A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care

University of Pennsylvania1 site in 1 country70 target enrollmentJune 19, 2018

ConditionsAbortion Second Trimester

InterventionsIbuprofen 600 mg OxyCODONE 5 Mg Oral Tablet

DrugsIbuprofen 600 mg OxyCODONE 5 Mg Oral Tablet

Overview

Phase: Phase 4
Intervention: Ibuprofen 600 mg
Conditions: Abortion Second Trimester
Sponsor: University of Pennsylvania
Enrollment: 70
Locations: 1
Primary Endpoint: Maximum Pain Score
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 19, 2018

End Date

February 7, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

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