International Journal of Gynecology and Obstetrics 125 (2014) 49–52
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Acceptability and feasibility of medical abortion with mifepristone and misoprostol in Nigeria Friday Okonofua a,b, Oladapo Shittu c, Tara Shochet d,⁎, Ayisha Diop d, Beverly Winikoff d a
Department of Obstetrics and Gynaecology, University of Benin, Benin City, Nigeria Women’s Health and Research Centre, Benin City, Nigeria Department of Obstetrics and Gynecology, Ahmadu Bello University Teaching Hospital, Zaria, Nigeria d Gynuity Health Projects, New York, USA b c
a r t i c l e
i n f o
Article history: Received 8 July 2013 Received in revised form 14 October 2013 Accepted 29 December 2013 Keywords: Medical abortion Mifepristone Misoprostol Nigeria
a b s t r a c t Objective: To examine the acceptability and feasibility of medical abortion in Nigeria. Methods: In total, 250 women who were eligible for legal pregnancy termination with a gestational age of up to 63 days since last menstrual period were enrolled in Benin City and Zaria between May 2005 and October 2006. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. Women returned 2 weeks later for an assessment of abortion status. Results: The vast majority (96.3%) of women had successful complete abortions. Ultrasound was used to determine outcome in less than one-third (28.9%) of participants. Most women (83.2%) took the misoprostol at home. Almost all (96.2%) participants were satisfied or very satisfied with the abortion method. Conclusion: The introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care in Nigeria and other settings in which access to legal abortion services is limited. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Unsafe abortion in Nigeria is a major public health problem and one of the main causes of maternal mortality and morbidity. Current estimates indicate that approximately 610 000 unsafe abortions occur annually in Nigeria [1], accounting for at least 13% (possibly 30%–40%) of maternal deaths each year [2]. Abortion in Nigeria is allowed only if the pregnancy threatens a woman’s life. In addition to legal indications, safe abortion care is often sought after a woman has already attempted to abort using an unsafe method or provider [2]. Women in need of care should have access to the best and safest possible abortion technologies and services. Expanding the availability of medical abortion is especially important in settings in which access to legal abortion services is limited. The majority of safe abortions performed in Nigeria are conducted via dilation and curettage or by manual vacuum aspiration [2]. Mifepristone is not registered for abortion in Nigeria, even though mifepristone plus misoprostol—a proven safe and non-surgical means of pregnancy termination—has been available in many countries for well over a decade [3–6]. In 2010, Nigeria added misoprostol to its Essential Medicines List for incomplete and spontaneous abortion [7]; furthermore, in a Nigerian study treating incomplete abortion with misoprostol, both ⁎ Corresponding author at: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA. Tel.: +1 212 4480 1230; fax: +1 212 448 1260. E-mail address: [email protected] (T. Shochet).
women and clinicians were very satisfied with the method [8]. Introducing medical abortion with mifepristone and misoprostol in Nigeria could foster the expansion of the range of services currently available and improve service delivery. In addition, many women prefer medical over surgical abortion; reasons given often include avoiding surgery and/or avoiding pain [9–12]. Home administration of misoprostol is as safe and effective as clinic administration and is highly satisfactory to women [3,13,14]. It also reduces the number of clinic visits, which could lower the cost burden for both women and providers. Expanding choice in abortion services is an important step in improving the quality of reproductive health care in Nigeria. The aim of the present study was to explore the acceptability of medical abortion for early-pregnancy termination in Nigeria using mifepristone followed by misoprostol 2 days later, and to examine the feasibility of home administration of misoprostol. 2. Materials and methods The present study examined the acceptability and feasibility of a simplified medical abortion regimen in Nigeria between May 11, 2005, and October 1, 2006. Women eligible for legal termination of pregnancy presenting at 1 of the 2 sites (Women’s Health and Research Centre in Benin City and Ahmadu Bello University Teaching Hospital in Zaria) were recruited for participation. Study eligibility included living or working within a reasonable distance of the study site; gestational age of up to 63 days since last menstrual period (determined via physical
0020-7292/$ – see front matter © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.10.009
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F. Okonofua et al. / International Journal of Gynecology and Obstetrics 125 (2014) 49–52
exam, menstrual history, and/or ultrasound); general good health, including absence of conditions contraindicating the use of mifepristone and misoprostol for pregnancy termination; and willingness to provide an address and/or telephone number for purposes of follow-up. Physicians at each site had prior experience with misoprostol, using it for treatment of first- and second-trimester incomplete abortion. Study approval was provided by the ethical review committees at the University of Benin and Ahmadu Bello University Teaching Hospital, and all participants gave written informed consent. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. They were also given mild analgesics (4 × 500-mg paracetamol tablets) to take as needed, as well as the cell phone number of a study nurse, who could be called with questions at any hour of the day. Participants were asked to return to the clinic 2 weeks after administering the regimen for an assessment of abortion status. Ultrasound was not part of the protocol but could be used at the clinician’s discretion to determine outcome. Women with ongoing, viable pregnancies were offered surgical abortions. Women with nonviable pregnancies or incomplete abortions were offered either immediate surgical evacuation or the option of waiting another week. All women were asked to complete an exit interview at the end of the study to provide acceptability information about the abortion. Much of the care was handled by mid-level clinicians; at the Women’s Health and Research Centre, treatment and follow-up were provided exclusively by a nurse–midwife. The primary outcome of the study was method efficacy. Secondary outcomes included location of misoprostol administration, frequency and duration of adverse effects, and satisfaction with the method. Data were entered into SPSS version 14.0 (IBM, Armonk, NY, USA), and all analyses were conducted using STATA version 11 (StataCorp, College Station, TX, USA).
