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Knowledge and attitudes of norplant among adolescent females
Adolesc Pediatr Gynecol (1994) 7:69-75
Adolescent and Pediatric Gynecology
Springer-Verlag York Inc.
© 1994
New
Original Studies Knowledge and Attitudes of Norplant Among Adolescent Females K.J. Kozlowski, M.D., W.W. Ohlhausen, M.D., A.M. Warren, A. Hendon, P. Davis, V.1. Rickert, Psy.D. Departments of Pediatrics, Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, Arkansas
Abstract. Study Objective: To evaluate adolescent females' knowledge and attitude s of the side effects of the Norplant System. Design: A prospective case control study was employed using multivariate statistical analyses. Settin g: An outpatient specialty adolescent gynecology clinic in a rural southern state. Participants: Of the 213 females approached, 206 agreed to participate by providing written informed consent. However, data from only 192 of these 206 adolescents were subjected to statistical tests because data was missing from the other 14 subjects. Main Outcome Measures: Knowledge and attitudes of concern for visibility, general safety, skin discoloration, and irregular menses were used as outcome variables. Demographic and related variables such as sexual activity and race were employed as indicator variables. Results: Logistic regression analyses were conducted on each outcome variable after first completing bivariate analyses. Multivariate analyses found improved knowledge was significantly associated with those adolescents currently using Norplant , sexual activity, and positive history of pregnancy. This same analytic plan found that visibilit y concerns were most likely associated with higher income and sexually active female Norplant users; similar findings were found for general safety and irregular menses where both were associated with current Norplant use ; and skin discoloration was only associated with prior pregnancy history . Conclusions: Our data suggest that knowledge among the general adolescent female population is poor. However , the adolescents who currently employ this contraceptive method posse ssed better knowledge and were more concerned with possible side effects. Thus , counseling detailing potential side effects and co smetic changes should be given at each follow-up visit. Address reprint requests to: Karen J. Kozlowski, M.D., Depart-
ment of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, 4301 West Markham, Little Rock, AR 72205, USA
Key Words. Norplant-Contracepti ves , side effects-Contracepti ve methods
Introduction Over one million female s aged 15-19 years become pregnant each year and the va st majority (84%) of these pregnancies are unintended. 1-3 Though there are many contraceptive methods a vailable to preclude unintended pregnancy , contraceptive use and contraceptive compliance continues to be problematic among adolescent s.v" Successful implementation of contraceptive measures in this age group require mature, thoughtful, well-informed decisions accompanied by the motivation to carry out these decisions. The Norplant sy stem was developed as a longterm contraceptive method requiring little user compliance and ease of delivery . Because of these characteristics , it ha s particular appeal to primary care providers servicing adolescent females. The system consists of six flexible sila stic capsules subdermally placed in a medial location in the upper arm under local anesthesia. Each of the six capsules contain 36 mg levonorgestrel which is gradually released to render continuous, effective contraception over a 5-year period ." Clinical studies have shown that the pregnancy rate with Norplant is les s than 11100 women/year. 7 By far the most common side effect associated with Norplant is irregular uterine bleeding, but others include headache , weight changes, increase in facial hair, breast tenderness, fluid retention, and depression. The occurrence of irregular bleeding results from low levels of levonorgestrel in the bloodstream not completely suppressing gonadotropin re-
70
Kozlowski et al.: Adolescents and Norplant
lease. Follicular development might then occur, but the progestin level is sufficient to inhibit the positive estradiol feedback on the hypothalamus in such a way that the luteinizing hormone (LH) surge is avoided and ovulation fails to occur. Estradiol levels then fall, and spotting may result.P'" Patient satisfaction and successful utilization of Norplant, or any method of birth control, depends on adequate knowledge and accurate perceptions of the method used. The purpose of this study was to evaluate adolescent females' knowledge and attitudes towards the Norplant system. Our study population consisted of all adolescent female patients seen in a general adolescent gynecology clinic, and evaluations were made whether sexual experience, past history of pregnancy, or demographic factors such as race, age, or socioeconomic status (SES) were significant among the participation responses. Also examined were their perceptions of potential side effects associated with Norplant use. Methods Female adolescents who were receiving care from an outpatient adolescent gynecology (GYN) clinic at Arkansas Children's Hospital from October of 1991 until May of 1992 were asked to complete selfreport questionnaires examining knowledge and attitudes toward Norplant. Adolescents receiving care at this outpatient clinic were seen for a broad array of gynecologic concerns such as family planning, recurrent pelvic pain, as well as primary care complaints. Appointments were generated by patients, referrals from hospital-based clinics, physicians, parents, school-based health clinic nurses, or health department clinics. This specialty GYN clinic is located in central Arkansas and provides service for all who request medical treatment, regardless of their ability to pay. After each female was escorted to an exam room by a staff nurse, a female research assistant explained the purpose of the present study and inquired if she would be interested in participating. After her questions had been answered, the adolescent was allowed to complete the measures described below in the privacy of the exam room. However, if the physician entered the room to assess and provide medical treatment, the remaining items were completed at the conclusion of the medical visit. Of the 213 females approached, 206 agreed to participate by providing written informed consent. However, because 14 subjects had few responses, data from 192 subjects were used in compiling the results. The seven adolescents who refused to par-
ticipate in the study felt it was too time consuming. The average age of subjects was 16.8 years (range 12-20 years) with a mean onset of menses at 9.3 years. Most adolescents were sexually active (78%) with an average age of debut of 14.9 years. Subjects were defined as sexually active if they endorsed the item, "have you ever had sex." Of those reporting sexual activity, approximately half indicated that the frequency of intercourse was 10 or more times per month. Approximately 38% of this sample reported a history of pregnancy, 27% reported past history of at least one sexually transmitted disease, (STD) and 66% reported current contraceptive use with slightly less than half (n = 57) using the Norplant System (see Table 1). The self-report questionnaires that were employed to obtain information were developed by reviewing current literature as well as literature used by previous investigators. These included measures of socioeconomic status and other demographic information; questions regarding sexual behavior and practices; and knowledge of Norplant as well as attitudes towards specific side effects such as irregular menses, skin discoloration, and visibility. In order to assess knowledge of Norplant, a series of eight questions was developed using the handbook on Norplant that had been developed by WyethAyerst to inform females about this newest contraceptive method. Using a multiple choice and "true, false, don't know" format, we inquired what Norplant was, length of time it precluded pregnancy, Table 1. Sample Characteristics of Adolescent Females (n = 192)
Variable Payment status Commercial insurance Medicaid Self-pay Missing" Race Black White Sexually active Yes No Missing Current contraception use Yes No STD Yes No Missing Pregnancy Yes No Missing
n
Percent
55 61 73 3
28.6 31.8 38.0 1.6
78 114
40.6 59.4
150 41 1
78.1 21.4 .5
127 65
66.1 33.9
52 135 5
27.1 70.3 2.6
73 114 5
38.0 59.4 2.6
"Subject did not provide a response to item.
