Clinical Trials Directory

Trials / Completed

CompletedNCT01708330

The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Bridgeport Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures. 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.

Conditions

Interventions

TypeNameDescription
DRUGLidocaine2% Lidocaine gel
DRUGPlacebo gelodorless, colorless gel will be used as a placebo

Timeline

Start date
2012-10-01
Primary completion
2015-07-01
Completion
2016-07-01
First posted
2012-10-16
Last updated
2016-07-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01708330. Inclusion in this directory is not an endorsement.