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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laminaria | Active Comparator | laminaria placed for cervical dilation; usual standard of care in study clinic |
|
| Dilapan-S | Experimental | experimental treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laminaria | Device | place device in cervix for dilation |
| |
| Dilapan-S |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Procedure time to complete early second-trimester dilation and evacuation (D&E) | Day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24402587 | Derived | Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080. |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of 72 eligible and enrolled participants, 3 were excluded from analysis because they did not receive an abortion (2 in the Same-day Dilapan-S group, and 1 in the Overnight laminaria group).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Dilapan-S |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedure Time | Procedure time to complete early second-trimester dilation and evacuation (D&E) | 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. | Posted | Mean | Standard Error | minutes | Day of procedure |
|
Day of procedure and one-week follow-up
Patients were assessed for unexpected or serious adverse events on the day of the study procedure, and were asked one week later to report any hospital or doctor visit necessitated by complications of the study procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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-inadequate power to compare complications directly between study groups. Procedure time was chosen as a proxy for procedural difficulty and thus potential complications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abby Sokoloff | UCSF | 4155140440 | sokoloffa@obgyn.ucsf.edu |
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| Device |
Place in cervix for dilation. |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
|
| 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 | 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. | Posted | Number | participants | Day of procedure |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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. | 0 | 34 | 0 | 34 |
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| Cervical laceration |
|
| Additional dilation |
|