Kozlowski et al.: Adolescents and N orplant where it is implanted, visibility of Norplant, ability for patient and others to feel implants, whether implants move under the skin, and whether implants will break if arm bumped or was grabbed roughly. Attitudes towards side effects were also examined in this particular questionnaire. For the purposes of this study, side effects assessed included visibility of the implants (whether youths would be concerned by wearing sleeveless tops) irregular menses, general safety, and skin discoloration. Responses were coded on a 4-point scale ranging from "no concern or upset" to "very upset or very concerned." Sexual behaviors and practices of each adolescent female were obtained through selfreport where the adolescent was asked to respond to simple questions asking whether or not she was sexually active, had a past history of pregnancies and/or STD, and whether she currently used contraception. In addition, if she also indicated a current or past contraceptive use, she was asked to indicate the contraceptive methods which included oral contraceptives, condoms, and/or Norplant. With regard to the latter, this service had been implanting adolescents with this contraceptive method and as a result, those adolescent females who were returning for their first follow-up appointment (n = 57) were also asked to complete the knowledge measure so their data could be used as well in the present study. The Hollingshed Four Factor Index of Social Status, a revision of the more commonly used scale, Hollingshed Index of Social Status, assessed four different aspects of socioeconomic status including marital status, gender, occupation, and education. Each adolescent was asked to describe her current household living situation in order to determine her parents' marital status, education levels, and occupation. This measure yields a single sum score from 9 to 66. These scores are subdivided into five levels of social status such as professionals, skilled craftsmen or sales workers, and unskilled laborers and menial workers. Statistical Analysis
In order to obtain a single knowledge score, adolescents were given I point for each correct response and no points for responses answered incorrectly or identified by the response "don't know." These points were summed to yield a single score from 0 to 8 with 0 indicating no knowledge and 8 indicating high knowledge. History of pregnancy, current contraceptive use, and sexually transmitted disease were based upon the teens response (yes, no) to a single question in each of these areas. With regard to attitudes of side effects of Norplant, single ques-
71
tions were asked in each of four areas and included concern with regard to wearing sleeveless tops, upset with possible skin discoloration, general concerns about Norplant's side effects, and concern with irregular menses. The response to each of these questions was assessed on an instrument with a 4-point scale. However, for the purpose of analysis, the responses were dichotomized to indicate no concern/upset or concern/upset. Hence, those responses that indicated slight concern or much concern were grouped together in order to use each one of these side effects as appropriate outcome measures. Bivariate analysis (Student's t-test, chisquare) were used to compare each independent variable with knowledge of Norplant and each of the four side-effect questions. In addition, logistic regression analysis which controls for the effects of all other variables were computed for knowledge, as well as for each side-effect measure. All variables were included in each of the five logistic regression models as well as socioeconomic status and age in order to control for the effects of these. Results In order to examine differences in knowledge of Norplant bivariate comparisons (chi-square, Student's t-test) were computed. As can be seen in Table 2, black adolescents had a higher mean knowledge score than whites (p < 0.024), as well as sexually active teens who were much more likely to have a higher knowledge score (p < 0.000). In addition, those adolescents who reported previous use of contraceptives, past history of pregnancy, or a STD, had significantly higher knowledge when Table 2. Bivariate Comparisons of Norplant Knowledge Variable Race Black White Sexually active Yes No Current use of contraception Yes No Contraceptive method Norplant Other Pregnancy Yes No STD Yes No
Mean
SD
4.71 3.85
2.38 2.69
4.60 2.73
2.54 2.29
4.88 2.88
2.47 2.33
6.56 3.74
1.39 2.34
5.55 3.29
2.40 2.35
4.88 3.87
2.40 2.62
p-Value 0.024
0.000
0.000
0.000
0.000
0.016
Kozlowski et al.: Adolescents and Norplant
72
compared with those who did not report these characteristics. Although not surprising, those adolescents who had been implanted with Norplant, on the average, answered correctly six and a half questions as compared with almost four by adolescent females reporting different types of contraceptive methods. This finding is particularly relevant because these adolescents were seen at their first follow-up appointment approximately 8-10 weeks postimplantation. A logistic regression analysis was computed to determine what variables were significantly associated with high knowledge while controlling for the confounding effects of all other variables. A cutoff of six correct answers or greater was used to define those adolescents as high knowledge, and those females with scores less than this were identified as low knowledge. All variables were entered in the model including age and race. As can be seen on Table 3, four variables were significantly associated with high Norplant knowledge (sexual activity, pregnancy, contraceptive method, and age) in the present sample. Although not unexpected, those adolescent females who were using Norplant were 11 times more likely than those using other types of contraceptive methods to be more knowledgeable, as well as those adolescent females who were sexually active being three and a half times more likely to have higher scores than those girls not reporting sexual activity. Finally, those adolescent females with past history of pregnancy were also almost three times more likely to have better knowledge than those with no history of pregnancy. This finding is not necessarily surprising because in our clinic population this newest contraceptive method is frequently discussed with those adolescent females during the course of their prenatal visits. In addition, age was also significantly associated with high Norplant knowledge. Table 4 presents characteristics across each side effect. With regard to concerns with visibility, those teens who were sexually active and used some other contraceptive method besides Norplant were significantly more likely to endorse concern than Table 3. Odds Ratios and Confidence Intervals from Logistic Regression Analysis on Norplant Knowledge Variable
Odds Ratio
Sexual activity" Active vs. inactive Pregnancyb Pregnant vs. nonpregnant Contraceptive method" Norplant vs. other Age"
'o < 0.05;
bp
< 0.03;
cp
< 0.001.