3. Results In total, 250 women were enrolled in the study. Fifty-nine (23.6%) women were lost to follow-up and, thus, were included only in demographic analyses. Participant characteristics are presented in Table 1. Successful abortion was recorded for most (96.3%) participants (Table 2). Of the 7 (3.7%) women who underwent surgical intervention, 2 had an ongoing pregnancy, 3 had an incomplete abortion, and 2
Table 2 Outcomes (n = 250). Outcome
No. (%)
Success (n = 191)a Surgical intervention (n = 191)a Ongoing pregnancy (n = 191)a Incomplete abortion/retained products of conception (n = 191)a Woman’s request (n = 191)a Ultrasound used to determine outcome at follow-up (n = 173)a,b Misoprostol taken at home (n = 191)a Women who made an unscheduled visitc Women who called the clinicd
184 (96.3) 7 (3.7) 2 (1.0) 3 (1.6) 2 (1.0) 50 (28.9) 159 (83.2) 28 (11.2) 46 (18.4)
a
Fifty-nine women lost to follow-up. Data not available for 18 women. Seventeen women had 1 unscheduled visit; 10 women had 2 unscheduled visits; 1 woman had 3 unscheduled visits. d Twenty-five women made 1 call to the clinic; 13 women made 2 calls to the clinic; 8 women made 3 or more calls to the clinic. b c
requested intervention prior to study completion. Ultrasound was used to determine outcome for less than one-third (28.9%) of participants; it was used more frequently at the Zaria site than at the Benin City site (51.9% vs 24.7%; data not shown). Most women (159/191 [83.2%]) chose to take the misoprostol at home. (Of the 59 women for whom follow-up data were unavailable, 52 planned to take the misoprostol at home, 6 planned to take it at the clinic, and 1 did not specify; data not shown.) There were no significant differences in outcome according to location of misoprostol administration. Twenty-eight (11.2%) women made an unscheduled visit to the clinic and 46 (18.4%) called the clinic during the study. Reasons for unscheduled visits included heavy bleeding, cramping, vomiting, and anxiety. Most of the women with outcome data who made unscheduled visits (25/28 [89.3%]) and/or who called the clinic (42/46 [91.3%]) had successful abortions (data not shown). There were no serious adverse events (e.g. hospital admissions or blood transfusions) noted for any of the participants. Women reported an average of 6.7 days of bleeding (3.3 days of heavy bleeding, 2.5 days of normal bleeding, and 0.9 days of spotting) (Table 3). Close to two-thirds of participants (62.0%) reported pain, while approximately one-quarter reported nausea or vomiting (26.1% and 26.6%, respectively); 12.5% reported fever/chills.
