Recent advances in family PlanningRavi M R

Postgraduate student

JSSMC

• World’s population expected to reach 9 billion by 2050.

• India accounts for 17% of world’s population.

Appropriate family planning measures:

1) Would slow the pace of population growth.

2) Decrease abortion related complications and deaths.

3) Cut down maternal care costs.

4) Promote better maternal health.

5) Improve the health of children through better nutrition and care.

• Current scenario in India:

Couple protection rate: 50.7%

Unmet need=12.8%

In urban population: 9.7%

In rural population: 14.1%

contraceptive prevalence rate: 54.1%

DEFINITION

• “A way of thinking and living that is adopted voluntarily, upon the basis of knowledge, attitudes and responsible decisions by individuals and couples, in order to promote the health and welfare of the family group and thus contribute effectively to the social development of a country”.

Objectives

To avoid unwanted births

To bring about wanted births

To regulate the intervals between pregnancies

To control the time at which births occur in relation

to the ages of the parent ; and

To determine the number of children in the family

1. The United Nations Conference on Human Rights at Teheran in 1968 recognized family planning as a basic human right.

2. The Bucharest Conference on the World Population held in August 1974 endorsed the same view.

'Plan of Action' that

"all couples and individuals have the basic human right to decide freely and responsibly the number and spacing of their children and to have the information, education, and means to do so".

3.The World Conference of the International Women's Year in 1975 also declared -

“The right of women to decide freely and

responsibly on the number and spacing of their

children and to have access to the information

and means to enable them to exercise that right”.

Modern concept of family planning

(1) The proper spacing and limitation of births.

(2) Advice on sterility,

(3)Education for parenthood.

(4) Sex education,

(5) Screening for pathological conditions related reproductive system,

(6)Genetic counseling

(7) Premarital consultation and examination,

(8) Carrying out pregnancy tests,

(9) Marriage counseling,

(10) The preparation of couples for the arrival of their child,

(11) Providing services for unmarried mothers,

(12) Teaching home economics and nutrition,

(13) Providing adoption services

• The objective of the Family Welfare Programme in India is that people should adopt the "small family norm" to stabilize the country's population at the level of some 1,533million by the year 2050 AD.

In the 1970s, - do ya teen bas.

In the 1980s - 2 - child norm

The current emphasis is on three themes:

"Sons or Daughters – two will do";

"Second child after 3 years", and Universal Immunization”.

ELIGIBLE COUPLES• A currently married couple wherein the wife is

in the reproductive age, which is generally assumed to lie between the ages of 15 – 45

COUPLE PROTECTION RATE (CPR)

• An indicator of the prevalence of conraceptive practice in the community

• It is defined as “the per cent of eligible couples effectively protected against childbirth by one or the other approved methods of family planning”.

• Demographers are of the view that the demographic goal of NRR : 1 can be achieved only if the CPR exceeds 60 per cent.

Evolution of Family Planning Program

• 1951:Family planning programme adopted by government of INDIA

• 1961-66:*Extension education approach *introduction of IUD *integrated approach was adopted in 1966

• 19698: * social marketing for Condoms was introduced * lippes loop was introduced

• 1969-74:Family planning services under PHC *All INDIA hospital postpartum programme *Medical termination of pregnancy Act,1971

5th Plan• 1975-80:Family planning to family welfare programme *Community Involvement *Child Marriage restraint Act 1978

6th Plan• 1985:Strengthening of maternal and child health *Strengthening family welfare7th Plan • Further inclusion of various programmes under MCH

8th Plan• 1992:Child survival and safe motherhood pragramme

• 1996:Review of safe motherhood component of CSSM

9th Plan• 1997:Reproductive and Child health (RCH)

10th plan(2002-2007)• RCH II was launched with few modifications after

evaluating RCH I

Reproductive and Child Health approach has been defined as

• “People have the ability to reproduce and regulate their fertility.

• Women are able to go through pregnancy and child birth safely.

• The outcome of pregnancies is successful in terms of maternal and infant survival and well being

• Couples are able to have sexual relations free of fear of pregnancy and of contracting disease”

• Expansion of choices of contraceptives

• Estimated that every additional method, increases the contraceptive prevalence rate increased by 12 %.

