Intra Uterine Device Insertion in Nulliparous Women

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Over the last several years, more and more women are choosing intrauterine contraception (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal sterilization, with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. Intrauterine contraception has many attributes besides its effectiveness; it is easily reversible, has a low side-effect profile, and provides a long-term solution for contraception (10 years for the copper T380 and 5 years for the levonorgestrel IUD). In addition, using an IUD for birth control requires little on-going effort by the woman to be effective and offers immediate return to fertility with its removal.

The biggest increase in users is among nulliparous women (women who have not had children), due to increased awareness of the safety of modern IUDs in this population, and the many benefits of the method. In fact, The copper IUD (Paragard) is now FDA approved for use in nulliparous women, and the American College of Obstetricians and Gynecologists supports the use of both copper and levonorgestrel IUDs in nulliparous women. The cervix of a nulliparous woman has a smaller diameter which can lead to more difficult and uncomfortable IUD insertions. Many providers avoid offering IUDs to nulliparas because of fears that the procedure will be more difficult, and may require cervical dilation, placement of a paracervical nerve block, or placement under ultrasound guidance, none of which are standard for parous women. The medication misoprostol is a prostaglandin E1 analog. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their nulliparous patients a dose of this drug prior to IUD insertion. Misoprostol is commonly used to dilate the cervix for similar procedures as in first trimester abortions, hysteroscopy and endometrial biopsies. Its efficacy in cervical priming for IUD insertion is unknown, and some concern exists that uterine contractions caused by the drug may lead to device expulsion or displacement.

In this study, the investigators propose to ask nulliparous women who have undergone contraceptive counseling and decided to use an IUD for birth control to be randomized to the use of misoprostol or placebo prior to their scheduled IUD placement.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Alprostadil; Misoprostol

Criteria

Inclusion Criteria:

• Desires IUD placement

• 18 years old or older

• negative pregnancy test

• no prior pregnancies beyond 14 6/7 weeks

• no pelvic inflammatory disease (PID) in last 3 months

• no current cervicitis

• no contraindications to IUD insertion (see exclusion criteria below)

• willing to follow-up in 6-8 weeks for a standard IUD follow-up visit

• Determined by her clinician to be an appropriate candidate for an IUD.

Exclusion Criteria:

• Active cervical infection

• current pregnancy

• prior pregnancy beyond 15 weeks' gestation

• uterine anomaly

• fibroid uterus

• copper allergy/Wilson's disease (for Paragard)

• undiagnosed abnormal uterine bleeding

• cervical or uterine cancer

• allergy to misoprostol (study drug)