Table 3 Bleeding and adverse effects reported by women on the take-home card (n = 184).a,b
Table 1 Participant characteristics (n = 250). Characteristic Age, y (n = 220) b20 20–29 30–39 ≥40 Gravidity (n = 170) 0 1 2 ≥3 Previous spontaneous abortion (n = 101) 0 1 ≥2 Gestational age, d (n = 210) b43 43–49 50–56 57–63 Education completed (n = 178) Less than secondary school (below grade 11) Secondary school/A-levels (grade 11–13) Some university or higher (grade 14 or higher)
Value No. (%) 22 (10.0) 172 (78.2) 25 (11.4) 1 (0.5) 37 (21.8) 51 (30.0) 36 (21.2) 46 (27.1) 51 (50.5) 30 (29.7) 20 (19.8) 98 (46.7) 30 (14.3) 26 (12.4) 56 (26.7)
Heavy bleedingc No. of women No. of days Normal bleedingc No. of women No. of days Spottingc No. of women No. of days Pain No. of women No. of days Nausea No. of women No. of days Vomiting No. of women No. of days Fever/chills No. of women No. of days a
67 (37.6) 27 (15.2) 84 (47.2)
160 (87.0) 3.3 ± 2.3 (0–12) 106 (57.6) 2.5 ± 2.8 (0–12) 77 (41.8) 0.9 ± 1.5 (0–7) 114 (62.0) 1.5 ± 1.5 (0–5) 48 (26.1) 0.4 ± 0.9 (0–4) 49 (26.6) 0.4 ± 0.7 (0–3) 23 (12.5) 0.3 ± 1.0 (0–7)
Values are given as number (percentage) or mean ± SD (range). Of the 191 women who returned for follow-up, 184 provided their “Side Effect” cards. c Of the 184 women, 8 (7 successes and 1 with intervention) did not report any bleeding adverse effects. b
F. Okonofua et al. / International Journal of Gynecology and Obstetrics 125 (2014) 49–52 Table 4 Women’s reports of satisfaction and experience with the method (n = 191). No. (%) Overall satisfaction with method Satisfied/very satisfied Neutral Unsatisfied/very unsatisfied Would select method again if needed Would recommend method to a friend Would change misoprostol location if medical abortion needed in the future Among those who took misoprostol at home Among those who took misoprostol in clinic Was given enough pain medication
176/183 (96.2) 2/183 (1.1) 5/183 (2.7) 178/184 (96.7) 180/182 (98.9)
4/145 (2.8) 9/29 (31.0) 140/179 (78.2)
The vast majority of women (96.2%) were satisfied or very satisfied with the abortion method (Table 4). In addition, most would select the method again if needed and would recommend the method to a friend (96.7% and 98.9%, respectively). Participants were also asked where they would take misoprostol if they needed medical abortion in the future. Significantly fewer women who had taken misoprostol at home (4/145) compared with those who had taken it at the clinic (9/29) would change their location preference in the future if medical abortion were needed again (P b 0.001). 4. Discussion The data presented further demonstrate the efficacy of mifepristone–misoprostol for early medical abortion [3–6]. In addition, participants reported high levels of satisfaction with the method—a response observed near universally in medical abortion studies [15]. These findings indicate that medical abortion with mifepristone and misoprostol could be successfully introduced for legal termination of pregnancy throughout Nigeria. Recent efforts to register mifepristone-misoprostol combination packs in a range of countries, including those with limited legal access to medical abortion, show an increasing role for this regimen in a variety of settings worldwide. Most participants chose to administer misoprostol at home, with no difference in outcome—consistent with results from other medical abortion studies [3,5,16,17]. Very few women who selected home use would switch to clinic use in the future if medical abortion were needed again, showing that home use of misoprostol is both feasible for and highly acceptable to Nigerian women. A similar preference for home use was shown in South Africa [18] and Ghana (unpublished data). In addition, recent research has demonstrated a growing interest in, and satisfaction with, medical abortion in Ethiopia [10]. Together, these findings indicate a regional acceptability that supports continued introduction and expansion of medical abortion in other Sub-Saharan African settings. Home use is a particularly important option for hospitals and clinics with limited staff availability, as well as in settings in which distances to the clinic are prohibitive to multiple visits [19]. To further reduce the travel burden on women, alternatives to in-clinic follow-up such as phone follow-up [20], with or without a semi-quantitative home pregnancy test, could be implemented [20,21]. Ultrasound was used to confirm outcome in less than one-third of the women in the present study, demonstrating that neither ultrasound equipment nor a trained sonographer is needed in order to provide medical abortion. The success rate was slightly lower among women for whom ultrasound was used. While the difference was not significant, it indicates either that clinicians may be more likely to intervene if they see debris on ultrasound than if they use other methods for assessing completion or that ultrasound was selectively used for women already suspected of having incomplete abortion [22,23]. During the study, a nurse was available to answer questions by phone 24 hours per day, 7 days per week. Approximately one-fifth (18.4%) of participants made use of this service. There were no differences in the
