- Email: [email protected]
Utilization of Home Pregnancy Testing Among Women at Risk for Unintended Pregnancy
Women’s Health Issues 19 (2009) 263–267
www.whijournal.com
UTILIZATION OF HOME PREGNANCY TESTING AMONG WOMEN AT RISK FOR UNINTENDED PREGNANCY Mary D. Nettleman, MD, MSa,*, Adejoke B. Ayoola, RN, PhDb, and Jennifer R. Brewer, MAa a
Department of Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan b Assistant Professor, Department of Nursing, Calvin College, Grand Rapids, Michigan Received 25 August 2008; revised 17 March 2009; accepted 18 March 2009
Purpose. We sought to determine whether a brief intervention increased home pregnancy test utilization among women at risk for unintended pregnancy. Methods. The intervention included education, consultation with a nurse, and the provision of a free home pregnancy test kit. Participants were 35 women aged 18–39 years from a Medicaid population who were having unprotected intercourse and who were not trying to conceive. The women received education on pregnancy testing and the importance of early recognition of pregnancy. All women received a free home pregnancy test kit. The main outcome measures were pregnancy test use and appropriateness of use. Main Findings. During the 3-month follow-up period, 62% of participants used the home pregnancy test kit, which was approximately 3 times higher than the self-reported testing rate before the study (p , .001). The most common reason for use was a late period (median 5 days late when test was done). Women also purchased additional kits to confirm the initial test result (median 2 kits per episode of use). Conclusion. The intervention increased utilization of home pregnancy test kits among women at risk of unintended pregnancy. All study participants used the test appropriately. These results can serve as a framework for interventions to improve early pregnancy recognition.
Introduction
D
espite advances in contraception and attempts to reduce unintended pregnancies, many adult women admit to having unprotected intercourse when they were not trying to conceive (Ahluwalia, Whitehead, & Beensyl, 2007). Unfortunately, population-based studies have shown that women with unintended pregnancies recognize their pregnancies later than women who are trying to conceive (Kost, Landry, and Darroch, 1998; Floyd, Decoufle, & Hungerford, 1999). Delayed recognition of pregnancy is associated with inadvertent continuation of risk behaviors that affect the health of the fetus and is also associated with delayed entry into prenatal care (Centers for Disease
Funded in part by a grant from the Michigan Department of Community Health. * Correspondence to: Mary D. Nettleman, MD, MS, Professor of Medicine, Michigan State University College of Human Medicine, B427 Clinical Center, East Lansing, Michigan 48823. E-mail: [email protected]. Copyright Ó 2009 by the Jacobs Institute of Women’s Health. Published by Elsevier Inc.
Control and Prevention [CDC], 2000). Once pregnancy is recognized, most women adopt healthier behaviors and reduce or eliminate behaviors that may adversely affect the fetus (Kost et al., 1998; Pirie, Lando, Curry, McBride, & Grothaus, 2000). Thus, it is logical to encourage women at risk for unintended pregnancy to test promptly for pregnancy when menses are late or pregnancy is suspected (Peacock et al., 2001). Standard preconceptual guidelines, however, do not include recommendations for early testing when pregnancy is suspected (CDC, 2006). In part, this may be because it is unclear whether women at risk would be willing to test more frequently. Home pregnancy testing is an option that allows a woman to determine her pregnancy status conveniently and rapidly. Observational studies have linked use of home pregnancy tests with earlier recognition of conception (Morroni & Moodley, 2007). However, data from 1988 showed that only 33% of U.S. women had used a home pregnancy test (Hatcher et al., 2007), and that use was more common among older, white, 1049-3867/09 $-See front matter. doi:10.1016/j.whi.2009.03.006
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married, highly educated women. Less is known about the current acceptability or use of home pregnancy testing in women from other populations such as unmarried women from lower income populations or women at high risk for unintended pregnancy. We hypothesized that receiving an intervention with educational and motivational components, and having a test kit on hand would increase test utilization among adult women at risk for unintended pregnancy. Methods Flyers announcing the study were mailed to women residing in a single urban area. The mailing list was obtained from a commercial marketing source (Alesco Data Group; available from: alescoleads.com) and was focused on households with unmarried women between the ages of 18 and 39 with a household income of less than $30,000. Interested women were directed to call a phone number for more information. Callers went through an automated telephone screener to assess eligibility. Women were eligible if they were between 18 and 39 years of age, were receiving Medicaid or had a child on Medicaid, were unmarried, not sterile, were sexually active, not pregnant, not currently trying to get pregnant, and reported at least one episode of unprotected intercourse in the past 6 months. Unprotected sex was defined as vaginal intercourse with a fertile male without the use of barrier or hormonal methods or emergency contraception. Medicaid status was included in the eligibility requirements because a goal was to provide recommendations to the Medicaid program. Women who were eligible and interested were asked to call a research assistant who explained the study and scheduled an appointment if the woman agreed. Participants were mailed a copy of the informed consent document before their visit and had an opportunity to discuss the study in person when they arrived in clinic. All participants provided written informed consent and the study was approved by the Institutional Review Board. The project was conceived as a pilot study to determine the feasibility of a larger, randomized, controlled trial. The anticipated sample size for the study was 35 women. According to the National Survey of Family Growth, 8% of women in this age group are not using hormonal contraception, but are sexually active and fertile (Chandra, Martinez, Mosher, Abma, & Jones, 2005). Because of the additional eligibility criteria for our study (not desiring pregnancy, income status), we mailed the flyer to 3,500 addresses. Enrollment was closed after the first 35 eligible women were enrolled. Participants attended a clinic visit where they viewed a 25-minute educational video about early
