Recent advances in family planning

1. Recent advances in family Planning Ravi M R Postgraduate student JSSMC

2. World’s population expected to reach 9 billion by 2050. India accounts for 17% of world’s population.

3. 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.

4. 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%

5. 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”.

6. 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

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

8. 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”.

9. Modern concept of family planning 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

10. (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

11. 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

12. The current emphasis is on three themes: "Sons or Daughters – two will do"; "Second child after 3 years", and Universal Immunization”.

13. 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

14. 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.

15. 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

16. 5 th Plan 1975-80:Family planning to family welfare programme *Community Involvement *Child Marriage restraint Act 1978 6 th Plan 1985:Strengthening of maternal and child health *Strengthening family welfare 7 th Plan Further inclusion of various programmes under MCH

17. 8th Plan 1992:Child survival and safe motherhood pragramme 1996:Review of safe motherhood component of CSSM 9 th Plan 1997:Reproductive and Child health (RCH) 10 th plan(2002-2007) RCH II was launched with few modifications after evaluating RCH I

18. 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”

19. 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

20. 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 strengt hened

21. Contraceptive methods Preventive methods to help women avoid unwanted pregnancies. IDEAL CONTRACEPTIVE Safe Effective Acceptable Inexpensive Reversible Simple to administer Independent of coitus Long lasting to avoid frequent administration Requiring little or no medical supervision

22. 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.

23. Classification of contraceptive methods II. TERMINAL METHODS Male sterilization Female sterilization

24. Recent advances in family planning methods

25. Advances in Male contraception Male Hormonal Contraception Methods Nonhormonal Methods

26. 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

27. 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

28. 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

29. 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

30. 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

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

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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. Contraction Inhibitor Pill “Dry Orgasm” W hen 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 . 8/28/2013 40

40. Injectable silicone plugs O ften used by men in China as a potential alternative to vasectomy. There are two tested types of injected plugs Medical-grade polyurethane (MPU) M edical-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 .

41. 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.

42. 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

43. SILCS Diaphragm Simple-to-use Single-size, Reusable device with a contoured rim that fits most women diaphragm is made of silicone

44. 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.

45. 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 .

46. 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

47. 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

48. 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

49. New formulation of Depo-Provera: Depo- subQ Provera 104, for delivery with Uniject Depo-subQ Provera 104: New formulation for subQ injection 30% lower dose (104 mg vs. 150 mg) Rapid onset of action Approved by USFDA (2005) and UK Potential for home- and self-injection Available for roll-out in 2011 ; Uniject : Single dose, single package Prefilled, sterile, non-reusable Short needles for subQ injection (easier use by non-clinical personnel/CHWs ) Compact; easy to use and store Potential “home run”

50. 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

51. 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

52. 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 .

53. 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.

54. 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

55. 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

56. Newer Natural methods Standard Days Method The Two Day Method

57. 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

58. 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

59. India is the 7 th largest country but 2 nd 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”.

60. References Park K. Textbook of Preventive and Social Medicine. 21 st ed. Jabalpur(India): Banarsidas Bhanot Publishers; 2011 Text book of public health and community medicine. 1 st 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

61. 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

62. Thank you