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proportion of women who called the nurse according to location of misoprostol administration (home, 24.5% vs clinic, 21.9%; P = 0.83), which demonstrates that health-seeking behavior is not affected by where misoprostol is taken. In addition, more than half (58.7%) of the women who called did not make an unscheduled visit, indicating that their concerns were allayed by the nurse. The availability of phone contact is a useful tool in the expansion of services, especially when in-clinic follow-up may be difficult for women. Furthermore, the management of calls by a nurse rather than an OB/GYN shows the task-shifting nature of this method whereby lower-level clinicians can provide the required services, leaving more skilled clinicians free to deal with more complex medical issues. Options for safe abortion that are highly effective, acceptable to women, and easy to provide must be available for women who are eligible for abortion services in Nigeria. However, many providers, including private practitioners, are untrained or undertrained in abortion provision [24]. The present study shows how the introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care. The research also demonstrates the successful introduction of medical abortion in a low-resource country and can serve as a guide for introduction in other low-resource areas. Acknowledgments The study was funded by an anonymous donor. Conflict of interest The authors have no conflicts of interest. References [1] Raufu A. Unsafe abortions cause 20 000 deaths a year in Nigeria. BMJ 2002;325(7371): 988. [2] Sudhinaraset M. Reducing unsafe abortion in Nigeria. Issues Brief (Alan Guttmacher Inst) 2008(3):1–3. [3] Hajri S, Blum J, Gueddana N, Saadi H, Maazoun L, Chélli H, et al. Expanding medical abortion in Tunisia: women's experiences from a multi-site expansion study. Contraception 2004;70(6):487–91. [4] Shannon C, Wiebe E, Jacot F, Guilbert E, Dunn S, Sheldon WR, et al. Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial. BJOG 2006;113(6):621–8. [5] Bracken H, Gliozheni O, Kati K, Manoku N, Moisiu R, Shannon C, et al. Mifepristone medical abortion in Albania: results from a pilot clinical research study. Eur J Contracept Reprod Health Care 2006;11(1):38–46. [6] Karki C, Pokharel H, Kushwaha A, Manandhar D, Bracken H, Winikoff B. Acceptability and feasibility of medical abortion in Nepal. Int J Gynecol Obstet 2009;106(1):39–42. [7] Federal Republic of Nigeria. Essential Medicines List. Fifth Revision. Abuja, Nigeria: Federal Ministry of Health; 2010. http://apps.who.int/medicinedocs/documents/ s19018en/s19018en.pdf. Accessed September 23, 2013. [8] Dah T, Akiode A, Awah P, Fetters T, Okoh M, Ujah I, et al. Introducing misoprostol for the treatment of incomplete abortion in Nigeria. Afr J Reprod Health 2011;15(4):42–50. [9] Moreau C, Trussell J, Desfreres J, Bajos N. Medical vs. surgical abortion: the importance of women's choice. Contraception 2011;84(3):224–9. [10] Woldetsadik MA, Sendekie TY, White MT, Zegeye DT. Client preferences and acceptability for medical abortion and MVA as early pregnancy termination method in northwest Ethiopia. Reprod Health 2011;8:19. [11] Ngoc N, Winikoff B, Clark S, Ellertson C, Am K, Hieu D, et al. Safety, efficacy and acceptability of mifepristone-misoprostol medical abortion in Vietnam. Int Fam Plan Perspect 1999;25(1):10–4. [12] Winikoff B, Sivin I, Coyaji KJ, Cabezas E, Bilian X, Sujuan G, et al. The acceptability of medical abortion in China, Cuba and India. Int Fam Plan Perspect 1997;23(2):73–8 89. [13] Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ 2011;89(5):360–70. [14] Elul B, Hajri S, Ngoc NN, Ellertson C, Slama CB, Pearlman E, et al. Can women in less-developed countries use a simplified medical abortion regimen? Lancet 2001;357(9266):1402–5. [15] Swica Y, Raghavan S, Bracken H, Dabash R, Winikoff B. Review of the literature on patient satisfaction with early medical abortion using mifepristone and misoprostol. Expert Rev Obstet Gynecol 2011;6(4):451–68. [16] Ngoc NT, Nhan VQ, Blum J, Mai TT, Durocher JM, Winikoff B. Is home-based administration of prostaglandin safe and feasible for medical abortion? Results from a multisite study in Vietnam. BJOG 2004;111(8):814–9.
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[17] Bracken H, Family Planning Association of India (FPAI)/Gynuity Health Projects Research Group for Simplifying Medical Abortion in India. Home administration of misoprostol for early medical abortion in India. Int J Gynecol Obstet 2010;108(3):228–32. [18] Kawonga M, Blanchard K, Cooper D, Cullingworth L, Dickson K, Harrison T, et al. Integrating medical abortion into safe abortion services: experience from three pilot sites in South Africa. J Fam Plann Reprod Health Care 2008;34(3):159–64. [19] Raghavan S, Tsereteli T, Kamilov A, Kurbanbekova D, Yusupov D, Kasimova F, et al. Acceptability and feasibility of the use of 400 μg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: evidence from Uzbekistan. Eur J Contracept Reprod Health Care 2013;18(2):104–11. [20] Perriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception 2010;81(2):143–9.
[21] Lynd K, Blum J, Ngoc NT, Shochet T, Blumenthal P, Winikoff B. Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up. Int J Gynecol Obstet 2013;121(2):144–8. [22] Winikoff B, Ellertson C, Clark S. Analysis of failure in medical abortion. Contraception 1996;54(6):323–7. [23] Fiala C, Safar P, Bygdeman M, Gemzell-Danielsson K. Verifying the effectiveness of medical abortion; ultrasound versus hCG testing. Eur J Obstet Gynecol Reprod Biol 2003;109(2):190–5. [24] Omo-Aghoja LO, Hammed A, Okonofua FE, Okpani OA, Koroye OC, Ojobo S, et al. A survey of attitudes and practices of reproductive health and family planning services among private medical practitioners in four states of the Niger-Delta region of Nigeria. Qual Prim Care 2011;19(5):325–34.
