- Email: [email protected]
Rates of continuation and satisfaction of immediate intrauterine device insertion following first- or second-trimester surgical abortion: a French prospective cohort study
European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
Contents lists available at SciVerse ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Rates of continuation and satisfaction of immediate intrauterine device insertion following first- or second-trimester surgical abortion: a French prospective cohort study Aure´lie Flamant a,b, Lobna Ouldamer a,b,c,*, Gilles Body a,b, Nathalie Trignol-Viguier a,b a b c
Department of Gynecology, University Hospital of Tours, 2 Boulevard Tonnele´, 37044 Tours, France University Franc¸ois Rabelais, Tours, France INSERM Unit U1069, Tours, France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 November 2012 Received in revised form 11 March 2013 Accepted 21 April 2013
Background: Immediate postsurgical abortion insertion of intrauterine devices (IUDs) could substantially reduce the risk of repeat abortion. Studies have demonstrated efficacy and safety, and postabortum insertion would likely increase rates of usage. There are few data in the literature concerning rates of continuation and satisfaction after immediate postabortion IUD insertion. Study design: We performed a prospective cohort study of women undergoing surgical abortion and choosing immediate insertion of IUD for contraception. We followed at six months rates of continuation, expulsion, removal and pregnancy, and reasons for discontinuation of IUD postinsertion. Results: 137 patients were included. At 6 months, we were able to contact 112 of them. The continuation rate was 78.6% (95% confidence intervals (CI) [69.8, 85.8]) and the satisfaction rate was high at 85.2% (95%CI [76.1, 91.1]). Three (2.7%) expulsions occurred. Removals occurred in 18.75%. Conclusions: We found that women choosing immediate postsurgical abortion IUD insertion had high rates of continuation and satisfaction. ß 2013 Elsevier Ireland Ltd. All rights reserved.
Keywords: Intrauterine devices Immediate postabortum insertion Continuation Copper IUD LNG IUS
1. Introduction France has a 40% rate of unintended pregnancy for women of all ages. Women who have abortions are at high risk of repeat unintended pregnancies in the subsequent year [1]. More than half of all unintended pregnancies occur as a result of inconsistent use and discontinuation of contraceptives [2,3], even though several safe and highly effective methods of contraception are available. Long-acting contraceptives such as intrauterine devices (IUDs) are the most effective and cost-effective methods for women. They are safe for a wide range of women including those who are nulliparous or adolescent, and provide safe, highly effective, long-term reversible contraception that does not require active use once they have been inserted. Thus, they may be especially appropriate for many women following abortion. The failure rate with typical use is 0.1–0.8% in the first year, which is similar to the failure rate with female sterilization
* Corresponding author at: Department of Gynecology, CHU Bretonneau, 2 Boulevard Tonnele´, 37000 Tours, France. Tel.: +33 02 47474741; fax: +33 02 47473801. E-mail addresses: [email protected] (L. Ouldamer). 0301-2115/$ – see front matter ß 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejogrb.2013.04.006
[3], so the IUD confers nearly the same contraceptive efficacy as does tubal sterilization, yet it is simpler, less expensive and promptly reversible [4]. The literature has documented the safety of immediate postabortion IUD provision, which avoids the loss to follow-up of patients who do not return for IUD insertion [5–7]. Some authors reported that 25–60% of women who intend IUD use for postabortion contraception do not return for their scheduled insertion visit [6–11]. Women who receive an IUD immediately after surgical abortion experience few complications and are less likely to have an unintended pregnancy than those who delay getting an IUD by several weeks [12,13]. Multiple studies have shown that immediate IUD insertion following abortion has complication rates similar to those reported for interval insertion [5–7]. Abortions present a considerable economic burden on society. Reducing unintended pregnancy requires a multifaceted approach that includes better education about sexuality and contraception and improved access to higher quality family planning counseling and services. A transition from contraceptive methods that require continuing motivation and conscientious use to long-acting reversible contraceptives would markedly reduce unintended pregnancies.
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
The aim of our study was to determine patient continuation, satisfaction, and motives underlying discontinuation with postaspiration immediate IUD insertion. 2. Materials and methods Our study is a descriptive single-center prospective clinical study. The study protocol was approved by the institutional review board. All women who were enrolled gave written informed consent. We included outpatients in the planned parenthood department of the university hospital of Tours, France, from October 1, 2010 to March 31, 2011. Inclusion criteria were: women aged 18 years and older, able to understand and give consent, who underwent immediate postabortion IUD insertion after a first- or second-trimester surgical abortion. Women were not eligible if they were unable to give informed consent or if they had: congenital or acquired uterine anomaly, known or suspected cervical dysplasia, acute pelvic inflammatory disease, untreated acute cervicitis or vaginitis, confirmed Chlamydia trachomatis or Neisseria gonorrheae infection in the previous 6 months or hypersensitivity to any component of copper or levonorgestrel-releasing IUS (allergy to copper or Wilson’s disease for those desiring the copper IUD). Participation in the study was considered complete if the patients were reachable at 6 months and could report if they had their IUD or not and completed the survey. Six-month follow-up visits began in April 1, 2011 and concluded in September 30, 2011. Patients make contraceptive choices during the preabortion counseling. Each patient was counseled about her contraceptive options before the abortion. The risks, benefits and side effects of each type of contraception were discussed. After counseling on IUD options, the women chose the IUD that was preferable to them. The IUDs were inserted immediately after uterine aspiration for termination of pregnancy of less than 15 weeks’ duration. According to patient choice, a levonorgestrel or a copper IUD was inserted using standard insertion technique, without ultrasound guidance. Demographic data (age, race, gravidity/parity, number of prior abortions, gestational age at the time of abortion, income level) were obtained on the day of the surgical abortion through a preprocedure questionnaire: we also asked the women questions such as whether or not they had a favorable opinion on IUD before insertion. All subjects were scheduled for an appointment two weeks after the surgical abortion and IUD insertion. Six months after the procedure, the women returned to the hospital for a final study visit and if not, they were contacted by phone. A survey form was developed for the standardized collection of information. Menstrual disturbance was defined as the occurrence of longer or less prolonged menstrual bleeding, amenorrhea, increased or less abundant menstrual bleeding, spotting or irregular menstrual cycles. Patient satisfaction was on a fourpoint scale (‘‘very dissatisfied’’, ‘‘somewhat dissatisfied’’, ‘‘somewhat satisfied’’, ‘‘very satisfied’’). Repondents were asked if they had seen a doctor since their abortion, or if they had their IUD removed for any reason. Statistical analyses were performed by R 2.13.1 (http:// www.cran.r-project.org/), for numeric data: values are expressed as mean and median values standard deviation (SD). Numeric data were analyzed with Student’s t-test if normally distributed: if not, the Mann–Whitney test was used for comparison of data. Categorical data were analyzed with the chi-squared test or with Fisher’s exact test.
