Copper Containing Intrauterine Contraceptive Device
NOVA T 380
Patient name:
Insertion date:
Inserted by:
First check-up visit:
Next visits:
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The period of use is five years. The IUD should be removed or replaced by (month/year): ____/____
Please retain this leaflet and record card for future reference.
NOVA T 380 is a T-shaped device that is inserted into the womb to prevent pregnancy. The vertical arm of the T-frame is wound with a pure copper wire, resulting in a copper surface area of approximately 380 mm2. The wire contains a silver core which has been shown to prevent breaking of the wire. Two removal threads are tied to the loop at the lower end of the vertical arm.
The most recent studies show that copper intrauterine devices (IUDs) affect reproduction at an early stage by preventing fertilization. The IUD affects the movement of the sperm and egg and also inhibits the capacity of sperm to fertilize eggs.
During its lifetime, NOVA T 380 releases copper into the womb, but in such minute amounts that there is no risk for the woman. The average daily intake of copper from a normal diet is far greater than that received from the device.
The device should not be used if you have any of the following conditions:
NOVA T 380 is not the method of first choice for young women who have not given birth.
Examination before insertion may include a Pap smear,and other tests, e.g., for infections, including sexually transmitted diseases, as necessary. A gynecological examination should be performed to determine the position and size of the womb.
Copper IUDs may increase menstrual blood loss and dysmenorrhea. NOVA T 380 may not be the method of first choice for women with excessive menstrual bleeding, anemia, dysmenorrhea, or for women receiving anticoagulants. If these conditions develop during use of NOVA T 380, removal of the device should be considered.
NOVA T 380 may be used with caution in women who have congenital heart disease or valvular heart disease at risk of infective endocarditis. Antibiotic prophylaxis should be administered to these patients when inserting or removing the IUD.
You can have an IUD inserted at any time during the menstrual cycle. To minimize the risk of an undetected pregnancy, the best time of insertion is within seven days from the onset of the menstrual bleeding. The IUD can also be inserted immediately after abortion provided that there are no genital infections. The IUD should not be inserted earlier than 6 weeks after delivery.
An instrument called a speculum is inserted into the vagina and the cervix is cleansed with an antiseptic solution. The IUD is then inserted into the womb via a thin, flexible plastic tube. You can feel this, but it should not cause much pain.
NOVA T 380 offers protection against pregnancy for five years, after which the device has to be removed. A new device can be inserted immediately; you should have the results of a recent Pap smear.
You can check yourself if the strings are in place after your period. Gently put your finger into your vagina after your period and feel for the strings near the opening of your uterus (cervix).
Do not pull the strings because you may accidentally pull out NOVA T 380. If you cannot feel the strings, contact your doctor.
The device can be easily removed at any time by your doctor, after which pregnancy is possible. Removal is usually a painless procedure. Fertility returns to normal after removal of NOVA T 380.
If pregnancy is not desired, the removal should be carried out during the menstrual bleeding. Intercourse within a week before removal of the IUD in the mid-cycle may lead to pregnancy. Therefore, another contraceptive should be used for a few days before and after the removal.
You should have your IUD checked 4 - 12 weeks after insertion, and thereafter regularly, at least once a year. In addition, you should contact your doctor if any of the following occurs:
It is perfectly normal for you to experience disturbances in menstrual bleeding during the first few months. The number of bleeding and spotting days may increase. Additionally, bleeding may be heavier. For a short period after insertion, you may experience abdominal pain. Prolonged pain and heavy bleeding may mean that the IUD has been partially expelled, in which case the device must be removed and a new one inserted in the correct position. Pregnancy in the case of the method failure may be ectopic. Pelvic inflammatory disease may occur during the use of the IUD
Some women may experience pain and dizziness after insertion. If these do not pass within half an hour in the resting position, the device may not be correctly positioned. An examination should be carried out and the IUD removed if necessary. Allergic skin reactions may be due to the device.
During insertion, NOVA T 380 is protected within the insertion tube in order to reduce the risk of infection. Despite this, there is an increased risk of pelvic infection immediately after the insertion. Pelvic infections in IUD users are often related to sexually transmitted diseases. The risk of infection is increased if the woman or her partner has multiple sexual partners. Pelvic infections must be treated promptly. Pelvic infection may impair fertility and increase the risk of ectopic pregnancy. The IUD must be removed if there are recurrent pelvic infections or if an acute infection does not respond to treatment within a few days.
In very rare cases, usually during insertion, the IUD may penetrate or perforate the wall of the womb. The risk is increased during the postpartum period. An IUD which has become lodged outside the uterine cavity is not effective for contraception and must be removed as soon as possible.
The muscular contractions of the womb during menstruation may sometimes push the IUD out of place or expel it. Possible symptoms are pain and abnormal bleeding. If the IUD is displaced, the effectiveness is reduced. It is recommended that you check for the threads with your fingers, for example while having a shower. You should not pull the threads as this may displace the device. If you cannot feel the threads, you should avoid intercourse or use another contraceptive, and consult your doctor.
A pregnancy is unlikely while using NOVA T 380. However, if you become pregnant with the device in place and wish to continue the pregnancy, removal of the device is recommended. If it is not removed, there is a risk of miscarriage or premature birth. The pregnancy should be observed carefully. There is no evidence of birth defects in cases when a pregnancy continues to term with the device in place. If the device cannot be gently removed, termination of the pregnancy may be considered. If you wish to continue the pregnancy and the device cannot be withdrawn talk to your doctor who will offer you more information how to proceed. Especially if you experience cramping abdominal pain with fever you need to contact your doctor immediately.
Even though ectopic pregnancies may occur when IUDs are used, current data indicate that IUD users do not have a higher risk of ectopic pregnancy than women using no contraception. However, if a woman using an IUD becomes pregnant, she should be examined carefully. Women with a previous ectopic pregnancy, pelvic surgery or pelvic infection carry a higher risk of ectopic pregnancy. The possibility of an ectopic pregnancy should be considered if the start of your period was delayed, the bleeding is scanty and you have lower abdominal pain.
CE 0344
Date of revision of the leaflet
13.05.2003
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| Summary of Product Characteristics: Nova T380 |
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| Patient Information Leaflet (Alternative formats): Nova T380 (new window) |
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