See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/49785717

Natural Family Planning: An Update

Article  in  Canadian family physician Médecin de famille canadien · September 1986

Source: PubMed

CITATION READS

1 1,345

1 author:

Christine Derzko
University of Toronto
39 PUBLICATIONS   188 CITATIONS   

SEE PROFILE

All content following this page was uploaded by Christine Derzko on 26 February 2015.

The user has requested enhancement of the downloaded file.

 ---- - - - - - - - im il il i l - --
Christine M. Derzko
Natural Family Planning: An Update
SUMMARY
Natural Family Planning (NFP) is defined by
the World Health Organization (WHo) as
"methods for planning or avoiding
pregnancies by observation of the natural
signs and symptoms of the fertile and infertile
phase of the menstrual cycle. It is implicit in
the definition of natural family planning,
when used to avoid conception that drugs,
devices and surgical procedures are not used,
there is abstinence from sexual intercourse
during the fertile phase of the menstrual
cycle, and the act of intercourse, when it
occurs, is complete."' The fertile period may
be determined by using Rhythm, a calculation
based on previous cycles, basal body
temperature (BBT) charting alone, mucus
secretion alone (Billings or Ovulation
method), or symptothermal charting (Serena
method), which indudes observation of both
mucus and BBT. The effectiveness of each
method is discussed, and the social and
psychological profile of couples who use NFP
is reviewed. NFP methods can be used not
only to avoid pregnancy, but also to achieve
pregnancy and thus are particularly useful in
investigating and treating infertility. The
function of the -Family Life Clinic at St.
Michael's Hospital in Toronto is described.
(Can Fam Physician 1986; 32:1913-1921.)
Key words: natural family planning, reproduction, contraception
El mm
Dr. Derzko is an assistant
professor in the Department of
Obstetrics and Gynecology at the
University of Toronto, and is the
Director of the Reproductive
Endocrinology and Infertility
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
SOMMAIRE
L'Organisation mondiale de la sante definit les
methodes de planification familiale dites naturelles
comme etant des methodes permettant << de
planifier ou d'eviter les grossesses par l'observation
des signes et sympt6mes naturels des periodes de
fertilit6 et d'infertilit6 du cycle menstruel. II est
implicite dans la definition de la planification
familiale naturelle, lorsque pratiquee dans un but de
contraception, de ne pas faire usage de
medicaments, de moyen mecanique, de ne pas
recourir a une intervention chirurgicale, de
s'abstenir de relations sexuelles pendant la periode
de fertilite du cycle menstruel et que l'acte sexuel, au
moment d'une relation, soit complet. >> 1 On peut
determiner la periode de fertilite en utilisant la
m'thode rythmique, un calcul base sur les cycles
precedents, la courbe de temperature basale, les
secrtions de la muqueuse vaginale (methode
Billings cu d'ovulation), la courbe symptothermique
(methode Serena), laquelle inclut l'observation des
seretions et la courbe de temperature basale.
L'article discute de l'efficacit6 de chacune de ces
methodes et analyse le profil social et psychologique
des couples qui utilisent les methodes naturelles de
planification familiale. On peut utiliser ces methodes
non seulement pour eviter les grossesses, mais aussi
pour en choisir le moment et, a ce titre, elles sont
particulierement utiles pour investiguer et traiter
l'infertilite. L'auteur d6crit le r6le de la clinique
Family Life au St. Michael's Hospital de Toronto.
Division at St. Michael's Hospital, OVER THE LAST DECADE
Toronto. Reprint requests to: St. there has been a resurgence of
Michael's Hospital, Dept of interest in a more "natural" approach
Obstetrics and Gynecology, 30 to living. Many young adults, in their
Bond St., Toronto, Ont. M5B 1W8. attempt to seek harmony with nature,
are exploring alternate methods of
1913
 conception control which are more
natural than intrauterine contraceptive
devices (IUCD), birth-control pills,
and other chemical methods whose
long-term and short-term side-effects
they consider problematic. It is esti-
mated that about four per cent of cur-
rently married North American cou-
ples rely on NFP.2
Definition
Natural Family Planning is the tim-
ing of coitus in accordance with the
fertile phase of the menstrual cycle, to
achieve or prevent a pregnancy.
When pregnancy is to be avoided, pe-
riodic abstinence is practiced; the cou-
ple recognizes pre-ovulatory symp-
toms and signs, and refrains from
sexual intercourse and, indeed, any
genital contact until the infertile phase
of the cycle is reached. On the other
hand, couples wishing to conceive
learn to time intercourse so that it
takes place during this fertile phase.
Successful use of NFP requires funda-
mental knowledge and understanding
of the physiology of reproduction,
sometimes referred to as "fertility
awareness".
Reproductive Physiology:
Fertility Awareness
Successful use of a natural family-
planning method necessitates some
basic knowledge about both male and
female reproductive functioning. This
includes production and survival of
sperm in the male, ovum survival,
cervical mucus secretion, basal body
temperature changes, and other less
obvious symptoms and signs accom-
panying ovulation in the female. The
following is a summary of the major
points which are included in teaching
fertility awareness to patients.
The span of a woman's reproduc-
tive life lasts from menarche (average
age: 12.5 years), until menopause
(average age: 50.8 years). Fertility in
the woman is cyclical, with ovulation
occuring only once per cycle. The
ovum is fertilizable for 10-24 hours
while it floats freely in the fallopian
tube, and if it is not fertilized during
this time, pregnancy will not occur.
In the male, fertility begins with
the pubertal production of semen and
then lasts for the remainder of life.
Sperm production is continuous (not
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