95% Conf. into
3.42
(1.01,11.64)
2.76
(1.12, 6.82)
11.31 1.27
(4.18,30.67) (1.02, 1.59)
Table 4. Characteristics Across Side Effects of Norplant" Wearing sleeveless tops Concern Variables Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
(n == 60)
No concern (n == 131)
35.0% 65.0%
42.8% 57.2%
61.7% 38.3%
86.3% 13.7%
23.3% 76.7%
46.5% 53.5%
18.3% 81.7%
32.3% 67.7%
43.3% 56.7%
76.3% 23.7%
3.3% 96.7%
41.2% 58.8%
p-Value N.S.
0.000
0.002
0.047
0.000
0.000
Skin discoloration Upset
Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
(n == 105)
Not upset (n == 72)
36.2% 63.8%
45.8% 54.2%
75.2% 24.8%
86.1% 13.9%
52.9% 47.1%
46.5% 53.5%
23.3% 76.7%
34.3% 65.7%
65.7% 34.3%
69.4% 30.6%
22.9% 77.1%
41.7% 58.3%
N.S.
N.S.
0.002
N.S.
N.S.
0.008
General safety Variables Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes
Concern (n == 54)
No concerns (n == 112)
37.0% 63.0%
42.9% 57.1%
77.8% 22.2%
84.8% 15.2%
29.6% 70.4%
47.2% 52.8%
25.9% 74.1%
30.6% 69.4%
53.7%
76.8%
N.S.
N.S.
0.032
N.S.
0.003
Kozlowski et al.: Adolescents and Norplant Table 4. (Continued) General safety Variables No Contraceptive method Norplant Other
Concern (n = 54)
No concerns
46.3%
23.2%
13.0% 87.0%
42.0% 58.0%
(n = 112)
0.000
Irregular menses Concern No concerns (n = 154) (n = 20) Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
N.S. 39.0% 61.0%
45.0% 55.0%
79.2% 20.8%
85.0% 15.0%
35.8% 64.2%
63.2% 36.8%
27.6% 72.4%
36.8% 63.2%
65.6% 34.4%
85.0% 15.0%
25.3% 74.7%
70.0% 30.0%
N.S.
0.021
N.S.
N.S.
0.000
"The total subjects (concerned and not concerned) will not equal 192 because of missing data.
those sexually inactive females or those on Norplant. In addition, of those concerned with visibility, approximately 82% reported having no STD (p < 0.05), 77% had not experienced pregnancy, and about 57% reported no current contraceptive use. Only two variables significantly differed between those adolescent females who would be concerned or upset with skin discoloration after implantation: history of pregnancy and contraceptive method. Almost 71% of those reporting not to be upset with skin discoloration reported past history of pregnancy; of those reporting upset, 77% were using other methods of contraception (birth control pills, condoms). The variables-race, sexual activity, STD, and current contraceptive use-did not significantly differ from those reported being upset vs. not upset. Only two variables significantly differed between those who reported concern vs. no concern about irregular menses. Sixty-four percent of those concerned about the side effect of irregular menses reported no past history of pregnancy, and almost 75% of those who reported concern were using other contraceptive methods. Interestingly, approximately one-quarter of the sample were already on Norplant and continued to have concern
73
about irregular menses. With regard to the general safety of this newest contraceptive method, three variables differed significantly on this outcome measure: 70% of those who reported being concerned about its safety reported no past history of pregnancy; almost 54% of those reporting current contraceptive use also reported some concern; and an overwhelming 87% of those who reported concern were using contraceptive methods other than Norplant. Interestingly, 13% of those concerned identified themselves as current Norplant users. Table 5 presents the odds ratios in 95% intervals from the logistic regression analysis on attitudes of possible side effects. Forward step-wise inclusion of all variables found that three were significantly associated with visibility concerns. That is, adolescents who are currently using Norplant were 14 times more likely to be concerned about this problem than those using other types of contraceptive methods. In addition, sexually active adolescents were much more likely to be concerned. Finally, socioeconomic status was also found to relate to visibility concerns. Specifically, as the teens socioeconomic status increased, it was more likely to be associated with increased concern over seeing and perhaps feeling these six cylindrical inserts. With regard to skin discoloration, only one variable was significantly associated with this potential side effect and that was pregnancy. Those adolescent females reporting a past history of pregnancy were almost three times more likely to be concerned with this when controlling for all other variables than those with no reported history of pregnancy. General safety of this newest contraceptive method was found to be significantly associated with two variables, Interestingly, those on Norplant were four Table 5. Odds Ratios and Confidence Intervals from Logistic Regression Analyses on Attitudes of Possible Side Effects Variable
Odds ratio
95% Conf. int.
