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WHO MEC: Special situations

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1 WHO MEC: Special situations
This document is one important step in a process for improving access to quality of care in family planning by reviewing the medical eligibility criteria for selecting methods of contraception. It updates the third edition of Medical eligibility criteria for contraceptive use, published in 2004, and summarizes the main recommendations of an expert Working Group meeting held at the World Health Organization, Geneva,1–4 April 2008. The document provides recommendations for appropriate medical eligibility criteria based on the latest clinical and epidemiological data and is intended to be used by policy-makers, family planning programme managers and the scientific community. It aims to provide guidance to national family planning/reproductive health programmes in the preparation of guidelines for service delivery of contraceptives. MAR-2011-AP-(IN)-3627-SS 30-Aug-2012

2 Efficacy of methods Trussel's review contains the results of individual published surveys and studies. Failure rates (percentage of women with unintended pregnancy during the first year of use) are calculated for both perfect and typical use. The failure rate of some methods is the same with perfect and with typical use (eg, Implanon® birth control implant), whereas the difference in failure rate between perfect and typical use of other methods is significant (eg, withdrawal). Hormonal methods (pill, ring, patch, Depo-Provera®) are very effective when used perfectly (failure rate less than 1%), but with typical use the failure rate is upto 8%. Details of the table: Percentage of women experiencing an unintended pregnancy during the first year of typical useand the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States of America. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; . 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4. The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Nelson A, Cates W, Guest F, Kowal D. Contraceptive Technology: Eighteenth Revised Edition. New York, NY: Ardent Media, 2004 10. The treatment schedule is one dose within 120 hours after unprotected intercourse, and a second dose 12 hours after the first dose. Both doses of Plan B can be taken at the same time. Plan B (1 dose is 1 white pill) is the only dedicated product specifically marketed for emergency contraception. The Food and Drug Administration has in addition declared the following 22 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel or Ovral (1 dose is 2 white pills), Levlen or Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or Quasence (1 dose is 4 white pills), Tri-Levlen or Triphasil (1 dose is 4 yellow pills), Jolessa, Portia, Seasonale, or Trivora (1 dose is 4 pink pills), Seasonique (1 dose is 4 light-blue-green pills), Empresse (one dose is 4 orange pills), Alesse, Lessina, or Levlite, (1 dose is 5 pink pills), Aviane (one dose is 5 orange pills), and Lutera (one dose is 5 white pills). 11. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States of America. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

3 Contraceptive revolution – reversible methods
These are the pictorial examples of various reversible contraceptives methods like pills, injection, Implant, condoms, IUDs, vaginal ring etc.

4 WHO medical eligibility criteria for contraceptive use: classification
Condition: Category For which there is no restriction on use of the method 1 Where the advantages generally outweigh the theoretical or proven risks 2 Where the theoretical or proven risks usually outweigh the advantages of using the method 3 Represents an unacceptable health risk of the contraceptive method if used 4 Using the categories in practice Categories 1 and 4 are self-explanatory. Classification of a method/condition as category 2 indicates the method can generally be used, but careful follow-up may be required. However, provision of a method to a woman with a condition classified as category 3 requires careful clinical judgement and access to clinical services; for such a woman, the severity of the condition and the availability, practicality, and acceptability of alternative methods should be taken into account. For a method/condition classified as category 3, use of that method is not usually recommended unless other more appropriate methods are not available or acceptable. Careful follow-up will be required. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

5 WHO medical eligibility criteria for contraceptive use: classification
Category With clinical judgement With limited clinical judgement 1 use method in any circumstances Yes (use the method) 2 generally use the method 3 use of method not usually recommended unless other more appropriate methods are not available or not acceptable No (do not use the method) 4 method not to be used Where resources for clinical judgment are limited, such as in community-based services, the four category classification framework can be simplified into two categories. With this simplification, a classification of Category 3 indicates that a woman is not medically eligible to use the method. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

6 Contraceptive Methods Available in India
Contraceptive Methods Available in India. Abbreviations mentioned in WHO MEC Low-dose combined oral contraceptives: COCs Combined contraceptive Vaginal Ring: R Progestogen-only Pills: POPs Depot medroxyprogesterone acetate : DMPA Norethisterone enantate : NET-NE Intrauterine devices IUDs Levonorgestrel-releasing IUD (20 g/24hours): LNG-IUD Copper-bearing IUD: Cu-IUDs Implant IMP Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

7 Case 1 A 18 year old unmarried woman, seeking contraception advice
She also c/o; constant pelvic pain worsening during menses Medical History: None Family History: No reports of bleeding disorder Obstetrical History: G0P0A0 Investigations: USG-NAD

8 WHO Guidelines Condition Category COC Dysmenorrhea 1
Evidence: There was no increased risk of side-effects with COC use among women with dysmenorrhoea compared with women not using COCs. Some COC users had a reduction in pain and bleeding1 Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

9 Case-2 A 24 year old married woman, seeking contraception advice
She also C/O: constant pelvic pain worsening during menses Medical History: None Family History: No reports of bleeding disorder Obstetrical History: G0P0A0 Investigations: USG- free fluid in the cul-de-sac

10 WHO Guidelines Condition Category COC Endometriosis 1
Evidence: A Cochrane Collaboration Review identified one randomized controlled trial evaluating the effectiveness of COC use compared with a GnRH analogue in treating the symptoms of endometriosis. Women with endometriosis did not report worsening of the condition or any adverse events related to COC use1. In patients of endometriosis seeking contraception, as per WHO MEC criteria, there is no restriction on use of COC. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009 Vercellini P, Trespidi L, Colombo A, Vendola N, Marchini M, Crosignani PG. A gonadotrophin-releasing hormone agonist versus a low-dose oral contraceptive for pelvic pain associated with endometriosis. Fertility and Sterility 1993;60(1):75–9.

11 Case 3 A 35 year old female patient seeking advice on contraception
C/O: heavy menses Family history: Mother underwent surgery for hysterectomy at the age of 45 due to uterine fibroids Obs/Gyn History: G1P1A0 Investigations: USG- 4 heterogeneous structures, in the muscular layer without distortion of uterine cavity suggestive of leiomayomata.

12 (With or without distortion of uterine cavity)
WHO Guidelines Condition Category COC Uterine Fibroids (With or without distortion of uterine cavity) 1 Comments: COCs do not appear to cause growth of uterine fibroids Uterine fibroids: COCs do not appear to cause growth of uterine fibroids, and combined injectable contraceptivess, combined contraceptive patch, and combined contraceptive vaginal ring are not expected to either. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

13 Case 3 A 30 year old female patient complaining about irregular bleeding pattern seeks advice on contraception Family history: unknown Physical examinations: mild acne lesions on face and hirsutism on face and limbs Obs/Gyn History: G1P0A1

14 WHO Guidelines Condition Category COC
Irregular pattern without heavy bleeding Heavy or prolonged bleeding (includes regular and irregular patterns) 1 Vaginal bleeding patterns: Irregular menstrual bleeding patterns are common among healthy women. There is no restriction for use of COC in women with irregular vaginal bleeding seeking contraception. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

15 MEC use in women with different patterns of vaginal bleeding (WHO MEC 2009)
Vaginal Bleeding patterns Hormonal contraceptives Progesterone only Pills Progesterone only injections Irregular bleeding without heavy bleeding 1 2 Heavy or prolonged bleeding (includes regular or irregular) Unexplained vaginal bleeding (suspicious of serious pathology) before evaluation 3 Medical Eligibility criteria (MEC)  1: A condition for which there is no restriction for the use of the contraceptive method 2: A condition for which the advantages of using the method generally outweigh the theoretical or proven risks 3: A condition where the theoretical or proven risks usually outweigh the advantages of using the method 4: A condition that represents an unacceptable health risk if the contraceptive method is used.