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
CLINICAL ARTICLE
Acceptability and feasibility of medical abortion with mifepristone and misoprostol in Nigeria Friday Okonofua a,b, Oladapo Shittu c, Tara Shochet d,⁎, Ayisha Diop d, Beverly Winikoff d a
Department of Obstetrics and Gynaecology, University of Benin, Benin City, Nigeria Women’s Health and Research Centre, Benin City, Nigeria Department of Obstetrics and Gynecology, Ahmadu Bello University Teaching Hospital, Zaria, Nigeria d Gynuity Health Projects, New York, USA b c
a r t i c l e
i n f o
Article history: Received 8 July 2013 Received in revised form 14 October 2013 Accepted 29 December 2013 Keywords: Medical abortion Mifepristone Misoprostol Nigeria
a b s t r a c t Objective: To examine the acceptability and feasibility of medical abortion in Nigeria. Methods: In total, 250 women who were eligible for legal pregnancy termination with a gestational age of up to 63 days since last menstrual period were enrolled in Benin City and Zaria between May 2005 and October 2006. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. Women returned 2 weeks later for an assessment of abortion status. Results: The vast majority (96.3%) of women had successful complete abortions. Ultrasound was used to determine outcome in less than one-third (28.9%) of participants. Most women (83.2%) took the misoprostol at home. Almost all (96.2%) participants were satisfied or very satisfied with the abortion method. Conclusion: The introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care in Nigeria and other settings in which access to legal abortion services is limited. © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Unsafe abortion in Nigeria is a major public health problem and one of the main causes of maternal mortality and morbidity. Current estimates indicate that approximately 610 000 unsafe abortions occur annually in Nigeria [1], accounting for at least 13% (possibly 30%–40%) of maternal deaths each year [2]. Abortion in Nigeria is allowed only if the pregnancy threatens a woman’s life. In addition to legal indications, safe abortion care is often sought after a woman has already attempted to abort using an unsafe method or provider [2]. Women in need of care should have access to the best and safest possible abortion technologies and services. Expanding the availability of medical abortion is especially important in settings in which access to legal abortion services is limited. The majority of safe abortions performed in Nigeria are conducted via dilation and curettage or by manual vacuum aspiration [2]. Mifepristone is not registered for abortion in Nigeria, even though mifepristone plus misoprostol—a proven safe and non-surgical means of pregnancy termination—has been available in many countries for well over a decade [3–6]. In 2010, Nigeria added misoprostol to its Essential Medicines List for incomplete and spontaneous abortion [7]; furthermore, in a Nigerian study treating incomplete abortion with misoprostol, both ⁎ Corresponding author at: Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA. Tel.: +1 212 4480 1230; fax: +1 212 448 1260. E-mail address: [email protected] (T. Shochet).
women and clinicians were very satisfied with the method [8]. Introducing medical abortion with mifepristone and misoprostol in Nigeria could foster the expansion of the range of services currently available and improve service delivery. In addition, many women prefer medical over surgical abortion; reasons given often include avoiding surgery and/or avoiding pain [9–12]. Home administration of misoprostol is as safe and effective as clinic administration and is highly satisfactory to women [3,13,14]. It also reduces the number of clinic visits, which could lower the cost burden for both women and providers. Expanding choice in abortion services is an important step in improving the quality of reproductive health care in Nigeria. The aim of the present study was to explore the acceptability of medical abortion for early-pregnancy termination in Nigeria using mifepristone followed by misoprostol 2 days later, and to examine the feasibility of home administration of misoprostol. 2. Materials and methods The present study examined the acceptability and feasibility of a simplified medical abortion regimen in Nigeria between May 11, 2005, and October 1, 2006. Women eligible for legal termination of pregnancy presenting at 1 of the 2 sites (Women’s Health and Research Centre in Benin City and Ahmadu Bello University Teaching Hospital in Zaria) were recruited for participation. Study eligibility included living or working within a reasonable distance of the study site; gestational age of up to 63 days since last menstrual period (determined via physical
0020-7292/$ – see front matter © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.10.009
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F. Okonofua et al. / International Journal of Gynecology and Obstetrics 125 (2014) 49–52
exam, menstrual history, and/or ultrasound); general good health, including absence of conditions contraindicating the use of mifepristone and misoprostol for pregnancy termination; and willingness to provide an address and/or telephone number for purposes of follow-up. Physicians at each site had prior experience with misoprostol, using it for treatment of first- and second-trimester incomplete abortion. Study approval was provided by the ethical review committees at the University of Benin and Ahmadu Bello University Teaching Hospital, and all participants gave written informed consent. Participants received 200 mg of oral mifepristone in the clinic and then took 400 μg of oral misoprostol 2 days later—choosing to either return to the clinic or take it at home. They were also given mild analgesics (4 × 500-mg paracetamol tablets) to take as needed, as well as the cell phone number of a study nurse, who could be called with questions at any hour of the day. Participants were asked to return to the clinic 2 weeks after administering the regimen for an assessment of abortion status. Ultrasound was not part of the protocol but could be used at the clinician’s discretion to determine outcome. Women with ongoing, viable pregnancies were offered surgical abortions. Women with nonviable pregnancies or incomplete abortions were offered either immediate surgical evacuation or the option of waiting another week. All women were asked to complete an exit interview at the end of the study to provide acceptability information about the abortion. Much of the care was handled by mid-level clinicians; at the Women’s Health and Research Centre, treatment and follow-up were provided exclusively by a nurse–midwife. The primary outcome of the study was method efficacy. Secondary outcomes included location of misoprostol administration, frequency and duration of adverse effects, and satisfaction with the method. Data were entered into SPSS version 14.0 (IBM, Armonk, NY, USA), and all analyses were conducted using STATA version 11 (StataCorp, College Station, TX, USA).
