PARAGARD T380A SUMMARY
ParaGard®T 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.
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.
Clinical Trials Related to Paragard T380a (Copper Intrauterine)
Quick Start Insertion of Mirena and ParaGard [Completed]
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
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
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
Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section [Completed]
This is a pilot study of up to 10 women, which will test the hypothesis that the placement
of copper IUDs through the uterine incision at the time of uncomplicated elective C-section
is technically feasible and acceptable to women seeking long-term contraception.
Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study [Recruiting]
The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form
of contraception. The postpartum period is an important moment for contraceptive
intervention; however there are many barriers to women obtaining birth control postpartum.
The use of the IUD in the immediate postpartum setting offers many advantages and is
considered safe, but the risk of expulsion appears to be higher than with interval
insertion. Previous studies have shown the rate of expulsion of the copper IUD in the
postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the
levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12
months. While studies related to the copper IUD use ring forceps or the operator's hand for
placement of the IUD, the only published study investigating immediate postplacental
levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The
investigators therefore ask the question, is there a difference in expulsion rates between
levonorgestrel and copper IUDs placed post-placentally when all providers undergo a
standardized training, use a standardized insertion technique, and when patient level
characteristics are controlled by randomization?
The investigators propose to perform a prospective cohort trial comparing the rates of
expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in
the uterus within 10 minutes of the delivery of the placenta, using a standardized technique
(placement with a ring forceps or the operator's hand) after all providers undergo a formal
didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD
has a higher rate of expulsion as compared to the copper IUD. Additional objectives include
a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized
expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the
investigators will document the natural history of the location of the IUD within the uterus
when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks,
and 3 months postpartum, to better understand the relationship between position of the IUD
and subsequent expulsion.
Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes [Completed]
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
Long-Acting Reversible Contraception [Active, not recruiting]
In the proposed study, women aged 18-29 seeking oral or injectable contraception will be
offered an opportunity to try LARC instead; the FDA-approved options include two types of
intrauterine products and one type of subdermal contraceptive implant. Over a 24 month
period, the experiences of LARC users will be compared to the experiences of those opting
for their initial short-acting method.
Page last updated: 2011-12-09