pregnancy and the importance of early pregnancy recognition. Early pregnancy education included a primer on early fetal development and the effects of folic acid, smoking, alcohol, hypertension, and hyperglycemia on the developing fetus. Basic information about conception and contraception was also provided. The video was a narrated PowerPoint presentation based on information from the literature and the CDC website (www.cdc.gov/ncbddd/preconception). Participants completed a pre- and post-video survey. The acronym ‘‘FRAMES’’ is used to describe the features of effective brief interventions (Bien, Miller, & Tonigan, 2005): Feedback, Responsibility for change lying with the individual, Advice-giving, providing a Menu of change options, an Empathic counseling style, and the enhancement of Self-efficacy. The components of the ‘‘brief intervention’’ were used to increase women’s knowledge and improve motivation to use pregnancy test kit. A nurse was trained to use reflective listening during interactions with the women and encouraged the participants to identify ways to recognize pregnancy early, providing guidance rather than dictating direction (Rollnick et al., 2005). A change plan was developed by the participant to describe her plans with respect to using home pregnancy test to recognize pregnancy early. Women were informed that a negative test was not 95% reliable until 1 day after a missed period was due. Earlier testing was not considered to be inappropriate unless the woman’s period was late and she failed to do a confirmatory test. Upon leaving, each participant received a ‘‘Planning Pack’’ that included information on early pregnancy recognition and a copy of the participant’s change plan. A commercially available, Food and Drug Administration-approved pregnancy test kit with two test strips was included in the Planning Pack (One StepPregnancy Test, Sales Enterprises, Inc, Rockville MD). For women with specific medical problems (e.g., smoking, obesity, high blood pressure, diabetes), additional brochures about the impact of the condition in pregnancy were included. Brochures were obtained from March of Dimes and the American College of Obstetrics and Gynecology. Contraception was not provided as part of the intervention. However, participants were provided with a list of community resources where contraception could be obtained. A follow-up phone call was made by the nurse approximately 2 weeks after the clinic visit. The purpose of the phone call was to ask if the participant had any questions and to review the change plan. Participants were invited to return to the clinic at 3 months for follow-up and completed the follow-up survey. Results were analyzed descriptively. The primary outcome measures were use of the home pregnancy test kit and appropriateness of use. Differences in categorical data between pregnancy testing before and after the intervention were evaluated using the Fisher
M. D. Nettleman et al. / Women’s Health Issues 19 (2009) 263–267
and the c2 tests. The p-value for statistical significance was set at .05 (2 sided). Results The 35 women had a median age of 27, a median household income of less than $20,000 per year, and had intercourse with an average of 1.25 male partners in the past 6 months. Only 20% had used a home pregnancy test in the previous 6 months (Table 1), although 91% had used at least 1 test in their lifetime. The women had an incomplete understanding of recommendations for and events in early pregnancy. Only 22 (63%) of women thought that folic acid was recommended for all pregnant women, and only 9 (26%) knew that folic acid could reduce the risk of neurologic defects. Similarly, only 22 women (63%) thought that behavioral change should occur before conception in women at risk for pregnancy. Thirty-four women completed the 3-month followup survey (97%); one was lost to follow-up. Of the 34 women, 21 (62%) used a home pregnancy test at least once during the 3-month follow-up compared with 20% in the 6-month period before the intervention (p , .001). These 21 women cited an average of 1.4 reasons each for using the test (Table 2). Women used between one and five tests per episode (mean, 2.1). An episode was defined as testing that occurred within a single monthly menstrual cycle. Women were followed for 3 months. Women who used multiple tests purchased the additional test kits on their own. Of those who used multiple tests per episode, one woman used the second test to demonstrate the result to another person. The remaining women used multiple tests to confirm the first result. Some women felt that a more expensive test would be more accurate or preferred a brand name to the generic test provided by the study. There were 15 late periods reported during the 3 month follow-up, occurring in 13 women (38% of participants). These periods were a median of 10 days late. A pregnancy test was used in 10 of these 15 late periods Table 1. Baseline Characteristics (n ¼ 35)
Education: high school or above Any previous pregnancy Previous unintended pregnancy Used a home pregnancy test in the past 6 months Caucasian African-American Body mass index > 30 High blood pressure Current smoker Diabetes diagnosis More than 7 drinks per week or >5 per occasion in the past 6 months
n
%
33 32 23 7
94 91 66 20
19 14 17 2 16 1 4
54 40 49 6 46 3 11
265
Table 2. Reasons for Using a Home Pregnancy Test (n ¼ 21 women testing) Reason*
n
%
Unprotected sex Period was late Physical symptoms suspicious for pregnancy Did not trust the effectiveness of their contraception Needed test before starting contraception
13 10 5
62 48 24
1
5
1
5
* Women could choose multiple reasons.
(67%), which were used an average of 6 days after the period was due. One woman used the test 2 days before her period was due because she had symptoms of pregnancy and the test was positive. Five women with late periods did not use a pregnancy test. Two of these women were sexually abstinent that month. Three stated that they had planned to test, but that their period was only late by 1 or 2 days. Twelve women who did not have a missed period still used the pregnancy test. These women tested before their period was due. One woman used the test before starting hormonal birth control. Eleven women used the test because they had unprotected sex. From the survey results, these women understood that the test was not reliable when used before a missed period. All 11 subsequently had a period that started on time All women who used a pregnancy test felt that they understood the directions and used the test appropriately. All women demonstrated proficiency in using the home pregnancy test kit when observed by the nurse. Fifty-nine percent had at least one episode of unprotected sex during the 3-month follow-up, compared with 100% during the 6 months before the intervention (p , .01).
