Download Section One - Introductions and Overview

Curriculum for Non-Clinical Providers
in Washington State
Notes to the trainer:
PATH is a nonprofit, nongovernmental organization dedicated to improving health, especially the health of
women and children. The Emergency Contraception: Increasing Awareness in Diverse Communities
Project is a two-year project to increase awareness of and access to emergency contraception among
low-income and diverse audiences.
This curriculum was developed using information gathered through a 1999 assessment of the knowledge of
and attitudes toward emergency contraception among medical providers and men and women in diverse
communities in Washington State. The purpose of this training is to augment their knowledge by providing
accurate, up-to-date information about emergency contraception in a time-efficient format. The training is
designed to be conducted within one hour. It can be used in a variety of settings including in-service
training, new employee orientation, and staff meetings.
The trainer’s notes that follow are intended to guide the trainer through the issues related to emergency
contraception; they are not meant to be used as a lecture script. Key messages are included as bullet points
at the beginning of each section. Points of particular importance have been marked with arrows in the text.
Question slides have been included to promote discussion and an interactive learning environment. These
can be used as an opportunity for dialogue that may help non-clinical providers begin to think about
applying this emergency contraception information to their own client interactions.
The presentation can be used in three formats: slides, overhead transparencies, or PowerPoint. PATH
encourages the trainer/presenter to adapt and modify the training curriculum to best meet the
needs of the audience. In addition to the training presentation, a packet of materials on emergency
contraception should be provided to each training participant to reinforce the key points covered in the
training. The packet includes:
 Questions and answers regarding emergency contraception
 Prototype client materials
 Comprehensive bibliography of curriculum references and citations
 List of agencies and organizations endorsing emergency contraception
 Emergency Contraception: Client Materials for Diverse Audiences booklet
 List of pharmacies in Washington State that provide emergency contraceptive pills through prescriptive
authority (for Washington State providers)
For more information or clarification, please contact the following PATH staff:
Jennifer Winkler, Program Associate
Barbara Crook, Program Officer
Jane Hutchings, Senior Program Officer
PATH
4 Nickerson Street
Seattle, WA 98109
(206) 285-3500
Website: http://www.path.org
E-mail: [email protected]
Trainer’s Notes
Section One – Introductions and Overview
Key Messages:
 Stress that curriculum was developed based on recent needs
assessment
 Emphasize practical focus of training
 Explore current knowledge of emergency contraception
Slide
1
Introductions and welcome. (Ask participants to share their prior
experiences with emergency contraception.)
In late 1999, PATH conducted a needs assessment with
non-clinical providers regarding their knowledge of and attitudes
toward emergency contraception. This training is a result of those
findings; efforts were made to include only practical, time-efficient
tools and techniques to accommodate providers’ challenging
schedules.
Non-clinical providers are in a unique position to raise awareness
around the important topic of emergency contraception. Many
providers work with clientele at high risk for unintended
pregnancy. These providers have an opportunity to get the word
out to their clients about the role emergency contraception can
play in the prevention of unintended pregnancy.
This training contains a wealth of practical information that service
providers can communicate directly to their clients. It also
contains background information on the ways in which
emergency contraception works, which providers would not be
expected to share with clients in the course of a brief appointment.
This depth of information, however, should assist providers in
better communicating key points of information to their clientele.
Slide
2
Learning objectives:
 Understand the critical role of EC in pregnancy prevention
 Understand EC safety and effectiveness
 Clarify role of non-clinical providers in educating clients about
EC
 Identify mechanisms for raising awareness of EC within client
population
 Increase awareness of EC resources
Non-Clinical Providers 2
Section Two – Unintended Pregnancy
Key Messages:
 Understand magnitude of problem of unintended pregnancy
 Clarify potential role of emergency contraception in reducing
unintended pregnancy
Slide
3
Slide
4
Why is emergency contraception needed?
Because there is no perfect form of contraception and there are
very few perfect contraceptors.