269
3. Results Between October 1, 2010 and March 31, 2011, a total of 557 women aged 18 years and older underwent a surgical abortion in the planned parenthood department of the university hospital of Tours. Among them, 226 (40.6%) had immediate insertion of IUD (213 under local anesthesia and 13 under general anesthesia). 137 women enrolled and completed the initial survey: 94 (68.6%) had a copper IUD (Cu-IUD) and 43 (31.4%) had a levonorgestrel-releasing intrauterine system (LNG-IUS). Two women out of three chose a Cu-IUD because of: fear of subsequent amenorrhea or refusal of any hormonal contraception or because of the price for patients without medical insurance: 30 euros for a Cu-IUD versus 130 euros for a LNG-IUS. The age distribution is described in Table 1 and baseline data for participants are presented in Table 2. Over 36% of patients were nulliparous and close to 1 in 2 women had graduated from high school. Over 24% were not using anything for contraception at the time of conception and 35% had had a previous induced abortion. Concerning beliefs about the safety and efficacy of IUDs: at inclusion, of the 137 women who completed the initial survey 55.5% had a favorable opinion about IUDs, 23.3% were neutral and 20.5% had an unfavorable opinion. Almost all patients (95.6%) stated that the IUD insertion was a choice of their own. 111 women (87%) attended the two-week follow-up visit. 112 patients (81.75%) completed the study: at 6 months we were unable to reach 25 (18.25%) women despite multiple attempts at telephone contact. Women lost to follow-up were younger (p = 0.0008) with a higher gestational age (p = 0.0016). Of the 112 patients with immediate insertion of IUD whom we were able to contact, the continuation rate at six months was 78.6% (95% confidence intervals (CI) [69.8, 85.8]). Continuation did not differ between the LNG-IUS and the copper IUD: 80% of LNG-IUS users (n = 28) and 77.9% of copper IUD users (n = 60) were still using their contraceptive method (p = 0.80). Discontinuation rates were highest among those aged between 25 and 30 years (p = 0.023), and in women with prior abortion (p = 0.018). There were three expulsions (2.7%) of which one pregnancy occurred after unnoticed expulsion. 21 women (18.75%) had their IUD removed after a mean delay of 2.7 months (minimum = 1 week, maximum = 5.75 months). The reasons the IUD was removed were: personal reasons for six women (pregnancy planning n = 5, psychological intolerance n = 1), medical reasons for 15 (removal because of bleeding problems n = 10 (nine Cu-IUDs that caused increase of menstrual bleeding, and one LNG-IUS responsible of spotting between menstrual cycles), cramping or pain n = 3 (two LNG-IUS and one Cu-IUD), pelvic inflammatory disease n = 2 (one confirmed Chlamydia trachomatis and one Neisseria gonorrhea infection). After IUD removal, six women requested and received a second IUD insertion (three Cu-IUD and three LNG-IUS). The alternative choices for contraception were estrogen-progestogen pills for nine women, no method for eight women and one Nuvaring. In term of complications, there were no reported perforations. In the continuation group, side effects were as follows: menstrual Table 1 Age distribution of the women by IUD type. Copper IUD (%)
LNG IUS (%)
Mean
Age (years)
27.4
30
18–20 20–25 25–30 30–35 35
12.8 24.5 25.5 22.3 14.9
0 20.9 23.3 25.6 30.2
270
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
Table 2 Baseline patient characteristics. n (%) Marital status (n = 136) Single Married Partnered
55 (40.1) 32 (23.4) 49 (35.8)
Educational level (n = 137) High-school graduate or less Some college College graduate College postgraduate
39 30 52 16
(28.5) (21.9) (38) (11.7)
Occupation (n = 137) Working Student Housewife Not working
76 26 19 16
(55.5) (19) (13.9) (11.7)
Race or ethnic group European North african Black Other
110 (80.3) 7 (5.1) 12 (8.75) 8 (5.8)
Religion practice (n = 135) Yes No
25 (18.2) 110 (80.3)
Gestational age <10 weeks 10–12 weeks >12 weeks
96 (70.1) 33 (24.1) 8 (5.8)
Number of prior abortions 0 1 2 3
89 (65) 38 (27.8) 5 (3.6) 5 (3.6)
Parity 0 1 2 3
50 37 28 22
(36.5) (27) (20.4) (16.1)
