Awareness of combined oral contraceptives use among Jordanian women: A cross-sectional study

Purpose: To investigate Jordanian women’s knowledge, attitude, awareness and practice regarding combined oral contraceptives (COCs) benefits and risks. Methods: A cross-sectional study was conducted on 300 Jordanian women attending the Obstetrics and Gynecology clinics at Jordan University Hospital, Amman, Jordan. A closedand open-ended questionnaire was used to explore Jordanian participants' knowledge, attitude and practice regarding COCs use, effect and side effects. Structured interviews were conducted by a trained research team. Thus, it was a pharmacist-assisted survey, and lay language was used to explain difficult medical terminology Results: Most of participants were prescribed COCs by their physicians (77.1 %), half of them depend on others' experiences and media as sources of information rather than consulting their healthcare team. Half of participants have an idea of non-contraception uses of COCs (50.3 %). One fourth of women (26.0 %) believed that using COCs decreases fertility or even causes infertility, especially if used before their first pregnancy (43.3 %). Women in their middle age were more uncertain about the relation between COCs use and anemia (p = 0.014) or dysmenorrhea pain (p = 0.005). While women who used COCs believed more that the pills regulate menstruation (p < 0.001) and decrease dysmenorrhea pain (p < 0.001) compare with women who had never used COCs pills. Women in general are uncertain if COCs use has negative or positive relation with some types of cancer such as ovarian, cervical and breast. Women who are not affiliated to the healthcare professions were more uncertain about the relation between COCs use and atherosclerosis risk (p = 0.002), MI (p = 0.025) and stroke risk (p = 0.035). Conclusion: There is insufficient awareness and knowledge of the beneficial and non-contraceptive uses of COCs. Educational programs are needed to improve women’s awareness of the benefits and risks of COCs.


INTRODUCTION
Unintended pregnancy may pose risk on women's and infants' health and increase medical cost on both governments and individuals [1]. There are various methods of contraception including, hormonal contraceptives such as combined oral contraceptives (COCs), implant or intra uterine device (IUD), condoms and vasectomy or tubal ligation [2]. Contraceptive methods differ in their efficacy, safety, cost and convenient use [3].
COCs are widespread, effective and reversible contraceptive approach used worldwide [4]. COCs provide many non-contraceptive indications such as treating dysfunctional uterine bleeding, organizing menstrual cycle irregularity (breakthrough bleeding and amenorrhea) and treating androgenisation symptoms (seborrhea, acne, hirsutism, alopecia) [5]. Minor adverse effects such as nausea, headache, breast tenderness, and weight gain are tolerable, easier to manage and mostly reversible. While major adverse effects and risks need medical intervention include severe headache, deep vein thrombosis (DVT), stroke and increasing risk of some cancers like breast cancer and cervical cancer [6].
Women's knowledge, beliefs and experiences regarding side effects and risks of COCs can impact their willingness to use or continue using COCs [7]. Women with negative intolerable side effects complaints are more likely to discontinue using oral contraceptives (OC) [8]. On the other hand, women who knew the non-contraceptive benefits of the pills or had previous experience of using the pills with few side effects were more satisfied with their use [9].
Here in Jordan and according to the demographic health survey (DHS) results at 2012; the births per woman for the 3 years prior to the survey is 3.5 and around 42 % of Jordanian married women are using a method of contraception; mainly the IUD (21 %) followed by hormonal contraceptive pill (8 %) and male condom (8 %) [10]. Several studies were conducted to investigate contraception use among Jordanian women [11][12][13]. Nevertheless; no recent studies have been conducted since the last two decades to address this subject, so there is a need to explore Jordanian women knowledge, attitude, awareness and practice towards COCs use. Hence, the current study was conducted to explore baseline knowledge, attitude, beliefs and practice of Jordanian women regarding effect/side effects and benefits/risks associated with COC pills use. Another objective was to investigate information resources utilized by Jordanian women concerning COCs benefits and risks.