cyclical as it is in women), and there- (LH) peak, and that this corresponds
fore impregnation can occur at any to an increase in peripheral proges-
time. Normally, in a non-hostile envi- terone levels to more than 4 ng/ml.8
ronment, sperm survive 24-48 hours, The actual release of the ovum proba-
but in hostile, acidic, vaginal secre- bly occurs on the day before the time
tions they die within 4-6 hours. In of the first temperature elevation.
estrogenic mucus, the fertilizing ca- Sometimes a mid-cycle dip in temper-
pacity of sperm is believed to be 3-5 ature to the lowest level of the cycle
days. The process of fertilization it- may be recognizable, and this is be-
self requires about 5-8 hours to com- lieved to coincide with ovulation it-
plete.3 self.
Cervical mucus is the outward
manifestation of the internal hormonal Basal Body Temperture
milieu.4 It is produced cyclically, in
response to estrogenic stimulation of The thermogenic effect of proges-
terone acting on the hypothalamus is
the mucus-producing glands of the
cervix, peaking in response to peak- well known to cause the rise in tem-
estrogen secretion and disappearing as perature of the luteal phase, which
progesterone secretion appears and produces the biphasic graph charac-
becomes dominant. Estrogenic cervi- teristic of ovulation. Temperatures
cal mucus is clear, acellular, copious, should be taken orally, vaginally or
of low viscosity, has a spinnbarkeit rectally, always at the same time and
(thready stretchiness) which increases under the same circumstances every
as estrogen levels rise, and produces a day. Usually, a basal body tempera-
ferning pattern when allowed to dry ture is taken at a fixed time daily be-
fore rising from bed. Although there
on a slide. With the onset of proges-
terone secretion, the mucus becomes is consensus that the temperature rise
in a biphasic graph is indicative of
white, cellular, scanty, thick and
sticky, the spinnbarkeit decreases to ovulation, unfortunately, there is little
less than 1 cm and, when left to dry consensus about precisely when the
ovulation occurs in relation to the BBT
on a slide, the ferning is replaced by a
"beaded'" pattern. chart. Dates ranging from two days
before the temperature rise to three
The cervix acts as a reservoir as days after the elevation have been
well as a filter for sperm. Sperm can proposed as THE ovulation date. It is
be found in the oviduct within five agreed, however, that the thermal
minutes after ejaculation. During the shift demarcates the end of the fertile
estrogenic phase, sperm storage is phase.
known to occur, with the gradual re- Studies have shown that in 95% of
lease of sperm into the upper tract. women aged 20-40 years, menstrual
cycles vary in length from 21-36
days. The cycle consists of a follicu-
Timing of Hormones and lar phase of 10-21 days and a luteal
Menstrual Cycle Events phase of 1 1-16 days. Thus, a follicu-
Studies have shown that mean time lar phase of <10 days is considered
intervals exist during the menstrual short, of >21 days is called long.
cycle. (See Table 1.) More important, a luteal phase of
Speroff states that a significant <11 days is considered to be short
temperature rise is not noted until two and in infertile women may indicate a
days after the luteinizing hormone need for further investigation.
Table 1
Timing of Hormones and Menstrual Cycle Events
Events Mean time Median time
E 2 peak to LH peak 24 hours5 24 hours6
LH peak to ovulation 9 ± 2 hours5 16.2 hours6
onset LH rise to ovulation 27.3 hours7 32 houre
E 2 peak to ovulation 34 + 3 hours5 24 hours6
Duration of E 2 rise 82.5 hours5
1915
Types of
Natural Family Planning
1. Calendar Rhythm
The so-called "rhythm method" of
natural family planning was devel-
oped on the basis of early work by
Fraenkel, Ogino and Knaus, which
defined the duration of the luteal
phase. Given a predicted survival
time of 12-24 hours for the ovum
and 72 hours for sperm, the fertile
phase can be calculated as follows:
1. The length of the menstrual cycle
is recorded over the preceding 12
cycles.
2. The shortest and longest cycles are
determined.
3. The first day of the fertile period is
calculated by subtracting 19 from the
length of the short-est cycle.
4. The last day of the fertile period is
determined by subtracting 11 from the
longest cycle.
Coitus is to be avoided, therefore,
between days (shortest cycle length
- 19) and (longest cycle length - 11).
This method has proven to be
rather unreliable, because most
women's cycles are variable enough
to require long periods of abstinence
to be sure of avoiding pregnancy. Ef-
fectiveness has been calculated as
ranging between 14.49 and 34.510
pregnancies/100 woman years.
2. Basal Body Temperature Charting
There is general agreement that a
biphasic temperature graph is indica-
tive of ovulation. The exact time,
however, when ovulation occurs, is
difficult to determine from the BBT
chart alone. The onset of the infertile
phase is much easier to determine.
The commonest criterion used to de-
termine the beginning of the infertile
phase is the "coverline". This is de-
fined as a line drawn on a BBT graph:
(0. 1°F (or 0.05°C)) which is above
the highest normal temperature of the
low pre-ovulatory temperatures, ig-
noring the temperature of the first
four days of the cycle and those af-
fected by disturbances. At least six
low-temperature points must be re-
corded before drawing the coverline.
The infertile period is that part of the
cycle when intercourse cannot result
in conception. From the third (some
say the second) day that a temperature
above the coverline has been recorded
until day one of menses, intercourse
will not cause conception.
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
If BBT charting is used strictly ac-
cording to this rule (i.e., avoiding in-
tercourse and, indeed, any genital
contact until after the third day of
high temperature has been recorded),
this method is totally effective in pre-
venting conception. The effectiveness
of the method when applied strictly,
ranges between 0.811-6. 612 pregnan-
cies/100 woman years.
