Dilapan-S | Participants Who Experienced Complications or Need for Additional Dilation | Reaspiration | 3 participants |
| Dilapan-S | Participants Who Experienced Complications or Need for Additional Dilation | Cervical laceration | 0 participants |
| Dilapan-S | Participants Who Experienced Complications or Need for Additional Dilation | Additional dilation | 22 participants |