METHODS
This cross-sectional study was conducted in Jordan University Hospital (JUH), the largest teaching hospital in Amman, the capital city of Jordan. Participants' were recruited over a period of six months from July to December 2013. Participants' interviews were conducted in Obstetrics and Gynecology clinics at JUH. Ethical approval was obtained from the Institutional Review Board (IRB) at JUH.
A closed and open-ended questionnaire was used to explore Jordanian participants' knowledge, attitude and practice toward the COCs use, effect and side effects. Structured interviews were conducted by the trained research team so this is a pharmacist-assisted survey and lay language was used to explain difficult medical terminology.
A convenience non-random sampling approach was used to recruit women who were older than 17 years and eligible for study entry. Women were invited to participate and provided with full related information about the study aims. Signed participation informed consents were obtained based on a standard written statement.
During the anonymous questionnaire development and in order to ensure the content validity, an inclusive literature review was conducted. Furthermore, in order to ensure face validity, the prepared questionnaire was evaluated individually by two clinical pharmacists, one statistician and one sociologist. After that pilot testing and discussions were performed to confirm questions clarity. The study was piloted on around 30 educated and noneducated women before the formal start of the data collection. Accordingly, few questions were changed and these data were excluded from the final analysis.
The questionnaire consisted of four parts; the first part was considered to collect patient information including age, education, occupation, medical affiliation and marital status. The second part assessed patients' knowledge, attitude, awareness and practice toward COCs use, effects/side effects, and benefits/risks ratio. Participants were asked to express their views and beliefs on the effect of COCs use on conception, infertility, and menstruation. The relationship between COCs use and probable risks such as breast or/and cervical cancers, cardiovascular and cerebral complications. The expected benefits obtained from COCs use such ovarian cancer prevention, anemia and dysmenorrhea. The third part assessed the patient's pattern of COCs use in case of missed doses, what are the sources of information they need about COCs and what is their reference of consultation if there is any question about COCs use.
The last part was designed especially for women who had used COCs at least once during their lifetime. It was designed to collect patient information about patients' pattern of COCs use; including the duration of COCs use, the starting time of COCs in relative to participant's pregnancies schedule (before 1 st pregnancy, after 1 st pregnancy, after 2 nd pregnancy or at any time), any baseline physical examination and laboratory checkup (the uterus, pelvic, breast examination and lipid profile monitoring), and whether or not women had received doctor's/pharmacist consultation or prescription before using the pill.

Data analysis
Data were coded and entered using the Statistical Package for Social Sciences (SPSS © , version 22.0) database for statistical analysis. Descriptive statistics with corresponding 95% confidence intervals (CIs) were constructed. Differences between the various groups were evaluated using the chi-square test and Fisher exact test for categorical variables. ANOVA for normally distributed continuous data were used, while Kruskal-Wallis test and Spearman correlation were used for skewed variables as appropriate. P values less than 0.05 were considered statistically significant.

