Lost IUD Clinical Trial
| NCT number | NCT00308841 |
| Other study ID # | B.30.2.SDÜ.0.01.00.01.301.01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | March 29, 2006 |
| Last updated | October 17, 2008 |
| Verified date | September 2005 |
| Source | Suleyman Demirel University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ministry of Health |
| Study type | Interventional |
Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing
patient discomfort during the removal of a "lost" intrauterine device (IUD).
Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who
underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the
lidocaine group and 34 to the saline group. The main outcome measure was the intensity of
pain during, immediately after, and 20 minutes after the procedure, assessed by a visual
analog scale. Statistical analysis was performed using Friedman's test with Bonferroni
correction, Student's t test, and 2.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: patients undergoing a minor gynecologic procedure for removal of a "lost" IUD. Exclusion Criteria: women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Süleyman Demirel University, School of Medicine | Isparta |
| Lead Sponsor | Collaborator |
|---|---|
| Suleyman Demirel University |
Turkey,
Güney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a "lost" intrauterine device: a randomized, controlled trial. Obstet Gynecol. 2006 Jul;108(1):119-23. — View Citation