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Six-month and 1-year continuation rates following postpartum insertion of implants and intrauterine devices
Contraception 92 (2015) 532 – 535
Original research article
Six-month and 1-year continuation rates following postpartum insertion of implants and intrauterine devices☆ Irene Woo a,⁎, Sara Seifert a , Dacia Hendricks c , Roxanne M. Jamshidi b , Anne E. Burke b , Michelle C. Fox b a b
Gynecology and Obstetrics, Johns Hopkins Institution, 600 North Wolfe Street, Phipps 279 Baltimore, MD, USA, 21287 Department of Family Planning, John Hopkins Bayview Medical Center, 4940 Eastern Ave Baltimore, MD, USA, 21224 c Howard University College of Medicine, 520 W St North West, Washington DC, USA, 20059 Received 30 December 2014; revised 19 September 2015; accepted 21 September 2015
Abstract Objective: Studies show immediate postpartum (PP) insertion increases use of contraceptive implants and intrauterine devices (IUDs). Our objective was to compare the satisfaction and continuation rates of the two types of devices at 6 months and 1 year following PP insertion. Study Design: We enrolled 133 women in a prospective cohort study following immediate PP insertion of an implant or IUD at two academic hospitals during 8 months of 2011. Subjects completed an enrollment survey during hospital admission and a follow-up phone survey 6 months and 1 year PP. Results: At 6 months PP, 72% of subjects provided follow-up information. Implant users were more likely to be using the originally-placed device (40/41, 98% vs. 45/55, 82%, p=0.02); nine women reported IUD expulsions. When accounting for replacement of expelled IUDs, IUD continuation at 6 months was 89% yielding similar continuation rates between groups (p=0.12). At 1 year PP, 51% provided follow-up. Of those, 82% still had a LARC method in place with similar continuation by device type (84% for implants, 81% for IUDs, p=0.96). Overall, satisfaction was similarly high in both groups. Conclusion: Due to IUD expulsion, implants had a higher continuation rate than IUDs six months following immediate PP insertion. After replacement of expelled IUDs, continuation and satisfaction were similar for both devices at 6 months and 1 year. Implications: Placement of implants and IUDs immediately PP can lead to high satisfaction. Despite early IUD expulsions, continuation rates were similar to those placed outside of the immediate PP period. © 2015 Elsevier Inc. All rights reserved. Keywords: Long acting reversible contraception; postpartum contraception; contraception continuation; contraception compliance
1. Introduction Long-acting reversible contraceptive (LARC) methods, defined here as implants and IUDs, are highly effective methods of birth control in large part because they do not rely on the user for compliance or continuation after device placement. LARC devices are more effective than other forms ☆ Conflicts of Interest: Dr. Michelle Fox is currently employed by Merck pharmaceuticals, the manufacturer of the contraceptive implant used in this study; this research was completed prior to her association with the company. The opinions expressed in this publication are those of the authors and not of Merck. ⁎ Corresponding author at: Department of Gynecology and Obstetrics, Johns Hopkins Institution, 600 North Wolfe Street, Phipps 279 Baltimore, MD, USA, 21287. Tel.: + 1 610 659 8417. E-mail address: [email protected] (I. Woo).
http://dx.doi.org/10.1016/j.contraception.2015.09.007 0010-7824/© 2015 Elsevier Inc. All rights reserved.
of contraception due to fewer opportunities for user error and high long-term continuation rates [1–3]. LARC methods remain underutilized in the United States (US). Only 6.4% of US women of reproductive age surveyed in 2011-2013 reported current use of an IUD within the last month [4]. Because 35% of pregnancies in the US are conceived within 18 months of a previous birth, PP contraceptive provision is crucial to prevent short interpregnancy intervals and the associated risks of preterm birth, low birth weight and preeclampsia [5]. In one study, nearly 50% of women instructed to abstain from sexual intercourse until 6 weeks PP reported having unprotected sex earlier [6]. Women who express intention to use IUDs for contraception during prenatal care frequently do not receive the method during the PP period [7]. The immediate PP period is increasingly seen
I. Woo et al. / Contraception 92 (2015) 532–535
as a particularly favorable time for implant or IUD insertion because motivation for contraception is high and access to care is already assured. The study objectives were to assess the continuation rate and satisfaction with the etonogestrel implant compared to IUDs at 6 months and 1 year following immediate PP placement. We hypothesized that implant continuation would be higher than IUD continuation, given the known risk of IUD expulsion following immediate PP insertion (14-20%, compared to 3% for interval insertion) [8–14]. We also compared our PP LARC continuation rates with expected continuation following standard interval insertion, using published literature for comparison [11,14].
