Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Intravaginal 2% lidocaine gel | Experimental | Intravaginal insertion of 4mL of 2% lidocaine gel |
|
| Group 2: Intravaginal placebo gel | Placebo Comparator | Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intravaginal insertion of 4mL 2% lidocaine gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain From Baseline to 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). | change in pain score from baseline (before IUD insertion) to time of IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale | After inserting the gel but prior to IUD insertion |
| Percentage of IUDs Considered by Physicians Easy to Insert |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel B Rapkin, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27500351 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In total, 79 women presenting for IUD insertion at OPC, UPP, and GMO were approached for participation.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Intravaginal 2% Lidocaine Gel | 4 ml of 2% lidocaine gel for self vaginal insertion |
| FG001 | Group 2: Intravaginal Placebo Gel | Intravaginal insertion of 4ml of placebo gel (K-Y Jelly) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomization is blinded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Intravaginal 2% Lidocaine Gel | 4mL of 2% lidocaine gel for vaginal self-administration ) |
| BG001 | Group 2: Intravaginal Placebo Gel | 4mL placebo gel (K-Y Jelly) for vaginal self-administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Randomization was blinded. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain From Baseline to 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). | Posted | Median | Inter-Quartile Range | change in visual analog scale score | change in pain score from baseline (before IUD insertion) to time of IUD insertion |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Intravaginal insertion of 4mL placebo gel Placebo: KY Jelly |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerable Pain | Reproductive system and breast disorders | Pain at time of IUD insertion |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dionne Best | UPittsburgh | 412-641-5496 | dbest@upmc.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C042973 | K-Y jelly |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | KY Jelly |
|
|
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. |
| Directly after IUD insertion |
| Need for Pain Medication up to 7 Days | Number of women taking pain medication for at least one day following IUD insertion | 7 days post-insertion |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Gender | Count of Participants | Participants |
|
Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel
|
|
| Secondary | To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD | Number of participants who rated self-application of study gel as "some what easy" or "very easy" on Likert scale | Posted | Number | participants who found gel easy to use | After inserting the gel but prior to IUD insertion |
|
|
|
| Secondary | Percentage of IUDs Considered by Physicians Easy to Insert | 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. | Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later. | Posted | Number | 95% Confidence Interval | percentage of insertions declared easy | Directly after IUD insertion |
|
|
|
| Secondary | Need for Pain Medication up to 7 Days | Number of women taking pain medication for at least one day following IUD insertion | Posted | Number | participants | 7 days post-insertion |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Study Drug | Intravaginal insertion of 4mL 2% lidocaine gel Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |