1 GYNE 4 - Family Planning

Gynecology 1.4

FAMILY PLANNING: Contraception and Sterilization

OUTLINE I. Introduction II. Hormonal Contraception III. Mechanical Contraception IV. Barrier Contraception V. Sterilization _____________________________________________________________ REFERENCE: All included in this trans is from the lecturer’s ppt except otherwise specified. [1] Recording INTRODUCTION Mass sterilization camp in India  12 women died after mass sterilization (tubectomy/tubal ligation)  Possibility of toxic shock syndrome since rusty equipment were noted  The doctor performed 80 tubectomies on Saturday (November 8, 2014)  Women paid $23 for sterilization Philippine population statistics 2008  Philippine population is still increasing1  Growth rate of 2.4%1  Birth rate, crude rate > per 1, 000 people: 24.16 per 1, 000 people (71st out of 195 countries)  Contraception: 46% coverage (51st out of 89)  Infant mortality rate: 24.24 (84th out of 179)  Maternal mortality: 170 per 100,000 (49th out of 136); 162 per 100,000 (NSO)  Total expenditure on health as % of GDP: 2.9 (178th of 185), this is very low!1 Fertility Rates, By Wealth Index  Women want 2-3 children only but they’re having more Percentage using contraception among women age 15-49, married or in union, 2011 [Percentage of Filipino women of reproductive age currently using contraception]  The prevalence of use of traditional (withdrawal, rhythm) methods is greater in the Philippines compared to other countries1  Contraception Prevalence Rate in the Philippines suggest need for family planning Maternal and fetal morbidity and mortality due to contraception  There is no data on deaths or morbidity due to contraception in the Philippines and some women are afraid of using contraceptives1  On the other hand, 12% of maternal deaths were due to unsafe abortion o Maternal morbidity and mortality due to unintended pregnancy1 o Cytotec brought from Quiapo1 o Hilot inserts catheter into the uterus and put NSS1 Table 1. Statistics on Maternal Morbidity and Mortality in the Philippines 2008 1 3, 700 women Died (1,600 did not want to become pregnant 2 1, 000 women Died from abortion and its complications 3 90, 000 women Hospitalized for complications

Dr. Bongala Nov. 13, 2014

Table 2. 2008 Maternal Morbidity Ratio 162 per 100,000 live births Causes 1 Infection/ sepsis 2 Obstructed labor 3 Hemorrhage 4 Hypertensive disorders 5 Others: Abortion Table 3. Failure Rates during First Year of Use in the United States METHOD PREGNANCY Lowest Expected Typical No method 85% 85% Combined pill (Progesterone 0.1 7.6 and estrogen) Progestin only 0.5 3.0 IUDs 0.1 0.1  Levonorgestrel 0.6 0.8  Cu- T Implant 0.05 0.2 Injectable 0.3 0.3 Female sterilization 0.05 0.05 Male sterilization 0.1 0.15 Spermicide 6.0 25.7 Periodic Abstinence 9.0  Calendar 3.0  Ovulation 2.0  Symptothermal 1.0 Post- ovulation Withdrawal 4.0 23.6 Condom 3.0 13.9  Male 5.0 21.0 Female Cervical Cap 20.0 40.0  Parous 9.0 20.0 Nulliparous     

Failure of contraception because some women just ask neighbors about what contraceptives they use and how they take it1 Hormone-secreting IUDS have high success rate1 Abstinence (usual method used by many) has very high failure rate1 Failure of withdrawal method: presence of sperm in preejaculate1 Failure of condom: putting condom in wallets, expired condoms1

Figure 1. Contraceptive use effectiveness. Pregnancy rates with perfect and typical use, by method 

THE MERMEN | MENDOZA, C. | MENDOZA, G. | MENDOZA, J. | MERCADO, L. | MERILLENO, A.