RESULTS
The questionnaire was delivered by hand to a target sample of 380 women, three hundred women between the ages of 17 and 54 years completed the questionnaires with a response rate of 79 %. It revealed that the majority of women (68.6 %) were educated (diploma degree or higher) but mostly not affiliated in the medical field (81.0 %). Almost two thirds of the women never used the COCs while around 39.0 % of them used COCs at least once in their life. Demographic details are shown in Table 1.
When asked about their source of information regarding COCs uses, benefits, side effects, and complications, it appeared that around half of the participants (52.0 %) depend on self and people experiences as a source of information. On the other hand, only 13.6 % of them depend on media, television and other sources such as internet to get information needed. The majority of them (79.9 %) confirmed that they will ask the doctor if they have any question, but a small percent (4.7 %) of them will ask the pharmacist, data are summarized in Table 2.  Others 11 (4.05) *Some data was missing, subsequently totals do not always add to 300 Table 3 summarizes the data obtained particularly from the participants who used COCs at least once in their life (N = 118). Around 79 % of them have 1 to 6 children and all of them used COCs for contraception. More than one third of the participants used COC pills for less than one year, half of them used the pills for a duration ranged from 1 to 9 years (50.8 %) with small percent still used the pills for more than 9 years (8.5%).  As shown in Table 4, almost one fourth of women considered COCs use as safe. About 20 % of women considered it as harmful, while, 40.0 % of them were not sure about the safety of using COCs. Half of participants do have an idea for uses of COC pills other than contraception (50.3 %). About one fourth of women (26.0 %) believed that using COCs will decrease fertility or even cause infertility especially if used before the first pregnancy (43.3 %). Although 38.7 % of women believed that COCs use doesn't affect fertility totally. A good percent of women believe that COC pills do have positive effect in organizing menstruation (58.3 %).
The participants were asked about the relation between the use of COCs and probable complications such as some types of cancer (e.g. cervical and breast), cardiovascular/cerebral complications (e.g. atherosclerosis, stroke and myocardial infarction), Deep venous thrombosis (DVT) and weight gain. They were also asked about the relation between the use of COCs and their benefits against anemia dysmenorrhea pain, ovarian and endometrial cancer. These data are summarized in Table 5 and Table 6. Table 5 shows women's knowledge, attitude, believe and practice regarding the relation between the COCs and different expected benefits, while table 6 shows women's knowledge, attitude, believe and practice regarding the relation between the COCs and different expected risks. Women in the middle age (25 -35 years) were more uncertain about the relation between COCs use and anemia (p = 0.014) or dysmenorrhea pain (p = 0.005). While women who used COCs believed more that the pills regulate menstruation (p < 0.001) and decrease dysmenorrhea pain (p < 0.001) versus women who never used COCs pills. Women in general are uncertain if COCs use has negative or positive relation with some types of cancer such as ovarian, cervical and breast. When questioning women regarding COCs use and risks; women who are not affiliated in the medical field were more uncertain about the relation between COCs use and atherosclerosis (p = 0.002), MI (p = 0.025) and stroke (p = 0.035). On the other hand, Women in general are uncertain if COCs use has negative relation with DVT. Regarding weigh gain, there was a significant difference between married women and single women in regard to beliefs; that is married women believed that COCs use increases body weight more than single ones (p = 0.02) and women who never used COCs believed that the pills increase body weight more than COCs users (p = 0.002). The detailed results are summarized in Table 5 and Table 6.
Non-users of COCs (61.0% of participants) were more uncertain about the safety of using COCs (p < 0.001), believe more that COCs use decrease fertility (p < 0.001), don't know the presence of non-conception uses for COCs (p = 0.016) and believe more that COCs use increase weight (p = 0.002) depending on non-official sources of information such as internet and media (p < 0.001) than COCs users.