 Around 10 million couples at risk for unintended pregnancy
have sexual intercourse every night in America.1
 On any given night, approximately 27,000 condoms break or
slip.1
It is important to remember that even those couples using
contraception faithfully and correctly can experience
contraceptive failure
The most recent data show that annually 49%, or approximately
2.65 million pregnancies are unintended at the time of
conception.2 In Washington, that proportion is even higher: 55%
(57,000 pregnancies). 3
It is important to keep in mind that unintended pregnancy is not
just a problem of teens or unmarried women. The Institute of
Medicine found in 1995 that the proportion of pregnancies that
were unintended at the time of conception was high for every
group of women.4
 77% of women over age 40
 40% of married women
 82% of teens age 15-19
 88% of never-married women
 75% of women at or below poverty level
 45% of women above poverty level
Non-Clinical Providers 3
Slide
5
Slide
6
The definition of unintended pregnancy is:
Pregnancy that is unwanted or mistimed at conception.
Unintended pregnancy does not mean unwanted births or
unloved children. It does mean less opportunity to prepare:
 Pre-pregnancy risk identification
 Management of preexisting conditions
 Changes in diet and vitamins
 Avoidance of alcohol, toxic exposure, and smoking
Consequences of unintended pregnancies can be significant:
 Approximately half of all unintended pregnancies end in
abortion.
 If the pregnancy is carried to term, the mother is at greater risk
of depression and physical abuse; she is at greater risk of not
achieving her educational, financial, and career goals; and her
relationship is at three times the risk of dissolution, as
compared with women whose pregnancy is intended.
 The child of an unintended pregnancy is at greater risk of
being born at low birthweight, dying in the first year of life, and
being abused and neglected, compared to a child who was
planned.4
Also, the economic consequences of unintended pregnancy are
substantial. In Washington State, 53% of Medicaid-funded births
are unintended, translating into annual estimated costs of $136
million in maternity care, labor and delivery, and medical costs. 5,6
Slide
7
The important public health implications of unintended pregnancy
led the Institute of Medicine to recommend that the nation adopt
the following new social norm: All pregnancies should be
intended–that is, they should be consciously and clearly desired
at the time of conception.4
Non-Clinical Providers 4
Section Three – Emergency Contraception
Key Messages:
 Women are not informed about EC
 Providers are not talking about it
Slide
8
Slide
9

One major step in addressing this issue is to increase
knowledge and awareness of emergency contraception.
Emergency contraception can be used to prevent pregnancy
AFTER sex.
However, there currently are obstacles to the widespread use of
emergency contraception:
 Many women do not know about the method: a 1997 survey
showed that only 11% of women knew the basic facts about
EC, and only 1% had ever used it.7
 Data on health care providers reveal that few discuss EC with
their clients. Approximately 1 in 10 providers routinely
discusses EC with his/her clients.7
 These data are supported by PATH’s 1999 interviews and
surveys with medical providers and women from diverse
communities. PATH found that the topic of emergency
contraception is rarely raised in the context of a medical visit
and many clients have never heard about EC.
Many factors make it difficult for clients to open the discussion
about EC:
 Shame about improper use of, or lack of use of, contraception
 Discomfort discussing topics related to sexuality
 Cultural issues related to provider/client relationship
 Fears about confidentiality (particularly with adolescents and
individuals from ethnically and racially diverse communities)
Without education about emergency contraception, women are
unable to make truly informed contraceptive choices. It is
important that a wider range of service providers work to raise
awareness. Within the context of your interactions with clients,
you have the opportunity to play a pivotal role in expanding
women’s awareness of, and access to, this critical contraceptive
option.
Non-Clinical Providers 5
Section Four – Background on EC
Key Messages:
 EC has been in use for over 30 years
 Two types of EC: pills and IUD
 ECPs must be taken within 72 hours of unprotected sex
Slide
10
Key point
Key point
Slide
11
Emergency contraception is not new. High-dose estrogens were
used for emergency contraception in the 1960s, but their
availability was not widely recognized until recently.
There are two primary types of emergency contraception:
 Emergency contraceptive pills (ECPs) are two high doses of
the same hormones found in ordinary birth control pills. ECPs
must be initiated within 3 days (72 hours) of unprotected
sex. They are sometimes referred to as “the morning-after pill,”
despite the 3-day window of opportunity for their use. ECPs
are not the same as RU486—the French abortion
pill—and will not disrupt an established pregnancy.
 IUD insertion within 5 days (120 hours) of unprotected sex is
also an effective form of emergency contraception and has the
added benefit of providing the client with a long-term
contraceptive method. Because ECPs can be used more
widely, they are the focus of this training.
