Abstract
Objective: To
study the contraceptive practice of women using combined oral contraceptive pills
and intrauterine contraceptive devices in 4 Jordanian military hospitals;
(Prince Hashem Bin Al Hussein, Prince Ali Bin Al Hussein, Princess Haya Bent Al
Hussein, and Queen Alia Hospitals) and to study the reasons for discontinuation
of these methods among women less than 44 years of age.
Methods: A
retrospective analysis of the family planning medical files of 5800 clients who
were current or past user of the contraceptive pills or intrauterine devices
for contraception during the period between January 2007 and December 2009 was
done. Fifty-eight percent (3367/ 5800) were current or past contraceptive pills
users and 41% (2433/5800) were current or past intrauterine device users. Women
included in the study were those who had discontinued using the pills or the
devices for more than 6 months (n = 3200), which in turn were divided into two
groups: Group A, oral contraceptive pills users (n=2050) and Group B, intrauterine
devices users (n = 1150). We then analyzed according to age, parity, obstetric
history, medical history, duration of contraception and reasons for
discontinuation of these methods; the data were compared between the two groups.
Results:
The use of contraceptive
methods varies across age, but combined oral contraceptive pills was found to
be the most commonly used method among the study population. Only 29% of group
A discontinued the pills because of their desire to conceive compared to 23.6 %
of group B. Fifty-two percent of group A stopped the pills because of undesired
side effects, compared to 65 % among group B. Four-point-four percent of group
A stopped the method due to medical indication compared to 3.2% in group B. Fourteen-point-six
percent of group A stopped the pills for personal reasons or lack of availability
of the drugs and 8.2% of group B had the device removed because it reached the
expired date (being in uterus for 10 years). However, this is not considered a reason
for discontinuation. The main side effects of combined oral contraceptives were
breast discomfort, mood changes, weight gain, headache, nausea and vomiting,
whereas the commonest side effects related to intrauterine contraceptive device
were menstrual bleeding disorders, recurrent vaginal infection, and pelvic pain.
Conclusion:
In spite of the safety
and high efficacy of combined oral contraceptive pills and intrauterine devices
as contraceptive methods more than half discontinued their use because of
undesired side effects. This may be improved by careful patient selection and
appropriate counseling.
Key
words:
Contraception, Copper
T380A, Discontinuation.
JRMS September 2011; 18(3): 27-33
Introduction
Combined
Oral Contraceptives (COC) and Intrauterine Contraceptive Device (IUD) are safe
and effective methods of contraception. They are the most commonly used forms
of reversible contraceptive methods worldwide.(1,2) However,
they still cause some side effects, such as menstrual bleeding disorders,
headache, breast discomfort, and weight gain, which in turn may lead to
discontinuation of their use.(3)
COC
pills are used by more than 10 million women in the United States(4)
and 100 million women worldwide.(1)
COC
pills provide high degree contraceptive efficacy when used properly, about 5
per 100 women with typical use and less than 1 per 100 women with perfect use
become pregnant per year.(1)
One third of the unintended pregnancies that occur in the United States
are because of pills misuse, failure or discontinuation.(5)
COC
pills have some short-term and long-term non-contraceptive health benefits: they
are considered preventive of ovarian cancer, endometrial cancer, ectopic
pregnancy, pelvic inflammatory disease, and menstrual disorders.(6-10)
Since
the early 1960s, when IUDs were made of inert materials, the devices have
undergone many improvements - first by inclusion of copper and subsequently a
progesterone releasing system like Mirena device, which were used recently in Jordan and the Middle East.
The Copper T380A family and the levonorgestrel 20 (LNG) IUDs represent the most
effective reversible contraceptive methods yet studied in long-term randomized
trials.(11,12) The
most widely used copper-bearing IUD, and the one for which there is greatest
information on safety and effectiveness, is the TCu380A. Intra-uterine devices
achieve their contraceptive effect by several mechanisms. Intra-uterine devices
prevent sperm from reaching the uterine cavity and the fallopian tubes, where
fertilization occurs. A foreign-body reaction in the uterine cavity to an IUD
causes cellular and biochemical changes that may also be toxic to sperm.(13) With copper bearing devices the
duration of effectiveness depends on the surface area of copper. The Copper T
380A is safe and highly effective for at least 12 years (approved for 10 years
of use in the United States)
with an annual pregnancy rate of 0.4 per 100 women.(14)
Adverse
effects of COC
pills and IUD are mainly responsible for discontinuation of use.(15,16) This
study identifies some of the factors that are thought to be associated with
discontinuation of COC pills and IUD and also considers the contraceptive
behavior of women after cessation.