Within the last few years, compu-
terized thermometers have been intro-
duced which not only record day-to-
day BBTs but frequently are also
equipped to display graphically the
temperatures recorded for the entire
cycle. Furthermore, a red and a green
light (green=infertile, red=fertile) on
the thermometer serves as a guide to
coital timing appropriate to the cou-
ple's needs. Other innovations which
assist the woman in determining im-
pending ovulation include a vaginal
probe to measure tissue conductance
changes which reflect rising pre-
ovulatory estrogen effects on the va-
gina, and a urine dip-stick LH rapid
assay to determine the pre-ovulatory
LH surge.
3. Ovulation (Billings) Method
Australian doctors John and Evelyn
Billings pioneered the method of ob-
serving cervical mucus as a predictor
of ovulation. Women are taught to
observe mucus patterns at the vulva
for a sensation of wetness and lubrica-
tion by using a combination of ordi-
nary sensation, Kegel exercises,
finger palpation, a wipe through with
toilet paper or a combination of these.
The mucus on the toilet tissue is then
inspected for colour and spinnbarkeit.
Cervical mucus, secreted by the
cervix, undergoes changes in response
to the secretion of estrogen and pro-
gesterone. Following menses, before
the estrogen levels reach a critical
point, several "dry" days occur.
These are the infertile days. Grad-
ually, as the woman's cycle pro-
gresses, the 'dryness' is replaced by a
sensation of moistness, which in-
creases under the influence of rising
estrogen levels to a sensation of wet-
ness and slipperiness when the mucus
is noted to develop spinnbarkeit. This
is the fertile phase of the cycle.
Brown has reported that once a
threshold level for E 2 of
15 ug/100 ml/24 hours is exceeded,
the mucus becomes sufficiently wa-
tery to be felt at the vulva."3 It is in
this fertile mucus, particularly in the
cervical crypts where they are well
protected from the hostile vaginal en-
vironment, that sperm are able to sur-
vive for days. The last day of fertile
mucus is called the peak day. Peak
mucus has been shown to correlate
well with the LH surge and is followed
by ovulation, which usually occurs
one day following peak mucus
(+ 2-3 days). Following ovulation,
rising progesterone levels inhibit
mucus secretion and result in sticki-
ness or dryness felt at the vulva. Men-
struation occurs two weeks after peak
mucus.
In the ovulation method, women
learn to differentiate estrogenic cervi-
cal mucus from other vaginal secre-
tions: infected vaginal discharge, se-
minal ejaculate, secretions of sexual
arousal, lubricants and vaginal medi-
cations. Patients are instructed to re-
strict coitus to dry days from the ces-
sation of menses until the onset of
mucus secretion. They must then ab-
stain from intercourse until the fourth
day following peak mucus each time a
secretion build-up is noted. Even dur-
ing the dry days coitus is restricted to
alternate days, in order that mucus
build-up not be confused with seminal
discharge. With the onset of proges-
terone secretion, the mucus becomes
sticky for a couple of days, then to-
tally disappears, and the woman feels
dry. During the period of secretion of
fertile mucus all genital contact must
be avoided. The use of barrier
methods combined with the Billings
Method during the fertile phase of the
cycle, although it is practised by
many couples, is considered unac-
ceptable by the proponents of the
Method.
Couples using the Billings Method
record their findings on a monthly
graph using a series of colour-coded
stamps: RED-bleeding, GREEN-dry-
ness, WHITE with picture of BABY-
mucus, YELLOW-sticky mucus, x-
peak mucus, RED-STIPPLED-spotting.
Additional changes that occur in-
clude softening and ascent of the cer-
vix, and dilation of the cervical os,
both of which are maximal at mid-
cycle. With the onset of progesterone
secretion and ovulation, the cervix
drops back and again lies low in the
vagina, retums to its usual firmness
and develops a closed cervical os with
thickened secretions that solidify and
form the protective mucus plug which
blocks further entry to the uterine cav-
ity. Instructor couples teaching the
1917
Billings Method to other client cou-
ples strongly recommend observing
these cervical changes to confirm the
mucus findings.
The ovulation method has a major
advantage over the rhythm method
and the BBT method in that it predicts
ovulation. With reasonable reliability,
it permits coitus during dry days, be-
tween the cessation of menses and the
onset of pre-ovulatory mucus secre-
tion. For some women, the need to
observe only one sign, mucus secre-
tion, is an advantage. For other
women, who are perhaps less experi-
enced and somewhat unsure of the
method, it may create considerable
anxiety. An international study by a
World Health Organization Task
Force reported in 1981 that by the end
of the first observation cycle, 93% of
women were able to recognize their
mucus pattern, and 91% understood
the method well.14 Because of the
subjective nature of this approach to
family planning (i.e., the woman's
recognition of vulvar wetness), care
must be taken to include the husband
or sexual partner in discussions and
follow-up, lest he be made to feel that
his only contribution is sexual abstin-
ence.
Measurements of the effectiveness
of using the mucus method vary, de-
pending on whether total number of
pregnancies or method-failure-related
pregnancies per 100 woman years are
discussed. Total failure rates range
from a high of 39.7/100 woman years
reported by Wade et al.,15 to a low of
9.7 pregnancies/100 woman years
found in Dolack's study.16
There is also a variation in method-
related pregnancy rates, ranging from
12.2 pregnancies/ 100 woman years in
Johnson's Australian study,"7 to 0
pregnancies/100 woman years in
Klaus and Fagan's U.S. study. ' 8
Special Circumstances
Under certain circumstances, ovu-
lation is abnormal or fails to occur at
all. This is particularly true peri-men-
archally, during lactation, pre-
menopausally and after discontinuing