Contraceptives which you do not have to remember to take have low failure rates! 1 Page 1 of 7

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HORMONAL CONTRACEPTION Oral Contraceptive Pills o COC (Combined oral contraceptives) o POP (Progesterone only pills) Injectable contraceptives- DMPA Patch contraceptives- EVRA Implants- Norplant, Implanon IUD with Progesterone- Mirena HORMONAL CONTRACEPTION: A HISTORY Ludwig Haberlandt (1885- 1932) “Grandfather of the pill” Professor of Physiology at the Medical University of Innsbruck, Austria In 1919, he implanted the ovaries of a pregnant rabbit under the skin of a non- pregnant one, making it infertile for several months despite frequent coitus. He suggested that a substance with similar biological properties (as the hormone secreted by the corpeus luteum) could be the basis for a human oral contraceptive. Late 1920s, he tried to develop the idea of “temporary hormonal contraception”, then contradictory to the moral, ethic, religious and political agendas. Haberlandt wrote: “As long certain levels of progesterone persist in the circulation, hormonal signals favouring the ripening of additional ovarian follicles, thickening of the endometrium and release of the ova would not occur.” In 1932, after his death, his tests were dropped and forgotten. Russell Marker (March 12, 1902- March 23, 1995) Organic chemist Pennsylvania State University In 1939, he discovered that the yam plant, barbaso, abundant in New Mexico contained high levels of “sapogenins”, which served as precursors of steroid hormones. He developed a method of synthesizing progesterone from these plant compounds. In 1944, he co-founded SYNTEX and broke the monopoly of European pharmaceuticals. Gregory Pincus and Min Chueh Chang They were reproductive Physiologists In 1951, they showed that injections of progesterone suppressed ovulation in rabbits. This ushered the “era of oral contraception by ovulation inhibitors” with progesterone. In 1953, they published the ovulation- inhibiting potency of progesterone and some of its derivatives administered by several routes.

Table 4. Different Generations of OCPs. GENERATION ETHINYL ESTRADIOL First >50 ug Second 30-35 ug

20-30 ug

Fourth

20-30 ug

Norethindrone Levonorgestrel Norgestimate Cyproterone acetate Gestodene Desogestrel Drospirenone

Table 5. Newer OCP formulations, variation in dose Monophasic All 21 active pills contain the same amount of estrogen and progestin Biphasic 21 active pills contain 2 different estrogen and progestin combinations (e.g. 10/11) Triphasic 21 active pills contain 3 different estrogen and progestin combinations (e.g. 6/5/10) Table 6. Definitions of the different generations of OCPs Low does oral Products containing 50ug ethinyl estradiol oral contraceptives Second- generation Products containing levonorgestrel, oral contraceptives norgestimate, and other members of the norethindrone family with 20, 30 or 35ug ethinyl estradiol Thirdgeneration Products containing desogestrel or gestodene oral contraceptives with 20, 30 or 35ug ethinyl estradiol For table on Combined Oral Contraceptives in the Philippines, please refer to appendix A Table 7. Progestin components. New progestins: Minimize androgenic effects  Desogestrel Comparable with previous low- dose products  Gestodene  Contraceptive efficacy  Norgestimate  Breakthrough bleeding  Amenorrhea  Carbohydrate metabolism Decreased androgenicity  Increase in SHBG  Decreased free testosterone

Margaret Sanger and Katherine McCormick Became known during the 1960s Margaret Sanger was the founder of the American Birth Control Movement. She led the campaign in the US that would gradually -over decades- desensitize the general public on matters of sex Katherine McCormick was the financier for the movement, is a suffragist and a philanthropist. She was dedicated to the birth control movement because she feared having with her husband due to his schizophrenia. EVOLUTION OF THE COMBINED ORAL CONTRACEPTIVE PILLS Combines OCPs: progesterone and estrogen Needed very high doses of progesterone to stop ovulation → added ethinyl estradiol

Third

PROGESTOGEN

New progestin:  Drosperinone

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THE MERMEN | MENDOZA, C. | MENDOZA, G. | MENDOZA, J. | MERCADO, L. | MERILLENO, A.

Analogue of Spironolactone Biochemical profile is similar to progesterone  High affinity for the mineralocorticoid receptor  antimineralocorticoid effect  Antiandrogenic activity Caution is recommended in regard to serum K+ levels  Abnormal renal, adrenal or hepatic function

ORAL CONTRACEPTIVES Estrogen o Ethinyl estradiol o Mestranol Progesterone o Norgestrel and Levonorgestrel: Nordette o Desogestrel | Page 2 of 7

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Norgestimate Gestodene Drospirenone

MECHANISM OF ACTION OF OCPs Hypothalamic Inhibition o Suppression of hypothalamic gonadotropin- releasing factors Pituitary Inhibition o Prevents secretion of FSH and LH