Visibility concerns Contraceptive method Norplant vs. others Sexual activity Yes vs. No SES Pregnant Yes vs. no Contraceptive method Norplant vs. others SES Contraceptive method Norplant vs. others
13.7 3.5 1.02 Skin discoloration
(3.10,60.13) (1.44,7.92) (1.001, 1.042)
2.7 General concern
(1.38, 5.2)
4.4 1.02 Irregular menses
(1.7,11.5) (1.001, 1.04)
6.2
(2.1, 18.3)
74
Kozlowski et al.: Adolescents and Norplant
and a half times more likely to evidence concern about this contraceptive method even though they had already been implanted. In addition, those adolescents from reported higher levels of socioeconomic status were also likely to endorse general concern. With regard to irregular menses, those adolescents using Norplant were much more likely to be concerned with this side effect when controlling for the effects of all other variables. Discussion
The high rate of teenage pregnancy illustrates the difficulty of contraceptive management in adolescent females. Poor compliance with previously available methods of contraceptives (OCPs, diaphragms, condoms, etc.) have been cited as a major factor. The introduction of Norplant offers a new type of effective, continuous, long-term contraception requiring minimal user compliance. Successful implementation of any form of contraception requires adequate patient education and well-informed decisions. Written materials, pamphlets, and video presentations providing information about Norplant and its associated side effects are available through most health care facilities, but despite this, many of our study participants had difficulty correctly answering 50% of the knowledge questions regarding Norplant. This may reflect the lack of female adolescents' medical exposure and the associated counseling, as well as the inaccuracy of knowledge gained from informal, non-health care-related media avenues. Of the patients exhibiting higher levels of knowledge pertaining to Norplant, associated factors included current Norplant use, past history of pregnancy, positive history of STD, and advanced adolescent age. These characteristics reflect an increased sexual awareness and increased exposure to health care providers with the corresponding additional counseling received. As previously described, Norplant is associated with a number of side effects and cosmetic changes, but adolescent attitudes towards its use was generally positive. However, we were specifically interested in identifying potential side effects that might incite dissatisfaction and subsequent Norplant removal. Questions presented that addressed these issues included concerns wearing sleeveless tops, possible skin discoloration at implantation site, general safety associated with Norplant use, and concerns regarding irregular uterine bleeding. Occasionally, Norplant capsules may be visible by close observation in a woman wearing a sleeveless top. Likewise, skin discoloration secondary to progestin release also would be visible if it oc-
curred. The adolescents who tended to be most concerned with these side effects were sexually active Caucasian females who had not experienced any documented STDs. Interestingly, adolescents who had previously been pregnant or currently were using Norplant or some other form of contraception were more apt to be upset with skin discoloration occurring with Norplant use. Only 3% of adolescent females currently using Norplant expressed concern about wearing sleeveless tops. Regarding the general safety of Norplant, adolescent females that had never been pregnant and were using some other form of birth control expressed concern associated with its safety. Overall, however, over two-thirds of adolescents felt Norplant was safe. Finally, irregular menses was identified as a significant concern for the majority of participants sampled and would affect their satisfaction with Norplant despite being forewarned of this effect at the time of insertion. The most common adolescent female characteristics associated with concern for irregular bleeding were sexually active Caucasian females using some other form of contraception who had never had a STD or been pregnant. Approximately one out of four adolescent females expressing concern currently were using Norplant. Interestingly, this side effect was listed as a significant concern in another Norplant study involving women aged approximately 10 years older than our study sample. The majority of their study participants were willing to tolerate irregular bleeding in order to use what they felt was a safe and effective method of birth control. In their study, menstrual abnormalities was the only side effect consistently tolerated, and others such as weight changes, acne, headaches, and depression were often poorly tolerated and led to removal of the implants." This has led some centers to test patient tolerance of a progestin-only contraceptive with a short course of an oral formulation prior to placement of Norplant. Conclusion
Patient satisfaction and successful utilization of Norplant depends on adequate knowledge and accurate perceptions of its use. Counseling by health care providers when discussing contraceptive methods and at the time of Norplant placement improves patients' level of knowledge, but continued misperceptions and inaccurate knowledge may still exist leading to patient dissatisfaction. Counseling detailing potential side effects and cosmetic changes should be performed at each visit. Because of Norplant's long-term duration of action and the poten-
Kozlowski et al.:
Adolescents and Norplant
tial of associated side effects, a short course of progestin-only oral preparation may be considered prior to Norplant placement.
References 1. Henshaw SK, Van Vort J: Teenage abortion, birth, and pregnancy statistics: an update: Fam Plann Perspect 1989; 21:85 2. U.S. Dept of Health and Human Services: Health people 2000: National Health Promotion and disease objectives. 1990. Washington, DC, U.S. Government printing office; (PHS) 91-50-212 3. Moore KA, Simms MC, Betsey CL: Choice and Circumstance: Racial Differences in Adolescent Sexuality and Fertility. New Brunswick, NJ, Transaction Books, 1986
75
4. Mosher WD, Pratt WF: Contraceptive Use in the United States, 1973-1988. National Center for Health Statistics. Advance Data. 1990; 182: 1 5. DuRant RH, Jay MS: A social psychologic model of female adolescents' compliance with contraceptives. Semin Adolesc Med 1987; 3:135 6. Wyeth Laboratories, Inc: Conference Proceedings. Presented at the Norplant Investigators Symposium, January 25-28, 1990. Palm Desert, CA 7. Sivin R: International experience with Norplant and Norplant-2 contraceptive. Study Fam Plann 1988; 19: 81 8. Wyeth Laboratories, Inc: Investigational Drug Brochure. General Report on Levonorgestrel (#5104), 1989 9. Darney PB, Atkinson E, et al: Acceptance and perceptions of Norplant among users in San Francisco, USA. Stud Fam Plann 1990; 21; 3:152
Adolescent and Pediatric Gynecology
Springer-Verlag York Inc.
