Clinical trial NCT00886834: Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Official title: A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: IUD insertion
Nulliparous women
Contraception
Family Planning
IUD insertion in nulliparous women
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Detailed description: Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. 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 use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* negative pregnancy test
* no prior pregnancies beyond 14 6/7 weeks
* no PID in last 3 months
* no current cervicitis
* be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 14 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: Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)
timeFrame: Immediately post IUD insertion
Secondary outcomes:
measure: Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)
timeFrame: prior to insertion, immediately after insertion, and prior to clinic discharge
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Planned Parenthood Association of Utah
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah Department of Obstetrics and Gynecology
name: David Turok, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.
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.