16 DSG+EE Vs LNG+EE: Which one has better affect on acne hirsutism and weight change
Sanam and Ziba, Saudi Med J 32:23-26, 2011

17 Design and Method Amir hospital & Health Centers, Family Planning
Women ranging from years with no contraindication to OCs and have not used hormonal contraception in past 6 months Amir hospital & Family Planning Clinic Health Centers, Samnan, Iran n=100 Baseline analysis: weight, acne, number of leisions, hirsutism evaluation, SHBG levels and free testosterone DSG+EE Grp n=50 Randomization 0 months LNG+EE Grp n=50 1months 2 months 3 months 4 months 6 months 5 months Outcome analysis: weight, acne, number of leisions, hirsutism evaluation, SHBG levels and free testosterone

18 The effect of the pill on weight, hirsutism and acne
0.012 1.0±2.0 2.8±4.2 Terminal hirsutism severity 0.000 -1.7±2.9 0.3±1.8 Hirsutism severity changes 0.836 2.7±4.4 2.5±4.3 Base hirsutism severity Hirsutism 0.001 -3.0±6.2 0.4±3.3 Number of acne changes 0.011 1.8±3.6 4.7±6.7 Terminal number of acne 0.758 4.8±8.2 4.3±7.0 Base number of acne Acne 0.0±2.5 3.3±3.6 Weight Changes (Kg) 0.902 65.3±11.0 65.8±15.6 Terminal Weight (Kg) 0.576 65.3±10.6 63.2±15.6 Base Weight (Kg) Weight P-Value DSG+EE LNG+EE Parameters Sanam and Ziba, Saudi Med J 32:23-26, 2011

19 Case 4 A 28 year old female patient seeking advice on contraception
C/O: constant lower abdominal pain and lower back pain Obs/Gyn History: G0P0A1 . (Surgical abortion of an unplanned pregnancy at a local clinic, two months ago.) Investigations: USG- Relevant findings in transvaginal sonogram shows normal ovary close to thickened fallopian tube in right adnexa

20 Pelvic Inflammatory Disease
WHO Guidelines Condition Category COC Pelvic Inflammatory Disease (PID-Current) 1 Comments: COCs may reduce the risk of PID. Pelvic inflammatory disease (PID): COCs may reduce the risk of PID among women with STIs, but do not protect against HIV or lower genital tract STIs. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009

21 A summary of a few more situations where COC are favorable…
Condition Category Additional Notes (Evidence/Comments) COC Gestational Trophoblastic Disease (decreasing or undetectable levels of β-HCG/ persistently elevated β-HCG levels or malignant disease) 1 Evidence found COC use did not increase the risk of postmolar trophoblastic disease and some COC users experienced a more rapid regression in hCG levels, compared with non-users. Endometrial Cancer COC use reduces the risk of developing endometrial cancer. While awaiting treatment, women may use COCs. In general, treatment of this condition renders a woman sterile. Ovarian Cancer COC use reduces the risk of developing ovarian cancer. While awaiting treatment, women may use COCs. In general, treatment of this condition renders a woman sterile. Cervical Ectropion Cervical ectropion is not a risk factor for cervical cancer, and there is no need for restriction of combined hormonal contraceptive use Gestational Trophoblastic Disease: Evidence: Following molar pregnancy evacuation, the balance of evidence found COC use did not increase the risk of postmolar trophoblastic disease and some COC users experienced a more rapid regression in hCG levels, compared with non-users. Limited evidence suggests that use of COCs during chemotherapeutic treatment does not significantly affect the regression or treatment of post-molar trophoblastic disease compared with women who used a non-hormonal contraceptive method or DMPA during chemotherapeutic treatment. Medical eligibility criteria for contraceptive use. (ed 4). A WHO Family planning cornerstone. 2009 MAR-2011-AP-(IN)-3627-SS 30-Aug-2012


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