INTRAUTERINE DEVICE

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Hormone Releasing Intrauterine Device:

Hormone Releasing Intrauterine Device Presented by SONAM M. GANDHI 1

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An Intrauterine Contraceptive Device is a device inserted into the uterine cavity and left for varying periods of time for the purpose of contraception. Intrauterine Contraceptive Device 2

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The IUD doesn’t require regular supply nor there any problem of disposal affecting privacy. It does not interfere with sex. It doesn’t have any systemic side effects. It works as soon as it is inserted. The return of fertility following removal is immediate. Long lasting. Advantages 3

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Some women report that their periods become heavier, longer or more painful. They usually settle down after a couple of months. Risk of developing Pelvic Inflammatory Disease (P.I.D). It does not protect from sexually transmitted diseases (STDs). The pain following insertion of IUD is due to uterine cramps, which usually subsides within a week and is mostly relieved by analgesics. Disadvantages & Common Side Effects 4

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Use for Married Women of Reproductive Age % Using IUDs Asia Europe Latin America & Caribbean Africa Oceania North America Worldwide Use Of IUDs 5

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4.6 4.5 4.1 4.1 3.9 3.6 3.8 % Satisfied Vaginal Ring IUD Injection OC Patch Condoms Other 87 86 80 79 75 60 52 MOST SATISFIED LEAST SATISFIED Satisfaction with Contraceptive Methods 6

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There are two types of IUD; 1) Non - medicated IUD: a) Ring – shaped IUD made up of stainless steel. b) Plastic IUD fabricated from polyethylene or polypropylene. 2) Medicated IUD: Copper – bearing IUD. Hormone – releasing IUD. Classification 7

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Exert its contraceptive action by producing a sterile inflammatory response in the endometris by its mechanical interaction. Ring shaped IUDs- stainless steal- CHINA. Plastic shaped IUDs-fabricated from polyethylene, polypropylene-ASIA, SOUTH AFRICA. Lippes loop IUDs-UNITED STATE. 8 Non-medicated IUDs

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Doyle and Clewe (1968) first initiated the use of hormone- releasing IUDs . Croxatto showed two year later that a progestin (such as megetrola acetate) released at a control rate from a silicone capsule inserted in rabbit uterine cavity is able to prevent implantation. 9 Hormone Releasing IUDs

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Evolution of a T-shaped progesterone-releasing IUD in which a drug containing silicone capsule forms an integral part of the vertical limb of the polyethylene T device. A rapid release of progesterone (  300  g/day) was observed, encapsulating the progesterone in a polymeric device with low progesterone permeability. 10

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Pharris et al., encapsulated a suspension of progesterone microcrystals in a silicone medical fluid within a rate-limiting barrier prepared from ethylene vinyl acetate copolymer . The release rate of progesterone from this device was found to be 65  g/day. This was later selected as the final design of the IUD, and called as Progestasert and it got approval in 1975 from US FDA as a medicated IUD for 12 months intrauterine contraception. 11

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Hormonal IUDs are more effective than other IUDs in relieving cramps. Pregnancy rates are lower than other IUDs. Amount of bleeding reduces significantly so more suitable for women with heavy periods. 12 Advantages

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Insertion is relatively painful for the patient, as the device is a little bulky. Some women have reported complaints of breast tenderness, ache which, usually settles down within 3 months. Irregular bleeding and absence of menses are common with users. Infection due to the adhesions inside the uterus that blocks the tubal openings. 13 Disadvantages

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Contraception Menorrhagia(heavy periods) Endometriosis Chronic pelvic pain Dysmenorrhea Anaemia In some cases use of an IUS may prevent a need for a hysterectomy 14 Clinical Uses

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Frequency of ovulation is reduced. Cervical mucus is changed to obstruct passage of sperm through the cervix. The presence of a foreign body in the uterus prompts the release of a leucocytes and prostaglandins by the endometrium, substances that are hostile to both sperm and eggs. The endometrium is thinned. It has been suggested that this inhibits implantation of embryos, though no experiment has yet confirmed or disapproved this theory. 15 Mechanism Of Contraception

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Postpartum between 48 hrs & 4 weeks (increased IUD expulsion rate with delayed postpartum insertion). Current deep vein thrombosis (DVT) or pulmonary embolus (PE). Past history of breast cancer. Ovarian cancer. AIDS (unless clinically well on anti-retroviral therapy). Active liver disease. 16 Contraindications