disturbance 42 (70%) in the Cu-IUD users vs 17 (61%) in the LNGIUS users (p = 0.38), pain or cramping 31 (52%) in the Cu-IUD users vs 11(39%) in the LNG-IUS users (p = 0.27). Rates of satisfaction (somewhat or very satisfied) among women continuing their IUD did not differ between the LNG-IUS and the Cu-IUD users (82.1% of LNG-IUS users (n = 23) and 86.7% of Cu-IUD users (n = 52) (p = 0.81). 4. Comments Women who seek an abortion are highly motivated to use contraceptive methods afterwards. High quality counseling about future methods of contraception is very important before the abortion. Studies have shown that immediate initiation of any contraceptive method following abortion is linked to lower risk of repeat abortion, with immediate use of an IUD being most effective in reducing this risk [12,13]. IUD insertion was commonly scheduled 2–6 weeks after an abortion procedure, mainly due to concerns about increased risk of expulsion, infection and perforation with immediate insertion in the post-abortal uterus due to its softness and enlargement, but many of the women who do not attend follow-up contraceptive appointments are at high risk of unintended pregnancy [14]. Initiation of contraception immediately after termination of pregnancy is important as over 90% of women will ovulate within a month of the procedure. [15]. Immediate placement of IUD after abortion may be beneficial for several reasons: only a single
visit is required for both the termination and contraception, the patient has a highly effective contraceptive immediately after her procedure and lower risk of unplanned pregnancy, with avoidance of additional discomfort from insertion at a later date [16–18]. Several large trials have demonstrated the safety and efficacy of placing an IUD after abortions [16–20]. Despite this evidence, however, some clinicians hesitate because of fears regarding possible expulsion, uterine perforation, infection and cost. IUDs do not increase the risk of acquiring a sexually transmitted disease in exposed women. The only infection issue is that an IUD should not be inserted if a woman has untreated gonorrhea or chlamydia. In the present study, 16% of the subjects had to discontinue IUD use within the first 6 months due to expulsion or other medical reasons. Expulsion of an IUD is an important factor affecting its safety and efficacy. Partially expelled IUDs should be removed promptly because their contraceptive efficacy is uncertain and they may rarely lead to complications [21]. Adding to the literature, our study examines discontinuation rates by IUD type. We found no variation in IUD discontinuation by the type of IUD. A recent review showed no increased likelihood of adverse health outcomes, including pain, bleeding, infection or IUD removal. IUD expulsion rates, while generally low, are higher after late first-trimester (9–12 weeks) compared with early firsttrimester abortions (<9 weeks) and after second-trimester (12–14 weeks) compared with first-trimester abortions. Our expulsion rate of 2.7% compares favorably with the reported expulsion rate. Unpredictable bleeding is the most common side effect and the most frequent reason for discontinuation. Most of the discontinuation found in our study was method switching rather than contraceptive abandonment altogether. The main side effects of IUDs were prolonged or excessive bleeding and abdominal pain during menstruation. In our study, the rate of removal due to bleeding/pain concerned 13 of the 15 women requesting IUD removals. The medical eligibility criteria of the World Health Organization (WHO) state that there is no restriction on the insertion of copper or hormone-releasing IUDs immediately after firsttrimester induced abortion. After second-trimester abortion, the advantages of using IUDs generally outweigh any theoretical or proven risks [22]. IUDs are also associated with acceptable adverse-events rates among adolescents and nulliparous women, and satisfaction rates among adolescents and young women using IUD are similar to the rates among older women [23–25]. High rates of satisfaction and continuation have been clearly demonstrated. A 3-year study investigating continuation and acceptability after 6 and 36 months of the LNG-IUS found in 165 women a continuation rate of 90% at 36 months, with 77% of women reporting they were very satisfied with the method. Few studies, however, have evaluated long-term continuation and satisfaction with immediate postabortion insertion. Our results suggest high rates of continuation of IUD among French women that have already experienced an unplanned pregnancy. We chose a 6-month follow-up period for our study because most of the IUD expulsions occur in the first 3–6 months after insertion. In a longer follow-up period, young women may be less motivated to continue with IUD use as time passes from the unintended pregnancy, as the situation over the years can change and the high motivation for contraception can be replaced by a desire for pregnancy [26]. This study has several strengths. Beside its prospective nature, IUDs were not all placed by the same providers, and this aspect increases the generalizability of our findings.