Discussion A brief, educational intervention coupled with a free home test kit was associated with an increased utilization of home pregnancy testing among adult women at risk for unintended pregnancy. All test use met the definition for appropriateness and all participants were able to demonstrate appropriate technique when using the test. This simple approach has the potential to increase use of home testing for pregnancy and possibly reduce delays in pregnancy recognition. Although home pregnancy test kits are readily available in stores, women who spontaneously purchase them may differ from those who are tested in clinicbased settings. Studies of adolescents indicate that those who used home pregnancy tests were more likely to have had a previous pregnancy, an earlier age at sexual debut, and were less likely to use contraception consistently (Shew, Hellerstedt, Sieving, Smith, & Fee, 2000). Less is known about test use in adult
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women. Our study showed that it was possible to increase the utilization of home pregnancy tests in a sample of adult women at risk of unintended pregnancy. Other studies have shown that brief education and motivation can affect contraception and drinking in adult women having unprotected intercourse (Ingersoll et al., 2005; Floyd et al., 2007). These studies involved one or more sessions with a trained counselor. In contrast, our study was nurse-based and focused on increasing testing for pregnancy in a population at risk. The reason for the increase in testing is likely to be multifactorial. There is a level of inconvenience and loss of privacy associated with driving to a store to purchase a test. By supplying a free test kit, the study may have lowered perceived barriers to testing (Rockett, Buck, Lynch, & Perreault, 2004). Willingness to test and awareness of the importance of testing could have been increased by the video and nurse-based intervention. Manufacturers recommend that women with negative tests undergo retesting in a few days if they continue to suspect pregnancy and the intervention included this information (Bastian, Nanda, Hasselblad, & Simel, 1998; Cole, Khanlian, Sutton, Davies, & Rayburn, 2004). Interestingly, most women who used the home pregnancy test kit also purchased and used additional kits to confirm that the results of the first test were accurate. There are some disadvantages to home pregnancy testing. Home testing does not allow for on-site counseling by a health professional, who could arrange prenatal care if the test were positive during a clinic visit. In addition, negative tests afford an opportunity for preconceptual counseling in a clinical setting (Zabin, Emerson, Ringers, & Sedivy, 1996). There is also a risk that a woman will not know how to use the test correctly or will rely on a false result, although this was not the case in our study. Although the study results are limited to utilization of pregnancy tests, the ultimate goal of increased testing would be to recognize a pregnancy as early as possible. Early pregnancy is an important time for fetal development. If women do not realize they are pregnant, they may inadvertently continue risk behaviors, including taking medications that affect fetal development. Of note, delays in pregnancy recognition have also been associated with later term abortions (Finer, Frohwirth, Dauphinee, Singh, & Moore, 2006). Delayed pregnancy recognition is particularly common among women who were not trying to get pregnant at the time of conception. Thus, unintended pregnancies are not recognized as promptly as intended pregnancies. However, once pregnancy is recognized, studies have shown that women actively attempt to reduce unhealthy behaviors regardless of intention status (Kost et al., 1998; Pirie et al., 2000). This study used a commercial mailing list to recruit participants. This is an inexpensive and effective method of contacting potentially eligible women, costing 4.5
cents per address in our study. Mailing lists can be purchased for addresses associated with specific income levels, marital status, gender, and locality. This approach may be useful to study the effects of home pregnancy testing in specific populations. Although most women in this population have visited clinics at some time to obtain contraception or other services, clinic-based recruitment is often time consuming and is limited to the population seeking care in the clinic at any given time. If home pregnancy testing is proven to be useful for increasing early pregnancy recognition or improving birth outcomes, a population-based approach to distribution might be more cost effective than clinic-based distribution models. This is an important policy issue that deserves future study: Home pregnancy test kits can cost as little as $1, creating the potential for significant cost savings in Medicaid programs. Although increased testing may be associated with reduced episodes of unprotected sex, our study did not include a control group to assess this finding further. In other studies in similar populations, approximately 28% of women in a control group stopped having unprotected sex over a 3-month period of time (Floyd et al., 2007). In our small study, 41% of women stopped having unprotected sex. Larger, controlled studies are needed to determine if this is an effect of the intervention. The study is subject to several limitations. Statistically significant increases in test kit use were seen, but the sample size was small and may not be representative of larger populations. The increase in testing could have been caused by the educational video, the nurse’s brief intervention, and/or by the convenience of having the free test kit on hand when it was needed. Further research is needed to determine the relative impact of these components. The study was confined to the use of pregnancy testing among women at risk. Larger studies are needed to determine the effect of testing on pregnancy recognition, prenatal care, birth outcomes, or miscarriage/termination rates. Another limitation was that follow-up was limited to a 3-month period. To address these limitations, a larger, controlled study is needed. Finally, the study was confined to adult women who were unmarried and from a low-income population. Women in higher socioeconomic groups or married women may differ in their willingness to use home pregnancy tests. Current programs for unintended pregnancy, such as Title X of the Public Service Act (Gold, 2001; Stewart, Shields, & Hwang, 2003) have focused primarily on prevention through increasing access to contraception. Michigan has an additional program (Plan First!) granted in 2006 under a demonstration waiver that provides selected family planning services to women up to 185% of poverty level (Michigan Department of Community Health, 2006). Many programs cover clinicbased testing for suspected pregnancy and a few programs (State of Georgia, 2007) have allowed
