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Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women (LIVIIN)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01534520
First received: February 13, 2012
Last updated: October 27, 2016
Last verified: October 2016
February 13, 2012
October 27, 2016
June 2012
May 2013   (Final data collection date for primary outcome measure)
Change in Pain From Baseline to IUD Insertion [ Time Frame: change in pain score from baseline (before IUD insertion) to time of IUD insertion ]
To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).
To assess change in pain from baseline to IUD insertion as determined by 100mm visual analog scale (VAS) for self-administered intravaginal 2% lidocaine gel as compared to placebo gel. [ Time Frame: One year ]
Complete list of historical versions of study NCT01534520 on ClinicalTrials.gov Archive Site
  • To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD [ Time Frame: After inserting the gel but prior to IUD insertion ]
    Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale
  • Percentage of IUDs Considered by Physicians Easy to Insert [ Time Frame: Directly after IUD insertion ]
    The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be "easy" was calculated for each study group.
  • Need for Pain Medication up to 7 Days [ Time Frame: 7 days post-insertion ]
    Number of women taking pain medication for at least one day following IUD insertion
  • To evaluate patient acceptability of self-inserting the intravaginal study gel prior to IUD [ Time Frame: One year ]
  • To measure ease of IUD insertion as reported by physicians [ Time Frame: One year ]
Not Provided
Not Provided
 
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women: a Randomized Controlled Trial
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion.

This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion.

If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Lidocaine
    Intravaginal insertion of 4mL 2% lidocaine gel
    Other Names:
    • Lidocaine Jelly
    • Lidocaine Hydrochloride
  • Drug: Placebo
    KY Jelly
    Other Names:
    • K-Y Jelly
    • water based lubricant
  • Experimental: Group 1: Intravaginal 2% lidocaine gel
    Intravaginal insertion of 4mL of 2% lidocaine gel
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Group 2: Intravaginal placebo gel
    Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
    Intervention: Drug: Placebo
Rapkin RB, Achilles SL, Schwarz EB, Meyn L, Cremer M, Boraas CM, Chen BA. Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2016 Sep;128(3):621-8. doi: 10.1097/AOG.0000000000001596.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Nulliparous, as defined in this study as no history of pregnancy ≥ 24 weeks gestational age
  • Desires insertion of either levonorgestrel-releasing IUD (LNG-IUD) or copper T380A IUD (Cu-IUD)
  • No history of pregnancy in the last 6 weeks
  • Able to provide written informed consent in English and comply with all study procedures

Exclusion criteria:

  • Known allergy or hypersensitivity to lidocaine or other amino amide local anesthetics
  • Prior failed IUD insertion
  • Prior IUD use
  • Use of narcotic or benzodiazepine medication within the last 24 hours
  • U.S. Centers for Disease Control Medical Eligibility Criteria (MEC) category 3 or 4 classification for use of an IUD
  • Positive pregnancy test or reasonable risk of pregnancy due to unprotected heterosexual intercourse since the last menstrual period
Sexes Eligible for Study: Female
14 Years to 55 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01534520
SFP-RBR001
Yes
Not Provided
No
Not Provided
Sharon Achilles, University of Pittsburgh
University of Pittsburgh
Society of Family Planning
Principal Investigator: Rachel B Rapkin, MD University of Pittsburgh
University of Pittsburgh
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP