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Paragard T380a (Copper Intrauterine) - Summary




ParaGardT 380A Intrauterine Copper Contraceptive

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ParaGard is indicated for intrauterine contraception for up to 10 years. The pregnancy rate in clinical studies has been less than 1 pregnancy per 100 women each year.

See all Paragard T380a indications & dosage >>


Media Articles Related to Paragard T380a (Copper Intrauterine)

Domestic violence deters contraception
Source: Abortion News From Medical News Today [2015.04.02]
Domestic violence takes many forms. The control of a woman's reproductive choices by her partner is one of them.

'15 million unwanted pregnancies' created by low contraception in 35 poorer countries
Source: Abortion News From Medical News Today [2015.02.05]
Some 90% of the 16.7 million unwanted pregnancies across a third of the world's population every year are due to a failure to use modern contraception, study suggests.

Research reveals more than half of young women who have abortions were using contraception when they fell pregnant
Source: Abortion News From Medical News Today [2014.04.30]
Reproductive health charity Marie Stopes UK has launched the findings of the first research in the UK into the contraceptive use of women aged 16-24 having one or more abortions.

Adolescent women 'more likely to have unsafe sex' if obese
Source: Sexual Health / STDs News From Medical News Today [2015.07.01]
Obese adolescent women were found less likely to use contraception than their peers with healthy weights, with those that did use contraception less likely to use it consistently.

Female cystic fibrosis patients need more contraceptive guidance, study finds
Source: Cystic Fibrosis News From Medical News Today [2015.05.11]
As life span for once-deadly disease increases, unplanned and mistimed pregnancies are commonOnly half of women with cystic fibrosis (CF) report using contraception and frequently apt to become...

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Published Studies Related to Paragard T380a (Copper Intrauterine)

Timing of copper intrauterine device insertion after medical abortion: a randomized controlled trial. [2011.09]
OBJECTIVE: To compare intrauterine device (IUD) use at 6 months in women randomized to receive an intrauterine copper contraceptive 1 week compared with 1 month after medical abortion... CONCLUSION: Immediate insertion increased uptake of the IUD without increasing expulsions or bleeding. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinialtrials.gov, . LEVEL OF EVIDENCE: I.

Immediate vs. delayed post-abortal copper T 380A IUD insertion in cases over 12 weeks of gestation. [2011.06]
BACKGROUND: The intrauterine device (IUD) is a safe, effective, well-tolerated form of contraception. Immediate placement after second-trimester abortion could increase high-tier contraception use in women who are at high risk for unintended pregnancy... CONCLUSION: Placing the IUD immediately after the procedure significantly increases the likelihood of use of effective contraception following a second-trimester procedure. Women who have an IUD placed immediately after their procedure may also be less likely to have a subsequent unplanned pregnancy. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Copper containing intra-uterine devices versus depot progestogens for contraception. [2010.06.16]
CONCLUSIONS: In the populations studied, the IUD was more effective than hormonal contraception with respect to pregnancy prevention. High quality research is urgently needed to compare the effects, if any, of these two commonly used contraception methods on HIV acquisition/seroconversion and HIV/AIDS disease progression.

Intrauterine contraception for adolescents aged 14-18 years: a multicenter randomized pilot study of levonorgestrel-releasing intrauterine system compared to the Copper T 380A. [2010.02]
BACKGROUND: Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data... CONCLUSIONS: This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.

The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial. [2009.08]
BACKGROUND: Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared... CONCLUSIONS: The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.

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Clinical Trials Related to Paragard T380a (Copper Intrauterine)

Quick Start Insertion of Mirena and ParaGard [Recruiting]
Intrauterine devices (IUDs) are an effective form of contraception, but only about 3. 4% of women in the US report using them. Women must often wait for their menses to start, or for results of screening for sexually transmitted infections (STIs), before their doctors will place IUDs for them. This is not the case with other birth control methods. Researchers know that it is safe to start oral contraceptive pills, transdermal patches or vaginal rings on the same day of a doctor's visit. In the investigators clinical practice, the investigators often place IUDs on the same day of a woman's visit, but outcomes have not been formally assessed.

Currently, there are two kinds of IUDs available in the United States: the ParaGard T380A and the Mirena levonorgestrel intrauterine system (LNG-IUS). The investigators want to know if women who have IUDs placed at any time during their menstrual cycle have different experiences regarding the following, compared to those who have IUDS placed during the first 7 days of their cycle: bleeding or cramping patterns, active pelvic infections, becoming pregnant more often during that first cycle (window pregnancy).

Women who come to their provider seeking an IUD for birth control will be asked to participate in this study. The investigators will ask them to keep track of their bleeding and cramping for three subsequent months to see if patterns differ according to the day in their menstrual cycle that the device was inserted. They will be randomly assigned either to record this information on paper, or to send in the information by responding to daily text messages.

The investigators want to know if women who have an IUD placed at any time during the menstrual cycle have different outcomes compared to those who have IUDs placed during the first 7 days of their cycle. If the investigators have this information, the investigators can make recommendations to physicians, help counsel patients, and potentially expand access to IUDs.

Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes [Recruiting]
The study is being done in order to gain information on the most suitable types of birth control in women who recently had gestational diabetes, or diabetes diagnosed during pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and releases a hormone called a progestin into the uterus. The copper IUD contains no hormones and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).

Early Postpartum Intrauterine Device (IUD) Placement [Recruiting]
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

Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement [Recruiting]
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.

Immediate Postplacental IUD [Recruiting]
The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for enrollment. If consented and meet inclusion criteria, they will be randomized after delivery to receive an IUD immediately postplacental or at their routine postpartum visit. Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon Health and Science University (OHSU) hospital will be considered for inclusion in the study. Women who desire an IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan is routinely documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet the criteria of poor prenatal clinic attendance and express interest in intrauterine contraception. Immediately after vaginal or cesarean delivery, consented subjects will be randomized to immediate postplacental IUD placement or IUD placement at their routine postpartum visit. Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women who received a postplacental IUD will be assisted in scheduling a routine postpartum visit with their primary provider. Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider. All subjects in the delayed group will be provided with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject cannot obtain an IUD at her usual place of care, the device will be placed at no cost through the WHRU. At 3 months after delivery, all subjects will be contacted by phone, text, or email to complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or elective IUD removal. The questionnaire will include questions regarding ease of placement and overall satisfaction with the timing of placement. Subjects will be compensated for their participation in the study after the 3 month contact.

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Page last updated: 2015-07-01

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