An interventional study of laminaria and Dilapan-S in Cervical Preparation, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-14.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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
University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
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Exclusion Criteria:
laminaria placed for cervical dilation; usual standard of care in study clinic
Device: laminaria
experimental treatment
Device: Dilapan-S
place device in cervix for dilation
Place in cervix for dilation.
Procedure Time
Procedure time to complete early second-trimester dilation and evacuation (D\&E)
Time frame: Day of procedure
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
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.
| Milestone | Laminaria | Dilapan-S |
|---|---|---|
| Started | 36 | 36 |
| Completed | 35 | 34 |
| Not completed | 1 | 2 |
| Withdrew: Protocol violation | 1 | 2 |
Procedure time to complete early second-trimester dilation and evacuation (D\&E)
| minutes | Overnight Laminaria | Dilapan-S |
|---|---|---|
| Procedure Time | 5.9 ± 2.9 | 8.1 ± 5.5 |
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
| participants | Overnight Laminaria | Dilapan-S |
|---|---|---|
| Bleeding requiring uterotonics | 10 | 7 |
| Reaspiration | 2 | 3 |
| Cervical laceration | 1 | 0 |
| Additional dilation | 8 | 22 |
Collected over Day of procedure and one-week follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laminaria | — | 0/35 (0%) | 0/35 (0%) |
| Dilapan-S | — | 0/34 (0%) | 0/34 (0%) |
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).
| Age, Categorical(Participants) | Laminaria | Dilapan-S | Total |
|---|---|---|---|
| <=18 years | 1 | 2 | 3 |
| Between 18 and 65 years | 34 | 32 | 66 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Laminaria | Dilapan-S | Total |
|---|---|---|---|
| Mean | 24 ± 7 | 27 ± 6 | 26 ± 6 |
| Sex: Female, Male(Participants) | Laminaria | Dilapan-S | Total |
|---|---|---|---|
| Female | 35 | 34 | 69 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Laminaria | Dilapan-S | Total |
|---|---|---|---|
| United States | 35 | 34 | 69 |
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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