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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Primary objective: To study the difference in dilation and evacuation (D&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™.
Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.
One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laminaria | Active Comparator | Patients in this arm will receive laminaria cervical dilators one day before D&E procedure. |
|
| Dilapan-S | Active Comparator | Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laminaria | Device |
| ||
| Dilapan-S |
| Measure | Description | Time Frame |
|---|---|---|
| D&E Procedure Time | Length of D&E procedure in minutes | The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2) |
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Inclusion Criteria:
Exclusion Criteria:
• Active bleeding or hemodynamically unstable at enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Planned Parenthood of New York City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of New York City | New York | New York | 10012 | United States |
If eligible for study participation, the member of the research team will review study procedures and the risks and benefits of participation with the patient, and obtain informed consent for study participation. Once informed consent is obtained, participants will be assigned a screening number. Research staff will then administer a verbal 10-minute survey (Form 1) to collect demographic information and assess baseline pain, bleeding, nausea and other pregnancy-related symptoms.
Eligible patients identified during surgical abortion services by tracking gestational age using electronic health record. Patients seeking abortion services undergo standard clinical procedures for pre-operative evaluation, and routine abortion counselling and surgical consent. After clinic staff confirmed patient is eligibility, research staff tell her about the study and, if the patient is interested in study participation, screen her for inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laminaria | Patients in this arm will receive laminaria cervical dilators one day before D&E procedure. Laminaria |
| FG001 | Dilapan-S | Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure. Dilapan-S |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laminaria | Patients in this arm will receive laminaria cervical dilators one day before D&E procedure. Laminaria |
| BG001 | Dilapan-S | Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure. Dilapan-S |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | D&E Procedure Time | Length of D&E procedure in minutes | Posted | Mean | Standard Deviation | minutes | The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2) |
|
2 years
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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 | Patients in this arm will receive laminaria cervical dilators one day before D&E procedure. Laminaria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Training and Research | Planned Parenthood of New York City | 212-274-7340 | ctri@ppnyc.org |
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|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Dilapan-S | Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure. Dilapan-S | 0 | 89 | 0 | 89 |
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