M. D. Nettleman et al. / Women’s Health Issues 19 (2009) 263–267
individual providers to distribute pregnancy test kits for women to have on hand. However, the programs do not reimburse a woman if she purchases a home test kit. The ultimate goal of this line of research is to reduce delays in pregnancy recognition and improve birth outcomes. Despite the emphasis on preconceptual health, many women enter pregnancy with medical conditions or behaviors that are potentially detrimental to the fetus. A delay in pregnancy recognition can expose the fetus to an adverse environment and is a primary cause of delayed prenatal care (CDC, 2000). Thus, it is logical to increase the utilization of pregnancy tests among women at risk for delayed recognition. In this study, the frequency of home pregnancy testing increased after a brief, nurse-based intervention coupled with provision of a free test kit. These results provide a framework for future investigations in the emerging field of pregnancy recognition. References Ahluwalia, I. B., Whitehead, N., & Bensyl, D. (2007). Pregnancy intention and contraceptive use among adult women. Maternal and Child Health Journal, 11, 347–351. Bastian, L. A., Nanda, K., Hasselblad, V., & Simel, D. L. (1998). Diagnostic efficiency of home pregnancy test kits: A meta-analysis. Archives of Family Medicine, 7, 465–470. Bien, T. H., Miller, W. R., & Tonigan, J. S. (1993). Brief interventions for alcohol problems: A review. Addiction, 88, 315–336. Centers for Disease Control and Prevention (CDC). (2000). Entry into prenatal care—United States, 1989–1997. Morbidity and Mortality Weekly Report, 48, 393–398. Centers for Disease Control and Prevention (CDC). (2006). Recommendations to improve preconception health and health care—United States. Morbidity and Mortality Weekly Report, 55(RR06), 1–23. Chandra, A., Martinez, G.M., Mosher, W.D., Abma, J.C., & Jones, J. (2005). Fertility, family planning, and reproductive health of U.S. women: Data from the 2002 National Survey of Family Growth. National Center for Health Statistics. Vital Health Statistics, 23. Cole, L. A., Khanlian, S. A., Sutton, J. M., Davies, S., & Rayburn, W. F. (2004). Accuracy of home pregnancy tests at the time of missed menses. American Journal of Obstetrics and Gynecology, 190, 100–105. Finer, L. B., Frohwirth, L. F., Dauphinee, A., Singh, S., & Moore, A. M. (2006). Timing of steps and reasons for delays in obtaining abortions in the United States. Contraception, 74, 334–344. Floyd, R. L., Decoufle, P., & Hungerford, D. W. (1999). Alcohol use prior to pregnancy recognition. American Journal of Preventive Medicine, 17, 101–107. Floyd, R. L., Sobell, M., Velasquez, M. M., Ingersoll, K., Nettleman, M. D., Sobell, L., et al., , on behalf of the Project CHOICES Efficacy Study Group. (2007). Preventing alcohol-exposed pregnancies: A randomized controlled trial. American Journal of Preventive Medicine, 32, 1–10. Gold, R. B. (2001, February). Title X: Three decades of accomplishment. The Guttmacher Report on Public Policy, 5–8. Hatcher, R. A., Trussell, J., Stewart, F., Nelson, A., Cates, W., & Guest, F. (Eds.). (2007). Contraceptive technology (18th ed). New York: Ardent Media.
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Ingersoll, K., Ceperich, S., Nettleman, M., Karanda, K., Brocksen, S., & Johnson, B. A. (2005). Reducing alcohol-exposed pregnancy risk in college women: Initial outcomes of a clinical trial of a motivational intervention. Journal of Substance Abuse Treatment, 29, 173–180. Kost, K., Landry, D. J., & Darroch, J. E. (1998). Predicting maternal behaviors during pregnancy: Does intention status matter? Family Planning Perspectives, 30, 79–88. Michigan Department of Community Health. Reducing Unintended Pregnancy in Michigan. (2006). Available: www.michigan.gov/ documents/mdch/Media_Kit_-Governors_Blueprint_to_Prevent _Unintended_Pregnancies_175294_7.pdf. Accessed August 19, 2008. Morroni, C., & Moodley, J. (2007). The role of urine pregnancy testing in facilitating access to antenatal care and abortion services in South Africa: A cross-sectional study. BMC Pregnancy and Childbirth, 6, 26. Peacock, N. R., Kelley, M. A., Carpenter, C., Davis, M., Burnett, G., Chavz, N., et al. (2001). Pregnancy discovery and acceptance among low-income primiparous women: A multicultural exploration. Maternal and Child Health Journal, 5, 109–118. Pirie, P. L., Lando, H., Curry, S. J., McBride, C. M., & Grothaus, L. C. (2000). Tobacco, alcohol, and caffeine use and cessation in early pregnancy. American Journal of Preventive Medicine, 18, 54–61. Rockett, J. C., Buck, G. M., Lynch, C. D., & Perreault, S. D. (2004). The value of home-based collection of biospecimens in reproductive epidemiology. Environmental Health Perspectives, 112, 94–104. Rollnick, S., Butler, C. C., McCambridge, J., Kinnersley, P., Elwyn, G., & Resnicow, K. (2005). Consultations about changing behaviour. BMJ, 331, 961–963. Shew, M. L., Hellerstedt, W. L., Sieving, R. E., Smith, A. E., & Fee, R. M. (2000). Prevalence of home pregnancy testing among adolescents. American Journal of Public Health, 90, 974–976. State of Georgia. (2007). Maternal and Child Health Services, Title V Block Grant, Application for 2007 and report for 2005. Available: https://perfdata.hrsa.gov/mchb/mchreports/ documents/2007/ Narratives/GA-Narratives.pdf. Stewart, F. H., Shields, W. C., & Hwang, A. C. (2003). Title X: A surefire investment with at least a 300% return. Contraception, 68, 1. Zabin, L. S., Emerson, M. R., Ringers, P. A., & Sedivy, V. (1996). Adolescents with negative pregnancy test results. An accessible atrisk group. Journal of the American Medical Association, 275, 113– 117.