© 1994
New
Original Studies Knowledge and Attitudes of Norplant Among Adolescent Females K.J. Kozlowski, M.D., W.W. Ohlhausen, M.D., A.M. Warren, A. Hendon, P. Davis, V.1. Rickert, Psy.D. Departments of Pediatrics, Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, Arkansas
Abstract. Study Objective: To evaluate adolescent females' knowledge and attitude s of the side effects of the Norplant System. Design: A prospective case control study was employed using multivariate statistical analyses. Settin g: An outpatient specialty adolescent gynecology clinic in a rural southern state. Participants: Of the 213 females approached, 206 agreed to participate by providing written informed consent. However, data from only 192 of these 206 adolescents were subjected to statistical tests because data was missing from the other 14 subjects. Main Outcome Measures: Knowledge and attitudes of concern for visibility, general safety, skin discoloration, and irregular menses were used as outcome variables. Demographic and related variables such as sexual activity and race were employed as indicator variables. Results: Logistic regression analyses were conducted on each outcome variable after first completing bivariate analyses. Multivariate analyses found improved knowledge was significantly associated with those adolescents currently using Norplant , sexual activity, and positive history of pregnancy. This same analytic plan found that visibilit y concerns were most likely associated with higher income and sexually active female Norplant users; similar findings were found for general safety and irregular menses where both were associated with current Norplant use ; and skin discoloration was only associated with prior pregnancy history . Conclusions: Our data suggest that knowledge among the general adolescent female population is poor. However , the adolescents who currently employ this contraceptive method posse ssed better knowledge and were more concerned with possible side effects. Thus , counseling detailing potential side effects and co smetic changes should be given at each follow-up visit. Address reprint requests to: Karen J. Kozlowski, M.D., Depart-
ment of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, 4301 West Markham, Little Rock, AR 72205, USA
Key Words. Norplant-Contracepti ves , side effects-Contracepti ve methods
Introduction Over one million female s aged 15-19 years become pregnant each year and the va st majority (84%) of these pregnancies are unintended. 1-3 Though there are many contraceptive methods a vailable to preclude unintended pregnancy , contraceptive use and contraceptive compliance continues to be problematic among adolescent s.v" Successful implementation of contraceptive measures in this age group require mature, thoughtful, well-informed decisions accompanied by the motivation to carry out these decisions. The Norplant sy stem was developed as a longterm contraceptive method requiring little user compliance and ease of delivery . Because of these characteristics , it ha s particular appeal to primary care providers servicing adolescent females. The system consists of six flexible sila stic capsules subdermally placed in a medial location in the upper arm under local anesthesia. Each of the six capsules contain 36 mg levonorgestrel which is gradually released to render continuous, effective contraception over a 5-year period ." Clinical studies have shown that the pregnancy rate with Norplant is les s than 11100 women/year. 7 By far the most common side effect associated with Norplant is irregular uterine bleeding, but others include headache , weight changes, increase in facial hair, breast tenderness, fluid retention, and depression. The occurrence of irregular bleeding results from low levels of levonorgestrel in the bloodstream not completely suppressing gonadotropin re-
70
Kozlowski et al.: Adolescents and Norplant
lease. Follicular development might then occur, but the progestin level is sufficient to inhibit the positive estradiol feedback on the hypothalamus in such a way that the luteinizing hormone (LH) surge is avoided and ovulation fails to occur. Estradiol levels then fall, and spotting may result.P'" Patient satisfaction and successful utilization of Norplant, or any method of birth control, depends on adequate knowledge and accurate perceptions of the method used. The purpose of this study was to evaluate adolescent females' knowledge and attitudes towards the Norplant system. Our study population consisted of all adolescent female patients seen in a general adolescent gynecology clinic, and evaluations were made whether sexual experience, past history of pregnancy, or demographic factors such as race, age, or socioeconomic status (SES) were significant among the participation responses. Also examined were their perceptions of potential side effects associated with Norplant use. Methods Female adolescents who were receiving care from an outpatient adolescent gynecology (GYN) clinic at Arkansas Children's Hospital from October of 1991 until May of 1992 were asked to complete selfreport questionnaires examining knowledge and attitudes toward Norplant. Adolescents receiving care at this outpatient clinic were seen for a broad array of gynecologic concerns such as family planning, recurrent pelvic pain, as well as primary care complaints. Appointments were generated by patients, referrals from hospital-based clinics, physicians, parents, school-based health clinic nurses, or health department clinics. This specialty GYN clinic is located in central Arkansas and provides service for all who request medical treatment, regardless of their ability to pay. After each female was escorted to an exam room by a staff nurse, a female research assistant explained the purpose of the present study and inquired if she would be interested in participating. After her questions had been answered, the adolescent was allowed to complete the measures described below in the privacy of the exam room. However, if the physician entered the room to assess and provide medical treatment, the remaining items were completed at the conclusion of the medical visit. Of the 213 females approached, 206 agreed to participate by providing written informed consent. However, because 14 subjects had few responses, data from 192 subjects were used in compiling the results. The seven adolescents who refused to par-
ticipate in the study felt it was too time consuming. The average age of subjects was 16.8 years (range 12-20 years) with a mean onset of menses at 9.3 years. Most adolescents were sexually active (78%) with an average age of debut of 14.9 years. Subjects were defined as sexually active if they endorsed the item, "have you ever had sex." Of those reporting sexual activity, approximately half indicated that the frequency of intercourse was 10 or more times per month. Approximately 38% of this sample reported a history of pregnancy, 27% reported past history of at least one sexually transmitted disease, (STD) and 66% reported current contraceptive use with slightly less than half (n = 57) using the Norplant System (see Table 1). The self-report questionnaires that were employed to obtain information were developed by reviewing current literature as well as literature used by previous investigators. These included measures of socioeconomic status and other demographic information; questions regarding sexual behavior and practices; and knowledge of Norplant as well as attitudes towards specific side effects such as irregular menses, skin discoloration, and visibility. In order to assess knowledge of Norplant, a series of eight questions was developed using the handbook on Norplant that had been developed by WyethAyerst to inform females about this newest contraceptive method. Using a multiple choice and "true, false, don't know" format, we inquired what Norplant was, length of time it precluded pregnancy, Table 1. Sample Characteristics of Adolescent Females (n = 192)
Variable Payment status Commercial insurance Medicaid Self-pay Missing" Race Black White Sexually active Yes No Missing Current contraception use Yes No STD Yes No Missing Pregnancy Yes No Missing
n
Percent
55 61 73 3
28.6 31.8 38.0 1.6
78 114
40.6 59.4
150 41 1
78.1 21.4 .5
127 65
66.1 33.9
52 135 5
27.1 70.3 2.6
73 114 5
38.0 59.4 2.6
"Subject did not provide a response to item.