• More methods included are – Injectable contraceptives –Depo-Provera and

Noristerat– Centchroman– Emergency contraception– Natural methods – LAM, SDM– Female condoms

• MO of PHC/CHC trained in atleast one method of sterilisation

• LHVs & ANMs- skilled based clinical training for spacing methods including IUCD insertion and removal, LAM, SDM and EC AWWs will be trained for counselling

• Social marketing of contraceptives, specially in rural areas will be strengthened

Contraceptive methods

Preventive methods to help women avoid unwanted pregnancies.

IDEAL CONTRACEPTIVE Safe EffectiveAcceptable InexpensiveReversible Simple to administerIndependent of coitusLong lasting to avoid frequent administration Requiring little or no medical supervision

• The present approach in family planning programmes is to provide a "cafeteria choice" that is to offer all methods from which an individual can choose according to his needs and wishes and to promote family planning as a way of life.

Classification of contraceptive methodsI. SPACING METHODS

Barrier Methods

Physical Methods

Chemical Methods

Combined Methods

Intrauterine Devices

Hormonal Methods

Post Conceptional Methods . Miscellaneous

II. TERMINAL METHODS

Malesterilization

Female sterilization

Recent advances in family planning methods

Advances in Male contraception

• Male Hormonal Contraception Methods

• Nonhormonal Methods

Male Hormonal Contraception Methods

Androgen formulations available for possible incorporation into a male hormonal contraceptive regimen

• Testosterone undecanoate– Dose interval- Oral, twice daily– Potential concern- Twice daily dosing, short and variable

duration

• 17α-Methyltestosterone– Dose interval- Oral, daily– Potential concern- Liver toxicity

• Intramuscular – Testosterone enanthate

• Dose interval-1–2 wk• Over all failutre rate was 5.3%, for an overall contraceptive

efficacy of 94.7%• Potential concern- delay in onset of full contraceptive action for

almost 3-4 months. Injections can be painful, high peak levels.• Side effects from weekly injections of 200 mg of TE in healthy

men include weight gain, a reversible 25% reduction in testicular volume, a 6% increase in hemoglobin, and a 10–15% decrease in serum HDL cholesterol

– Testosterone decanoate• Dose interval- 4–6 wk• Potential concern- Injections can be painful, high peak

levels

– Testosterone undecanoate• Dose interval- 8–12 wk• Potential concern- Injections can be painful,

nonphysiological pharmacokinetics• weight gain, a 9% increase in hemoglobin, and a 14%

decrease in HDL

• Subcutaneous– Testosterone implants

• Dose interval- 4 months• Potential concern- Surgical placement, occasional

painful expulsions

– MENT(7α-methyl-19-nortestosterone) implant• Steroidal androgen receptor modulator• Dose interval- 6 months• Surgical placement, poor sperm suppression, concern

regarding bone effects

• Transdermal – Testosterone patch(non scrotal)

•  Dose interval- daily• Potential concern- Poor efficacy, high frequency of skin irritation

– Testosterone gel• Dose interval-  daily• Potential concern- Possibility of partner transfer, daily application

needed

– Dihydrotestosterone gel• Dose interval-  daily• Potential concern- Poor efficacy

• Testosterone buccal system• Buccal • Manufactured under trade name Straint• Dose interval- Daily• Potential concern- an allergic reaction , Liver toxicity

• Testosterone + 5α-reductase inhibitor• Dose interval- Injection 1–2 wk, plus daily oral pill• Potential concern- 5α-Reductase inhibitor gave no

additional contraceptive benefit

Nonhormonal Methods

• Can target either sperm production (testicular targets) or sperm motility

•  Theoretically, agents targeted to these processes might be very specific, thus lacking the systemic side effects that plague hormonal method

• Testicular target:– Adjudin {1-(2,4-dichlorobenzyl)-1H-indazole-3-

carbohydrazide }also known as AF-2364• an analog of lonidamine (LND)• disrupt the interaction of spermatid-Sertoli cells by

interacting with specific proteins• Also know to be a potential anticancer drug

– Indenopyridine, CDB-4022• targets both Sertoli cells and germ cells• some studies have demonstrated irreversible testicular

effects of CDB-4022 administration in rodents• longer-term studies of CDB-4022 in nonhuman

primates will likely be necessary before testing in humans

• Has provided a promising preclinical data for a potential oral, non hormonal male contraceptive