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
There are also several important limitations. The IUD was not always confirmed to be present by a provider at the 6-month visit (but self reported), so it is not possible to be certain of true continuation rates or expulsion rates. Another limitation is the substantial proportion of women (18.25%) lost to follow-up. Ongoing contact with women who have undergone an abortion is difficult. A high proportion of patients had to be called multiple times, and in many cases the patient’s contact number was not in service or had been disconnected. These problems are inherent in any research protocol but were especially prominent in this high-risk population. This trend may have led to underestimates of the rates of expulsion, unintended pregnancy and infection. The women who did not return to follow-up were younger than the other members of their cohort, a characteristic of an increased risk for unintended pregnancy. Nevertheless, our study adds to the growing global evidence that discontinuation rate increases with decreasing age and increasing gestational age at abortion. Discontinuation may be a marker of prior poor adherence. Such results should be kept in mind by health care professionals in order for them to anticipate difficulties and to engage women in more discussion about the efficacy of IUDs. Studies showed a direct improvement in contraceptive continuation due to interventions on the part of health care professionals [27]. With an experienced provider, the risks with immediate insertion are low and likely to be outweighed by the immediate provision of highly effective contraception, improved long-term contraceptive compliance and greater patient satisfaction. Aside from benefiting the individual patient, IUD use offers substantial public health benefits, including reduced cost and decreased
Appendix A. Pre procedure questionnaire
271
occurence of repeat abortions, when compared with the many other methods. In conclusion, our data support the fact that immediate IUD insertion at the time of surgical abortion is convenient for many women since the motivation is high for contraception. The immediate provision of effective contraception following abortion is an important programmatic measure that health care providers can take to help reduce unintended pregnancy and thereby, to help reduce repeat abortion. Abortion counseling should include the presentation of reliable long-term contraceptive methods that could be initiated at the time of abortion. Because of its documented safety, immediate IUD insertion after surgical abortion should be offered to allow more women who desire this highly effective form of reversible contraception to receive it. Larger randomized trials will more accurately assess long-term continuation rates and patients’ experience of side effects and acceptability of IUD insertion. Condensation Women choosing immediate postsurgical abortion IUD insertion had high rates of continuation and satisfaction. Acknowledgement We thank the staff of the planned parenthood department of the university hospital of Tours for their contributions to the study. There was no funding for this study.
272
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
References [1] Moreau C, Bouyer J, Bajos N, et al. Frequency of discontinuation of contraceptive use: results from a French population-based cohort. Hum Reprod 2009;24:1387–92. [2] Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health 2006;38: 90–6. [3] Trussell J. Contraceptive failure in the United States. Contraception 2004;70: 89–96. [4] Grimes DA, Lopez LM, Manion C, et al. Cochrane systematic reviews of IUD trials: lessons learned. Contraception 2007;75(6 Suppl.):S55–9. [5] Gillett PG, Lee NH, Yuzpe AA, et al. A comparison of the efficacy and acceptability of the Copper-7 intrauterine device following immediate or delayed insertion after first-trimester therapeutic abortion. Fertil Steril 1980;34:121–4. [6] Pakarinen P, Toivonen J, Luukkainen T. Randomized comparison of levonorgestrel- and copper-releasing intrauterine systems immediately after abortion, with 5 years’ follow-up. Contraception 2003;68:31–4. [7] Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. Br J Obstet Gynaecol 2001;108:1168–73.
273
[8] Stanek AM, Bednarek PH, Nichols MD, et al. Barriers associated with the failure to return for intrauterine device insertion following first-trimester abortion. Contraception 2009;79:216–20. [9] Paul M, Lackie E, Mitchell C, et al. Is pathology examination useful after early surgical abortion? Obstet Gynecol 2002;99:567–71. [10] Cameron ST, Glasier AF, Logan J, et al. Impact of the introduction of new medical methods on therapeutic abortions at the Royal Infirmary of Edinburgh. Br J Obstet Gynaecol 1996;103:1222–9. [11] Grossman D, Ellertson C, Grimes DA, et al. Routine follow-up visits after firsttrimester induced abortion. Obstet Gynecol 2004;103:738–45. [12] Heikinheimo O, Gissler M, Suhonen S. Age, parity, history of abortion and contraceptive choices affect the risk of repeat abortion. Contraception 2008; 78:149–54. [13] Goodman S, Hendlish SK, Reeves MF, et al. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception 2008;78:143–8. [14] Cremer M, Bullard KA, Mosley RM, et al. Immediate vs. delayed post-abortal copper T 380A IUD insertion in cases over 12 weeks of gestation. Contraception 2011;83:522–7. [15] Go¨c¸men A, Demirpolat N, Ays¸in H. The efficacy of immediate post-abortion intrauterine device insertion. Clin Exp Obstet Gynecol 2002;29:274–6.
274
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
[16] Grimes DA, Gallo MF, Grigorieva V, et al. Fertility awareness-based methods for contraception. Cochrane Database Syst Rev 2004;(4):CD004860. [17] Grimes DA, Lopez LM, Schulz KF, et al. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev 2010;(6):CD001777. [18] Grimes DA, Mishell Jr DR. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception 2008;77:6–9. [19] Luukkainen T, Allonen H, Haukkamaa M, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987;36:169–79. [20] Nielsen NC, Nygren KG, Allonen H. Three years of experience after post-abortal insertion of Nova-T and Copper-T-200. Acta Obstet Gynecol Scand 1984;63: 261–4. [21] Bednarek PH, Creinin MD, Reeves MF, et al. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med 2011;364:2208–17.
[22] World Health Organization. WHO medical eligibility criteria for contraceptive use:. 4th ed. Geneva: World Health Organization; 2009. ˜ as JL, Albert A, Carrasco F. Intrauterine contraception in nulligravid vs [23] Duen parous women. Contraception 1996;53:23–4. [24] Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med 2001;345:561–7. [25] Veldhuis HM, Vos AG, Lagro-Janssen ALM. Complications of the intrauterine device in nulliparous and parous women. Eur J Gen Pract 2004;10:82–7. [26] Mechanism of action, safety and efficacy of intrauterine devices. WHO Technical Report Series 1987; 753:1–91. [27] Halpern V, Grimes DA, Lopez L, et al. Strategies to improve adherence and acceptability of hormonal methods for contraception. Cochrane Database Syst Rev 2006;(1):CD004317.
