Abortion Second Trimester
Conditions
Brief summary
The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.
Interventions
DRUGIbuprofen 600 mg
Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-speaking women * 18 years or older * Access to cell phone with text-messaging capability/data * Receiving cervical preparation for induced abortion * Able to complete baseline survey on smartphone/tablet at screening visit
Exclusion criteria
* History of opioid or alcohol abuse * Contraindications or allergy to ibuprofen * Contraindications or allergy opioid medications * Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Pain Score | 24 hours | Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning no pain and 10 meaning the worst possible pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain. | 35 |
| Ibuprofen + Oxycodone Ibuprofen 600 mg: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
OxyCODONE 5 Mg Oral Tablet: Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Total | Ibuprofen | Ibuprofen + Oxycodone |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 8.1 | 30.2 years STANDARD_DEVIATION 7.7 | 30.9 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 19 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 11 Participants | 10 Participants |
| Region of Enrollment United States | 70 participants | 35 participants | 35 participants |
| Sex: Female, Male Female | 70 Participants | 35 Participants | 35 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 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 35 / 35 | 35 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Maximum Pain Score
Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning no pain and 10 meaning the worst possible pain)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Maximum Pain Score | 4.66 score on a scale | Standard Deviation 2.86 |
| Ibuprofen + Oxycodone | Maximum Pain Score | 6.51 score on a scale | Standard Deviation 2.5 |