Author Descriptions Mary Nettleman is a women’s health researcher who is interested in contraception, early pregnancy recognition and preconceptional health. She is Professor and Chair of Medicine at Michigan State University’s College of Human Medicine. Adejoke Ayoola is a nurse and assistant professor at Calvin College Department of Nursing. Before coming to Calvin College, she served as a registered/licensed midwife and Public Health Nurse in Nigeria. Her research focuses on early pregnancy recognition and its impact on prenatal care and birth outcomes. Jennifer Brewer is research assistant at Michigan State University.
www.whijournal.com
UTILIZATION OF HOME PREGNANCY TESTING AMONG WOMEN AT RISK FOR UNINTENDED PREGNANCY Mary D. Nettleman, MD, MSa,*, Adejoke B. Ayoola, RN, PhDb, and Jennifer R. Brewer, MAa a
Department of Medicine, College of Human Medicine, Michigan State University, East Lansing, Michigan b Assistant Professor, Department of Nursing, Calvin College, Grand Rapids, Michigan Received 25 August 2008; revised 17 March 2009; accepted 18 March 2009
Purpose. We sought to determine whether a brief intervention increased home pregnancy test utilization among women at risk for unintended pregnancy. Methods. The intervention included education, consultation with a nurse, and the provision of a free home pregnancy test kit. Participants were 35 women aged 18–39 years from a Medicaid population who were having unprotected intercourse and who were not trying to conceive. The women received education on pregnancy testing and the importance of early recognition of pregnancy. All women received a free home pregnancy test kit. The main outcome measures were pregnancy test use and appropriateness of use. Main Findings. During the 3-month follow-up period, 62% of participants used the home pregnancy test kit, which was approximately 3 times higher than the self-reported testing rate before the study (p , .001). The most common reason for use was a late period (median 5 days late when test was done). Women also purchased additional kits to confirm the initial test result (median 2 kits per episode of use). Conclusion. The intervention increased utilization of home pregnancy test kits among women at risk of unintended pregnancy. All study participants used the test appropriately. These results can serve as a framework for interventions to improve early pregnancy recognition.
Introduction
D
espite advances in contraception and attempts to reduce unintended pregnancies, many adult women admit to having unprotected intercourse when they were not trying to conceive (Ahluwalia, Whitehead, & Beensyl, 2007). Unfortunately, population-based studies have shown that women with unintended pregnancies recognize their pregnancies later than women who are trying to conceive (Kost, Landry, and Darroch, 1998; Floyd, Decoufle, & Hungerford, 1999). Delayed recognition of pregnancy is associated with inadvertent continuation of risk behaviors that affect the health of the fetus and is also associated with delayed entry into prenatal care (Centers for Disease
Funded in part by a grant from the Michigan Department of Community Health. * Correspondence to: Mary D. Nettleman, MD, MS, Professor of Medicine, Michigan State University College of Human Medicine, B427 Clinical Center, East Lansing, Michigan 48823. E-mail: [email protected]. Copyright Ó 2009 by the Jacobs Institute of Women’s Health. Published by Elsevier Inc.
