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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR PARAGARD T 380A

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Clinical Trials for Paragard T 380a

Trial ID Title Status Sponsor Phase Summary
NCT01147497 Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women Completed Emory University N/A Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.
NCT01422226 Intra Uterine Device Insertion in Nulliparous Women Terminated University of Colorado, Denver N/A 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.
NCT01594476 Early Postpartum Intrauterine Device (IUD) Placement Terminated Society of Family Planning Phase 4 Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Paragard T 380a

Condition Name

Condition Name for Paragard T 380a
Intervention Trials
Contraception 6
Female Contraception 1
Pregnancy 1
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Condition MeSH

Condition MeSH for Paragard T 380a
Intervention Trials
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Clinical Trial Locations for Paragard T 380a

Trials by Country

Trials by Country for Paragard T 380a
Location Trials
United States 7
Dominican Republic 1
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Trials by US State

Trials by US State for Paragard T 380a
Location Trials
Colorado 2
California 1
Oregon 1
Georgia 1
Utah 1
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Clinical Trial Progress for Paragard T 380a

Clinical Trial Phase

Clinical Trial Phase for Paragard T 380a
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Paragard T 380a
Clinical Trial Phase Trials
Completed 4
Terminated 2
Active, not recruiting 1
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Clinical Trial Sponsors for Paragard T 380a

Sponsor Name

Sponsor Name for Paragard T 380a
Sponsor Trials
Society of Family Planning 2
University of Colorado, Denver 2
Bayer 1
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Sponsor Type

Sponsor Type for Paragard T 380a
Sponsor Trials
Other 12
NIH 1
Industry 1
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