Contraception 12

MOD ERN C ON TRAC EPT IV E TECHNI QUES

By E. Ejiro Emuveyan Associate Professor of Obstetrics & gynaecology Department of Obstetrics & Gynaecology College of Medicine, University of Lagos P.M.B. 12003 Lagos

MALTHUS IAN C ONCE RNS

TOO MANY PEOPLE REPRODUCING TOO RAPIDLY ●

RETARDS ECONOMIC GROWTH

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DESTROYS THE ENVIRONMENT

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OVERSTRETCHES SOCIAL SERVICES

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Worl d Po pu lat ion Pro file 1 Beginning of last century 2b 1970 4b 2000 6b Rate of increase 1.2% Estimated doubling time 42 yrs 10 Largest Countries in Population China 1304 India 1104 USA 296 Indonesia 222 Brazil 184

Worl d Po pu lat ion Pro file 2 ●

1/3 under 15 years of age

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25% live in developed or industrialised countries with low fertility rates

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75% live in less developed countries that are characterized by high fertility rates, high maternal and infant mortality and low life expectancy

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Number of women in reproductive age increased between 1990 and 2000 by about 200m posing great challenge to scientific community

In di cat ions fo r f am ily pl ann ing ●

Individual

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Spacers

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Limiters

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Avoid childbearing because of severe disease in pregnancy

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Pregnancy is life threatening to the mother as in case of severe aortic stenosis

For a ll I ndi cati ons , p ro viders of Fam ily Pl ann ing Must provide accurate information about benefits and risks of: (i) Pregnancy (ii) Contraception

To be noted specifically are: Medical conditions that may substantially increase risk of some form of birth control usually increase the risk associated with pregnancy to an even greater extent. Policy some less developed countries promote contraception in an effort to curb undesired

Fe rt ility Co nt ro l Most sensitive and intimate decision Religious or philosophical convictions Clinician approach it with sensitivity Empathy, maturity and non-judgmental behaviour

How So cio-Eco nom ic Ch ang es Af fect Cont race pt ive Pr act ice ●

Adolescents experiencing higher pregnancy rates

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Women in later stages of reproductive lifespan now tending to delay childbearing until in their 30s and 40s.

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Demographic Shift more women aged 30-44 years than those aged 15-29 years. needs of women with divergent social or economic circumstances.

NIG ERI AN POP UL AT ION PR OF IL E Mid 2005 131.5 PRB ❁ Fertility rate: 5.9 per woman ❁ Pop. Growth rate 2.4 ❁ Living below USS2 per day 91% ❁ women using all methods 12 % modern methods 8% ❑ Age Profile ❁

Women in reproductive age (15-44 yrs. -22.8% Children Under 15 years 43.0%

CONT RACE PTIVE P REV ALE NCE Worldwide (2005)-38.1m (53%) use effective methods

Nigeria (1998) Ghana Benin 7% Guinea-Conakry Kenya 32% Tanzania

6% 19% 4% 20%

HIST ORY OF FA MI LY P LA NNING ❑ ❑

Religious and Moral Issues Natural Family-Planning ✦ Coitus interruptus - Oldest method (17th century) ✦ Abstinence - Total/Periodic

❑ Rev. Thomas Malthus - One of the founding fathers. ❑ 1864 - Gabriel Fallopio - Linen Sheath for Coitus.

BACK GROU ND H IST ORY CO NTINUES ❁

STONES IN THE WOMB OF CAMELS

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1880 - CHEMICAL AGENTS AND MECHANICAL DEVICES (INTRAVAGINAL AND INTRAUTERINE)

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1977 - IPPF - OVER 100 COUNTRIES

LE GAL ASP ECT S O F CONTRA CEP TION ❥

Without Restrictions

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Information to Teenagers debatable

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US Supreme Court ruling in 1977 minors have constitutional right of access.

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Provision for teenagers should be done within the the confines of appropriate restraints.