Contents lists available at SciVerse ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Rates of continuation and satisfaction of immediate intrauterine device insertion following first- or second-trimester surgical abortion: a French prospective cohort study Aure´lie Flamant a,b, Lobna Ouldamer a,b,c,*, Gilles Body a,b, Nathalie Trignol-Viguier a,b a b c
Department of Gynecology, University Hospital of Tours, 2 Boulevard Tonnele´, 37044 Tours, France University Franc¸ois Rabelais, Tours, France INSERM Unit U1069, Tours, France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 November 2012 Received in revised form 11 March 2013 Accepted 21 April 2013
Background: Immediate postsurgical abortion insertion of intrauterine devices (IUDs) could substantially reduce the risk of repeat abortion. Studies have demonstrated efficacy and safety, and postabortum insertion would likely increase rates of usage. There are few data in the literature concerning rates of continuation and satisfaction after immediate postabortion IUD insertion. Study design: We performed a prospective cohort study of women undergoing surgical abortion and choosing immediate insertion of IUD for contraception. We followed at six months rates of continuation, expulsion, removal and pregnancy, and reasons for discontinuation of IUD postinsertion. Results: 137 patients were included. At 6 months, we were able to contact 112 of them. The continuation rate was 78.6% (95% confidence intervals (CI) [69.8, 85.8]) and the satisfaction rate was high at 85.2% (95%CI [76.1, 91.1]). Three (2.7%) expulsions occurred. Removals occurred in 18.75%. Conclusions: We found that women choosing immediate postsurgical abortion IUD insertion had high rates of continuation and satisfaction. ß 2013 Elsevier Ireland Ltd. All rights reserved.
Keywords: Intrauterine devices Immediate postabortum insertion Continuation Copper IUD LNG IUS
1. Introduction France has a 40% rate of unintended pregnancy for women of all ages. Women who have abortions are at high risk of repeat unintended pregnancies in the subsequent year [1]. More than half of all unintended pregnancies occur as a result of inconsistent use and discontinuation of contraceptives [2,3], even though several safe and highly effective methods of contraception are available. Long-acting contraceptives such as intrauterine devices (IUDs) are the most effective and cost-effective methods for women. They are safe for a wide range of women including those who are nulliparous or adolescent, and provide safe, highly effective, long-term reversible contraception that does not require active use once they have been inserted. Thus, they may be especially appropriate for many women following abortion. The failure rate with typical use is 0.1–0.8% in the first year, which is similar to the failure rate with female sterilization
* Corresponding author at: Department of Gynecology, CHU Bretonneau, 2 Boulevard Tonnele´, 37000 Tours, France. Tel.: +33 02 47474741; fax: +33 02 47473801. E-mail addresses: [email protected] (L. Ouldamer). 0301-2115/$ – see front matter ß 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ejogrb.2013.04.006
[3], so the IUD confers nearly the same contraceptive efficacy as does tubal sterilization, yet it is simpler, less expensive and promptly reversible [4]. The literature has documented the safety of immediate postabortion IUD provision, which avoids the loss to follow-up of patients who do not return for IUD insertion [5–7]. Some authors reported that 25–60% of women who intend IUD use for postabortion contraception do not return for their scheduled insertion visit [6–11]. Women who receive an IUD immediately after surgical abortion experience few complications and are less likely to have an unintended pregnancy than those who delay getting an IUD by several weeks [12,13]. Multiple studies have shown that immediate IUD insertion following abortion has complication rates similar to those reported for interval insertion [5–7]. Abortions present a considerable economic burden on society. Reducing unintended pregnancy requires a multifaceted approach that includes better education about sexuality and contraception and improved access to higher quality family planning counseling and services. A transition from contraceptive methods that require continuing motivation and conscientious use to long-acting reversible contraceptives would markedly reduce unintended pregnancies.
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
The aim of our study was to determine patient continuation, satisfaction, and motives underlying discontinuation with postaspiration immediate IUD insertion. 2. Materials and methods Our study is a descriptive single-center prospective clinical study. The study protocol was approved by the institutional review board. All women who were enrolled gave written informed consent. We included outpatients in the planned parenthood department of the university hospital of Tours, France, from October 1, 2010 to March 31, 2011. Inclusion criteria were: women aged 18 years and older, able to understand and give consent, who underwent immediate postabortion IUD insertion after a first- or second-trimester surgical abortion. Women were not eligible if they were unable to give informed consent or if they had: congenital or acquired uterine anomaly, known or suspected cervical dysplasia, acute pelvic inflammatory disease, untreated acute cervicitis or vaginitis, confirmed Chlamydia trachomatis or Neisseria gonorrheae infection in the previous 6 months or hypersensitivity to any component of copper or levonorgestrel-releasing IUS (allergy to copper or Wilson’s disease for those desiring the copper IUD). Participation in the study was considered complete if the patients were reachable at 6 months and could report if they had their IUD or not and completed the survey. Six-month follow-up visits began in April 1, 2011 and concluded in September 30, 2011. Patients make contraceptive choices during the preabortion counseling. Each patient was counseled about her contraceptive options before the abortion. The risks, benefits and side effects of each type of contraception were discussed. After counseling on IUD options, the women chose the IUD that was preferable to them. The IUDs were inserted immediately after uterine aspiration for termination of pregnancy of less than 15 weeks’ duration. According to patient choice, a levonorgestrel or a copper IUD was inserted using standard insertion technique, without ultrasound guidance. Demographic data (age, race, gravidity/parity, number of prior abortions, gestational age at the time of abortion, income level) were obtained on the day of the surgical abortion through a preprocedure questionnaire: we also asked the women questions such as whether or not they had a favorable opinion on IUD before insertion. All subjects were scheduled for an appointment two weeks after the surgical abortion and IUD insertion. Six months after the procedure, the women returned to the hospital for a final study visit and if not, they were contacted by phone. A survey form was developed for the standardized collection of information. Menstrual disturbance was defined as the occurrence of longer or less prolonged menstrual bleeding, amenorrhea, increased or less abundant menstrual bleeding, spotting or irregular menstrual cycles. Patient satisfaction was on a fourpoint scale (‘‘very dissatisfied’’, ‘‘somewhat dissatisfied’’, ‘‘somewhat satisfied’’, ‘‘very satisfied’’). Repondents were asked if they had seen a doctor since their abortion, or if they had their IUD removed for any reason. Statistical analyses were performed by R 2.13.1 (http:// www.cran.r-project.org/), for numeric data: values are expressed as mean and median values standard deviation (SD). Numeric data were analyzed with Student’s t-test if normally distributed: if not, the Mann–Whitney test was used for comparison of data. Categorical data were analyzed with the chi-squared test or with Fisher’s exact test.