Methods
This
is a retrospective study which was conducted in four military hospitals;
(Prince Hashem Bin Al – Hussein in Zarka, Prince Ali Bin Al Hussein in Karak,
Princess Haya Bent Al Hussein in Aqaba, and Queen Alia Hospitals in Amman), in
which we reviewed the family planning medical files for a total of 5800 married
women who were either current or past users of COC pills or IUD (TCu380A type)
for contraception during the period from January 2008 to December 2009. Past users
were defined as those who were using COC or IUD before being included in the
study but not currently using them, whereas current users of COC or IUD those
who were using them for more than 6 months before being included in the study. A
standard proforma for data collection across all hospitals was used.
Three-thousand
two hundred women were divided into two groups: pill users group (n= 2050) and IUD
users group (n= 1150). Information about age, parity, obstetric history,
gynecology history, contraceptive history regarding method of contraception,
side effects, duration of use and reasons behind discontinuation were taken
from the family planning files and records. In the present study we
concentrated on category of side effects, reasons given for discontinuation of
COC or IUD, and contraceptive behaviour after discontinuation. The data
collected were compared between the two groups.
Statistical
analysis
Percentages
were examined using a Chi-square test. A p-value of <0.05 was considered
statistically significant. Data were analyzed using the statistical package for
social science (SPSS), software version 17. The Chi-squared test (X2) is a significance test
applied to the comparison of proportions. When there are only two categories of
data (only one degree of freedom) the X2
test should strictly not be used. There have been various attempts to
correct this deficiency and the simplest is to apply the Yates correction to
the data. We are sure that this convention has been observed.
Results
All
women included in the study were still married and
aged less than 44 years with an average 33.8 years, with an average of 3.7
living children. Three thousand two hundred women (55.2 %) discontinue using
either COC or IUD during the study period. Table I illustrates the age
distribution of clients included in the study and percentage of women who discontinued
the COC or IUD use. Women using the IUD were older than women using COC for
contraception. Furthermore women use the COC more commonly than IUD for
contraception although the percentage of discontinuation is more among COC
users. However, it is still considered statistically non significant for those
older than 35 years of age at the time of stopping the method.
As
shown in Table II only 29 % (595/2050) of pill users group stopped the COC due
to a desire for pregnancy compared to 23.6% (271/1150) of IUD users group. One
thousand and sixty-six clients of pills users group (52%) discontinue COC
because of undesired side effects compared to 65% (747 / 1150) of IUD users
group. Four point four percent stopped the COC due to medical indication (pregnancy,
development of hypertension, breast lumps, diabetes) compared to 3.2% of IUD
users group stopped due to medical indication (pregnancy over the loop,
malignancy, perforation and missed loop), however, it is considered statistically
non significant for medical indications. Fourteen point six percent of group A
stopped the pills for personal reasons whereas 8.2% removed the IUD because it
reached the expired date (being in situ for 10 years or more).
In
studying the reasons of COC discontinuation, about half of clients (n= 1066)
quitted using COC because of undesired side effects. These occured mainly (61%)
in the first 6 months of COC use as shown in Table III. Most of the clients
used to report one or more side effects and then we tabled these side effects
and their percentage against the total number of patients who quitted the pills
due to side effects (n=1066 cases). Breast discomfort was the most common side
effect reported 62.6% (667/1066 cases). Less frequent side-effects included nausea and
vomiting, dizziness, and irregular bleeding. Table IV shows the percentage of
side effects as reported by study population.
Studying
the reasons of IUD discontinuation we noticed that about two thirds of women
discontinued its use because of its side effects. Most women mentioned
a combination of side effects as shown in Table V. The main side effects were menstrual bleeding
disorders, pelvic and /or low back pain, and genital
infections. Most of these side effects (50.1%) occurred within the first 6
months of insertion. (Table VI).
Tables V and VI
also demonstrate the relationship between age and the reasons behind
discontinuation of COC and IUD. More than half of women younger than 25 years
of age discontinued COC and IUD (55% and 60.6 % respectively) due to their
desire to conceive (Table VII). Discontinuation of COC or IUD for medical
reasons was mainly among women older than 35 years of age (44% and 62.2%
respectively). Half of the women (49.8%) who stopped COC because of their side
effects were younger than 25 years of age whereas women who discontinued IUD
because of its side effects were the older (46.2% among women older than 35 years).
Discussion
Although
the practice of contraception varies among different populations, the COC pill
and IUD are the most commonly used methods of contraception among women
attending military hospitals. Both can be safely provided after a careful
medical and gynaecological history.