Control and Prevention [CDC], 2000). Once pregnancy is recognized, most women adopt healthier behaviors and reduce or eliminate behaviors that may adversely affect the fetus (Kost et al., 1998; Pirie, Lando, Curry, McBride, & Grothaus, 2000). Thus, it is logical to encourage women at risk for unintended pregnancy to test promptly for pregnancy when menses are late or pregnancy is suspected (Peacock et al., 2001). Standard preconceptual guidelines, however, do not include recommendations for early testing when pregnancy is suspected (CDC, 2006). In part, this may be because it is unclear whether women at risk would be willing to test more frequently. Home pregnancy testing is an option that allows a woman to determine her pregnancy status conveniently and rapidly. Observational studies have linked use of home pregnancy tests with earlier recognition of conception (Morroni & Moodley, 2007). However, data from 1988 showed that only 33% of U.S. women had used a home pregnancy test (Hatcher et al., 2007), and that use was more common among older, white, 1049-3867/09 $-See front matter. doi:10.1016/j.whi.2009.03.006
264
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married, highly educated women. Less is known about the current acceptability or use of home pregnancy testing in women from other populations such as unmarried women from lower income populations or women at high risk for unintended pregnancy. We hypothesized that receiving an intervention with educational and motivational components, and having a test kit on hand would increase test utilization among adult women at risk for unintended pregnancy. Methods Flyers announcing the study were mailed to women residing in a single urban area. The mailing list was obtained from a commercial marketing source (Alesco Data Group; available from: alescoleads.com) and was focused on households with unmarried women between the ages of 18 and 39 with a household income of less than $30,000. Interested women were directed to call a phone number for more information. Callers went through an automated telephone screener to assess eligibility. Women were eligible if they were between 18 and 39 years of age, were receiving Medicaid or had a child on Medicaid, were unmarried, not sterile, were sexually active, not pregnant, not currently trying to get pregnant, and reported at least one episode of unprotected intercourse in the past 6 months. Unprotected sex was defined as vaginal intercourse with a fertile male without the use of barrier or hormonal methods or emergency contraception. Medicaid status was included in the eligibility requirements because a goal was to provide recommendations to the Medicaid program. Women who were eligible and interested were asked to call a research assistant who explained the study and scheduled an appointment if the woman agreed. Participants were mailed a copy of the informed consent document before their visit and had an opportunity to discuss the study in person when they arrived in clinic. All participants provided written informed consent and the study was approved by the Institutional Review Board. The project was conceived as a pilot study to determine the feasibility of a larger, randomized, controlled trial. The anticipated sample size for the study was 35 women. According to the National Survey of Family Growth, 8% of women in this age group are not using hormonal contraception, but are sexually active and fertile (Chandra, Martinez, Mosher, Abma, & Jones, 2005). Because of the additional eligibility criteria for our study (not desiring pregnancy, income status), we mailed the flyer to 3,500 addresses. Enrollment was closed after the first 35 eligible women were enrolled. Participants attended a clinic visit where they viewed a 25-minute educational video about early
pregnancy and the importance of early pregnancy recognition. Early pregnancy education included a primer on early fetal development and the effects of folic acid, smoking, alcohol, hypertension, and hyperglycemia on the developing fetus. Basic information about conception and contraception was also provided. The video was a narrated PowerPoint presentation based on information from the literature and the CDC website (www.cdc.gov/ncbddd/preconception). Participants completed a pre- and post-video survey. The acronym ‘‘FRAMES’’ is used to describe the features of effective brief interventions (Bien, Miller, & Tonigan, 2005): Feedback, Responsibility for change lying with the individual, Advice-giving, providing a Menu of change options, an Empathic counseling style, and the enhancement of Self-efficacy. The components of the ‘‘brief intervention’’ were used to increase women’s knowledge and improve motivation to use pregnancy test kit. A nurse was trained to use reflective listening during interactions with the women and encouraged the participants to identify ways to recognize pregnancy early, providing guidance rather than dictating direction (Rollnick et al., 2005). A change plan was developed by the participant to describe her plans with respect to using home pregnancy test to recognize pregnancy early. Women were informed that a negative test was not 95% reliable until 1 day after a missed period was due. Earlier testing was not considered to be inappropriate unless the woman’s period was late and she failed to do a confirmatory test. Upon leaving, each participant received a ‘‘Planning Pack’’ that included information on early pregnancy recognition and a copy of the participant’s change plan. A commercially available, Food and Drug Administration-approved pregnancy test kit with two test strips was included in the Planning Pack (One StepPregnancy Test, Sales Enterprises, Inc, Rockville MD). For women with specific medical problems (e.g., smoking, obesity, high blood pressure, diabetes), additional brochures about the impact of the condition in pregnancy were included. Brochures were obtained from March of Dimes and the American College of Obstetrics and Gynecology. Contraception was not provided as part of the intervention. However, participants were provided with a list of community resources where contraception could be obtained. A follow-up phone call was made by the nurse approximately 2 weeks after the clinic visit. The purpose of the phone call was to ask if the participant had any questions and to review the change plan. Participants were invited to return to the clinic at 3 months for follow-up and completed the follow-up survey. Results were analyzed descriptively. The primary outcome measures were use of the home pregnancy test kit and appropriateness of use. Differences in categorical data between pregnancy testing before and after the intervention were evaluated using the Fisher
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and the c2 tests. The p-value for statistical significance was set at .05 (2 sided). Results The 35 women had a median age of 27, a median household income of less than $20,000 per year, and had intercourse with an average of 1.25 male partners in the past 6 months. Only 20% had used a home pregnancy test in the previous 6 months (Table 1), although 91% had used at least 1 test in their lifetime. The women had an incomplete understanding of recommendations for and events in early pregnancy. Only 22 (63%) of women thought that folic acid was recommended for all pregnant women, and only 9 (26%) knew that folic acid could reduce the risk of neurologic defects. Similarly, only 22 women (63%) thought that behavioral change should occur before conception in women at risk for pregnancy. Thirty-four women completed the 3-month followup survey (97%); one was lost to follow-up. Of the 34 women, 21 (62%) used a home pregnancy test at least once during the 3-month follow-up compared with 20% in the 6-month period before the intervention (p , .001). These 21 women cited an average of 1.4 reasons each for using the test (Table 2). Women used between one and five tests per episode (mean, 2.1). An episode was defined as testing that occurred within a single monthly menstrual cycle. Women were followed for 3 months. Women who used multiple tests purchased the additional test kits on their own. Of those who used multiple tests per episode, one woman used the second test to demonstrate the result to another person. The remaining women used multiple tests to confirm the first result. Some women felt that a more expensive test would be more accurate or preferred a brand name to the generic test provided by the study. There were 15 late periods reported during the 3 month follow-up, occurring in 13 women (38% of participants). These periods were a median of 10 days late. A pregnancy test was used in 10 of these 15 late periods Table 1. Baseline Characteristics (n ¼ 35)
Education: high school or above Any previous pregnancy Previous unintended pregnancy Used a home pregnancy test in the past 6 months Caucasian African-American Body mass index > 30 High blood pressure Current smoker Diabetes diagnosis More than 7 drinks per week or >5 per occasion in the past 6 months
n
%
33 32 23 7
94 91 66 20
19 14 17 2 16 1 4
54 40 49 6 46 3 11
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Table 2. Reasons for Using a Home Pregnancy Test (n ¼ 21 women testing) Reason*
n
%
Unprotected sex Period was late Physical symptoms suspicious for pregnancy Did not trust the effectiveness of their contraception Needed test before starting contraception
13 10 5
62 48 24
1
5
1
5
* Women could choose multiple reasons.