3. Results In total, 250 women were enrolled in the study. Fifty-nine (23.6%) women were lost to follow-up and, thus, were included only in demographic analyses. Participant characteristics are presented in Table 1. Successful abortion was recorded for most (96.3%) participants (Table 2). Of the 7 (3.7%) women who underwent surgical intervention, 2 had an ongoing pregnancy, 3 had an incomplete abortion, and 2
Table 2 Outcomes (n = 250). Outcome
No. (%)
Success (n = 191)a Surgical intervention (n = 191)a Ongoing pregnancy (n = 191)a Incomplete abortion/retained products of conception (n = 191)a Woman’s request (n = 191)a Ultrasound used to determine outcome at follow-up (n = 173)a,b Misoprostol taken at home (n = 191)a Women who made an unscheduled visitc Women who called the clinicd
184 (96.3) 7 (3.7) 2 (1.0) 3 (1.6) 2 (1.0) 50 (28.9) 159 (83.2) 28 (11.2) 46 (18.4)
a
Fifty-nine women lost to follow-up. Data not available for 18 women. Seventeen women had 1 unscheduled visit; 10 women had 2 unscheduled visits; 1 woman had 3 unscheduled visits. d Twenty-five women made 1 call to the clinic; 13 women made 2 calls to the clinic; 8 women made 3 or more calls to the clinic. b c
requested intervention prior to study completion. Ultrasound was used to determine outcome for less than one-third (28.9%) of participants; it was used more frequently at the Zaria site than at the Benin City site (51.9% vs 24.7%; data not shown). Most women (159/191 [83.2%]) chose to take the misoprostol at home. (Of the 59 women for whom follow-up data were unavailable, 52 planned to take the misoprostol at home, 6 planned to take it at the clinic, and 1 did not specify; data not shown.) There were no significant differences in outcome according to location of misoprostol administration. Twenty-eight (11.2%) women made an unscheduled visit to the clinic and 46 (18.4%) called the clinic during the study. Reasons for unscheduled visits included heavy bleeding, cramping, vomiting, and anxiety. Most of the women with outcome data who made unscheduled visits (25/28 [89.3%]) and/or who called the clinic (42/46 [91.3%]) had successful abortions (data not shown). There were no serious adverse events (e.g. hospital admissions or blood transfusions) noted for any of the participants. Women reported an average of 6.7 days of bleeding (3.3 days of heavy bleeding, 2.5 days of normal bleeding, and 0.9 days of spotting) (Table 3). Close to two-thirds of participants (62.0%) reported pain, while approximately one-quarter reported nausea or vomiting (26.1% and 26.6%, respectively); 12.5% reported fever/chills.
