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Emergency Contraception-Whats New?
1.
2. • Medical Director-Shrikhande Fertility Clinic, Nagpur
• Chairperson Designate ICOG 2020
• National Corresponding Editor-Journal of OB/GY of India JOGI
• National Corresponding Secretary AMWI
• Senior Vice President FOGSI 2012
• Founder Patron & President –ISOPARB Vidarbha Chapter
• Received Nagpur Ratan Award at the hands of Union Minister Shri
Nitinji Gadkari
• Received Bharat excellence Award for women’s health
• Received Mehroo Dara Hansotia Best Committee Award for her work as
Chairperson HIV/AIDS Committee, FOGSI
• Received appreciation letter from Maharashtra Government for her work
in the field of SAVE THE GIRL CHILD
• Immediate Past President Menopause Society, Nagpur
• President Nagpur OB/GY Society 2005-06
• Delivered 11 orations and 450 guest lectures
• Publications-Twenty National & Eleven International
• Sensitized 2 lakh boys and girls on adolescent health issues
Dr. Laxmi Shrikhande
Nagpur
4. BACKGROUND
• India was the first country in the world to adopt an official population
policy and launch official family planning program way back in 1952
which remains the mainstay of family planning efforts
5. DEMOGRAPHICS
• Even though a wide variety of
contraceptive choices are
available in India, contraceptive
usage in the country is only
56% as per the WHO global
health statistics 2012
56
44
Contraceptive Usage In India
Population using
Contraceptives methods
Population not using any
method for
Contraception
*WHO global health statistics 2012
6. UNINTENDED PREGNANCY
• Each year, approximately 85 million women (41 %) in the world face an
unintended pregnancy, more than one in seven of these cases occurs in
India
• 46 million unwanted pregnancies end in abortion each year, 20 million
of which are unsafe.
Singh V et al. Int J Adv Med. 2014 Aug;1(2):105-112
7. THE COVID-19 CONTEXT
• Work from home
• increase in consensual sexual activity
• fears about exposure to the virus –reluctant to visit hospital
10. RESPONSE TO THE PROBLEM
• With the use of effective contraception, 90% of abortion-related and
20% of pregnancy-related morbidity and mortality can be prevented
• Emergency contraceptive Pills are largely underutilized in India, which if
taken correctly can reduce the risk of an unintended pregnancies which in
turn will reduces 8% maternal mortality
Munakampe, M.N, BMC Health Serv Res (2018)
11. WHAT IS EMERGENCY CONTRACEPTION ??
• Emergency contraception (EC) is a method of contraception used as an
emergency step taken before menstruation is missed, to prevent
pregnancy following Unprotected Sexual Intercourse(UPSI) or expected
failure of contraception
• They are popularly also called as ‘Morning after pill’ or “postcoital
contraceptives.”
https://www.acog.org/patient-resources/faqs/contraception/emergency-
contraception
12. INDICATIONS FOR EMERGENCY CONTRACEPTION
ECPs are indicated when:
• no contraceptive was used;
• a contraceptive was used incorrectly;
• a contraceptive was used correctly but was immediately observed to have
failed
FSRH, Emergency Contraception March 2017
13. INDIAN SCENARIO
• In India, ECP was introduced in 2002 by the Ministry of Health and Family Welfare
(MoHFW) and was made an over the counter (OTC) drug in 2005
• Less than one-third women are aware of ECP and less than one percent have ever
used it
*Indian J Community Med. 2015 Jan-Mar; 40(1): 49–55
15. YUZPE METHOD
• Oldest form of post-coital emergency contraception
• This method involves taking two pills each containing 50 µg of ethinylestradiol and
0.50 mg of dl-norgestrel or 1 .5 mg levonorgestrel within the first 72 hours .