THE LAW PRO VIDE S T HAT ALL P ERSONS MU ST ❆

Detailed Information about the use of the

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METHOD(S),

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BENEFITS

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RISKS,

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SIDE EFFECTS

CONSE NT AN D SER VIC E Documentation Of Discussion with client and her understanding of what has been said is of legal importance. ● When using methods that require instrumentation or some type of surgical approach use of consent forms that outline information discussed and the patient’s understanding is important. ● Consent form serves as evidence if needed that: (I) Counselling about use of particular birth control method was given (II) Patient appeared to be competent to understand what was said to her ●

ME THODS CLASSIFICATION TRADITIONAL OR FOLK - Coitus Interruptus - Post coital Douche - Lactational Amenorrhoea - Periodic Abstinence (Rhythm, Natural Family Planning) BARRIER - Condom(Male and Female) - Diaphragm - Cervical Cap - Vaginal Sponge

ME THODS

HORMONAL - Oral - Injectable - Implantable Long-Acting Progestins OTHER CONTRACEPTIVES - IUCD - Sterilisation - Tubal Ligation - Vasectomy

NA TU RAL C ONTRA CEP TION A. PERIODIC ABSTINENCE/RHYTHM METHOD ● LONG AND CHEQUERED HISTORY ● FERTIILE PERIOD 2-3 days after ovulation 2 days before no less than 2 days after ● PROMOTED BY CATHOLICS Types of periodic abstinence Calendar method Combined temperature/calendar method Cervical mucus (Billings) method Symptothermal method Data subject to bias

B.

COITUS INTERR

UPTUS

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Oldest Method of Reversible Contraception

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Withdrawal before Ejaculation. Demands Sufficient Self Control

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Statistics not reliable

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Failure rate - 10 Preg/100 Women Years

C.

LAC TA TI ONA L A MENOR RHEA METH OD ●

Women Less Fertile When Nursing

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Exclusive Breast Feeding for Six Months Supplemental Feedings Alters Patterns Of Lactation/Intensity Of Infant Suckling.

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Amnenorhoea Must Be Maintained

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2% Pregnancy Rate If Properly Used.

HI ST ORY O F OR AL CO NTA CEPTI ON HISTORY 19th Century- Lack of follicular development in pregnancy 1921 Ludwig Haberlandt 1929 Oestrogen Synthesized 1934 Progesterone synthesized 1959 First OC (Norethynodrel Menstranol) 1960 Progressive lower dose pills.

TYPE S (A)

Combined Oral Contraceptives (COCS). Sequential - E Pill 15-16 days followed E/P for 5 days Problem: Than normal incidence of endometrial cancer Phasic - Monophasic, Biphasic, Triphasic 28 days regimen (last 7 days placebo) (B)

Progesterone only pill/Minpill (POP) Taken everyday (Microdose nonstop progestins) Efficacy less than that of COC and occasional causes amenorrhoea (C) Post Coital Contraceptive pill/morning - After pill ➢ E only Yuzpe, Danazol, Mesopristone

USAGE & FAI LURE RATES ● ●

60 m current users worldwide Affected by age, family size, Politics

❑ ● ●

FAILURE RATES COC 0.2 - 1 per 100 woman years POP 0.3 - 5 per 100 woman years PCC varies with types

HORM ONAL CONT RACEP TION HISTORY: 19TH CENTURY TO 1934 Late 19th Century: Ovarian follicles do not develop during pregnancy 1921 Ludwig Harberlandt First proposed Hormonal Sterilisation 1929 Molecular structure of Oestrogen determined 1934 Molecular structure of Progesterone determined

HORM ONAL CONT RACEP TION HISTORY:

1952 - 1960

1952 - Colton and Djerassi independently synthesized substances with progesterone like activity (Progestogens or progestins) 1956 - Rock J, Pincus G and Garcia C.R demonstrated that norethynodrel suppressed ovulation (Science 124:128) 1959 - Rock, Garcia, Pincus and Rice-Wray conducted large clinical trials in Puerto Rico using a combined oral contraceptive containing 10mg norethynodrel and 0.15mg mestranol.

FAC TOR S CO NSIDER ED T O F IN D TH E R IGHT ORAL C ON TRACEP TION 1. The constitutional type of the woman on the woman of somatic and historical data. 2. Tolerance shown towards the hormonal contraceptives previously taken and the type of side effects occurred. 3. Contraindications because of health status disposition to thrombosis lactation or special conditions (only occasional sexual intercourse).