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ESTROGEN Prevents ovulation by suppression of hypothalamic GnRH releasing factors Prevents pituitary secretions of FSH and LH inhibits implantation by altering normal endometrial maturation Faster ovum transport → egg reaches the endometrium before endometrium is ready to accept it Used in morning after pills1 PROGESTERONE Produces thick, scanty, cellular cervical mucus that impairs sperm transport – This is the major action of progesterone Inhibits sperm capacitation Endometrium unfavourable to blastocyst implantation o Because it becomes very thin; considered as the second defense in the event that there is still fertilization despite contraceptive use1 Inhibits ovulation by suppressing gonadotropins Does not really act on ovulation except for the newer forms 1 EFFICACY OF ORAL CONTACEPTIVE PILLS

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Method o Start on day 1 of menses o Do not miss a daily hormonal pill in 21 or 24 days (12- hour window) o Strict adherence to 7 or 4 pill- free days critical to obtaining reliable, effective contraception o Even if no pills have been missed, patients should be instructed to use a back- up method for at least 7 days after an episode of gastroenteritis

Table 8. Drugs that may reduce estrogen and progesterone oral contraceptive efficacy INTERACTING DRUG DOCUMENTATION Anti-TB Rifampicin Established Antifungal Griseofulvin Strongly suspected Anticonvulsants Phenytoin Strong suspected, clinical trial and sedatives Mephenytoin data lacking Phenobarbital Primidone Carbamazepine Ethosuximide Antimicrobials – o Tetracycline, o Two small trials found no NO EFFECT! doxycycline association o Penicillin o No association documented o Ciprofloxacine o No effect on efficacy of a 30 ug EE + DSG OC o Ofloxacin o No effect on efficacy of a 30 ug EE + LNG OC 

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BENEFICIAL EFFECTS OF ORAL CONTACEPTIVE PILLS Lower incidence of PID o Because with the use of pills, thick cervical mucus develops so bacteria cannot penetrate1 Prevents ectopic pregnancy o Because you prevent ovulation1 Less iron deficiency anemia o Progesterone leads to thinned endometrium leading to less volume of endometrial blood1 Less dysmenorrhea o Because of the less volume of endometrial blood1 Less PMS Less endometriosis o Due to less menstruation1 Decrease incidence of endometrial and epithelial ovarian cancer o Because the thicker the endometrium, the higher the chance of endometrial cancer; with progesterone, the endometrium is thinned so there is protection; epithelial ovarian cancer is related to the number of ovulations a woman will have in her lifetime, so with pills, you do not ovulate decreasing the chances of ovarian cancer1 Decrease incidence of benign breast tumors Non Contraceptive Benefits: o Lowered chances of colon CA o Lowered Acne especially Diane 35 o Decreased Premenstrual Dysphoric Disorder – Psych symptoms happen COMBINED ORAL CONTRACEPTIVE: WHO ELIGIBILITY CRITERIA FOR CONTRACEPTIVE USE 2004 Category 1: A condition for which there is no restriction for the use of the contraception method

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Category 2: A condition where the advantages of using the method outweigh theoretical or proven risks o Smoking woman < 35 years o Migraine without aura in a woman aged < 35 years o DM without complications o Family history of DVT or pulmonary embolism in first- degree relatives o Breastfeeding and 6 months or more post- partum o History of hypertension during pregnancy o Uncomplicated vascular heart disease o Unexplained vaginal bleeding o Undiagnosed breast mass o Symptomless gallbladder disease o Obesity 30 mg/km2 BMI – The bigger the patient is, the less effective the hormones are

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Category 3: A condition where the theoretical or proven risks usually outweigh advantages (Contraindications) o Smoking up to 15 cigarettes daily in women > 35 years old o BP systolic 14-159 mmHg/ diastolic of 90-99mmHg o Hyperlipidemia o Migraine without aura in women >35years old o History of breast CA without disease for the last 5 years o Breastfeeding 6 weeks- 6 months post-partum o < 21 days post- partum o Mild cirrhosis o Symptomatic gallbladder disease o Drug treatment affecting liver enzymes:  Rifampicin

Anything that has a high liver degradation component would affect your pills1

THE MERMEN | MENDOZA, C. | MENDOZA, G. | MENDOZA, J. | MERCADO, L. | MERILLENO, A.