ECPs can be used any time unprotected intercourse has
occurred:
 A woman was raped
 No contraception was used
 A condom slipped, leaked, or broke, or was used incorrectly
 A diaphragm or cervical cap was inserted incorrectly, removed
too soon, or torn
 Two consecutive birth control pills were missed in a cycle
 An IUD was partially or totally expelled
 A three-month contraceptive injection was missed by more
than two weeks
 A one-month contraceptive injection was missed by more than
three days
Non-Clinical Providers 6
Slide
12
Key point
ECPs are not as effective as regular contraceptive methods. The
discussion or use of ECPs should be used as a bridge to explore
the client’s long-term birth control options.
 Repeated use of ECPs is not known to be harmful, but should
be discouraged due to high cumulative failure rates. If ECPs
were to be used frequently, the failure rate during a full year of
use would be higher than that of regular hormonal
contraceptives and most other contraceptive methods.
 ECPs do not protect against STDs. People at risk for STDs
should be encouraged to use condoms for STD protection.
ECPs may serve as a good back-up contraceptive method in
case of condom breakage or slippage.
Non-Clinical Providers 7
Section Five – ECP Safety and Effectiveness
Key Messages:
 ECPs are safe and effective
 No absolute contraindications
 Do not interfere with an established pregnancy
Key point
Slide
13
There are no known conditions that would prevent a woman from
taking ECPs. The use of hormones is short-term, the dosage is
very small, and the hormones leave the body quickly. Because
the duration of use is short, experts believe that even women who
cannot take oral contraceptives (e.g., smokers) can safely use
ECPs. 8
The American College of Obstetricians and Gynecologists
(ACOG) emergency contraceptive practice patterns state that no
published studies have reported evidence-based criteria
contraindicating the use of this treatment. ACOG further states
that there is neither evidence of increased risk nor evidence of
decreased safety among women who have contraindications to
oral contraceptives. 9
The International Planned Parenthood Federation has stated
there are no absolute contraindications to emergency
contraceptive pills due to the small overall hormone dose and
short duration of use.10
Key point
Slide
14
Slide
15
Regarding pregnancy:
 ECPs cannot dislodge an established pregnancy—that is,
they do not cause an abortion.
 Studies of oral contraceptives taken inadvertently in early
pregnancy show that ECP hormones do not have an adverse
effect on fetal development. 11
There are two types of ECPs: the progestin-only regimen and the
combined regimen. This summary table shows that:
 The progestin-only regimen is more effective than the
combined regimen.
 It is associated with a lower incidence of nausea and vomiting.
 Regardless of which method is used, the first dose must be
taken with 72 hours after intercourse. The second dose follows
12 hours later. 12
Non-Clinical Providers 8
Slide
16
The effectiveness of ECPs varies depending on the type
prescribed. An ECP called Plan B™, which contains only
progestin, reduces the risk of pregnancy by 89%. This means if
100 women had unprotected sex once during the second or third
week of their cycle, 8 would likely become pregnant. If all 100
used the progestin-only regimen, only one would become
pregnant, an 89% reduction.12, 13
Slide
17
An ECP called Preven™, which contains a combination of
estrogen and progestin, reduces the risk of pregnancy by 75%.
This means if 100 women had unprotected sex once during the
second or third week of their cycle, 8 would likely become
pregnant. If all 100 used the combined regimen, only 2 would
become pregnant, a 75% reduction. 13, 14
Non-Clinical Providers 9
Section Six – ECP Mechanism of Action
Key Messages:
 Mechanism of action is unclear
 Clear communication with clients is an essential component of
informed choice
Slide
18
Key point
Emergency contraceptive pills work through several possible
mechanisms of action.
 Clinical studies have shown that ECPs work the same way as
ordinary birth control pills, by preventing or delaying the
release of a woman’s egg (ovulation).15,16,17
 ECPs may prevent pregnancy by affecting the uterine lining or
endometrium, so that a fertilized egg cannot implant.
However, research on these effects of ECP treatment is not
clear on whether the changes in the uterine lining would
prevent implantation.15,16,18,19,20
 It is also possible that ECPs could prevent fertilization by
affecting the movement of sperm and their ability to fertilize an
egg, but no conclusive data exist regarding this possible
mechanism of action.
