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NCT01422226 · ClinicalTrials.gov registry record · NA
Intra Uterine Device Insertion in Nulliparous Women
A NA study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT01422226 is a NA study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 3 participants.
The verdict
NCT01422226, a NA study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study 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, an
Interventions
- OTHER Placebo
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01422226
The ClinicalTrials.gov registry entry for NCT01422226 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01422226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01422226 about?
NCT01422226 is a clinical study titled "Intra Uterine Device Insertion in Nulliparous Women". 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...
What is the current status of trial NCT01422226?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2011-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01422226?
The interventions under investigation include: Placebo (OTHER), Misoprostol (DRUG).
Who is sponsoring clinical trial NCT01422226?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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