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Category 4: A condition which represents an unacceptable health risk if OCP is used o Breastfeeding 15 cigarettes per day in women 35 years old and above o BP >160 mmHg/ >100 mmHg o Migraine with aura o DM with vascular complications o Past or present evidence of DVT or pulmonary embolism o Major surgery with prolonged immobilization o Thrombogenic mutations o Complicated valvular heart disease o Breast cancer within the past 5 years o Active viral hepatitis, liver tumor and cirrhosis EFFECTS OF ORAL CONTACEPTION VENOUS THROMBOEMBOLISM Venous thromboembolism o Deep vein thrombosis o Pulmonary embolism WHO collaborative study of CV disease and steroid hormone contraception (Avoid these 2! 1) o Levonorgestrel vs non- users: O.R. 3.5 o Desogestrel vs non- users: O.R. 9.1 Risk declined with increasing duration of use of OCPs Risk slightly greater with desogestrel or gestodene use Smoking > 10 cigarettes per diay increased the risk OCP w/ 20 ug estrogen had a lower risk than products w/ 30-40 ug Progesterone Only Pills have no increased risk ARTERIAL THROMBOSIS Arterial thrombosis o Acute myocardial infarction o Stroke Smoking produced an additive increase in risk of arterial thrombosis abut had no effect on risk of venous thromboembolism

ACUTE MYOCARDIAL INFARCTION Table 9. Transnational case-control study of MI CASES CONTROLS O.R. Any OC use 57 156 2.35 50 ug 14 22 4.32 estrogen Old progestin 28 71 2.96 New 7 49 0.82 progestin 

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Anticonvulsants- Phenytoin, carbamazepine, barbiturates, primidone, topiramite, oxcarbazepine

C.I. 1.42- 3.89 1.5911.74 1.54- 5.66 0.29- 2.31

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88 485

485 women will have MI if they are >/= 35, smoking, and taking OCP1

Combined oral contraceptives and myocardial infarction WHO multicenter study 2002  368 cases of acute MI  Factors associated with increased risk of MI: o Smoking o History of hypertension o DM o RHD o Abnormal blood lipid o Family history of stroke or MI  Factors not associated with increased risk of MI: o Duration of use and past use did not affect risk o Not related to estrogen dose and no influence on type of dose of progestin   

STROKE Older case-control and cohort studies: Increased risk of cerebral thrombosis among current users of high-dose oral contraceptives Thrombotic stroke not increased in healthy, non-smoking women with 35 10  Non- smokers  Non- smokers and OCs 40

Smokers Smokers and OCs

STROKE ABSENT 18 718 95% CI (5.15- 5.75)

Women with migraine who use OCP have an increased risk of stroke (Very significant!) 1 GUIDELINES OF THE FAMILY PLANNING ORGANIZATION OF THE PHILIPPINES First 3 weeks postpartum COCs should not be used during the first 3 weeks post- partum to avoid the risk of thromboembolic complications >21 days blood coagulation and fibrinolysis: Normal; COCs can then be used if mother does not breastfeed Progesterone only pills can be started at any time after delivery if mother chooses not to breastfeed PROGESTERONE ONLY PILLS (POPs) Contraceptive with progestin only in a smaller dose | Page 4 of 7

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They have developed this such that it can already stop ovulation even if it only contains progesterone1 Preparations available in the Philippines: o Desogestrel (Cerazette) 75ug o Lynestrenol (Exulton) No effect on blood pressure or coagulation factors Negligible effect on lipid metabolism

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GUIDELINES OF THE FAMILY PLANNING ORGANIZATION OF THE PHILIPPINES: PROGESTERONE ONLY PILLS (POPs) POPs may be used by women with no contraindications and who are/ have: o Adolescents o > 35 years o With varicose veins o With sickle cell disease PROGESTERONE ONLY PILLS (POPs): WHO ELIGIBILITY CRITERIA FOR CONTRACEPTIVE USE 2004 Category 1: A condition for which there is no restriction for the use of the contraceptive method Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks Category 3: A condition where the theoretical or proven risks usually outweigh the advantages of using the method. POPs should not generally be used in the presence of: o Current DVT or Pulmonary embolism o Active viral hepatitis o Liver tumor o Severe decompensated cirrhosis o History of breast cancer and no disease for the last 5 years o Breastfeeding and