The
actual incidence of discontinuation of the use of COC or IUD varies between different
studies,(15,16) Colli et
al(18) reported that 42% and 44% discontinued using COC
and IUD respectively within 24 months of
starting. Despite the occurrence of
considerable discontinuation of COC or IUD as a method of contraception, few
studies have attempted to examine the factors that lie behind stopping these
methods of contraception. The reasons reported for discontinuation COC and IUD
were: desire for pregnancy, husband’s disapproval, the cost, desire of more
effective contraceptive method, unavailability or inconvenience and many other
reasons. This study showed that about two thirds of COC users and half IUD
users quitted using them within three years. The occurrence of side effects was
cited as the main reason for quitting COC (52%) and IUD (65%), which is
consistent with other studies. Khan
reported that 53% of rural women in Banglaish
quit COC due to side effects,(7) whereas it was
reported to be 46% by Rosenberg et al.(5)
Table I. Age distribution of the
COC and IUD users included in the study and percentage of women discontinued
COC and IUD
|
Age (yrs)
|
Number of women discontinue COC
|
% of women discontinued COC
|
Number of women discontinue IUD
|
% of women discontinue IUD
|
P value
|
|
<
25
|
1033/1554
|
66.5
|
280/695
|
40.3
|
<0.0001
|
|
25 – 34
|
672/1166
|
57.6
|
392/836
|
46.9
|
<0.0001
|
|
>34
|
345/647
|
53.3
|
478/982
|
48.7
|
0.0740
|
|
Total
|
2050/3367
|
60.9
|
1150/2433
|
47.3
|
<0.0001
|
Table
II.
Reasons of discontinuation of COC and IUD
|
Reason of
discontinuation of contraceptive method
|
|
COC users
(2050)
|
IUD users
(1150)
|
P value
|
|
Desire of pregnancy
|
N (%)
|
595 (29)
|
271 (23.6)
|
0.0009
|
|
Undesired side
effects
|
N (%)
|
1066 (52)
|
747 (65)
|
<0.0001
|
|
Medical indications
|
N (%)
|
90 (4.4)
|
36 (3.2)
|
0.0960
|
|
Personal reasons
|
N (%)
|
299 (14.6)
|
0 (0)
|
<0.0001
|
|
Reached expiry date
|
N (%)
|
0
|
94 (8.2)
|
<0.001
|
Table
III.
Duration of COC use in relation to reasons for discontinuation
|
Cause
|
Duration
|
<6 months
|
6-12 months
|
1 to 2 years
|
>2 years
|
|
Desired pregnancy (N
595)
%
|
27
4.5
|
69
11.6
|
125
21
|
374
62.9
|
|
Side effects (N 1066)
%
|
650
61
|
284
26.6
|
103
9.7
|
29
2.7
|
|
Personal reasons (N
299)
%
|
55
18.4
|
68
22.7
|
81
27.1
|
95
31.8
|
Table IV. Side effects leading to
cessation of COC use (1066 cases)
|
Side
effects of COC
|
NO. of clients
|
%
|
|
Breast
discomfort
|
667/1066
|
62.6
|
|
Weight
gain
|
600/1066
|
56.3
|
|
Mood changes
|
535/1066
|
50.2
|
|
Headache
|
518/1066
|
48.6
|
|
Nausea/Vomiting
|
437/1066
|
44.4
|
|
Dizziness
|
346/1066
|
32.5
|
|
Irregular
bleeding
|
322/1066
|
30.2
|
|
Others
|
110/1066
|
10.3
|
Table
V. Side
effects leading to cessation of IUD use
|
Side effect of IUD
|
Number of clients (747)
|
%
|
|
Menstrual Bleeding
disorder
|
406
|
54.4
|
|
Pelvic and low
backache
|
360
|
48.2
|
|
Infections
|
269
|
36.0
|
Table
VI.
Duration of using IUD in relation to reason for discontinuation
|
Cause of
discontinuation
|
<6 months
|
6 – 12 months
|
1 to 2 years
|
>2 years
|
|
Pregnancy desire (272) (%)
|
8 (2.9)
|
15 (5.5)
|
87 (32)
|
162 (59.6)
|
|
Side effects (747) (%)
|
374 (50.1)
|
310 (41.5)
|
54 (7.2)
|
9 (1.2)
|
|
Medical causes (37)
(%)
|
14 (37.8)
|
8 (21.6)
|
7 (18.9)
|
8 (21.6)
|
|
Device expired date
(94) (%)
|
0 (0)
|
0 (0)
|
0 (0)
|
94 (100)
|
Table
VII.