Kozlowski et al.: Adolescents and N orplant where it is implanted, visibility of Norplant, ability for patient and others to feel implants, whether implants move under the skin, and whether implants will break if arm bumped or was grabbed roughly. Attitudes towards side effects were also examined in this particular questionnaire. For the purposes of this study, side effects assessed included visibility of the implants (whether youths would be concerned by wearing sleeveless tops) irregular menses, general safety, and skin discoloration. Responses were coded on a 4-point scale ranging from "no concern or upset" to "very upset or very concerned." Sexual behaviors and practices of each adolescent female were obtained through selfreport where the adolescent was asked to respond to simple questions asking whether or not she was sexually active, had a past history of pregnancies and/or STD, and whether she currently used contraception. In addition, if she also indicated a current or past contraceptive use, she was asked to indicate the contraceptive methods which included oral contraceptives, condoms, and/or Norplant. With regard to the latter, this service had been implanting adolescents with this contraceptive method and as a result, those adolescent females who were returning for their first follow-up appointment (n = 57) were also asked to complete the knowledge measure so their data could be used as well in the present study. The Hollingshed Four Factor Index of Social Status, a revision of the more commonly used scale, Hollingshed Index of Social Status, assessed four different aspects of socioeconomic status including marital status, gender, occupation, and education. Each adolescent was asked to describe her current household living situation in order to determine her parents' marital status, education levels, and occupation. This measure yields a single sum score from 9 to 66. These scores are subdivided into five levels of social status such as professionals, skilled craftsmen or sales workers, and unskilled laborers and menial workers. Statistical Analysis
In order to obtain a single knowledge score, adolescents were given I point for each correct response and no points for responses answered incorrectly or identified by the response "don't know." These points were summed to yield a single score from 0 to 8 with 0 indicating no knowledge and 8 indicating high knowledge. History of pregnancy, current contraceptive use, and sexually transmitted disease were based upon the teens response (yes, no) to a single question in each of these areas. With regard to attitudes of side effects of Norplant, single ques-
71
tions were asked in each of four areas and included concern with regard to wearing sleeveless tops, upset with possible skin discoloration, general concerns about Norplant's side effects, and concern with irregular menses. The response to each of these questions was assessed on an instrument with a 4-point scale. However, for the purpose of analysis, the responses were dichotomized to indicate no concern/upset or concern/upset. Hence, those responses that indicated slight concern or much concern were grouped together in order to use each one of these side effects as appropriate outcome measures. Bivariate analysis (Student's t-test, chisquare) were used to compare each independent variable with knowledge of Norplant and each of the four side-effect questions. In addition, logistic regression analysis which controls for the effects of all other variables were computed for knowledge, as well as for each side-effect measure. All variables were included in each of the five logistic regression models as well as socioeconomic status and age in order to control for the effects of these. Results In order to examine differences in knowledge of Norplant bivariate comparisons (chi-square, Student's t-test) were computed. As can be seen in Table 2, black adolescents had a higher mean knowledge score than whites (p < 0.024), as well as sexually active teens who were much more likely to have a higher knowledge score (p < 0.000). In addition, those adolescents who reported previous use of contraceptives, past history of pregnancy, or a STD, had significantly higher knowledge when Table 2. Bivariate Comparisons of Norplant Knowledge Variable Race Black White Sexually active Yes No Current use of contraception Yes No Contraceptive method Norplant Other Pregnancy Yes No STD Yes No
Mean
SD
4.71 3.85
2.38 2.69
4.60 2.73
2.54 2.29
4.88 2.88
2.47 2.33
6.56 3.74
1.39 2.34
5.55 3.29
2.40 2.35
4.88 3.87
2.40 2.62
p-Value 0.024
0.000
0.000
0.000
0.000
0.016
Kozlowski et al.: Adolescents and Norplant
72
compared with those who did not report these characteristics. Although not surprising, those adolescents who had been implanted with Norplant, on the average, answered correctly six and a half questions as compared with almost four by adolescent females reporting different types of contraceptive methods. This finding is particularly relevant because these adolescents were seen at their first follow-up appointment approximately 8-10 weeks postimplantation. A logistic regression analysis was computed to determine what variables were significantly associated with high knowledge while controlling for the confounding effects of all other variables. A cutoff of six correct answers or greater was used to define those adolescents as high knowledge, and those females with scores less than this were identified as low knowledge. All variables were entered in the model including age and race. As can be seen on Table 3, four variables were significantly associated with high Norplant knowledge (sexual activity, pregnancy, contraceptive method, and age) in the present sample. Although not unexpected, those adolescent females who were using Norplant were 11 times more likely than those using other types of contraceptive methods to be more knowledgeable, as well as those adolescent females who were sexually active being three and a half times more likely to have higher scores than those girls not reporting sexual activity. Finally, those adolescent females with past history of pregnancy were also almost three times more likely to have better knowledge than those with no history of pregnancy. This finding is not necessarily surprising because in our clinic population this newest contraceptive method is frequently discussed with those adolescent females during the course of their prenatal visits. In addition, age was also significantly associated with high Norplant knowledge. Table 4 presents characteristics across each side effect. With regard to concerns with visibility, those teens who were sexually active and used some other contraceptive method besides Norplant were significantly more likely to endorse concern than Table 3. Odds Ratios and Confidence Intervals from Logistic Regression Analysis on Norplant Knowledge Variable
Odds Ratio
Sexual activity" Active vs. inactive Pregnancyb Pregnant vs. nonpregnant Contraceptive method" Norplant vs. other Age"
'o < 0.05;
bp
< 0.03;
cp
< 0.001.