birth-control pills. Under these cir-
cumstances, the secretion of estro-
genic mucus may be quite erratic.
Peri1nenarche/preinenopause
During both extremes of reproduc-
tive life (i.e., peri-menarchally and
peri-menopausally), ovulatory irregu-
1918
larities are common. The ovulatory
response to hypothalamic-pituitary
stimulation is not predictable and, in-
deed, may not occur at all. Thus, the
possibilities may range from normal
ovulation, through short luteal/long
follicular phase, to a total anovula-
tion. Similarly, mucus secretion may
fluctuate from copious to erratic to
imperceptible if there is lack of estro-
gen. Menses may also be absent,
spotty or excessive. During both of
these periods, therefore, the mucus
method for coital timing is difficult
and frequently unreliable.
Childbirth
Following parturition, the return of
ovulation and pre-ovulatory mucus is
highly unpredictable. Even after spon-
taneous abortion, determining when
ovulation resumes is uncertain. It is
recommended that mucus observation
begin at three weeks post partum in
the non-lactating woman, and at about
six weeks in the nursing mother.
Many factors determine the return of
ovulation including frequency, dura-
tion and intensity of feedings, in addi-
tion to maternal nutrition and general
physical health. There is no consistent
or predictable mucus pattern while a
woman is breastfeeding.
Oral contraceptives
After discontinuation of the pill,
the return of normal ovulation is vari-
able and indeed may be considerably
delayed, particularly in women with a
history of irregular menses or oligo-
menorrhea. The ovulation method,
which depends on mucus recognition,
is therefore unreliable as a predictor
of the safe period until ovulatory
function normalizes.
4. Sympto-Thermal Charting (Serena
Method)
The fourth natural approach to con-
ception control is symptothermal
charting (STC), also known as the
Serena Method. Serena (taken from
the French SErvice de REgulation des
NAissances) was established in La-
chine, Quebec, by Gille and Rita
Breault in the mid-1950s. After inten-
sively studying the natural approaches
to family planning, the couple began
a program of instruction for other
couples. They trained teacher couples
and organized them into teams, each
with a medical and a moral advisor. Advantages of STC: The STC method is
The movement spread widely somewhat more complex to learn be-
throughout Quebec and parts of On-
tario. These dedicated volunteers not
only teach the technical aspects of fer-
tility control, but also provide couples
with the psychological and moral sup-
port necessary during the times of
sexual abstinence, which may be par-
ticularly difficult during the initial
learning period.
Symptothermal charting relies on
observation of cervical mucus and
other physiological indicators of ovu-
lation, in combination with the infor-
mation offered by BBT changes. Symp-
toms observed include:
1. Mucus secretions at the vulva that
resemble raw egg white. As described
earlier, this mucus increases in re-
sponse to rising levels of estrogen,
peaks at ovulation, then disappears as
progesterone dominates the endocrine
scene.
2. Vulvar fullness, also an estrogen ef-
fect, is reported by many women at the
same time as peri-introital lubrication
is noted.
3. Cervical palpation before ovulation
reveals a progressively higher, more
open, softer and straighter cervix that
is flowing with mucus. With the onset
of progesterone secretion, the cervix
drops lower, closes, hardens, feels dry
and comes to lie posteriorly against the
vaginal wall.
4. Mittelschmerz, or mid-cycle pain,
is variable in duration, severity and lo-
cation. Sharp, short-lived, localized
pain may be due to actual follicle rup-
ture. More often, however, congestion
and edema of peri-ovarian tissues is
the likely cause of the discomfort,
especially if it is long lasting.
5. Mid-cycle spotting or bleeding is
believed to result from the mid-cycle
pre-ovulatory drop in estrogen secre-
tion and the loss of support to the en-
dQmetrium.
6. Mastalgia or a feeling of breast
heaviness and sensitivity may also re-
sult from a drop in estrogen concentra-
tion at mid-cycle, but more commonly
it is believed to be the result of proges-
terone secretion.
7. Other cyclic symptoms reported in-
clude premenstrual acne, depression,
edema, weight gain and increased ap-
petite and cravings, particularly for
sugar. Migraine headaches, nausea,
visual disturbances and changes in
body odours have also been reported,
but these symptoms are less reliable.
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
cause it takes into consideration mucus fertility Clinic complaining of inability
symptoms, BBT changes and numerous to conceive, about 30% of the women
other signs and symptoms. On the become pregnant within six months of
other hand, it is a much more reliable being instructed in STC. For the re-
guide to the fertile period than any of mainder, the STC teaching becomes the
the component parts individually. Be- foundation for subsequent investiga-
cause of the complementary nature of tion and management of their inferti-
the observations, STC widens the limits lity. A single look at a symptother-
which each individual fertility indica- mally charted cycle readily indicates
tor would have. It is especially useful that ovulation has taken place (bipha-
in such conditions as vaginitis or sic graph), that appropriate mucus
fever, which blur one or other of the changes have occurred, and that coital
signs of ovulation. timing has been appropriate. Further-
more. there is a correct time during the
Effectiveness of STC: The successful cycle when each fertility test should be
use of STC in conception control ap- done. The test will repeatedly yield ab-
pears to depend upon two major fac- normal results if the timing has been
tors: inappropriate (e.g., a post-coital test
a) whether absence of mucus or calcu- done too early in the follicular phase or
lation or a combination of both in the luteal phase of the cycle). Fol-
were used at the beginning of the lowing treatment, the improved results -