This treatment is repeated 12 hours later
• The Yuzpe method works by delaying or inhibiting ovulation, when utilized during the
first half of the menstrual cycle
• It is only effective if follicles are not already well developed
16. EFFICACY OF YUZPE REGIMEN
• After a single act of unprotected sexual intercourse, the Yuzpe regimen fails in about
2 of women who use it correctly (1.9%, 95 CI 1.4–2.4 %)
• The crude failure rate is 1-5 per 100 woman-months while the true reduction in
pregnancy risk is over 75
• It means, if 100 women have intercourse in the mid 2 weeks of their cycle,
approximately 8 will become pregnant. Use of emergency contraceptive pills would
reduce this number to 2 women (a 75 reduction)
Kubba AA. Eur. J Contracept. Reprod. Health Care 1997
17. SIDE EFFECTS WITH YUZPE METHOD
• The Yuzpe method has more pronounced side effects with 50% of women develop
nausea, and 20% develop vomiting (Yuzpe et al., 1982; Percival - Smith and Abercrombie, 1987; Ho and Kwan,
1993)
• Antiemetic medications are recommended if the Yuzpe method is used
• Changes in menstrual bleeding, mastalgia and increased risk of venous
thromboembolism are observed
18. LEVONORGESTREL (LNG)
• Levonorgestrel (LNG) is a progestin-only pill licensed in many countries around the
world
• Single dose oral tablet of LNG (1.5 mg) or two doses ( 0.75 mg each – 12 hours apart)
to be taken within 72 hours of unprotected intercourse
• LNG suppresses luteinizing hormone, which delays or inhibits ovulation
• In order to be effective, it must be administered before the LH surge begins. Thus
reasonable to infer that LNG is less effective when given closer to the time of
ovulation
Haeger et al. Contraception and Reproductive Medicine (2018) 3:20
19. • A randomized trial with1998 women at 21 centers worldwide undertaken by WHO
• This trial found that the crude pregnancy rate was 1.1% in the LNG group and 3.2%
in the Yuzpe method group, yielding a relative risk of 0.36 (95% CI = 0.18–0.70)
• The estimated efficacy, when used within 72 hours of intercourse was 85% for LNG,
compared with 57% in the Yuzpe method group
• The efficacy (based on estimates of conception probabilities) of LNG decreased with
time: from 95% at 24 hours to 58% when taken between 49–72 hours
20. EFFICACY OF LNG
• Efficacy of 1.5 mg of LNG may decrease among patients weighing more than 70 kg
or with a BMI greater than 26 kg/m2, with a four-fold risk of pregnancy in obese
women compared to women with a normal BMI
• In such cases needs doubling the dose to 3.0 mg, but effect is not well documented
• A further advantage of the levonorgestrel-only is the absence of ethinylestradiol,
therefore it avoids the risk of arterial or venous thrombosis
21. SIDE EFFECTS OF LEVONORGESTREL
• The most common side effects with LNG are nausea (23%) and vomiting (5.6%)
• Less common events include fatigue, dizziness, headache, and mastalgia
• Disruption in the menstrual cycle pattern may also occur
• When LNG is taken in the preovulatory stage of menses, the length of the cycle may
be abbreviated; in the peri- and postovulatory phases, cycle length is unaffected, but
the duration of bleeding is elongated in the subsequent cycle
22. MIFEPRISTONE
• Mifepristone, an anti-progestin synthetic steroid is studied mostly in China, as an
emergency contraceptive option within 120 hours of UPSI at much lower doses (10 to
50 mg)
• The mechanism of mifepristone as an EC occurs pre-implantation, hence not
considered an abortifacient here
• During the follicular phase, it delays the estrogen rise, LH surge, and ovulation, thus
lead to inhibition of ovulation
• After ovulation, mifepristone inhibits endometrial development, thus preventing
implantation
Marions L. Obstet Gynecol. 2002
23. EFFICACY OF MIFEPRISTONE
• A study by Xiao et al observed that doses of 10 mg and 25 mg had a similar efficacy
• Piaggio et al, who reviewed 12 clinical trials involving a total of 6,083 women given
doses of mifepristone varying between 5–600 mg for EC, concluded that 10 mg was
effective, with acceptable side effects, when used up to 5 days after unprotected sex
• Various studies also show, no significant differences in efficacy for women weighing
more than 75 kg with 10 mg mifepristone
• Therefore, the lowest dose is recommended.
• Mifepristone is currently used only in Armenia, China, Russia, and Vietnam for this
indication
Xiao BL at al. Hum Reprod. 2002
Piaggio G at al. Contraception. 2003
24. COPPER IUD
• The most effective form of emergency contraception, which is inserted within 5 day of
UPSI without change in efficacy
• Has advantage of providing ongoing contraception for up to 10 years
• The main mechanism of action of copper IUDs is inhibition of fertilization as the copper
ions released from the device have a toxic effect on sperm and ova, which affects their
mobility and viability
• Where fertilization does occur, implantation is prevented because of the inflammatory
response in the endometrium
• Both PRE-FERTILISATION and POST-FERTILISATION action
Australian family physician. 2017 Oct;46(10):722.
25. • In systemic review, 42 studies analyzed patients that had copper IUDs inserted 2–10
days after unprotected intercourse
• From a total of 7,034 patients around the world who had post-coital IUD insertions,
there were only 10 pregnancies, with a failure rate of only 0.14% (95% CI = 0.08%–
0.25%)
• Concludes, IUDs are a highly effective method of contraception after unprotected
intercourse
Cleland K et al. Human reproduction. 2012
26. SIDE EFFECTS WITH THE COPPER IUD
• The most common side effects with the copper IUD are pain during the
insertion process and increased menstrual bleeding.