 Timing plays a key role in how ECPs work; the menstrual
cycle day of intercourse and treatment both affect how ECPs
function. 21
[NOTE: These are the same ways oral contraceptive pills work]
Slide
19
Slide
20
ECPs’ role in preventing pregnancy:
 The National Institutes of Health (NIH), The Food and Drug
Administration (FDA), and ACOG all define pregnancy as
beginning at the completion of implantation. 11,22,23
 It takes about 6 days after ovulation for a fertilized egg to
begin to implant.
 Therefore, use of ECPs within 72 hours cannot result in
abortion.
 Lastly, as mentioned earlier, ECPs are not effective if
implantation has occurred and a woman is already pregnant.
Some women will want to base their decision on whether to use
ECPs on how they work. Thus, it is important that women clearly
understand how pills are believed to work in order to make an
informed choice.
Non-Clinical Providers 10
Slide
21
Important points to communicate to clients about the mechanism
of action are that ECPs:
 Will not interrupt or harm an established pregnancy (i.e., it is
not a medical abortion)
 Will not affect future fertility
 Are not the same as mifepristone (RU486, the “abortion pill”),
which is used to terminate an established pregnancy
 Work through various mechanisms
Non-Clinical Providers 11
Section Seven – Key Messages
Key Messages:
 ECP discussions should be brief but thorough
 ECP discussions should address clients’ concerns
Slide
22
(Discussion)
Slide
23
The training has covered a substantial amount of information up
to this point. Realizing that all of you have limited time with clients,
what key points on EC would you want to get across to your
clients?
When discussing ECPs with clients, it is important to provide
these key messages:
 ECPs must be taken within 72 hours of unprotected sex;
however, effectiveness is higher the sooner ECPs are
used.
 ECPs are safe and effective in preventing pregnancy after
sex.
 Women should clearly understand how ECPs work so that
they can make an informed choice about the method (for
example, knowing that ECPs may block implantation of a
fertilized egg).
 Do not cause abortion
 The potential for nausea and vomiting should be explained.
 It should be stressed that ECPs are not as effective as
regular contraceptive methods. The need for ECPs can
highlight a need for clients to know more about other birth
control methods.
 It is important to emphasize that ECPs do not protect
against STDs.
 Know the nearby locations that distribute emergency
contraception so that clear, accurate referrals can be
provided.
[NOTE: It is important to keep in mind that all women at risk of an
unintended pregnancy need to know about emergency
contraception [regardless of age or marital status] and would
benefit from this discussion.]
Slide
24
(Discussion)
In addition to these key clinical points, clients may come in with
their own set of concerns about the use of ECPs that should be
addressed in the course of a discussion. Based on your
experience, what do you think are concerns and questions your
clients may have about ECPs?
Non-Clinical Providers 12
Slide
25
PATH research among women and men of diverse communities
revealed the following client concerns:
 The impact of ECPs on future childbearing. ECP use does
not have an impact on future fertility.
 The threat to potential pregnancy. As we discussed earlier,
research presented to the FDA shows no evidence of negative
effects on a potential pregnancy.
 Relationship to abortion. ECPs do not disrupt an established
pregnancy and are medically defined as contraception and
pregnancy prevention.
 Religion is not predictive of individual’s interest in or
willingness to use emergency contraception.
 Expense of ECPs. ECPs are covered by Medicaid. Current
out-of-pocket costs will be discussed later in training.
 Concerns about confidentiality were raised repeatedly in the
course of our research. Adolescents and members of diverse
communities were especially concerned about the issue of
confidentiality and need reassurance about the confidential
client-provider relationship. Concerns about the importance of
maintaining confidentiality extend to interpreters as well.
Non-Clinical Providers 13
Section Eight – Providing ECPs
Key Messages:
 There are many ways to get ECPs
 Advance distribution/prescribing can improve client access to
ECPs
Slide
26
Slide
27
Women can obtain ECPs in several ways:
 Women can obtain ECPs or an ECP prescription in advance of
need from their doctor, nurse practitioner, or pharmacist.
 Medical clinics provide ECPs through either a scheduled
appointment or a walk-in visit when requested by clients.
 In some cases, ECPs can be provided by telephone by
medical clinics to clients upon request (many Planned
Parenthood clinics will prescribe ECPs over the telephone).
 In Washington State, pharmacists can establish a
collaborative drug therapy agreement with a medical provider
that enables the pharmacist to provide ECPs directly to
women.
To locate the clinic site or pharmacy nearest to the client, call the
Emergency Contraception Hotline, at 1-888-NOT-2-LATE
(1-888-668-2528), or call the Washington State Family Planning
Hotline at 1-800-770-4334 for family planning information by
county.