• Hydrothermal Male Control– Mild elevations in scrotal temperature, just above

that of the body core, can cause germ cell apoptosis 

– Heat using a scrotal water bath at 43 C (30 min/d for 6 consecutive days) in combination with exogenous testosterone decreased sperm count and motility and increased germ cell apoptosis during the first 12 wk of treatment compared with testosterone alone

• Targeting sperm motility– CatSper Blocker

• sperm-specific transmembrane proteins• The rise in intracellular calcium mediated by the

CatSpers is directly responsible for the increase in flagellar beat frequency that characterizes sperm hyperactivation

• RISUG(Reversible inhibition of sperm under guidance)– Is a polymer of styrene maleic anhydride– Injected into the lumen of the vas deferens using a

no-scalpel technique– to date both preclinical and clinical studies have

failed to demonstrate reversibility– A phase III trial of this method is apparently under

way and hopefully will include data on reversibility

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• Contraction Inhibitor Pill “Dry Orgasm”– When segments of vasa deferentia were exposed to

phenoxybenzamine or thioridazine , the longitudinal smooth muscle fibers did not contract.

– The circular smooth muscles did, causes, clamping the vas shut.

– Thioridizine’s side effects were so extreme(hives, difficult breathing;,swelling of face) that the manufacturer discontinued it in 2005, the common side effects of phenoxybenzamine are dizziness , fast heartbeat & stuffy nose.

• Injectable silicone plugs – Often used by men in China as a potential alternative to

vasectomy. – There are two tested types of injected plugs

• Medical-grade polyurethane (MPU) • Medical-grade silicone rubber (MSR).

The polymer (special ingredient) is injected directly into the vasa differentia, Once injected, the polymer solidifies in place, forming a

flexible plug.

• ORIGAMI Male Condom (OMC)– The ORIGAMI Male Condom™ (OMC) is the

first NON-rolled, NON- Latex, silicone condom.– expected to reach the market in early 2015,

pending regulatory approvals.

Advances in female contraception

• Spray On –Contraceptive Australian biotech company Acrux has come up

with a world’s first — a contraceptive spray for women. Metered Dose Transdermal System (MDTS) to administer a pre-

set dose of the Nestorone to the skin (forearm) every 14 days. The fast-drying spray gradually absorbed into the bloodstream. Suitable for

Breastfeeding mothers Who cannot tolerate contraceptive pills with oestrogens.

Leaves no visible residue & less irritation than patches

SILCS Diaphragm

•Simple-to-use •Single-size,

•Reusable device with a contoured rim that fits most women

•diaphragm is made of silicone

• Current status– Allowed for sales in Europe from march 2013– Regulatory applications for the US Food and Drug

Administration are under way.– Health systems assessments in India, South Africa,

and Uganda is being carried out to develop strategies for its introduction in developing-country markets.

• Essure – The Essure procedure involves placing a small &

flexible device called a Micro- insert into each fallopian tubes.

– The Micro- inserts are made from materials that have been well studied and used successfully in the heart and other parts of the human body for many years.

– Once the Micro-inserts are in place, body tissue grows

into the Micro- inserts, blocking the fallopian tubes.

• Adiana – Two-step procedure comprising

controlled thermal damage of the endosalpinx followed by insertion of a biocompatible matrix plug within the tubal lumen

– scar tissue forms around the silicone inserts, blocking off the fallopian tubes and preventing sperm from reaching the egg

New hormonal implants:Comparison of Sino-Implant, Jadelle, Implanon

Sino-implant (II) Jadelle Implanon

Manufacturer Shanghai Dahua Pharmaceutical

Bayer HealthCare Schering Plough /Organon

Formulation 150 mg levonorgestrel In 2 rods

150 mg levonorgestrel In 2 rods

68 mg etonogestrel In 1 rod

Mean Insertion & Removal time

Insertion: 2 min Removal: 4.9 min

Insertion: 2 min Removal: 4.9 min

Insertion: 1.1 min Removal: 2.6 min

Labeled duration of product use

4 years 5 years 3 years

Trocars Disposable Autoclavable /Disposable

Pre-loaded disposable

Cost of implant (US$)

$8.00 $21-23 $20

Cost per Year (if used for duration)

