Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
| Status: | Completed |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/14/2018 |
| Start Date: | June 2010 |
| End Date: | September 2011 |
A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women
Because of misoprostol's known ability to cause cervical dilation, some family planning
providers give their patients a dose of this drug prior to insertion. The goal of this study
is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
insertion and decreases pain.
providers give their patients a dose of this drug prior to insertion. The goal of this study
is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
insertion and decreases pain.
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380
(paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to
tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the
first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman
has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions.
Because of misoprostol's known ability to cause cervical dilation, some family planning
providers give their patients a dose of this drug prior to insertion. The goal of this study
is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
insertion and decreases pain. The null hypothesis is that misoprostol does not influence
difficulty of insertion or patient perception of pain. The primary outcome is the ability to
insert the IUD without dilation of the cervix or using ultrasound for guidance.
(paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to
tubal sterilization[1], with an overall unintended pregnancy rate of less than 1% in the
first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman
has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions.
Because of misoprostol's known ability to cause cervical dilation, some family planning
providers give their patients a dose of this drug prior to insertion. The goal of this study
is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases
insertion and decreases pain. The null hypothesis is that misoprostol does not influence
difficulty of insertion or patient perception of pain. The primary outcome is the ability to
insert the IUD without dilation of the cervix or using ultrasound for guidance.
Inclusion Criteria:
- 18 years
- negative pregnancy test
- no prior pregnancy beyond 19 6/7 weeks
- no pelvic inflammatory disease in last 3 months
- no current cervicitis
- willing to follow up in 1-2 months
Exclusion Criteria:
- active cervical infection
- current pregnancy
- prior pregnancy beyond 19 6/7 weeks
- uterine anomaly
- fibroid uterus distorting uterine cavity
- copper allergy or wilson's disease for ParaGard
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer
- sepsis associated with the most recent pregnancy
- current breast cancer for levonogestrel IUD
- inflammatory bowel disease
- allergy to misoprostol
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