Pos t-coit al co ntracept ion Four hormonal methods 1. The combined oral contraceptive pill 2. Oestrogen only 3. Progestogen only 4. Danazol Only the combined pill is recommended

COMPOSI TION AN D SI DE EFFEC T Two pills (Eugynon 50 micrograms of ethinyl estradiol and 250 micrograms of Levonorgestrel taken immediately and same dose repeated 12 hours later. Side-effects are nausea and vomiting and these can be alleviated by the concomitant administration of an antiemetic. - method should not be substituted for conventional contraceptive practice. - use of hormonal methods of postcoital contraception are an emergency

Va gina l C ontra cep tive P ill (VCP )

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Recent

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Undergoing multicentre trials

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Historical evolution from vaginal rings

IN TR A-UT ER IN E CO NTRACEPT IV ES Plastic devices placed in the uterine cavity to prevent pregnancy Different shapes, sizes and types

MAIN MECHANISM OF ACTION Interference with implantation Increase with sperm transport Inhibit capacitation

TYPE S 1. Non medicated (inert) e.g Lippes loop 2. Medicated - less bleeding and pain (a) CU DEVICES 1st Generation Cu 7 Cu T 2nd Generation Multiload 250 Nova T 3rd Generation Multiload 375 Cu T 380 A Flexigard 330 Cu Fix PP 330 Eficacy - 1.5 per 100 woman years (b) Progesterone Releasing Devices

MO ST SUITABLE

CLIENTS FO R IUCD AR E

- Parous women in mutually monogamous relationship

- No current or prior history of RTIs

INJEC TAB LE ST EROI DS Two types are currently in use ❋ DMPA Depot Medroxyprogesterone Acetate (up john) Supplied in aqueous microcrystalline suspension 150mg/ml in 1ml and 3ml/vials

DNO Depot Norethisterone Onanthate - derivative of 19nortestosterone supplied as 200mg/ml in benzyl benzoate and castor oil in 1ml vials. Third may be in use in the near future. CYDCLOPROVERA

ME CH ANISM OF ACT IO N 1. Inhibit ovulation by inhibiting the midcycle LH surge and suppresses the cyclic variation of oestrogen secretion by the ovaries. 2. Inhibit proliferation of the endometrium making it to become thin and atrophic and therefore the endometrium is unfavourable for implantation. 3. Makes the cervical mucus to

ADM INIST RAT IO N ❊I.M buttocks or upper arm ❊ DMPA Must be well shaken before filling the syringe site of injection must not be rubbed because this disperses the injection. Amorphous white deposit is left in the muscle which is slowly absorbed. ❊DNO Supplied on oily solution more difficult to inject and may cause some discomfort.

EFFE CT IV ENESS 100% Effective Pregnancy rates of 0.0 - 1.2 per 100 women years reported for 150mg. DMPA given every 12 weeks and 0.01 - 1.3 per 100 woman years for 200mg DNO given every 8 weeks.

SIDE EF FE CTS Menstrual Disturbances 1. Frequent and irregular bleeding 71% women of 1st injection 2. Amenorrhoea 54% of woman after 1 year of treatment. 35% have complete Amenorrhoea during at least 1 injection cycle. Amenorrhoea cycles becomes less frequent with Noristerat Management of Irregular bleeding ❊ With combined oral contraceptive ❊ Premarin 1.25 - 2.5mg daily x 21 days.

SIDE EF FE CTS 3. Weight gain Result of an increase appetite rather than fluid retention 4. Delayed return of fertility 6 - 12 months 2 years in extreme cases Quicker return of ovulation with DNO reported ❊ Women who have been treated for depression or have been depressed while

CO NTRAINDICAT IO NS ABSOLUTE ❊ Abnormal uterine bleeding ❊ Secondary amenorrhoea ❊ Arterial disease ❊ Cancer of the breast (except where used to treat endometrial cancer and breast cancer when much larger doses are required) ❊ Liver disease ❊ Trophoblastic disease until HCG levels are normal. RELATIVE ❊ Abnormal uterine bleeding - a definite established and possibility of genital malignancy eliminated. ❊ Depression may be aggravated malignancy eliminated. ❊ Investigations of carbohydrate metabolism

CARCINO GEN IC EFFECTS

Animal studies caused concern about Mammary tomours in female beagle dogs and discovery of endometrial cancer in two rhesus monkeys that received 50 times the human dose. WHO studies after 5 years of use, users have twice risk of carcinoma in situ

ONCE - A M ONTH I NJEC TA BL ES I N U SE 1. Dihydroxyprogesterone acetophenide (acetophenide 150mg and estradiol enanthate 10mg). DHPA/E2-EN “Deladroxate” or Perlutal 2. Deposit-Medroxyprogesterone acetate 25mg and estraldiol cypionate 5mg DMPA/E2C; HRP11Z “Cyclofem” or “Cycloprovera. 3. Norethisterone enanthate 50mg and estraldiol valerate 5mg NET-EN/E2V; HRP102 “Mesigyna” 4. 17 & Hydroxyprogesterone caproate 250mg andestraldiol valerate 5mg Chinese injectible No. 1 REFERENCES

Impl ants

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Synthetic polymers developed to provide sustained release of contraceptive steroids for prolonged use.