• Absolute contraindications to copper IUD placement are the same as
with routine insertion and include pregnancy (due to increased risk of
septic abortion and serious pelvic infection), undiagnosed vaginal
bleeding, malignant gestational trophoblastic disease, copper allergy
27. LIMITATIONS
• Despite the long-term contraceptive benefits of the copper IUDs, this
method remains underutilized
• The necessity of IUD placement by a trained health care provider, high
up-front costs, lack of provider and patient knowledge regarding the
IUD’s effectiveness and use as a form of EC, all contribute to the
relatively low use of the copper IUD as a form of EC
29. ULIPRISTAL ACETATE (UPA) 30 MG
Ulipristal acetate is a derivative of 19-
norprogesterone
It is a selective progesterone- receptor
modulator (SPRM)
30. ULIPRISTAL ACETATE 30 MG
Therapeutic indications:
Emergency contraception within 120 hours (5 days) of unprotected sexual
intercourse or contraceptive failure
For example:
- UPSI : Unprotected sexual intercourse
- Failure of condom : breakage ,slippage etc.
-Missed pill , patch , ring, injection , IUD expulsion etc.
31. DRUG APPROVAL
Use of this SPRM – Ulipristal Acetate 30 mg for EC was authorized by :
• In Europe by The European Medicines (EMEA) since 2009
• In USA by US Food and Drug Administration (FDA) since 2010 and
• In Australia, approved by the Therapeutic Goods Administration (TGA)
since March 2016
• In India, approved by DCGI in 2020
32. MECHANISM OF ACTION
UPA has an inhibitory effect on ovulation when
administered during the follicular phase
33. POSOLOGY
• The treatment consists of one tablet to be taken orally as soon as
possible, but no later than 120 hours (5 days) after UPSI or contraceptive
failure
• If vomiting occurs within 3 hours of the tablet intake, another tablet
should be taken
• If a woman’s menstrual period is late or in case of symptoms of
pregnancy, pregnancy should be excluded before the tablet is
administered
34. PHARMACOKINETICS - ULIPRISTAL ACETATE 30 MG
• The route of administration is oral
• Metabolism occurs in the liver
• UPA is metabolized to mono-demethylated and di-demethylated metabolites
predominantly mediated by CYP3A4
• The mono-demethylated metabolite is pharmacologically active
• The active terminal half-life after 30 mg single dose is estimated to be 32.4 ± 6.3 hours
• 90% of the excretion is with feces
Ferrero S. Expert opinion on drug metabolism & toxicology. 2018
35. DRUG INTERACTIONS - ULIPRISTAL ACETATE 30 MG
• UPA’s effectiveness may be reduced when it is taken concomitantly with
drugs like barbiturates, carbamazepine, phenytoin, griseofulvin, and
rifampin.
• In contrast , with CYP3A4 inhibitors such as itraconazole and
ketaconazole may increase plasma concentrations of UPA
• Alterations in gastric pH may also reduce absorption and plasma levels of
ulipristal acetate
• Thus, concomitant use of acid-suppressive drugs, such as PPI, H2 Blocker,
and antacids to be avoided
36. SIDE EFFECTS
• Headache
• Abdominal pain
• Nausea
• Dysmenorrhea
• Fatigue
• Dizziness
• Delayed menses by 2.1 days
*https://www.medscape.com/viewarticle/926833
38. SAFETY
• No teratogenic effects or birth defects have been associated with UPA
taken by a woman who does not realize she is already pregnant
• Though there are no adverse outcomes associated with breastfeeding
after taking UPA, American guidelines discourages mothers avoid giving
breastmilk in the 24 h following consumption of UPA , while European
guidelines suggest a 7-day window before resuming breastfeeding an
infant following the ingestion of UPA
Haeger KO. Contracept Reprod Med. 2018
39. CONTRAINDICATIONS - ULIPRISTAL ACETATE 30 MG
• Hypersensitivities to UPA
• Severe liver disease, owing to metabolism in liver
• Known or suspected pregnancy
40. HOW EFFECTIVE IS ULIPRISTAL ACETATE (UPA) COMPARED TO
LEVONORGESTREL (LNG)
55 with no
intervention
23 with LNG 9 with UPA
UPA is 2.5
times more
effective
than LNG
Glasier A et al. Lancet
2010
Pregnancy rates per 1000 women in the first 24 hours after unprotected sex
41. INTERVENTIONS FOR EMERGENCY CONTRACEPTION
The studies compared 25 different interventions of different types of emergency
contraception.
What do Authors have to say about UPA:
• Ulipristal acetate (UPA) is more effective than levonorgestrel
• UPA users were probably more likely to resume menstruation after the expected date
Cochrane Database of Systematic
Reviews 2019, Issue 1. Art. No.: CD001324
42. CAN EC BE REGULAR CONTRACEPTIVE METHOD??
• As the efficacy of repeated use of EC is generally lower than most
contraceptives regular use of EC is not advised as a contraceptive method
• Instead, we counsel women about all contraceptive and their use.