cycle; and are also readily seen on the STC.

b) whether the method was being used I

to prevent pregnancy or only to Who Uses

space births. Natural Family Planning?
Total pregnancies varied from 4.920 The social and psychological
to 15.919/100 woman years. Methodo-
characteristics
logical failure ranged from 3.7/100 NFP as a methodof ofcouples who choose
woman years,21 when absence of
conception control
were recently reported by Daly and
mucus was the only parameter used in
Herold.24 The
the pre-ovulatory period, to 0.0/100 between 20 and majority 30
(61%) were
years of age; two-
woman years22 when a combination of
thirds of them had completed post-sec-
calculation and absence of mucus was
used. Furthermore, in a five-country been ondary school education; 62% had
married for less than five years;
study, the variation in pregnancy rates and 75% were childless or had one
was from 4.1/100 woman years for
pregnancy prevention, to 14.8/100
child.
woman years for child spacing. For
Abstinence during the fertile period
was liberally defined by 61% of cou-
Canada, these rates were 1.1 and 16.1
respectively.23 This 1: 16 ratio under- ples as precluding intercourse, but per-
scores how important motivation is in
mitting stimulation, including genital
stimulation
the successful use of this method and, sharp contrastto toorgasm, which is in
indeed, of any method which depends traditional NFP teach-
ing.
on periodic abstinence.
Of those who were not pregnant
Planining ta pregnancy: aii aipplication
of STC: Although the term "family
when
ing to
questioned, 42% were continu-
use NFP, and 25% were using a
combination of fertility-awareness and
THE NEW
planning"' tends to evoke the image of
preventing pregnancy, this article barrier methods. Combination
would be incomplete if the importance NFP/barrier users were more likely to
LOOK OF
of this method in establishing a preg- have been married for over five years,
nancy, in addition to investigating and
treating the infertile
and have more children than users of
NFP only. They were, therefore, more
couple, were not likely
RELIABILITY
emphasized. Certainly, couples wh1o to be limiting their family size, New identification -
have used and understood the signs rather than merely spacing their chil- same proven formula
and symptoms of STC to prevent preg- dren, as were the users of NFP
alone.24 Fiorinal contains ASA, caffeine
nancy have little difficulty in applying and butalbital. It has the potential
that same information to timing coitus The Family Life Clinic for being abused and should be
appropriately to enable a pregnancy to at St. Michael's avoided in chronic pain states
occur. How exciting it is for them to
Hospital, requiring continuous daily use for
know exactly when conception oc- University of Toronto a prolonged period.
curred! The Family Life Clinic (FLC) was SANDOZ CANADA INC., Dorval, Quebec H9S 1A9
Among couples who present to our set up in 1974, in the Department of SANDOZ'
Reproductive Endocrinology and In- Obstetrics and Gynecology at St. Mi-
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986 L III'I
I
CIMlPrescribing
Psign ailTM
intfomation available on request.
mi
'Aprsolifletablets
(hydralazine hydrochloride)
Antihypertensive Agent
Actions
Hydralazine hydrochloride exerts its hypotensive
action by reducing vascular resistance through direct
relaxation of vascular smooth muscle.
Indications
APRESOLINE Oral: Essential hypertension.
APRESOLINE is used in conjunction with a diuretic
and/or other antihypertensive drugs but may be
used as the initial agent in those patients in whom, in
the judgment of the physician, treatment should be
started with a vasodilator.
APRESOLINE Parenteral: Severe hypertension when
the drug cannot be given orally or when there is an
urgent need to lower blood pressure (e.g. toxemia of
pregnancy or acute glomerulonephritis). It should
be used with caution in patients with cerebral vascular
accidents.
Contraindications
Hypersensitivity to hydralazine, coronary artery dis-
ease, mitral valvular rheumatic heart disease, and
acute dissecting aneurysm of the aorta.
Warnings
Hydralazine may produce in a few patients a clinical
picture simulating systemic lupus erythematosus,
in such cases treatment should be discontinued im-
mediately. Long-term treatment with adrenocortico-
steroids may be necessary. Complete blood counts,
L.E. cell preparations, and antinuclear antibody
titer determinations are indicated before and periodi-
cally during prolonged therapy with hydralazine
and if patient develops arthralgia, fever, chest pain,
continued malaise or other unexplained signs or
symptoms. If the results of these tests are abnormal,
treatment should be discontinued.
Usage in Pregnancy
Animal studies indicate that high doses of hydrala-
zine are teratogenic. Although there is no positive
evidence of adverse effects on the human fetus,
hydralazine should be used during pregnancy only if
the benefit clearly justifies the potential risk to the
fetus.
Precautions
Caution is advised in patients with suspected coron-