(67%), which were used an average of 6 days after the period was due. One woman used the test 2 days before her period was due because she had symptoms of pregnancy and the test was positive. Five women with late periods did not use a pregnancy test. Two of these women were sexually abstinent that month. Three stated that they had planned to test, but that their period was only late by 1 or 2 days. Twelve women who did not have a missed period still used the pregnancy test. These women tested before their period was due. One woman used the test before starting hormonal birth control. Eleven women used the test because they had unprotected sex. From the survey results, these women understood that the test was not reliable when used before a missed period. All 11 subsequently had a period that started on time All women who used a pregnancy test felt that they understood the directions and used the test appropriately. All women demonstrated proficiency in using the home pregnancy test kit when observed by the nurse. Fifty-nine percent had at least one episode of unprotected sex during the 3-month follow-up, compared with 100% during the 6 months before the intervention (p , .01).
Discussion A brief, educational intervention coupled with a free home test kit was associated with an increased utilization of home pregnancy testing among adult women at risk for unintended pregnancy. All test use met the definition for appropriateness and all participants were able to demonstrate appropriate technique when using the test. This simple approach has the potential to increase use of home testing for pregnancy and possibly reduce delays in pregnancy recognition. Although home pregnancy test kits are readily available in stores, women who spontaneously purchase them may differ from those who are tested in clinicbased settings. Studies of adolescents indicate that those who used home pregnancy tests were more likely to have had a previous pregnancy, an earlier age at sexual debut, and were less likely to use contraception consistently (Shew, Hellerstedt, Sieving, Smith, & Fee, 2000). Less is known about test use in adult
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women. Our study showed that it was possible to increase the utilization of home pregnancy tests in a sample of adult women at risk of unintended pregnancy. Other studies have shown that brief education and motivation can affect contraception and drinking in adult women having unprotected intercourse (Ingersoll et al., 2005; Floyd et al., 2007). These studies involved one or more sessions with a trained counselor. In contrast, our study was nurse-based and focused on increasing testing for pregnancy in a population at risk. The reason for the increase in testing is likely to be multifactorial. There is a level of inconvenience and loss of privacy associated with driving to a store to purchase a test. By supplying a free test kit, the study may have lowered perceived barriers to testing (Rockett, Buck, Lynch, & Perreault, 2004). Willingness to test and awareness of the importance of testing could have been increased by the video and nurse-based intervention. Manufacturers recommend that women with negative tests undergo retesting in a few days if they continue to suspect pregnancy and the intervention included this information (Bastian, Nanda, Hasselblad, & Simel, 1998; Cole, Khanlian, Sutton, Davies, & Rayburn, 2004). Interestingly, most women who used the home pregnancy test kit also purchased and used additional kits to confirm that the results of the first test were accurate. There are some disadvantages to home pregnancy testing. Home testing does not allow for on-site counseling by a health professional, who could arrange prenatal care if the test were positive during a clinic visit. In addition, negative tests afford an opportunity for preconceptual counseling in a clinical setting (Zabin, Emerson, Ringers, & Sedivy, 1996). There is also a risk that a woman will not know how to use the test correctly or will rely on a false result, although this was not the case in our study. Although the study results are limited to utilization of pregnancy tests, the ultimate goal of increased testing would be to recognize a pregnancy as early as possible. Early pregnancy is an important time for fetal development. If women do not realize they are pregnant, they may inadvertently continue risk behaviors, including taking medications that affect fetal development. Of note, delays in pregnancy recognition have also been associated with later term abortions (Finer, Frohwirth, Dauphinee, Singh, & Moore, 2006). Delayed pregnancy recognition is particularly common among women who were not trying to get pregnant at the time of conception. Thus, unintended pregnancies are not recognized as promptly as intended pregnancies. However, once pregnancy is recognized, studies have shown that women actively attempt to reduce unhealthy behaviors regardless of intention status (Kost et al., 1998; Pirie et al., 2000). This study used a commercial mailing list to recruit participants. This is an inexpensive and effective method of contacting potentially eligible women, costing 4.5