Table 3 Bleeding and adverse effects reported by women on the take-home card (n = 184).a,b
Table 1 Participant characteristics (n = 250). Characteristic Age, y (n = 220) b20 20–29 30–39 ≥40 Gravidity (n = 170) 0 1 2 ≥3 Previous spontaneous abortion (n = 101) 0 1 ≥2 Gestational age, d (n = 210) b43 43–49 50–56 57–63 Education completed (n = 178) Less than secondary school (below grade 11) Secondary school/A-levels (grade 11–13) Some university or higher (grade 14 or higher)
Value No. (%) 22 (10.0) 172 (78.2) 25 (11.4) 1 (0.5) 37 (21.8) 51 (30.0) 36 (21.2) 46 (27.1) 51 (50.5) 30 (29.7) 20 (19.8) 98 (46.7) 30 (14.3) 26 (12.4) 56 (26.7)
Heavy bleedingc No. of women No. of days Normal bleedingc No. of women No. of days Spottingc No. of women No. of days Pain No. of women No. of days Nausea No. of women No. of days Vomiting No. of women No. of days Fever/chills No. of women No. of days a
67 (37.6) 27 (15.2) 84 (47.2)
160 (87.0) 3.3 ± 2.3 (0–12) 106 (57.6) 2.5 ± 2.8 (0–12) 77 (41.8) 0.9 ± 1.5 (0–7) 114 (62.0) 1.5 ± 1.5 (0–5) 48 (26.1) 0.4 ± 0.9 (0–4) 49 (26.6) 0.4 ± 0.7 (0–3) 23 (12.5) 0.3 ± 1.0 (0–7)
Values are given as number (percentage) or mean ± SD (range). Of the 191 women who returned for follow-up, 184 provided their “Side Effect” cards. c Of the 184 women, 8 (7 successes and 1 with intervention) did not report any bleeding adverse effects. b
F. Okonofua et al. / International Journal of Gynecology and Obstetrics 125 (2014) 49–52 Table 4 Women’s reports of satisfaction and experience with the method (n = 191). No. (%) Overall satisfaction with method Satisfied/very satisfied Neutral Unsatisfied/very unsatisfied Would select method again if needed Would recommend method to a friend Would change misoprostol location if medical abortion needed in the future Among those who took misoprostol at home Among those who took misoprostol in clinic Was given enough pain medication
176/183 (96.2) 2/183 (1.1) 5/183 (2.7) 178/184 (96.7) 180/182 (98.9)
4/145 (2.8) 9/29 (31.0) 140/179 (78.2)
The vast majority of women (96.2%) were satisfied or very satisfied with the abortion method (Table 4). In addition, most would select the method again if needed and would recommend the method to a friend (96.7% and 98.9%, respectively). Participants were also asked where they would take misoprostol if they needed medical abortion in the future. Significantly fewer women who had taken misoprostol at home (4/145) compared with those who had taken it at the clinic (9/29) would change their location preference in the future if medical abortion were needed again (P b 0.001). 4. Discussion The data presented further demonstrate the efficacy of mifepristone–misoprostol for early medical abortion [3–6]. In addition, participants reported high levels of satisfaction with the method—a response observed near universally in medical abortion studies [15]. These findings indicate that medical abortion with mifepristone and misoprostol could be successfully introduced for legal termination of pregnancy throughout Nigeria. Recent efforts to register mifepristone-misoprostol combination packs in a range of countries, including those with limited legal access to medical abortion, show an increasing role for this regimen in a variety of settings worldwide. Most participants chose to administer misoprostol at home, with no difference in outcome—consistent with results from other medical abortion studies [3,5,16,17]. Very few women who selected home use would switch to clinic use in the future if medical abortion were needed again, showing that home use of misoprostol is both feasible for and highly acceptable to Nigerian women. A similar preference for home use was shown in South Africa [18] and Ghana (unpublished data). In addition, recent research has demonstrated a growing interest in, and satisfaction with, medical abortion in Ethiopia [10]. Together, these findings indicate a regional acceptability that supports continued introduction and expansion of medical abortion in other Sub-Saharan African settings. Home use is a particularly important option for hospitals and clinics with limited staff availability, as well as in settings in which distances to the clinic are prohibitive to multiple visits [19]. To further reduce the travel burden on women, alternatives to in-clinic follow-up such as phone follow-up [20], with or without a semi-quantitative home pregnancy test, could be implemented [20,21]. Ultrasound was used to confirm outcome in less than one-third of the women in the present study, demonstrating that neither ultrasound equipment nor a trained sonographer is needed in order to provide medical abortion. The success rate was slightly lower among women for whom ultrasound was used. While the difference was not significant, it indicates either that clinicians may be more likely to intervene if they see debris on ultrasound than if they use other methods for assessing completion or that ultrasound was selectively used for women already suspected of having incomplete abortion [22,23]. During the study, a nurse was available to answer questions by phone 24 hours per day, 7 days per week. Approximately one-fifth (18.4%) of participants made use of this service. There were no differences in the