ary-artery disease, at it may precipitate angina
pectoris or congestive heart failure, and it has been
implicated in the production of myocardial infarction.
The "hyperdynamic" circulation caused by APRESO-
LINE may accentuate specific cardiovascular
inadequacies, e.g. may increase pulmonary artery
pressure in patients with mitral valvular disease.
May reduce the pressor responses to epinephrine.
Postural hypotension may result.
Use with caution in patients with cerebral vascular
accidents and in patients with advanced renal
damage. Peripheral neuritis has been observed and
published evidence suggests an antipyridoxine
effect and the addition of pyridoxine to the regimen if
symptoms develop.
Blood dyscrasias consisting of reduction in hemo-
globin and red cell count, leukopenia, agranulocy-
tosis and purpura have been reported. In such cases
the drug should be withdrawn. Periodic blood counts
are advised during therapy. MAO inhibitors should be
used with caution in patients receiving hydralazine.
Slow acetylators should probably receive no more
than 200 mg of APRESOLINE per day. When a higher
dose is contemplated, and, whenever possible, it
may be advisable to determine the patient's acetyla-
tion phenotype.
Adverse Reactions
Within the first day or two: headache, palpitations,
tachycardia, anorexia, nausea, vomiting, diarrhea,
and angina pectoris. They are usually reversible when
dosage is reduced or can be prevented or mini-
mized by administering reserpine or a beta-blocker
together with hydralazine.
Less Frequent: nasal congestion; flushing; lacrima-
tion; conjunctivitis; peripheral neuritis,evidenced by
paresthesias, numbness, and tingling; edema; dizzi-
ness; tremors; muscle cramps; psychotic reactions
characterized by depression, disorientation, or
anxiety; hypersensitivity (including rash, urticaria,
pruritus, fever, chills, arthralgia, eosinophilia, and,
rarely hepatitis); constipation; difficulty in micturition;
dyspnea; paralytic ileus; lymphadenopathy; spleno-
megaly; blood dyscrasias, consisting of reduction in
hemoglobin and red cell count, leukopenia, agranu-
locytosis, thrombocytopenia with or without purpura;
hypotension; paradoxical pressor response.
1920
Late Adverse Reactions: Long-term administration at
relatively high doses may produce an acute rheuma-
toid state. When fully developed a syndrome resembl-
chael's Hospital, a teaching hospital
affiliated with the University of
ing disseminated lupus erythematosus occurs. The
frequency of these untoward effects increases with Toronto. Its mandate was to instruct
dosage and duration of exposure to the drug and is individuals and couples in all methods
higher in slowthan in fast acetylators. Antinuclear anti-
body and positive L.E.-cell tests occur. of family planning, including natural
Symptoms and Treatment of Overdosage
family planning. The Clinic's motto is:
Symptoms: hypotension, tachycardia, headache, "Fertility by choice through under-
generalized skin flushing, myocardial ischemia and standing". Through counselling and
cardiac arrhythmia can develop. Profound shock can
occur in severe overdosage. education, individuals or couples are
Treatment: No known specific antidote. Evacuate
gastric content, taking adequate precautions against best able to make a well-informed de-
aspiration and for protection of the airway; if general
conditions permit, activated charcoal slurry is instilled.
cision about the optimal method of fer-
tility control for them. Because birth
These procedures may have to be omitted or carried
out after cardiovascular status has been stabilized, control generally -and STC, specifi-
since they might precipitate cardiac arrhythmias or
increase the depth of shock.
Support of the cardiovascular system is of primary
cally, are recognized to be a shared re-
sponsibility, the participation of cou-
importance. Shock should be treated with volume
expanders without resortingto use of vasopressors, if ples in the instruction is encouraged.
possible.
If a vasopressor is required, a type that is least likelyto Greater effectiveness in using this
precipitate or aggravate cardiac arrhythmia should
be used, and the E.C.G. should be monitored while they
method can be anticipated if both
are being administered. partners attend the instruction sessions
Digitalization may be necessary. Renal function must and both participate in its implementa-
be monitored and supported as required.
No experience has been reported with extracorporeal
or peritoneal dialysis.
tion, whatever method is ultimately
chosen.
Dosage and Administration Within the past five years, the Fam-
Adjust dosage according to individual blood pressure
response. ily Life Clinic has become a vital and
Orally: Initial: 10 mg 4 times daily for the first 2 to 4 integral part of the Reproductive En-
days, 25 mg4 times dailyforthe remainder of thefirst
week, 50 mg 4 times daily for the second and subse-
quent weeks of treatment.
docrinology and Infertility Division. It
Maintenance: adjust dosage to lowest effective levels. is currently staffed by two nurse edu-