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The clinical contraceptive efficacy of progesterone releasing IUD was dependent upon the daily dose of progesterone released from the device. In 1 year studies performed with a placebo T – shaped device containing no progesterone, the rate of pregnancy was 22%. A daily dose of 10μg/day progesterone from IUD reduces the pregnancy rate considerably to 5.2%. 17 Clinical Effectiveness Of Progesterone Releasing IUDs

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25 μg/day dose --- pregnancy rate reduces to 2.7%. 65 μg/day dose --- pregnancy rate reduces to 1.1%. Only slight reduction – 0.6% in pregnancy rate was observed with 120 μg/day dose. Therefore, 65 μg/day of dose was selected as the final design of PROGESTASERT. 18

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Progesterone, the naturally occurring progestin rapidly inactivated by hepatic first pass metabolism when taken orally. Oral or systemic absorption of potent synthetic progestin or large doses of natural progesterone affects the target organ, like the pituitary & uterus, as well as nontarget organs simultaneously. These problems can be overcome by delivering the natural progesterone directly to the target organ (uterus) at low doses to prevent blastocyte implantation without inducing undesired hypothalamic – pituitary inhibition or other systemic effects, such as interruption of ovulation. 19 Need For Development Of Hormone Releasing IUDs

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20 Hormone-releasing Intrauterine Device ( Mirena ) And Inserter

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Precautions: IUDs may be inserted anytime during the menstrual cycle. Insertion may be performed during menstruation to provide additional reassurance that the woman is not pregnant. If insertion is planned during the luteal phase, another nonhormonal contraceptive should be used until after the next menses. 21 Insertion & Removal Of IUDs

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22 Patient Preparation: The physician should discuss with the patient the risks and benefits of the IUD and, if necessary, other forms of contraception. Administration of a nonsteroidal anti-inflammatory drug one hour before insertion may alleviate discomfort. The physician should instruct the patient about how to locate the IUD threads. It is necessary for the woman to locate the threads to verify the position of the IUD after each menstruation.

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23

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PELVIC INFLAMMATORY DISEASE (PID) AND STDs: PID is caused by certain STDs. PID is a serious condition that may result in infertility. In women who have STDs, an IUD will increase the risk of PID. POST PARTUM AND POST-ABORTION INSERTION: If an IUS inserted immediately postpartum (within 48hrs), perforation of the uterus is more likely to occur due to incomplete uterine involution (it usually completes by 4-6 weeks postpartum). To reduce the risk of infection, insertion of an IUS is not recommended for women who have had a medical abortion but have not yet had an ultrasound to confirm that the abortion was complete, or who have not yet had their first menstruation following chemical abortion. 24 Side Effects And Complications

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25 HORMONAL SIDE EFFECTS: Localized: Menstrual periods become lighter. In about 20% of women, stop completely within one year of insertion. Irregular bleeding is common in the first few months. Systemic: Enlarged follicles (ovarian cysts) have been diagnosed in about 12% of the subjects using a levonorgestrel IUS. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia . In most of the cases the enlarged follicles disappears spontaneously during two or three month’s observation. Surgical intervention is not usually required.

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EFFECT ON CANCER: Breast cancer cells are often hormone sensitive. PREGNANCY: Although the pregnancy rate during IUS use may be low, it is not a 100% effective method of birth control. If pregnancy does occur, presence of the IUS increases the risk of miscarriage, particularly during the second trimester. It also increases the risk of premature delivery. These increased risks end if the IUS is removed after pregnancy is discovered. 26

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1) Membrane controlled reservoir - type drug delivery devices a. Single component system b. Multicomponent system 2) Polymer matrix diffusion- controlled drug delivery devices a. Retrievable matrix device b. Biodegradable matrix device 3) Sandwich – type drug delivery device 4) Estriol-Releasing IUDs 5) Antifibrinolytic IUD 27 Developments in IUDs

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Levonorgestrel IUD 20 ( Mirena ): The hormone, Levonorgestrel is released gradually from the capsule. Life span is 5 – 7 years. Levonorgestrel is a much more potent synthetic progestogen than the natural progesterone and contraceptive effectiveness can be achieved with a release as low as 20  g/day. Effects on ovulation function and partial inhibition of ovulation were also observed. 28

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THANK YOU 29

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