DISCUSSION
Results of this study show lack of knowledge by most women regarding benefits and risk of COCs. More than half of women reported that they get their information from self and people experiences as a source of information, less depend on mass media. Only few respondents refer to the pharmacists to answer their questions about COCs use. Although COCs are the second most commonly used method for contraception in Jordan [10], there is a lack of knowledge regarding COCs efficacy and safety among Jordanian women. Gharaibeh et al, through their study found that there is no correlation between religious stance and contraception use. However, there was significant relationship between psychological comfort of participants and use of contraception [13]. On the other hand, Kridli and Newton investigated the relationship between OC previous consumption and intention to use them among 245 Jordanian married Muslim women. The results showed significant correlation between OC previous consumption and intention to use. However, there was no significant relationship between intention to use OC and selected demographic variables such as education, primary occupation and others. Moreover, the study found that family planning and protection places (40.9 %) followed by private doctor's office (38.4 %) are the most common places for participants to obtain contraception services. Interestingly, pharmacy was the least commonly used place to obtain contraception services [12].
According to Albsoul-Younes et al, study that examined perceptions of working Muslim Jordanian women towards the effectiveness and complications of their contraceptive techniques, it was found that concerns about safety were the main cause of discontinuation of contraception pills [11]. They reported that main methods used are intrauterine devices supplied freely from primary mother and child health care centers [11].
Fertility return after discontinuation of COC pills is a big concern among participants since more than half of them believe that COCs use causes infertility especially among the non-users of COCs. It was thought that COC pills affect fertility however, there is no study that proves this and the effect depends on the use duration and the estrogen dose used. Many studies investigated the effect of COC pills on fertility using different formulations showed that using COC pills is associated with short-term delay in the return to fertility [14]. Bagwell et al, reported that both the use and the dose of combined OC were associated with a lower frequency of primary infertility among young women [15]. Nevertheless, current study showed that around 40 % of participants used COC pills in their first period of marriage (before the first pregnancy or after the first delivery) and around half of participants (users and non-users of COCs) do believe that such use of COCs in the first period of marriage decrease the fertility or even causes infertility, and 43.3 % of the users believed that the risk of infertility increased if COCs were used before the first pregnancy. On the other hand, Hassan and Killick in their study concluded that a significant reduction in fecundity occurs after long term use of COCs, IUD or injectables [14].
Most of the recruited women were unsure about the relation between COCs use and cardiovascular/cerebral complication risks of atherosclerosis, vascular thrombosis, ischemic heart disease and stroke. Studies have shown that COCs use is associated with increased risk of cardiac and vascular complications, where women with thrombosis risk factors get benefit from newer agents such as progestin-only OCs which do not raise thrombosis risks [16].
The need to assess COCs relationship with different forms of cancer became a hot area for research. Many studies investigated COCs effects on cancer, their result varied from increasing the risk of some types to neutral effect or even considered as protective factor for some types of cancer [17]. Studies showed that COCs use is associated with increased risk of breast and cervical cancers especially with increasing duration of use [18,19]. However, COC use is linked to a significant reduction in the risk of ovarian, endometrial and colorectal cancers [17,20]. This risk reduction is greater with increasing duration of use and persists for 30 or more years after cessation of use [17]. Most of the participants in the current study were uncertain about both the beneficial and harmful relation of COCs use and different types of cancer.
Combined oral contraceptive pills can be used for many purposes other than contraception; the American College of Obstetricians and Gynecologists (ACOG) clarified non-contraceptive use of COC pills [21]. These noncontraceptive uses are related to the menstrual cycle including regulation of the menstrual cycle, premenstrual syndrome, menorrhagia and dysmenorrhea [21]. Recruited participants did not know the COCs non-contraceptive uses and their beneficial effect of COCs use against anemia, dysmenorrhea pain and menstruation organization.
Weight gain is usually considered an adverse effect of COCs, and many women and physicians believe that a relationship exists between weight gain and COCs use that has led to COCs discontinuation in most cases in many developed countries [22]. This fact explains the expected reason why many Jordanian women refuse to take COCs in this study more of the non-users believe more COCs use causes weight gain (p = 0.002). A recent large intervention review evaluated the potential correlation between contraceptive use and increase in weight and concluded that obtainable evidence was inadequate to determine the effect of combination contraceptives on weight [22]. Almost three-quarters of married women who had an experience in using COCs during their life believe that weight gain was related to COCs use (p = 0.02). Only one fourth of participants received baseline uterus, pelvic and breast examination and underwent basal laboratory monitoring. Such examination findings do not influence the judgment to prescribe or hold COCs; so according to ACOG guidelines such examinations are not needed prior to COCs initiation [23]. On the other hand, these examinations are usually established practices preceding hormonal contraception use and to determine whether women should receive hormonal contraceptives or not in order to decrease the risk of expected complications [24]. Clinicians worldwide necessitate such examinations before OC use, despite guidelines' recommendations indicating they are unnecessary and research suggesting they limit contraceptive use [24]. The small number of Jordanian women in current study who received baseline physical examination could be due to insurance obstacles or lack of knowledge regarding the importance of these examinations and laboratory monitoring.

Limitations of the study
The main limitation of this cross-sectional study is the use of a convenient non-random sampling approach with a larger sample size is needed. Although the questionnaire assessed Jordanian women's knowledge, attitude, awareness and practice towards combined oral contraceptives (COCs) benefits and risks, but this study does not assess the reasons behind the lack of knowledge by most women regarding benefits and risk of COCs. Therefore, further consideration should be given to study the healthcare providers' knowledge, attitude, awareness and practice towards COCs benefits and risks. Finally, increasing the sample size would also lead to more comprehensive findings.

CONCLUSION
There is a lack of knowledge by most women regarding benefits and risks of COCs. They have negative attitude regarding the use of COCs for both contraception and non-contraceptive benefits. This lack of knowledge among them could be multifactorial; shortage in the educational programs conducted by medical and WHO centers, improper consultation from the physicians when prescribing COCs to patients, only few women seek advice or consultation from the pharmacists. Accordingly, educational programs provided by healthcare professionals can improve women's knowledge to maximize COCs benefits and minimize side effects. This study can be used as a benchmark for healthcare providers and decision makers in Jordan to produce educational programs in cooperation with clinical pharmacists aiming at improving women awareness regarding COCs use.