The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
NCT ID: NCT01708330
Last Updated: 2016-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2012-10-31
2016-07-31
Brief Summary
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Women being treated at the Women \& Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.
The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo gel
Placebo gel applied topically to the cervix
Placebo gel
odorless, colorless gel will be used as a placebo
Lidocaine gel
2% lidocaine gel applied topically to the cervix
Lidocaine
2% Lidocaine gel
Interventions
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Lidocaine
2% Lidocaine gel
Placebo gel
odorless, colorless gel will be used as a placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vital signs are stable
* Ages 18 and older
* Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
* Estimated gestational age up to 10 weeks
* Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
* Able to read English or Spanish
* Able to give informed consent for involvement in the study
Exclusion Criteria
* Known sensitivity to any component of the lidocaine or placebo gel.
* In acute distress
* Unable to give informed consent
* Unable to read English or Spanish
18 Years
FEMALE
No
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Bridgeport Hospital
OTHER
Responsible Party
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Amanda Tower
Fellow
Locations
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Women and Infants Hospital Triage
Providence, Rhode Island, United States
Countries
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Other Identifiers
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12-0039
Identifier Type: -
Identifier Source: org_study_id
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