Intra Uterine Device Insertion in Nulliparous Women
Status:
Terminated
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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.