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proportion of women who called the nurse according to location of misoprostol administration (home, 24.5% vs clinic, 21.9%; P = 0.83), which demonstrates that health-seeking behavior is not affected by where misoprostol is taken. In addition, more than half (58.7%) of the women who called did not make an unscheduled visit, indicating that their concerns were allayed by the nurse. The availability of phone contact is a useful tool in the expansion of services, especially when in-clinic follow-up may be difficult for women. Furthermore, the management of calls by a nurse rather than an OB/GYN shows the task-shifting nature of this method whereby lower-level clinicians can provide the required services, leaving more skilled clinicians free to deal with more complex medical issues. Options for safe abortion that are highly effective, acceptable to women, and easy to provide must be available for women who are eligible for abortion services in Nigeria. However, many providers, including private practitioners, are untrained or undertrained in abortion provision [24]. The present study shows how the introduction of medical abortion with mifepristone and misoprostol could greatly expand current method options and improve the quality of reproductive health care. The research also demonstrates the successful introduction of medical abortion in a low-resource country and can serve as a guide for introduction in other low-resource areas. Acknowledgments The study was funded by an anonymous donor. Conflict of interest The authors have no conflicts of interest. References [1] Raufu A. Unsafe abortions cause 20 000 deaths a year in Nigeria. BMJ 2002;325(7371): 988. [2] Sudhinaraset M. Reducing unsafe abortion in Nigeria. Issues Brief (Alan Guttmacher Inst) 2008(3):1–3. [3] Hajri S, Blum J, Gueddana N, Saadi H, Maazoun L, Chélli H, et al. Expanding medical abortion in Tunisia: women's experiences from a multi-site expansion study. Contraception 2004;70(6):487–91. [4] Shannon C, Wiebe E, Jacot F, Guilbert E, Dunn S, Sheldon WR, et al. Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial. BJOG 2006;113(6):621–8. [5] Bracken H, Gliozheni O, Kati K, Manoku N, Moisiu R, Shannon C, et al. Mifepristone medical abortion in Albania: results from a pilot clinical research study. Eur J Contracept Reprod Health Care 2006;11(1):38–46. [6] Karki C, Pokharel H, Kushwaha A, Manandhar D, Bracken H, Winikoff B. Acceptability and feasibility of medical abortion in Nepal. Int J Gynecol Obstet 2009;106(1):39–42. [7] Federal Republic of Nigeria. Essential Medicines List. Fifth Revision. Abuja, Nigeria: Federal Ministry of Health; 2010. http://apps.who.int/medicinedocs/documents/ s19018en/s19018en.pdf. Accessed September 23, 2013. [8] Dah T, Akiode A, Awah P, Fetters T, Okoh M, Ujah I, et al. Introducing misoprostol for the treatment of incomplete abortion in Nigeria. Afr J Reprod Health 2011;15(4):42–50. [9] Moreau C, Trussell J, Desfreres J, Bajos N. Medical vs. surgical abortion: the importance of women's choice. Contraception 2011;84(3):224–9. [10] Woldetsadik MA, Sendekie TY, White MT, Zegeye DT. Client preferences and acceptability for medical abortion and MVA as early pregnancy termination method in northwest Ethiopia. Reprod Health 2011;8:19. [11] Ngoc N, Winikoff B, Clark S, Ellertson C, Am K, Hieu D, et al. Safety, efficacy and acceptability of mifepristone-misoprostol medical abortion in Vietnam. Int Fam Plan Perspect 1999;25(1):10–4. [12] Winikoff B, Sivin I, Coyaji KJ, Cabezas E, Bilian X, Sujuan G, et al. The acceptability of medical abortion in China, Cuba and India. Int Fam Plan Perspect 1997;23(2):73–8 89. [13] Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ 2011;89(5):360–70. [14] Elul B, Hajri S, Ngoc NN, Ellertson C, Slama CB, Pearlman E, et al. Can women in less-developed countries use a simplified medical abortion regimen? Lancet 2001;357(9266):1402–5. [15] Swica Y, Raghavan S, Bracken H, Dabash R, Winikoff B. Review of the literature on patient satisfaction with early medical abortion using mifepristone and misoprostol. Expert Rev Obstet Gynecol 2011;6(4):451–68. [16] Ngoc NT, Nhan VQ, Blum J, Mai TT, Durocher JM, Winikoff B. Is home-based administration of prostaglandin safe and feasible for medical abortion? Results from a multisite study in Vietnam. BJOG 2004;111(8):814–9.
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[17] Bracken H, Family Planning Association of India (FPAI)/Gynuity Health Projects Research Group for Simplifying Medical Abortion in India. Home administration of misoprostol for early medical abortion in India. Int J Gynecol Obstet 2010;108(3):228–32. [18] Kawonga M, Blanchard K, Cooper D, Cullingworth L, Dickson K, Harrison T, et al. Integrating medical abortion into safe abortion services: experience from three pilot sites in South Africa. J Fam Plann Reprod Health Care 2008;34(3):159–64. [19] Raghavan S, Tsereteli T, Kamilov A, Kurbanbekova D, Yusupov D, Kasimova F, et al. Acceptability and feasibility of the use of 400 μg of sublingual misoprostol after mifepristone for medical abortion up to 63 days since the last menstrual period: evidence from Uzbekistan. Eur J Contracept Reprod Health Care 2013;18(2):104–11. [20] Perriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception 2010;81(2):143–9.
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