Following titration, some patients may be maintained cators who have been thoroughly
on a twice daily schedule.
Usual maximum daily dose is 200 mg, up to 300 mg trained in all birth-control techniques,
daily may be required in some patients. In such cases particularly in NFP. More recently,
a lower dosage of APRESOLINE combined with a thia-
zide, reserpine or both, or with a beta-adrenergic- they have received extensive instruc-
blocking agent may be considered. When combining tion in infertility and abnormalities of
therapy, individual titration is essential to ensure that
the lowest possible therapeutic dose of each drug is the menstrual cycle. Under the direc-
administered.
Parenterally: patients should be hospitalized. Usual tion of reproductive endocrinologists,
dose is 20-40 mg I.M. or by slow I.V. injection or I.V. they teach patients, help interpret
driR repeated as necessary. Patients with marked
renal damage may require a lower dosage. symptothermal charts and test results,
For I.V. driR the ampoule(s) should be added to 5% arrange for appropriate testing to be
sorbitol solution, physiological saline or Ringer solution;
glucose solution is not suitable for this purpose. Blood done at the correct time in the cycle,
pressure levels should be monitored. It may begin to
fall within a few minutes after injection, with an aver- and provide extensive emotional and
age maximal decrease occurring in 10 to 80 minutes. psychological support to infertile cou-
In cases with a previously existing increased intra-
cranial pressure, lowering the blood pressure may ples.
increase cerebral ischemia.
Most patients can be transferred to oral APRESOLINE
within 24 to 48 hours. 1985 Statistics from the Family Life
Availability Clinic at St. Michael's Hospital,
Tablets of 10 mg: yellow, uncoated, biconvex, scored, Toronto
and imprinted "FA" on one side and "CIBA" on the
other. The FLC nurses see an average of
Bottles of 100 and 500.
Tablets of 25 mg: blue, coated, printed "GF" on one 130 clients each month and counsel an
side and "CIBA" on the other.
Bottles of 100 and 500. additional 75 clients by telephone. In
Tablets of 50 mg: pink, coated, printed "HG" on one 1985, they saw 450 new clients/client
side and "CIBA" on the other.
Bottles of 100 and 500. couples. (See Table 2.)
Ampoules: 1 ml, each containing 20 mg hydralazine
hydrochloride, 103.6 mg propylene glycol, 0.65 mg of
methyl-p-hydroxybenzoate and 0.35 mg of propyl-p- Table 2
hydroxybenzoate in water for injection. Reason for Attending
Boxes of 10.
Complete Prescribing Information available on request. a Family Life Clinic
References:
1 The Pharmacological Basis of Therapeutics, Sixth
Total no. new clients
(client couples) No.
Edition, Pages 799-801-Goodman and Gilman
1980. 2. Gifford, R.W., Isolated systolic hypertension to conceive 177
in the elderly. Postgraduate Medicine, Vol. 71,
No. 3, March 1982.3. Finnerty, F.A., M.D., Hyperten- NFP 130
sion in the elderly: Special considerations in
treatment. Postgraduate Medicine, Vol. 65, No. 5, STC with barrier 90
May 1979.4. Scriabine, A. Pharmacology of
Antihypertensive Drugs, Methyldopa, page 48,1980. Endocrine lx 12
STC post pill 41
Total 450
Mississauga. Ontario IPA
L5N 2W5 0 -4057 LCCPP CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
 The initial interview and teaching
session is expected to last 60-90 min-
utes. Two follow-up visits of 15-30
minutes are planned after the first and
third cycles. Subsequent visits are ar-
ranged according to patient need.
As has been observed in other NFP
clinics, we have noted that failures
often occur within a year if no follow-
up visit has taken place. For this rea-
son, clients are urged to attend the fol-
low-up visits if they are serious about
avoiding pregnancy and wish to use
NFP successfully. About 65% of our
clients return for at least one follow-up
visit.
The Effectiveness of NFP
The effectiveness of NFP is difficult
to analyse because couples may not
keep in touch with the clinic after the
second follow-up visit. Recognized
factors include the couple's motiva-
tion, the intensity of their desire to
avoid pregnancy, and the experience,
knowledge and motivation of the
teacher.
In 1985, ten unplanned pregnancies
occured among the 250 new couples
who presented for NFP instruction.
(See Table 3.)
The impact of the NFP program on
the successful investigation and treat-
ment of our infertile patients is harder
to quantify, but it is nevertheless re-
cognized as significant. All infertility
patients are referred for instruction in
STC. Using the symptothermal charts,
subsequent investigations are planned,
appropriate treatment prescribed, and
the success of treatment is gauged.
The nurses at Family Life Clinic are an
integral part of the team. In addition to
their other duties, they are frequently
called upon to provide emotional sup-
port for presenting couples. Because
they work so closely with the couples,
Table 3
Unplanned Pregnancies
of Attenders at a NFP Clinic
Reason for
NFP Method Failure
NFP alone Fertile phase
ignored
NFP +
Condoms & foam In fertile phase