95% Conf. into
3.42
(1.01,11.64)
2.76
(1.12, 6.82)
11.31 1.27
(4.18,30.67) (1.02, 1.59)
Table 4. Characteristics Across Side Effects of Norplant" Wearing sleeveless tops Concern Variables Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
(n == 60)
No concern (n == 131)
35.0% 65.0%
42.8% 57.2%
61.7% 38.3%
86.3% 13.7%
23.3% 76.7%
46.5% 53.5%
18.3% 81.7%
32.3% 67.7%
43.3% 56.7%
76.3% 23.7%
3.3% 96.7%
41.2% 58.8%
p-Value N.S.
0.000
0.002
0.047
0.000
0.000
Skin discoloration Upset
Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
(n == 105)
Not upset (n == 72)
36.2% 63.8%
45.8% 54.2%
75.2% 24.8%
86.1% 13.9%
52.9% 47.1%
46.5% 53.5%
23.3% 76.7%
34.3% 65.7%
65.7% 34.3%
69.4% 30.6%
22.9% 77.1%
41.7% 58.3%
N.S.
N.S.
0.002
N.S.
N.S.
0.008
General safety Variables Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes
Concern (n == 54)
No concerns (n == 112)
37.0% 63.0%
42.9% 57.1%
77.8% 22.2%
84.8% 15.2%
29.6% 70.4%
47.2% 52.8%
25.9% 74.1%
30.6% 69.4%
53.7%
76.8%
N.S.
N.S.
0.032
N.S.
0.003
Kozlowski et al.: Adolescents and Norplant Table 4. (Continued) General safety Variables No Contraceptive method Norplant Other
Concern (n = 54)
No concerns
46.3%
23.2%
13.0% 87.0%
42.0% 58.0%
(n = 112)
0.000
Irregular menses Concern No concerns (n = 154) (n = 20) Race Black White Sexually active Yes No Pregnant Yes No STD Yes No Current contraception use Yes No Contraceptive method Norplant Other
N.S. 39.0% 61.0%
45.0% 55.0%
79.2% 20.8%
85.0% 15.0%
35.8% 64.2%
63.2% 36.8%
27.6% 72.4%
36.8% 63.2%
65.6% 34.4%
85.0% 15.0%
25.3% 74.7%
70.0% 30.0%
N.S.
0.021
N.S.
N.S.
0.000
"The total subjects (concerned and not concerned) will not equal 192 because of missing data.
those sexually inactive females or those on Norplant. In addition, of those concerned with visibility, approximately 82% reported having no STD (p < 0.05), 77% had not experienced pregnancy, and about 57% reported no current contraceptive use. Only two variables significantly differed between those adolescent females who would be concerned or upset with skin discoloration after implantation: history of pregnancy and contraceptive method. Almost 71% of those reporting not to be upset with skin discoloration reported past history of pregnancy; of those reporting upset, 77% were using other methods of contraception (birth control pills, condoms). The variables-race, sexual activity, STD, and current contraceptive use-did not significantly differ from those reported being upset vs. not upset. Only two variables significantly differed between those who reported concern vs. no concern about irregular menses. Sixty-four percent of those concerned about the side effect of irregular menses reported no past history of pregnancy, and almost 75% of those who reported concern were using other contraceptive methods. Interestingly, approximately one-quarter of the sample were already on Norplant and continued to have concern
73
about irregular menses. With regard to the general safety of this newest contraceptive method, three variables differed significantly on this outcome measure: 70% of those who reported being concerned about its safety reported no past history of pregnancy; almost 54% of those reporting current contraceptive use also reported some concern; and an overwhelming 87% of those who reported concern were using contraceptive methods other than Norplant. Interestingly, 13% of those concerned identified themselves as current Norplant users. Table 5 presents the odds ratios in 95% intervals from the logistic regression analysis on attitudes of possible side effects. Forward step-wise inclusion of all variables found that three were significantly associated with visibility concerns. That is, adolescents who are currently using Norplant were 14 times more likely to be concerned about this problem than those using other types of contraceptive methods. In addition, sexually active adolescents were much more likely to be concerned. Finally, socioeconomic status was also found to relate to visibility concerns. Specifically, as the teens socioeconomic status increased, it was more likely to be associated with increased concern over seeing and perhaps feeling these six cylindrical inserts. With regard to skin discoloration, only one variable was significantly associated with this potential side effect and that was pregnancy. Those adolescent females reporting a past history of pregnancy were almost three times more likely to be concerned with this when controlling for all other variables than those with no reported history of pregnancy. General safety of this newest contraceptive method was found to be significantly associated with two variables, Interestingly, those on Norplant were four Table 5. Odds Ratios and Confidence Intervals from Logistic Regression Analyses on Attitudes of Possible Side Effects Variable
Odds ratio
95% Conf. int.
