Status:
COMPLETED
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Planned Parenthood Federation of America
Conditions:
Pain
Eligibility:
FEMALE
18-99 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different...
Detailed Description
The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block ...
Eligibility Criteria
Inclusion
- age 18 years or older
- voluntarily requesting pregnancy termination
- ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
- generally healthy
- English or Spanish speaking
- able or willing to sign an informed consent and agree to terms of the study
Exclusion
- gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites)
- incomplete abortion
- failed medical abortion
- required or requested IV sedation (prior to randomization)
- patient who declines Ibuprofen, Lorazepam or PCB
- medical contraindication or allergy to any of the study medications
- chronic use of narcotic pain medication or heroin
- significant physical or mental health condition
- adnexal mass or tenderness on pelvic exam consistent with inflammatory disease
- known hepatic disease
- women who, in the opinion of the investigator, are not suitable for the study protocol
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01466491
Start Date
October 1 2011
End Date
May 1 2013
Last Update
November 8 2019
Active Locations (2)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239
2
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97239