cents per address in our study. Mailing lists can be purchased for addresses associated with specific income levels, marital status, gender, and locality. This approach may be useful to study the effects of home pregnancy testing in specific populations. Although most women in this population have visited clinics at some time to obtain contraception or other services, clinic-based recruitment is often time consuming and is limited to the population seeking care in the clinic at any given time. If home pregnancy testing is proven to be useful for increasing early pregnancy recognition or improving birth outcomes, a population-based approach to distribution might be more cost effective than clinic-based distribution models. This is an important policy issue that deserves future study: Home pregnancy test kits can cost as little as $1, creating the potential for significant cost savings in Medicaid programs. Although increased testing may be associated with reduced episodes of unprotected sex, our study did not include a control group to assess this finding further. In other studies in similar populations, approximately 28% of women in a control group stopped having unprotected sex over a 3-month period of time (Floyd et al., 2007). In our small study, 41% of women stopped having unprotected sex. Larger, controlled studies are needed to determine if this is an effect of the intervention. The study is subject to several limitations. Statistically significant increases in test kit use were seen, but the sample size was small and may not be representative of larger populations. The increase in testing could have been caused by the educational video, the nurse’s brief intervention, and/or by the convenience of having the free test kit on hand when it was needed. Further research is needed to determine the relative impact of these components. The study was confined to the use of pregnancy testing among women at risk. Larger studies are needed to determine the effect of testing on pregnancy recognition, prenatal care, birth outcomes, or miscarriage/termination rates. Another limitation was that follow-up was limited to a 3-month period. To address these limitations, a larger, controlled study is needed. Finally, the study was confined to adult women who were unmarried and from a low-income population. Women in higher socioeconomic groups or married women may differ in their willingness to use home pregnancy tests. Current programs for unintended pregnancy, such as Title X of the Public Service Act (Gold, 2001; Stewart, Shields, & Hwang, 2003) have focused primarily on prevention through increasing access to contraception. Michigan has an additional program (Plan First!) granted in 2006 under a demonstration waiver that provides selected family planning services to women up to 185% of poverty level (Michigan Department of Community Health, 2006). Many programs cover clinicbased testing for suspected pregnancy and a few programs (State of Georgia, 2007) have allowed
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individual providers to distribute pregnancy test kits for women to have on hand. However, the programs do not reimburse a woman if she purchases a home test kit. The ultimate goal of this line of research is to reduce delays in pregnancy recognition and improve birth outcomes. Despite the emphasis on preconceptual health, many women enter pregnancy with medical conditions or behaviors that are potentially detrimental to the fetus. A delay in pregnancy recognition can expose the fetus to an adverse environment and is a primary cause of delayed prenatal care (CDC, 2000). Thus, it is logical to increase the utilization of pregnancy tests among women at risk for delayed recognition. In this study, the frequency of home pregnancy testing increased after a brief, nurse-based intervention coupled with provision of a free test kit. These results provide a framework for future investigations in the emerging field of pregnancy recognition. References Ahluwalia, I. B., Whitehead, N., & Bensyl, D. (2007). Pregnancy intention and contraceptive use among adult women. Maternal and Child Health Journal, 11, 347–351. Bastian, L. A., Nanda, K., Hasselblad, V., & Simel, D. L. (1998). Diagnostic efficiency of home pregnancy test kits: A meta-analysis. Archives of Family Medicine, 7, 465–470. Bien, T. H., Miller, W. R., & Tonigan, J. S. (1993). Brief interventions for alcohol problems: A review. Addiction, 88, 315–336. Centers for Disease Control and Prevention (CDC). (2000). Entry into prenatal care—United States, 1989–1997. Morbidity and Mortality Weekly Report, 48, 393–398. Centers for Disease Control and Prevention (CDC). (2006). Recommendations to improve preconception health and health care—United States. Morbidity and Mortality Weekly Report, 55(RR06), 1–23. Chandra, A., Martinez, G.M., Mosher, W.D., Abma, J.C., & Jones, J. (2005). Fertility, family planning, and reproductive health of U.S. women: Data from the 2002 National Survey of Family Growth. National Center for Health Statistics. Vital Health Statistics, 23. Cole, L. A., Khanlian, S. A., Sutton, J. M., Davies, S., & Rayburn, W. F. (2004). Accuracy of home pregnancy tests at the time of missed menses. American Journal of Obstetrics and Gynecology, 190, 100–105. Finer, L. B., Frohwirth, L. F., Dauphinee, A., Singh, S., & Moore, A. M. (2006). Timing of steps and reasons for delays in obtaining abortions in the United States. Contraception, 74, 334–344. Floyd, R. L., Decoufle, P., & Hungerford, D. W. (1999). Alcohol use prior to pregnancy recognition. American Journal of Preventive Medicine, 17, 101–107. Floyd, R. L., Sobell, M., Velasquez, M. M., Ingersoll, K., Nettleman, M. D., Sobell, L., et al., , on behalf of the Project CHOICES Efficacy Study Group. (2007). Preventing alcohol-exposed pregnancies: A randomized controlled trial. American Journal of Preventive Medicine, 32, 1–10. Gold, R. B. (2001, February). Title X: Three decades of accomplishment. The Guttmacher Report on Public Policy, 5–8. Hatcher, R. A., Trussell, J., Stewart, F., Nelson, A., Cates, W., & Guest, F. (Eds.). (2007). Contraceptive technology (18th ed). New York: Ardent Media.
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Author Descriptions Mary Nettleman is a women’s health researcher who is interested in contraception, early pregnancy recognition and preconceptional health. She is Professor and Chair of Medicine at Michigan State University’s College of Human Medicine. Adejoke Ayoola is a nurse and assistant professor at Calvin College Department of Nursing. Before coming to Calvin College, she served as a registered/licensed midwife and Public Health Nurse in Nigeria. Her research focuses on early pregnancy recognition and its impact on prenatal care and birth outcomes. Jennifer Brewer is research assistant at Michigan State University.