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Silastic capsules pf progestagens implanted subcutaneously or subdermally.

Impl ants ❊ Can be placed in vaginal rings In rings problems of erosion/vaginal/cervix/vaginal infection and inconvenience during S.I Norplant 6 (six capsules) - 5 years protection Multicentre trials in progress all over the world including Nigeria Now approved for use in several countries.

❊ Normogestrol Acetate Uniplant - 1 year

protection multicentre trials in progress all over the world including Lagos/Ibadan`

CO NTRACEP TIVE I MPLAN TS 1987 Dr. Sheldon Segal discovered subdermal implants. Advantages As for injectables Disadvantages As for injectibles Requires surgical procedure

CO NTRACEP TIVE I MPLAN TS (i) Norplant -6 capsules (levonorgestrel) - inserted inside inner aspect of the upper arm above the elbow. - provides 5 years protection - efficacy 1st year rates 0.2% and cumulative 5-year pregnancy rate 3.9% - side effects are time dependent with the rate declining by about 50% after 1 year. - no delay in restoration of fertility (ii) Norplant 2 capsules (iii) ST 1435 (Nestrone)-Lactation, less lipoprotein effects. (iv) Uniplant (Nomegestrel Acetate)

BIO DEG RADAB LE C ON TRACEP TIVE IMP LA NTS

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Does not require removal;

(i) Capronor - single; levonorgestrel (ii) Capronr II (iii) Capronor III (iv) Annuelle - 90% Norethindrone + 10% Cholesterol. Problems of Nonbiodegradable are those of removal

IMP LAN ON

Organon International Simple 30 mm silastic rod Release the progestin 3 keto -desogestrel at a rate of 30 ug per day Effective for two to three years Removal is quick and relatively simple 3 keto-Desogestrel may inhibit ovulation more than levonogestrel.

Norplan t 6 ❊ Norplant subdermal contraceptive the first represents the efforts of scientists of the Population Council who licensed Leiras of Finland in 1983 to manufacture and distribute Norplant. ❊ Norplant is a safe, effective method of reversible fertility regulation. ❊ Despite this, the apparent major shortcoming is menstrual disorders which cause about half of all discontinuations. ❊ The observed menstrual changes though not associated with a adverse alteration of haematological indices encouraged further research at the local mechanism underlying contraceptive induced endometrial bleeding. ❊ In view of observed undesirable side

Norplan t II ❊

Also from Population Council

❊ Two rods slightly longer than Norplant capsules

6

Two rods contain levonogestrel embedded homogeneously within the silastic rod which is covered by a thin sheath of plain silastic. ❊

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Side-effect similar to Norplant

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Easier to implant and to remove because there are fewer rods.

VAG INA L CONTRA CE PT IVE RING S

Method of long-term contraception which is entirely patient’s control. Steroids absorbed efficiently through vaginal epithelium. Advantages - Under patient’s control - not coitus related - no daily administration - greater contraceptive effect - milder adverse effects.

DESIG N OF VAGI NA L CONT RACE PT IV E RING S

Vaginal fornix around cervix - homogenous ring - shell ring - core ring

TYP ES OF VAGINAL CONTRAC EP TIVE RIN GS (a) Progestogen only (i) Levonogestrel - continuos low dose (ii) Progesterone - 90 days use - Natural - Prolongs lactational amenorrhoea - Ineffective during weaning (iii) ST 1435 (Nestrone) - 3 weeks in 1 weeks out. - less metabolic effects. (b) Combination rings (i) Levonogestrel/Ethinyl Estradiol (ii) 3 Keto-Desogestrel/EE (iii) Norethindrone Acetate/EE (iv) ST 1435/EE

BARR IE R DEV ICE S AND CH EM ICAL AG ENT S

40 million couples worldwide Over three centuries Initially limited acceptability Renewed interest - Aids pandemic