Visibility concerns Contraceptive method Norplant vs. others Sexual activity Yes vs. No SES Pregnant Yes vs. no Contraceptive method Norplant vs. others SES Contraceptive method Norplant vs. others
13.7 3.5 1.02 Skin discoloration
(3.10,60.13) (1.44,7.92) (1.001, 1.042)
2.7 General concern
(1.38, 5.2)
4.4 1.02 Irregular menses
(1.7,11.5) (1.001, 1.04)
6.2
(2.1, 18.3)
74
Kozlowski et al.: Adolescents and Norplant
and a half times more likely to evidence concern about this contraceptive method even though they had already been implanted. In addition, those adolescents from reported higher levels of socioeconomic status were also likely to endorse general concern. With regard to irregular menses, those adolescents using Norplant were much more likely to be concerned with this side effect when controlling for the effects of all other variables. Discussion
The high rate of teenage pregnancy illustrates the difficulty of contraceptive management in adolescent females. Poor compliance with previously available methods of contraceptives (OCPs, diaphragms, condoms, etc.) have been cited as a major factor. The introduction of Norplant offers a new type of effective, continuous, long-term contraception requiring minimal user compliance. Successful implementation of any form of contraception requires adequate patient education and well-informed decisions. Written materials, pamphlets, and video presentations providing information about Norplant and its associated side effects are available through most health care facilities, but despite this, many of our study participants had difficulty correctly answering 50% of the knowledge questions regarding Norplant. This may reflect the lack of female adolescents' medical exposure and the associated counseling, as well as the inaccuracy of knowledge gained from informal, non-health care-related media avenues. Of the patients exhibiting higher levels of knowledge pertaining to Norplant, associated factors included current Norplant use, past history of pregnancy, positive history of STD, and advanced adolescent age. These characteristics reflect an increased sexual awareness and increased exposure to health care providers with the corresponding additional counseling received. As previously described, Norplant is associated with a number of side effects and cosmetic changes, but adolescent attitudes towards its use was generally positive. However, we were specifically interested in identifying potential side effects that might incite dissatisfaction and subsequent Norplant removal. Questions presented that addressed these issues included concerns wearing sleeveless tops, possible skin discoloration at implantation site, general safety associated with Norplant use, and concerns regarding irregular uterine bleeding. Occasionally, Norplant capsules may be visible by close observation in a woman wearing a sleeveless top. Likewise, skin discoloration secondary to progestin release also would be visible if it oc-
curred. The adolescents who tended to be most concerned with these side effects were sexually active Caucasian females who had not experienced any documented STDs. Interestingly, adolescents who had previously been pregnant or currently were using Norplant or some other form of contraception were more apt to be upset with skin discoloration occurring with Norplant use. Only 3% of adolescent females currently using Norplant expressed concern about wearing sleeveless tops. Regarding the general safety of Norplant, adolescent females that had never been pregnant and were using some other form of birth control expressed concern associated with its safety. Overall, however, over two-thirds of adolescents felt Norplant was safe. Finally, irregular menses was identified as a significant concern for the majority of participants sampled and would affect their satisfaction with Norplant despite being forewarned of this effect at the time of insertion. The most common adolescent female characteristics associated with concern for irregular bleeding were sexually active Caucasian females using some other form of contraception who had never had a STD or been pregnant. Approximately one out of four adolescent females expressing concern currently were using Norplant. Interestingly, this side effect was listed as a significant concern in another Norplant study involving women aged approximately 10 years older than our study sample. The majority of their study participants were willing to tolerate irregular bleeding in order to use what they felt was a safe and effective method of birth control. In their study, menstrual abnormalities was the only side effect consistently tolerated, and others such as weight changes, acne, headaches, and depression were often poorly tolerated and led to removal of the implants." This has led some centers to test patient tolerance of a progestin-only contraceptive with a short course of an oral formulation prior to placement of Norplant. Conclusion
Patient satisfaction and successful utilization of Norplant depends on adequate knowledge and accurate perceptions of its use. Counseling by health care providers when discussing contraceptive methods and at the time of Norplant placement improves patients' level of knowledge, but continued misperceptions and inaccurate knowledge may still exist leading to patient dissatisfaction. Counseling detailing potential side effects and cosmetic changes should be performed at each visit. Because of Norplant's long-term duration of action and the poten-
Kozlowski et al.:
Adolescents and Norplant
tial of associated side effects, a short course of progestin-only oral preparation may be considered prior to Norplant placement.
References 1. Henshaw SK, Van Vort J: Teenage abortion, birth, and pregnancy statistics: an update: Fam Plann Perspect 1989; 21:85 2. U.S. Dept of Health and Human Services: Health people 2000: National Health Promotion and disease objectives. 1990. Washington, DC, U.S. Government printing office; (PHS) 91-50-212 3. Moore KA, Simms MC, Betsey CL: Choice and Circumstance: Racial Differences in Adolescent Sexuality and Fertility. New Brunswick, NJ, Transaction Books, 1986
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4. Mosher WD, Pratt WF: Contraceptive Use in the United States, 1973-1988. National Center for Health Statistics. Advance Data. 1990; 182: 1 5. DuRant RH, Jay MS: A social psychologic model of female adolescents' compliance with contraceptives. Semin Adolesc Med 1987; 3:135 6. Wyeth Laboratories, Inc: Conference Proceedings. Presented at the Norplant Investigators Symposium, January 25-28, 1990. Palm Desert, CA 7. Sivin R: International experience with Norplant and Norplant-2 contraceptive. Study Fam Plann 1988; 19: 81 8. Wyeth Laboratories, Inc: Investigational Drug Brochure. General Report on Levonorgestrel (#5104), 1989 9. Darney PB, Atkinson E, et al: Acceptance and perceptions of Norplant among users in San Francisco, USA. Stud Fam Plann 1990; 21; 3:152