269
3. Results Between October 1, 2010 and March 31, 2011, a total of 557 women aged 18 years and older underwent a surgical abortion in the planned parenthood department of the university hospital of Tours. Among them, 226 (40.6%) had immediate insertion of IUD (213 under local anesthesia and 13 under general anesthesia). 137 women enrolled and completed the initial survey: 94 (68.6%) had a copper IUD (Cu-IUD) and 43 (31.4%) had a levonorgestrel-releasing intrauterine system (LNG-IUS). Two women out of three chose a Cu-IUD because of: fear of subsequent amenorrhea or refusal of any hormonal contraception or because of the price for patients without medical insurance: 30 euros for a Cu-IUD versus 130 euros for a LNG-IUS. The age distribution is described in Table 1 and baseline data for participants are presented in Table 2. Over 36% of patients were nulliparous and close to 1 in 2 women had graduated from high school. Over 24% were not using anything for contraception at the time of conception and 35% had had a previous induced abortion. Concerning beliefs about the safety and efficacy of IUDs: at inclusion, of the 137 women who completed the initial survey 55.5% had a favorable opinion about IUDs, 23.3% were neutral and 20.5% had an unfavorable opinion. Almost all patients (95.6%) stated that the IUD insertion was a choice of their own. 111 women (87%) attended the two-week follow-up visit. 112 patients (81.75%) completed the study: at 6 months we were unable to reach 25 (18.25%) women despite multiple attempts at telephone contact. Women lost to follow-up were younger (p = 0.0008) with a higher gestational age (p = 0.0016). Of the 112 patients with immediate insertion of IUD whom we were able to contact, the continuation rate at six months was 78.6% (95% confidence intervals (CI) [69.8, 85.8]). Continuation did not differ between the LNG-IUS and the copper IUD: 80% of LNG-IUS users (n = 28) and 77.9% of copper IUD users (n = 60) were still using their contraceptive method (p = 0.80). Discontinuation rates were highest among those aged between 25 and 30 years (p = 0.023), and in women with prior abortion (p = 0.018). There were three expulsions (2.7%) of which one pregnancy occurred after unnoticed expulsion. 21 women (18.75%) had their IUD removed after a mean delay of 2.7 months (minimum = 1 week, maximum = 5.75 months). The reasons the IUD was removed were: personal reasons for six women (pregnancy planning n = 5, psychological intolerance n = 1), medical reasons for 15 (removal because of bleeding problems n = 10 (nine Cu-IUDs that caused increase of menstrual bleeding, and one LNG-IUS responsible of spotting between menstrual cycles), cramping or pain n = 3 (two LNG-IUS and one Cu-IUD), pelvic inflammatory disease n = 2 (one confirmed Chlamydia trachomatis and one Neisseria gonorrhea infection). After IUD removal, six women requested and received a second IUD insertion (three Cu-IUD and three LNG-IUS). The alternative choices for contraception were estrogen-progestogen pills for nine women, no method for eight women and one Nuvaring. In term of complications, there were no reported perforations. In the continuation group, side effects were as follows: menstrual Table 1 Age distribution of the women by IUD type. Copper IUD (%)
LNG IUS (%)
Mean
Age (years)
27.4
30
18–20 20–25 25–30 30–35 35
12.8 24.5 25.5 22.3 14.9
0 20.9 23.3 25.6 30.2
270
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
Table 2 Baseline patient characteristics. n (%) Marital status (n = 136) Single Married Partnered
55 (40.1) 32 (23.4) 49 (35.8)
Educational level (n = 137) High-school graduate or less Some college College graduate College postgraduate
39 30 52 16
(28.5) (21.9) (38) (11.7)
Occupation (n = 137) Working Student Housewife Not working
76 26 19 16
(55.5) (19) (13.9) (11.7)
Race or ethnic group European North african Black Other
110 (80.3) 7 (5.1) 12 (8.75) 8 (5.8)
Religion practice (n = 135) Yes No
25 (18.2) 110 (80.3)
Gestational age <10 weeks 10–12 weeks >12 weeks
96 (70.1) 33 (24.1) 8 (5.8)
Number of prior abortions 0 1 2 3
89 (65) 38 (27.8) 5 (3.6) 5 (3.6)
Parity 0 1 2 3
50 37 28 22
(36.5) (27) (20.4) (16.1)
