Abortion in Second Trimester
Conditions
Brief summary
Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
Detailed description
This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D&E) procedures. Pain levels and medication usage will also be assessed following the D&E procedure itself, up to 7 days after the procedure.
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know what type of dilator they have been assigned, however the medical care team (including investigators) will be aware.
Intervention model description
Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* scheduled D&E for 15+0 to 23+6 wga * ability to speak and read in English * ownership of smartphone with internet access and data plan
Exclusion criteria
\- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum pain above baseline following Laminaria versus Dilapan-S placement | First 24 hours after dilator placement | Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement |
| Time of maximum pain above baseline following Laminaria versus Dilapan-S placement | First 24 hours after dilator placement | Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain medication use after Laminaria versus Dilapan-S placement | First 24 hours after dilator placement | Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement |
| Maximum pain increase over baseline following D&E procedure | First week after D&E | Timed surveys measuring pain on Numeric Rating Scale (0-10), administered at 1 hour, 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure |
| Pain medication use after D&E | First week after D&E | Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure |
Countries
United States
Outcome results
None listed