Relationship between age and reasons given for discontinuation of COC and IUD
|
|
<25 years
|
|
25-35 years
|
|
>35 years
|
|
|
|
N
|
%
|
N
|
%
|
N
|
%
|
|
Desired pregnancy
COC (595)
IUD
(272)
P value
|
327
165
0.133
|
55
60.6
|
203
73
0.039
|
43.5
26.8
|
65
34
0.57
|
15.6
12.5
|
|
Side effects
COC (1066)
IUD (747)
P
value
|
531 112
<0.0001
|
49.8
15
|
317
290
<0.0001
|
29.7
38.8
|
218
345
<0.0001
|
20.5
46.2
|
|
Medical indication
COC (91)
IUD (37)
P
value
|
21
3
0.068
|
23
8.1
|
30
11
0.887
|
33
29.7
|
40
23
|
44
62.2
0.094
|
|
Personal reasons
COC (299)
|
154
|
51.5
|
122
|
40.8
|
23
|
7.7
|
|
Reached expiry date
IUD (94)
|
0
|
0
|
18
|
19.1
|
76
|
80.9
|
Discontinuation
of COC
This
study showed that breast discomfort was the most common
side effect
reported by
COC users 62.6%). Weight gain, mood changes, headache were reported in
56.3%, 50.2%, 48.6% respectively. Other
side effects reported by COC users include irregular bleeding, nausea,
vomiting, irritability, depression and vaginal dryness. The study showed that
most of women who quit using COC due to side effects did so in the first 6
months of use (61%), and after this period the frequency of discontinuation
decreased. A study in United States by Rosenberg MJ et al demonstrated
that the discontinuation of COC was more likely to occur if side effects
happened suddenly and especially if they were multiple because the probability of
its occurrence increases disproportionately with each additional side effect
experienced.(5)
It
is well documented that most side-effects are expected during the first few
months of starting COC use and most of them disappear after few cycles, this
may be explained by the woman's body adjusting to the hormones present in COC.
Good counselling, particularly that focused on low impact adverse effects, is
an important instrument to reduce drop out rate.(17)
The findings
of the present study demonstrates the importance of counselling the younger
women (<25yrs) as they form the
majority of cases who discontinued the pills due to poorly tolerated side
effects or poor compliance in using the method especially during the first year
of usage.
These findings are consistent with those of another study that showed 57%
of COC users who decided to stop were below 25
years of age.(5) However,other studies have reported no
significant association between the age of the COC users and their discontinuation of COC use, yet, the discontinuation rate was relatively
higher for women aged 35 years or more compared to their younger counterparts.(7)
Our study showed that 29% of COC users discontinued the method due to desired
of pregnancy which is very low when compared to other Jordanian study that
showed 74% discontinued the method due to pregnancy planning.(18)
The findings of our study also suggest that for
those COC users who developed side effects, 61% and 87.6% discontinued the
method within 6 months and 12 months of usage respectively. Khan reported that 59.5%
of all the patients who discontinued the use of oral contraceptives did so
before 12 months of usage. In addition, women with side effects experienced in
the first 3 months of COC use were 1.4 times more likely to discontinue COC use
than were women who did not have such an experience.(7)
However, the 1995 national survey of family growth reported overall 3% of women
discontinue use of COC for a method-related reason within six months of
starting use, and 6.9% do so within 12 months.(19)
Discontinuation
of IUD
This
study showed that menstrual cycle bleeding disorders form the most common
reason for IUD removal, which was reported by 16.7% (406/2433) clients of those
using IUD for contraception, which is comparable to clinical trials which showed
that 4-15% will remove the IUD because of menstrual bleeding disorder.(20,21)
Other studies showed that excessive or irregular bleeding, mainly in the first
three months after insertion, are the most frequent side-effects in users of
copper IUDs and are the main reasons for discontinuation of the method.(22)
Our
results are similar to other Jordanian study, which showed that 39.6%
discontinued IUD use because of a desire to conceive, 18.6% because of side
effects.(23) Our study also showed that 14.8 % (360/2433) and
11 % (269/2433) of IUD users discontinue it as a method of contraception
because of recurrent infection and pain related problems. This high percentage
may be related to the concern of users about the risk of impaired infertility
and the recovery of fertility after IUD use, particularly for low parity women.
However, Grimes et al found no evidence of adverse effect of IUD use on tubal
infertility.(24) This observation is further confirmed by
Farley et al(25) who found that PID among
IUD users is most strongly related to the insertion process and to background
risk of sexually transmissible disease. Pelvic inflammatory disease (PID) is an
infrequent event beyond the first 20 days after insertion. Because of this
increased risk with insertion, IUDs should be left in place up to their maximum
lifespan and should not routinely be replaced earlier, provided there are no
contraindications to continue their use and the woman wishes to continue with
the device.
Conclusion
The relatively high rate of discontinuation of contraceptive use suggests
a potential for improving patient management. Firstly, counselling should
include the consideration of potential side effects of their use, how long they
last, and how to manage them. Secondly, counselling should consider alternative
methods should primary choice prove unsuitable. Finally, we suggest that
monthly follow up visits should be scheduled for the first 6 months of commencing
COC or insertion of IUD.
Clinicians are encouraged to discuss with their
patients the reasons of discontinuation of an effective contraceptive method like
COC or IUD and assist them with their concerns or to switch to other effective
methods to protect them from unintended pregnancy.
We
recognize that this is a descriptive study and is limited in scope. Further
studies are clearly indicated.
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