Referring women to sources of ECPs in advance of need can
greatly improve the convenience of the method and can help
ensure that women have access to treatment as soon as they
need it. 24 This is particularly important in view of research that
demonstrates ECPs are more effective the sooner they are used.
Transportation was cited as a significant barrier for access to
ECPs; advance prescribing or distribution helps to minimize this
barrier.
Non-Clinical Providers 14
[Previous Slide, Continued:]
Some people raise concerns about whether providing ECPs to
women ahead of time will make them more likely to use them
irresponsibly. It is important to keep in mind the idea that the
decision to use ECPs following unprotected sex is a responsible
decision. Also, women who have used ECPs do not plan to use
them as a regular contraceptive method or expect that their
partner would suggest their use for regular contraception. A study
evaluating women’s experience receiving ECPs through a
demonstration project from Kaiser Permanente in San Diego
found that the overwhelming majority (97%) of women reported
that they would use ECPs again only in an emergency. Among the
84% who had informed their partner, 92% agreed that using ECPs
would not make their partner less willing to practice
contraception.25
Slide
28
In Washington State, collaborative agreements enable trained
pharmacists to provide ECPs directly to clients who request them
(either in advance or as needed). The pharmacist uses screening
criteria when dispensing the pills and regularly participates in a
quality-assurance review with the authorizing prescriber.




Currently, there are over 145 pharmacies participating in
collaborative agreements in Washington State.
In the first 16 months of the project, almost 12,000 ECP
prescriptions were provided directly by pharmacists.
A list of participating pharmacies in Washington State is
included in the information packet. Updated information about
accessing ECPs via participating pharmacies is also available
through the EC Hotline at 1-888-NOT-2-LATE
(1-888-668-2528).
Non-Clinical Providers 15
Section Nine – Cost and Cost-Effectiveness
Key Messages:
 Medicaid covers ECPs
 Current retail prices are $18 to $35 for pills alone
Slide
29
Medicaid covers ECP prescriptions:
 In Washington State, medical coupons cover both Preven
and Plan B as well as regular birth control pills prescribed in
special doses for use as emergency contraception.

Slide
30
Medicaid also covers both pills and pharmacist counseling
time for women who receive ECPs directly from their
pharmacist.
For clients using private insurance or private pay, the current
(2000) retail prices at pharmacies in the Seattle area are:
 For filling Preven or Plan B prescriptions written by
providers:
 If the pills are covered by insurance, then the client
commonly pays a co-pay of $5 to $10.
 If the client has no insurance coverage, the prices vary
from $18 to $35 for Plan B and $20 to $35 for Preven.
 If the client obtains ECPs directly through the pharmacist, they
would need to pay for both the prescription and the
consultation.
 In 2000, average pharmacist charges are $35 to $45 for
ECPs and counseling.
Non-Clinical Providers 16
Section Ten – Opportunities for ECP Discussion
Key Messages:
 It is important that service providers discuss ECPs with all their
clients
 Informational tools are available for service providers and for
clients
Slide
31
Slide
32
Slide
33
The following resources related to emergency contraception are
included in the training packets.
 Q & A for non-clinical providers
 Key messages to convey to clients
 EC referral card
 Emergency Contraception: Client Materials for Diverse
Audiences booklet
 List of pharmacies that provide ECPs in Washington State
 EC reference list
One key resource in the packet is the booklet entitled “Emergency
Contraception: Client Materials for Diverse Audiences.” The
pages of the booklet are designed to be photocopied into
pamphlets that contain EC information in 13 languages
These resources can help clients to locate clinics and pharmacies
in their area.
 The Emergency Contraception Hotline number
(1-888-NOT-2-LATE or 1-888-668-2528) provides ECP
information as well as a directory of clinics and Washington
State pharmacies listed by zip code.
 The website www.not-2-late.com provides the same
information online.
 Planned Parenthood offers information online at
http://plannedparenthood.org.

The Department of Social and Health Services sponsors a
Washington State Family Planning Hotline (1-800-770-4334).
Non-Clinical Providers 17
Slide
34
(Discussion)
In thinking about how you can emphasize ECPs in your
interactions with clients at risk of unintended pregnancy, some
questions to consider include:
 When do you plan to discuss ECPs?
