Intracervical Lidocaine Gel for IUD Insertional Pain
Completed · Not applicable · Has a placebo group
Conditions studied: Pain
In brief
The intrauterine device (IUD) is a form of birth control that is extremely effective and safe, even in women who have not yet had children. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method. This study will randomly (like flipping a coin) assign women who have chosen the IUD as their contraceptive into two groups. One group will have lidocaine anesthetic gel placed into their cervix prior to having the IUD inserted; the other will have an inert gel placed into their cervix instead. The level of pain at three different time points on a 10cm scale and the patient's satisfaction with the procedure will be compared between the two groups to see if using lidocaine gel helps decrease IUD insertional pain
Key facts
- Study ID
- NCT01214161
- Run by
- Columbia University
- People needed
- 200
- Starts
- 2010-10-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2016-04-07
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Self-select either a Paragard or Mirena IUD and are appropriate for insertion as determined by their provider
- Age 18-45
- Speak English or Spanish
You may not qualify if…
- Lidocaine allergy
- First trimester abortion or miscarriage in the previous six weeks
- Second trimester abortion or miscarriage in the previous 12 weeks
Where it is running
- Family Planning Clinic / Columbia University Family Planning Practice — New York, New York, United States
Full record on ClinicalTrials.gov
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