$2.00 $4.80 $6.70

• Nestorone-Ethinyl Estradiol Contraceptive Vaginal Ring– Contains 103 mg Nestorone (NESnew chemical entity)

and 17.4 mg ethinyl estradiol (EE)– Designed for 13 cycles (1 year) of use– Ring remains in the vagina for 3 weeks per cycle

followed by a ring-free week– Easily inserted by the woman; does not require trained

health care provider– Phase III trial of the NES/EE CVR Has Successfully

Been Completed

New formulation of Depo-Provera: Depo-subQ Provera 104, for delivery with Uniject

Depo-subQ Provera 104:t New formulation for subQ injection t 30% lower dose (104 mg vs. 150 mg)t Rapid onset of actiont Approved by USFDA (2005) and UKt Potential for home- and self-injection

t Available for roll-out in 2011;

Uniject: t Single dose, single packaget Prefilled, sterile, non-reusablet Short needles for subQ injection (easier use by

non-clinical personnel/CHWs)t Compact; easy to use and store

Potential “home run”

1)Continuous pill (Seasonale):• 0.15mg levonorgestrel and 0.03mg EE. • Women take pill for every day for 84 days

(12weeks), and then take hormone –free pills for 7days

• Yaz: 20 μg EE and 3 mg Drosperinone regimen.– has been marketed recently.– Yaz is currently the only COC with reported

evidence for and approved indication in the treatment of emotional and physical symptoms of premenstrual dysphoric disorder

• Ortho-Evra:– This combined patch delivers 150mcg of

progestogen and 20 mcg of EE per day.– Failure rate is 0.3 per 100 women. – Effectiveness is as good as the combined pill.– S/E: Breakthrough bleeding and mastalgia.

• Anti-Fertility Vaccines– Contraceptive vaccine either target

• Gamete production ( FSH and LH)• Gamete function• Gamete outcome (hCG).

CVs targeting gamete function are better choices but induce oophoritis affecting sex steroids.

The hCG vaccine is the first vaccine to undergo phase I and II clinical trials. Both the efficacy and the lack of immunotoxicity have been reasonably well demonstrated for this vaccine.

• Praneem – polyherbal cream, a spermicidal formulation.– purified extract from the dried seeds of an ancient

Indian plant Azadirachta indica (Neem)– formulation has shown high contraceptive efficacy

in rabbits and in monkeys after intravaginal application

• BufferGel – is a spermicidal gel being studied as a microbicide

active against HIV

• Duet :– Disposable diaphragm in development that will be

pre-filled with BufferGel. – It is designed to deliver microbicide to both the

cervix and vagina

• Newer Natural methods

– Standard Days Method

– The Two Day Method

• From a global standpoint, there is clearly a desire and need for more contraceptive options.

• Couples desire more choices for fertility control, and unplanned pregnancies continue to occur at alarming rates

• The hormonal approach to male contraception has made significant progress in the last decade in terms of clinical development

• Unfortunately, over the last few yr, the major pharmaceutical sponsors of male hormonal contraceptive research have withdrawn their support in this area of product development, making it difficult to complete the final phases of clinical development

• Government and not-for-profit sponsors will be needed in this environment to devote the necessary resources for long-term efficacy studies

• India is the 7th largest country but 2nd populous country in the world.

• We are crossing 1.21 billion in population.• We should take proper measures to control population

other wise we may run out of food and basic facilities.

• “Delay the first, postpone the second and prevent the third”.

References

• Park K. Textbook of Preventive and Social Medicine. 21st ed. Jabalpur(India): Banarsidas Bhanot Publishers; 2011

• Text book of public health and community medicine. 1st ed. Pune (India). Dept. of Community Medicine AFMC; 2009

• World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), Knowledge for Health Project. Family Planning: A Global Handbook for Providers (2011 update). Baltimore and Geneva: CCP and WHO, 2011

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528850 accessed on 26/08/2013 17.30hours

• http://www.path.org/projects/silcs.php accessed on 26/08/2013 18.00 hours

• http://www.ncbi.nlm.nih.gov/pubmed/17218411 accessed on 26/08/2013 18.20 hours

• http://www.mayoclinic.com/health accessed on 24/08/2013 15.00 hours

• http://www.contracept.org accessed on 24/08/2013 15.10 hours

Thank you