 With what groups of women will you discuss ECPs?
 Who will you refer for ECPs?
 Where will you refer clients?
In planning for emergency contraception services, it is important
to keep in mind the short time frame for treatment and to eliminate
as many barriers as possible.
Slide
35
In closing, we would like to emphasize that the most important
step service providers can take to improve the consistent and
appropriate use of contraception is to talk about it with their
clients. Results from the PATH needs assessment with diverse
populations in Washington State show that awareness regarding
EC is extremely limited. This means that you can play a critical
role in reducing unintended pregnancy by educating clients about
EC and referring for EC when appropriate.
The following recommendations can increase clients’ awareness
of EC:
 Routinely discuss the availability of ECPs as a back-up
method for contraceptive accidents.
 Make EC informational materials available in your settings
(waiting rooms, restrooms, offices) and distribute EC client
materials during appointments.
Encourage all (not just high-risk) clients to obtain
advance-of-need prescription for ECPs.
Slide
36
Close
Non-Clinical Providers 18
Reference List
Washington State Non-Clinical Curriculum
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2.
Henshaw S. Unintended pregnancy in the United States. Family Planning Perspectives
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3.
Schrager L. First Steps Database: Unintended Pregnancy. Olympia, WA: Research and Data
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Institute of Medicine. The Best Intentions: Unintended Pregnancy and the Well-Being of
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5.
PRAMS Surveillance Report. Washington State Department of Health, 1998.
6.
State Covered Maternity and Abortion Report. Washington State Department of Social and
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7.
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8.
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9.
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and Obstetrics 56(3):290-297, 1997.
10.
International Planned Parenthood Federation. IMAP statement on emergency contraception.
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11.
Food and Drug Administration. Prescription drug products; certain combined oral
contraceptives for use as post-coital emergency contraception; Notice. Federal Register.
62:8610-8612, 1997.
12.
Task Force on Postovulatory Methods of Fertility Regulation. Randomized controlled trial of
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contraception. Lancet 352:428-433, 1998.
13.
Association of Reproductive Health Professionals (ARHP). Emergency Contraception: Train
the Trainer. Washington D.C.: ARHP, 1999. Available online at www.arhp.org/ec/.
14.
Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness of the Yuzpe regimen
of emergency contraception. Contraception 57:363-369, 1998.
15.
Swahn M, Westlund P, Johannisson E, Bygderman M. Effect of post-coital contraceptive
methods on the endometrium and the menstrual cycle. Acta Obstetricia et Gynecologiica
Scandinavica 75:738-744, 1996.
Non-Clinical Providers 19
16.
Ling W, Robichaud A, Zayid I, Wrixon W, MacLeod S. Mode of action of DL-norgestrel and
ethinylestradiol combination in postcoital contraception. Fertility and Sterility 32:297-302,
1979.
17.
Rowlands S, Kubba A, Guillebaud J, Bounds W. A possible mechanism of action of danazol
and ethinylestradiol/norgestrel combination used as a postcoital contraceptive agency.
Contraception 33:539-545, 1986.
18.
Ling W, Wrixon W, Acorn T, Wilson E, Collins J. Mode of action of dl-norgestrel and
ethinylestradiol combination in postcoital contraception. III. Effect of preovulatory
administration following the luteinizing hormone surge on ovarian steroidogenesis. Fertility
and Sterility 40:631-636, 1983.
19.
Kubba A, White J, Guillebaud J, Elder M. The biochemistry of human endometrium after two
regimens of postcoital contraception; a dl-norgestrel/ethinylestradiol combination or danazol.
Fertility and Sterility 45:512-516, 1986.
20.
Taskin O, Brown R, Young D, Poindexter A, Wiehle R. High doses of oral contraceptives do
not alter endometrial 1 and 3 integrins in the late implantation window. Fertility and
Sterility 61:850-855, 1994.
21.
Von Hertzen H, Van Look P. Research on new methods of emergency contraception. Family
Planning Perspectives 28(2):52-57, 88, 1996.
22.
Office for Protection from Research Risks Reports. Protection of human subjects. Code of
Federal Regulations, 45 CFR 46.203, 1998.
23.
Committee on Terminology, The American College of Obstetricians and Gynecologists.
Obstetric-Gynecologic Terminology. Hughes E (ed.). Philadelphia, PA: F.A. Davis Company,
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