WithdrawnPhase 4

Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain

Stopped: Funding was denied.

United States0Started 2014-06

Plain-language summary

Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as \<4 cm dilation). * English speaking Exclusion Criteria: * Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD * chronic narcotic use, current or past history of illegal drug use (excluding marijuana) * allergy to lidocaine

What they're measuring

Pain at time of IUD insertion

Timeframe: During IUD insertion (no further follow up after patient leaves ofice)

Trial details

NCT IDNCT01967017

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

View on ClinicalTrials.gov More IUD Insertion Complication trials