Intra Uterine Device Insertion in Nulliparous Women

Study Overview
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Brief Summary
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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.

Detailed Description
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Hypothesis: The prostaglandin E1 analog misoprostol will ease insertion of intrauterine contraceptive devices in nulliparous women. Specific Aim 1: To evaluate the ability to place an IUD in the standard fashion, without ancillary measures, in nulliparous women who have received misoprostol versus placebo Specific Aim 2: To evaluate in nulliparous women who have chosen to receive an IUD whether pre-procedure misoprostol eases pain, compared to placebo Specific Aim 3: To evaluate whether misoprostol reduces the rate of complications of IUD placement, compared to placebo Study drug (misoprostol) is being obtained from the University of Utah Health Sciences Center, which is the main study site. The University of Utah Health Sciences Center has obtained an Investigational New Drug (IND) exemption from the FDA in order to use misoprostol for this use in this study. This study is part of a prospective meta-analysis. Deidentified data will be provided to the other sites in a password protected spreadsheet and sent via encrypted, secure email. No identifiable data will be shared with other sites or via the internet. We did not complete attachment G, use of the internet, because this research is not being done via the internet, and no identifiable data will be accessible via the internet or shared with other sites involved in the study. Only deidentified data will be made available to the other sites involved in the prospective meta-analysis.

Official Title
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IUD Insertion in Nulliparous Women: A Randomized, Placebo-Controlled Trial of Misoprostol for Cervical Priming

Conditions
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Contraception

Intervention / Treatment
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* Drug: Misoprostol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental active comparator<br>Drug: Misoprostol Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion | Drug: Misoprostol<br>* Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion<br>* Other names: synthetic prostaglandin E1 (PGE1) analog;|
| Placebo Comparator: Placebo comparator<br>Other: Placebo Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion | Other: Placebo<br>* Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of IUD Insertion (Use of Ancillary Measures) | The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion. | During the IUD insertion procedure, up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD, contraception, nulliparous, women