Abortion Second Trimester Clinical Trial
— OPTIONOfficial title:
A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care
Verified date | March 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | February 7, 2019 |
Est. primary completion date | February 7, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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") | 24 hours |