42
43. COUNSELLING POINTS
• Efficacy of ECs in general and method specifics
• Discuss Choice of method
• Side effects of methods
• Need for continuing and reliable contraception
• EC does not protect against risk of STIs
• Effect of BMI of efficacy (LNG less effective in obese women)
43
44. THE BOTTOM LINE
• EC is an important back-up contraceptive option at any time
• This is true more than ever during the COVID-19 pandemic, when access
to ongoing contraception may be limited
• Purchasing EC in advance of need can help people maintain autonomy
and reduce the risk of pregnancy during this crisis, but risk of STIs cant be
denied…
45. OCCASIONALLY, MEDIA COVERAGE HAS PORTRAYED ECP USE IN A NEGATIVE MANNER
They wrote:
• Often the male partner does not bring
the pills and this puts woman at more
risk
• Youngsters are using emergency pills
too often
• These pills should be sold only on a
doctor's prescription
46. NEED OF HOUR..
• The United Nations Population Fund, The World Health Organization, and The
International Federation of Gynecology and Obstetrics, advocate for easy access to
emergency contraceptive pills
• ECPs are safe and there are no absolute contraindications for usage of LNG or the
Yuzpe method, and the copper IUD
• Providers working with women in clinics, emergency departments, and pharmacies
should be familiar with the availability of medications, as well as options for
provision
• Patient preference, provider capability, and local availability will influence which
options are most preferable
47. SUMMARY
• The treatment must begin within the first 72 h after unprotected intercourse (for
hormonal regimens)
• The earlier emergency contraceptive treatment is started the more effective it is
48. My World of sharing happiness!
Shrikhande Fertility Clinic
Ph- 91 8805577600
shrikhandedrlaxmi@gmail.com
50. The Art of Living
Anything that
helps you to
become
unconditionally
happy and loving
is what is called
spirituality.
H. H. Sri Sri Ravishakar
Editor's Notes
Most couples in India do not want to use a contraceptive method on a long-term basis hence unwanted and unplanned pregnancies are commoM
Unlike the pills described below, the mechanism of the copper IUD is somewhat different. Pre-fertilization effects are prominent.
The copper composition can be toxic to both the ovum and the sperm.
Additionally, the foreign body induces a chronic inflammatory response, leading to release of cytokines and integrins. These inflammatory markers cause both a spermicidal effect and inhibit implantation even if fertilization does occur.
CDB-2914 (CDB: Contraceptive Development Branch of National Institute of Child Health and Human Development, NICHD), with 11 βaryl substitutions, is a derivative of 19-norprogesterone
Ulipristal acetate is a selective progesterone receptor modulator.5 It is a partial agonist, exerting agonist and antagonist activity at the progesterone receptor. While it has been used in the medical management of uterine fibroids,6 it is more commonly used for emergency contraception.
UPA is an orally active SPRM that binds with high affinity to the PR. It exerts agonistic/antagonistic effects on the PR (Figure 2). It also is a glucocorticoid receptor ligand, but with a lower antiglucocorticoid activity than mifepristone. It has no relevant affinity to the estrogen, androgen, and mineralocorticoid receptors
Ulipristal acetate is taken as a single 30 mg dose as soon as possible after unprotected intercourse, but has continuing efficacy up to five days later (120 hours), compared with 72 hours for levonorgestrel ECP.
Ulipristal acetate became available as an ECP in the European Union in 2009. This was followed by its release in the US in 2010. In March 2016, it became available in Australia as a Schedule 4 (prescription) item but, following approval by the Therapeutic Goods Administration (TGA),7 from 1 February 2017 it has become a Schedule 3 (pharmacist only) item, available over the counter
, the intake of UPA suppressed the increase in LH and the appearance of the peak. However, once LH levels had reached maximum values at the time of UPA administration, women ovulated normally.
As UPA is intensely metabolized by hepatic CYPs, CYP inducers
or inhibitors can modify its metabolism
Ulipristal acetate is metabolized to mono-demethylated and di-demethylated metabolites. Metabolism occurs predominantly by the cytochrome P450 (CYP) 3A4 hepatic isoenzyme and, to a lesser extent, by CYP 1A2.6,10 Although the mono-demethylated metabolite is pharmacologically active, the di-demethylated metabolite has no clinical activity. The half-life of the drug in plasma, following a single dose of 30 mg, is approximately 32.4 ± 6.3 hours.6 In pharmacokinetic and population studies, ulipristal acetate has not shown any significant variations in women of different races; however, the drug is not recommended for breast-feeding or postmenopausal women.6
The concomitant administration of medicinal products that tend to increase gastric pH may also decrease the drug’s efficacy
long-term management (up to four treatment course, separated
by a drug-free period until the start of the second
menstruation following the end of the previous treatment
course) of uterine leiomyomas