FE MA LE (a) Cap (i) Vaginal diaphragms most widely used spermicide types coil springs, flat spring, arcing failure rate 2-20 pregnancies per 100 women users per year of exposure. (ii) Cervical Cap (iii) Fem-cap (iv) Lea’s shield (v) Long Acting Spermicides releasing diaphragms (vi) PH sensitive releasing devices (b) Female condom Design - Pouch thin polyurethane with 2 flexible rings at each end/9one deep and the other at the intriotus) - Failure rate - 26% for the first year

FE MA LE

(c) Sponge (i) Today sponge - polyurethane and Nonoxynol-9 Toxic to Spermatozoa (ii) Protected (d) Chemical agents Foams, jellies, tablets, suppositories, aerosols Nonoxynol-9, Octoxynol-9, Menfegol

Male Co ndom 1864 -

Gabriel Fallopio Linen Sheath

20% of contraceptives use; renewed interest - Aids pandemic. (i)

Latex Teat ended Plain

(ii) Non-latex - polyurethane, plastics stronger, less rupture Failure rate:

3 per 100 woman years

High risk women - “Double Dutch” method

Vo lu nt ary Surg ical Cont race pt ion FEMALE STERILISATION Occlusion of the uterine tubes to prevent pregnancy commonest form of permanent contraception in Europe/N-America.

SURGICAL Commonest Approaches (a) Minilap (b) Laparoscopy (c) Laparotomy (d) Vaginal

TUBA L LIG AT ION T ECH NIQUES (a) (b) (c) (d) (e) (f)

Pomeroy Madlener Fimbriectomy Salpingectomy Uchinda Irvine E and F more effective (i) Occlusive bands or rings: Falope (ii) Occlusive clips - Filshie or Hulka - Clemems (iii) Tubal diathermy (Thermocoagulation) (iv) Hysterectomy COMPLICATIONS - immediate - delayed - long term

NON-SURGICA L

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via hysteroscopy

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by use of chemicals

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phenols

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quinacrine

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methyl cyano Accrylate

MA LE S TE RILISA TION (I) SURGICAL 16% of contraceptive use (i) Vasectomy (a) Scalpel (b) Non-scalpel - 1974: China, Ligation Excision (segmental) Coagulation (ii) Clips (iii) Silicone rods

MA LE S TE RILISA TION NON SURGICAL Percutaneous Intravasal Injection of Sclerosants viz (a) Carbolic Acid (b)N Butyl-cyno-acrylate OTHER MORE REVERSIBLE AGENTS INCLUDE: (c) Polyurethane Elastomers - form plugs (d)Styrene Malate Anhydride

OT HER MA LE CO NTRA CEP TION Research over 50 years TYPES (a) Androgens (b) Progestogens + Androgens (c) Danazol + Androgens (d) Gonadotrophin Releasing Hormone (GnRH). (e) Anti Progestogens Problems - continued sperm production - histamine like effects - GnRH Antagonists - Testosterone use viz lipoprotein changes, acne

ME THODS B EING DE VE LOP ED CONTRACEPTIVE VACCINES Research has been on for a few decades PRINCIPLES OF ACTION TYPES A:ANTI-PERIMPLANTATION VACCINE TT

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B-hCG=

B:HETEROSPECIES DIMER VACCINE

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HSD

C:CTP VACCINE - 37 AA Carboxyl terminal peptide of BhCG Linked to Diphtheria Toxoid as Carrier

ME THODS B EING DE VE LOP ED D: LH-RH VACCINES E: OTHERS: - Anti-Sperm - Anti-Ovum - Anti-Zona Pellucida - Recombinant Zona Pellucida Antigens F:

MALE VACCINES - Passive/Active Immunisation against FSH - Gn-RH Vaccine

CONCLUS ION PROGRESS MADE IN THE FIELD OF CONTRACEPTIVE DEVELOPMENT CAN BE SUMMED UP IN THE DECLARATION OF THE INTERNATIONAL SYMPOSIUM ON CONTRACEPTIVE RESEARCH AND DEVELOPMENT (YEAR 2000 AND BEYOND) “IF ALL THE PEOPLE OF THE WORLD ARE TO ENJOY THE HIGHEST POSSIBLE LEVEL OF HEALTH AND BASIC HUMAN RIGHTS, ITS IS IMPERERATIVE THAT CONTRACEPTIVE DEVELOPMENT CONTINUES UNHINDERED. MOREOVER, WITHOUT SUCH RESEARCH, IT WOULD BE DIFFICULT FOR THE WORLD TO