disturbance 42 (70%) in the Cu-IUD users vs 17 (61%) in the LNGIUS users (p = 0.38), pain or cramping 31 (52%) in the Cu-IUD users vs 11(39%) in the LNG-IUS users (p = 0.27). Rates of satisfaction (somewhat or very satisfied) among women continuing their IUD did not differ between the LNG-IUS and the Cu-IUD users (82.1% of LNG-IUS users (n = 23) and 86.7% of Cu-IUD users (n = 52) (p = 0.81). 4. Comments Women who seek an abortion are highly motivated to use contraceptive methods afterwards. High quality counseling about future methods of contraception is very important before the abortion. Studies have shown that immediate initiation of any contraceptive method following abortion is linked to lower risk of repeat abortion, with immediate use of an IUD being most effective in reducing this risk [12,13]. IUD insertion was commonly scheduled 2–6 weeks after an abortion procedure, mainly due to concerns about increased risk of expulsion, infection and perforation with immediate insertion in the post-abortal uterus due to its softness and enlargement, but many of the women who do not attend follow-up contraceptive appointments are at high risk of unintended pregnancy [14]. Initiation of contraception immediately after termination of pregnancy is important as over 90% of women will ovulate within a month of the procedure. [15]. Immediate placement of IUD after abortion may be beneficial for several reasons: only a single
visit is required for both the termination and contraception, the patient has a highly effective contraceptive immediately after her procedure and lower risk of unplanned pregnancy, with avoidance of additional discomfort from insertion at a later date [16–18]. Several large trials have demonstrated the safety and efficacy of placing an IUD after abortions [16–20]. Despite this evidence, however, some clinicians hesitate because of fears regarding possible expulsion, uterine perforation, infection and cost. IUDs do not increase the risk of acquiring a sexually transmitted disease in exposed women. The only infection issue is that an IUD should not be inserted if a woman has untreated gonorrhea or chlamydia. In the present study, 16% of the subjects had to discontinue IUD use within the first 6 months due to expulsion or other medical reasons. Expulsion of an IUD is an important factor affecting its safety and efficacy. Partially expelled IUDs should be removed promptly because their contraceptive efficacy is uncertain and they may rarely lead to complications [21]. Adding to the literature, our study examines discontinuation rates by IUD type. We found no variation in IUD discontinuation by the type of IUD. A recent review showed no increased likelihood of adverse health outcomes, including pain, bleeding, infection or IUD removal. IUD expulsion rates, while generally low, are higher after late first-trimester (9–12 weeks) compared with early firsttrimester abortions (<9 weeks) and after second-trimester (12–14 weeks) compared with first-trimester abortions. Our expulsion rate of 2.7% compares favorably with the reported expulsion rate. Unpredictable bleeding is the most common side effect and the most frequent reason for discontinuation. Most of the discontinuation found in our study was method switching rather than contraceptive abandonment altogether. The main side effects of IUDs were prolonged or excessive bleeding and abdominal pain during menstruation. In our study, the rate of removal due to bleeding/pain concerned 13 of the 15 women requesting IUD removals. The medical eligibility criteria of the World Health Organization (WHO) state that there is no restriction on the insertion of copper or hormone-releasing IUDs immediately after firsttrimester induced abortion. After second-trimester abortion, the advantages of using IUDs generally outweigh any theoretical or proven risks [22]. IUDs are also associated with acceptable adverse-events rates among adolescents and nulliparous women, and satisfaction rates among adolescents and young women using IUD are similar to the rates among older women [23–25]. High rates of satisfaction and continuation have been clearly demonstrated. A 3-year study investigating continuation and acceptability after 6 and 36 months of the LNG-IUS found in 165 women a continuation rate of 90% at 36 months, with 77% of women reporting they were very satisfied with the method. Few studies, however, have evaluated long-term continuation and satisfaction with immediate postabortion insertion. Our results suggest high rates of continuation of IUD among French women that have already experienced an unplanned pregnancy. We chose a 6-month follow-up period for our study because most of the IUD expulsions occur in the first 3–6 months after insertion. In a longer follow-up period, young women may be less motivated to continue with IUD use as time passes from the unintended pregnancy, as the situation over the years can change and the high motivation for contraception can be replaced by a desire for pregnancy [26]. This study has several strengths. Beside its prospective nature, IUDs were not all placed by the same providers, and this aspect increases the generalizability of our findings.