NFP +
condoms In fertile phase
NFP +
diaphragm & Jelly In fertile phase
Total
CAN. FAM. PHYSICIAN Vol. 32: SEPTEMBER 1986
View publication stats
they are often the first to learn from a Calderone MS, ed. Manual of contracep-
couple of their success in conceiving. tive practice. Baltimore: Williams and
Wilkins, 1964:129.
Conclusions 11. Doring GK. Ueber die zuverlaesigkeit
der temperaturmethode zur empfaengnis-
Natural family planning has broad verhuetung. Deutsche Med Wsc hr 1967;
applicability. It is not only useful as a 92:1055. Summary: The reliability of tem-
method of controlling conception, but perature
tion.
records as a method of contracep
also as a means of achieving preg- The Yeatrbook of Obs-Gyn 1968:354.
nancy. It is particularly helpful in in- 12. Marshall JA. Field trial of the basal
vestigating and managing infertility. body-temperature method of regulating
births. Lanicet 1968; 2:8- 10.
NFP is based on the observation of
13. Brown JS. In: Klaus H. Natural Family
signs and symptoms which reflect en- planning:
a review. Obstet Gvnec Sanl'
docrine changes occurring in the men- 1982; 37:134.
strual cycle. The scientific basis is 14.
WHO Task Force on Methods for the
sound. Of the several types of NFP, Determination
of the Fertile Period.
each has its advantages and limita- prospective multicenter trial of the ovula-A
tions. Each method can be success- tion method of natural family planning.
fully used when it is clearly under- The effectiven'ess phase. Fer^til Ster-il 198 1;
stood and appropriately applied. The 36:591.
time has come for a wider dissemina- 15. Wade ME, McCarthy P, Braunstein
tion of information about these Harris GD, Abernathy JR, Suchindran CM,
GS, Danzer HC, Uricchio WA. A
methods, in order that more physicians randomized prospective study of the use-
and patient/clients can take advantage effectiveness of two methods of natural
of them. * family planning. A/n J Obstet GYnecol
1981; 141:368.
16. Dolack L. Study confirms values of
References ovulation method. Hosp Propr 1978;
1. Flynn AM. Natural methods of family 59:64.
planning. Cl Obstet GYnec 1984; 1 1:66 1. 17. Johnson JA, Roberts DB, Spencer RB.
A surveY ev(alutationi of the efjficacv an
iel ejfi-
2. Klaus H. Natural family planning: a re-
view. Obs Gvn Surt, 1982; 37:128. ciencv ofjiiltral-il fniitilv planninig ser vices
aiud Inethocds in A ustrdlia. Repol-t of ( ie-
3. France JT, Graham FM, Gosling L, Hair search project. Sydney: St. Vincent's Hos-
PI. A prospective study of sex of offspring pital, 1978.
by timing intercourse relative to ovulation. 18. Klaus H, Fagan MU. Use-effectiveness
Fer-til Ster-il 1984; 4 1:894. and client satisfaction in six centers teach-
4. Colston Wentz A. Physiology of the ing the Billings Ovulation Method. Coni-
menstrual cycle [Lecture notes]. Inzfertility traception 1979; 6:613.
Update. Boston: Harvard Medical Schooi, 19. Johnson JA, Roberts DB, Spencer RB.
1984.
A surveY ev aluation of the efficacyan,tCSd effi-
5. Pauerstein CJ, Eddy CA, Croxatto HD, ciencv of naturaIl ftanily plaInnlinlg servi- ces
Hess R, Siler-Khodr TM, Croxatto HB. (111(1 mnethodls in Austratliai. Report of a re-
Temporal relationships of estrogen, pro- search pr-oject. Sydney: St. Vincent's Hos-
gesterone, and luteinizing hormone levels pital, 1978.
to ovulation in women and infrahuman pri-
mates. Aml J Obstet Gvnecol 1978; 20. Rice FJ, Lanctot CA, Garcia-Devesa
130:876. C. Effectiveness of the symptothermal
6. WHO Task Force on Methods for the method of natural family planning: an in-
Determination of the Fertile Period. Tem- ternational study. hIit J Fert 1981; 26:222.
poral relationships between ovulation and 21. Johnson JA, Roberts DB, Spencer RB.
defined changes in the concentration of A surveY ea/lunation of the efficacy tandtl effi-
plasma estrdiol-17B, LH, FSH, and pro- ciency of naltuir(l ftllynilv planning serv ices
gesterone. Am J Obstet Gvnecol 1980; aimid metho(Ils in Australia. Report of (1 re-
138:383. seair-ch project. Sydney: St. Vincent's Hos-
pital, 1978.
7. Garcia JE, Jones GS, Wright GL. Pre-
diction of the time of ovulation. Fer-til 22. Wade ME, McCarthy P, Braunstein
Steril 198 1; 36:308. GD, Abernathy JR, Suchindran CM,
Harris GS, Danzer HC, Uricchio WA. A
No. 8. Speroff L, Glass RH, Kase NG. Clinical randomized prospective study of the use-
gvyle/ologic(ll endcr inology (1,1d iniferti- effectiveness of two methods of natural
3 litv . 3rd ed. Baltimore: Williams and Wil- family planning. Am J Obstet Gynecol
kins, 1983. 1981; 141:368.
1 9. T ietze C. Use of effectiveness of contra- 23. Rice FJ, Lanctot CA, Garcia-Devesa
ceptive methods in the United States. In: C. Effectiveness of the symptothermal
2 Calderone MS, ed. Manuall of contracep- method of natural family planning: an in-
t ive prabc tic es. Baltimore: Williams and ternational study. hIt I Fert 1981; 26:222.
4 Wilkins, 1964: 131.
24. Daly KJ, Herold ES. Who uses natural
10 10. Tietze C. Use of effectiveness of con- family planning. Canl I Pub Heallth 1985;
traceptive mzethodis in the United,States. In: 76:20(7.
1921