Clinical trial NCT01307111: Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Official title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Misoprostol
IUD insertion
Nulliparous Women
Contraception
Family Planning
IUD insertion in nulliparous women
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 85
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

Detailed description: The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Eligibility criteria: Inclusion Criteria:

* 14 years old or older
* Negative pregnancy test
* No prior pregnancies lasting beyond 19 6/7 weeks
* Minimum 2 weeks after spontaneous or medical abortion
* Minimum 4 weeks post 2nd trimester or surgical abortion
* No previous IUD insertions
* No PID in last 3 months
* No current cervicitis
* Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

* Active cervical infection
* Current pregnancy
* Prior pregnancy beyond 19 6/7 weeks gestation
* Known uterine anomaly
* Fibroid uterus distorting uterine cavity
* Copper allergy/Wilson's Disease (for Paragard)
* Undiagnosed abnormal uterine bleeding
* Cervical or uterine cancer

Primary outcomes:
measure: Patient Perceived Pain on a 100-point Visual Analogue Scale.
timeFrame: Prior to insertion, immediately after insertion, and prior to clinic discharge.
Secondary outcomes:
measure: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.
timeFrame: Immediately post IUD insertion
Other outcomes:
Locations:
Study officials:
affiliation: University of New Mexico Department of Obstetrics and Gynecology
name: Eve Espey, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.