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
There are also several important limitations. The IUD was not always confirmed to be present by a provider at the 6-month visit (but self reported), so it is not possible to be certain of true continuation rates or expulsion rates. Another limitation is the substantial proportion of women (18.25%) lost to follow-up. Ongoing contact with women who have undergone an abortion is difficult. A high proportion of patients had to be called multiple times, and in many cases the patient’s contact number was not in service or had been disconnected. These problems are inherent in any research protocol but were especially prominent in this high-risk population. This trend may have led to underestimates of the rates of expulsion, unintended pregnancy and infection. The women who did not return to follow-up were younger than the other members of their cohort, a characteristic of an increased risk for unintended pregnancy. Nevertheless, our study adds to the growing global evidence that discontinuation rate increases with decreasing age and increasing gestational age at abortion. Discontinuation may be a marker of prior poor adherence. Such results should be kept in mind by health care professionals in order for them to anticipate difficulties and to engage women in more discussion about the efficacy of IUDs. Studies showed a direct improvement in contraceptive continuation due to interventions on the part of health care professionals [27]. With an experienced provider, the risks with immediate insertion are low and likely to be outweighed by the immediate provision of highly effective contraception, improved long-term contraceptive compliance and greater patient satisfaction. Aside from benefiting the individual patient, IUD use offers substantial public health benefits, including reduced cost and decreased
Appendix A. Pre procedure questionnaire
271
occurence of repeat abortions, when compared with the many other methods. In conclusion, our data support the fact that immediate IUD insertion at the time of surgical abortion is convenient for many women since the motivation is high for contraception. The immediate provision of effective contraception following abortion is an important programmatic measure that health care providers can take to help reduce unintended pregnancy and thereby, to help reduce repeat abortion. Abortion counseling should include the presentation of reliable long-term contraceptive methods that could be initiated at the time of abortion. Because of its documented safety, immediate IUD insertion after surgical abortion should be offered to allow more women who desire this highly effective form of reversible contraception to receive it. Larger randomized trials will more accurately assess long-term continuation rates and patients’ experience of side effects and acceptability of IUD insertion. Condensation Women choosing immediate postsurgical abortion IUD insertion had high rates of continuation and satisfaction. Acknowledgement We thank the staff of the planned parenthood department of the university hospital of Tours for their contributions to the study. There was no funding for this study.
272
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
References [1] Moreau C, Bouyer J, Bajos N, et al. Frequency of discontinuation of contraceptive use: results from a French population-based cohort. Hum Reprod 2009;24:1387–92. [2] Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health 2006;38: 90–6. [3] Trussell J. Contraceptive failure in the United States. Contraception 2004;70: 89–96. [4] Grimes DA, Lopez LM, Manion C, et al. Cochrane systematic reviews of IUD trials: lessons learned. Contraception 2007;75(6 Suppl.):S55–9. [5] Gillett PG, Lee NH, Yuzpe AA, et al. A comparison of the efficacy and acceptability of the Copper-7 intrauterine device following immediate or delayed insertion after first-trimester therapeutic abortion. Fertil Steril 1980;34:121–4. [6] Pakarinen P, Toivonen J, Luukkainen T. Randomized comparison of levonorgestrel- and copper-releasing intrauterine systems immediately after abortion, with 5 years’ follow-up. Contraception 2003;68:31–4. [7] Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. Br J Obstet Gynaecol 2001;108:1168–73.
273
[8] Stanek AM, Bednarek PH, Nichols MD, et al. Barriers associated with the failure to return for intrauterine device insertion following first-trimester abortion. Contraception 2009;79:216–20. [9] Paul M, Lackie E, Mitchell C, et al. Is pathology examination useful after early surgical abortion? Obstet Gynecol 2002;99:567–71. [10] Cameron ST, Glasier AF, Logan J, et al. Impact of the introduction of new medical methods on therapeutic abortions at the Royal Infirmary of Edinburgh. Br J Obstet Gynaecol 1996;103:1222–9. [11] Grossman D, Ellertson C, Grimes DA, et al. Routine follow-up visits after firsttrimester induced abortion. Obstet Gynecol 2004;103:738–45. [12] Heikinheimo O, Gissler M, Suhonen S. Age, parity, history of abortion and contraceptive choices affect the risk of repeat abortion. Contraception 2008; 78:149–54. [13] Goodman S, Hendlish SK, Reeves MF, et al. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception 2008;78:143–8. [14] Cremer M, Bullard KA, Mosley RM, et al. Immediate vs. delayed post-abortal copper T 380A IUD insertion in cases over 12 weeks of gestation. Contraception 2011;83:522–7. [15] Go¨c¸men A, Demirpolat N, Ays¸in H. The efficacy of immediate post-abortion intrauterine device insertion. Clin Exp Obstet Gynecol 2002;29:274–6.
274
A. Flamant et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 169 (2013) 268–274
[16] Grimes DA, Gallo MF, Grigorieva V, et al. Fertility awareness-based methods for contraception. Cochrane Database Syst Rev 2004;(4):CD004860. [17] Grimes DA, Lopez LM, Schulz KF, et al. Immediate postabortal insertion of intrauterine devices. Cochrane Database Syst Rev 2010;(6):CD001777. [18] Grimes DA, Mishell Jr DR. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception 2008;77:6–9. [19] Luukkainen T, Allonen H, Haukkamaa M, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987;36:169–79. [20] Nielsen NC, Nygren KG, Allonen H. Three years of experience after post-abortal insertion of Nova-T and Copper-T-200. Acta Obstet Gynecol Scand 1984;63: 261–4. [21] Bednarek PH, Creinin MD, Reeves MF, et al. Immediate versus delayed IUD insertion after uterine aspiration. N Engl J Med 2011;364:2208–17.
[22] World Health Organization. WHO medical eligibility criteria for contraceptive use:. 4th ed. Geneva: World Health Organization; 2009. ˜ as JL, Albert A, Carrasco F. Intrauterine contraception in nulligravid vs [23] Duen parous women. Contraception 1996;53:23–4. [24] Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med 2001;345:561–7. [25] Veldhuis HM, Vos AG, Lagro-Janssen ALM. Complications of the intrauterine device in nulliparous and parous women. Eur J Gen Pract 2004;10:82–7. [26] Mechanism of action, safety and efficacy of intrauterine devices. WHO Technical Report Series 1987; 753:1–91. [27] Halpern V, Grimes DA, Lopez L, et al. Strategies to improve adherence and acceptability of hormonal methods for contraception. Cochrane Database Syst Rev 2006;(1):CD004317.