2. Materials and methods Women were eligible for this prospective cohort study if they delivered a live infant at greater than or equal to 24 0/7 weeks gestation and received an immediate PP LARC method at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHMBC) from January 1, 2011 to August 31, 2011. Implant insertion anytime between delivery and hospital discharge qualified for this study. IUD insertion qualified if it had occurred within 10 minutes of the expulsion of the placenta. We only enrolled women who could provide a telephone contact number for study follow-up. Investigators recruited women after device placement and prior to hospital discharge; after obtaining informed consent, we asked them to complete an enrollment survey. Recruitment was dependent on investigator availability. We did not collect information regarding women who declined participation and have no information regarding the number of eligible women who we did not have the opportunity to invite to participate. The enrollment survey covered demographic and reproductive characteristics and past use of implants and IUDs. At 6 months and 1 year PP, we attempted to reach each subject by telephone with a maximum of 3 calls per listed phone number. If we were unable to reach a subject, we mailed a recall letter encouraging her to contact our research office. The 6- and 12-month telephone surveys assessed device continuation, satisfaction, side effects, potential LARC complications, and pregnancies. We measured satisfaction using a 10-point scale from 0 (unsatisfied) to 10 (completely satisfied). This study enrolled a convenience sample based on investigator availability for 8 months of recruitment. The planned convenience sample size of 50 subjects completing follow-up in each arm (implant vs. IUD) had 80% power to detect a 25% difference in continuation rates. The primary outcome was continuation of implants compared with IUDs at 6 months and 1 year PP. We compared continuation rates using Chi-square and Fisher’s exact method, when appropriate. We also assessed satisfaction rates for both types of devices. Statistical analysis was performed using Stata 12.1 (College Station, TX, USA). The Johns Hopkins Medical Institute (JHMI) IRB approved this study.
533
3. Results We enrolled one hundred and thirty three women in the study — 57 who received an implant and 76 who received IUDs. Table 1 shows the baseline characteristics of participants. Women who received implants were younger than women receiving IUDs (mean age 26 years vs. 28 years, p=.02). Implant users were less likely to report completion of childbearing (32% vs. 51%, p=.02) and less likely to have previously used a LARC method (2% vs. 13%, p=.04). Implant and IUD users were similar with regard to other baseline characteristics. Three-fourths of our cohort had expressed intention to use a LARC method for PP contraception during prenatal visits. At 6 months PP, 72% (96/133) of subjects completed the follow-up survey. At 1 year PP, we were able to contact 51% (68/133) of participants for follow-up. Those lost to follow-up at six months were more likely to have had a prior elective abortion (43% vs. 22%, p=.05) and more likely to be single (57% vs. 33%, p=.04). Demographics of subjects with and without 1 year follow-up were similar with regard to type of device they received, prior LARC use, education, insurance and marital status (Table 2). The few women (15 of the total) who received prenatal care at the faculty practice had higher rate of 1-year follow-up than women with other
Table 1 Enrollment demographics. Demographics
Intrauterine Device Implant p value N=76 (57%) N=57 (43%)
Age (mean) Prior births (median) Prior elective abortions (median) Prior use of any LARC methods Race/Ethnicity Nonhispanic White Hispanic White Nonhispanic Black Hispanic Black Asian Other Relationship Status Single Married Long-term partner Divorced Education b 8th grade Some high school High school graduate Some college College graduate Beyond college Insurance Private Medical assistance Uninsured (device provided by grant)
27 2 0 10 (13%)
25 2 0 1 (2%)
0.02 0.58 0.42 0.04
19 (25%) 23 (30%) 29 (38%) 1 (1%) 2 (3%) 2 (3%)
18 (31%) 20 (35%) 16 (28%) 0 (0%) 2 (4%) 1 (2%)
0.76
24 (32%) 24 (32%) 27 (36%) 1 (1%)
23 (40%) 38 (26%) 18 (32%) 1 (2%)
0.75
9 (12%) 24 (32%) 18 (24%) 19 (25%) 3 (4%) 3 (4%)
12 (21%) 16 (28%) 18 (32%) 8 (14%) 3 (5%) 0 (0%)
0.23
11 (14%) 49 (65%) 15 (21%)
5 (9%) 37 (65%) 15 (26%)
0.52
534
I. Woo et al. / Contraception 92 (2015) 532–535
Table 2 Demographics of those that did and did not follow up at 12 months. No follow up Follow up p value N=65 N=68 Type of Device IUD Implant Prior LARC No Yes Education b8th grade Some high school High school graduate Some college College graduate Beyond college Relationship Status Single Married Long-term partner Divorced Insurance Private Medical assistance Uninsured (device provided by grant) Clinic site Academic hospital clinic Private clinic/faculty practice Center for addiction and pregnancy Community clinic⁎ Other
0.34 33 (51%) 32 (49%)
43 (63%) 25 (37%)
56 (86%) 9 (14%)
55 (81%) 13 (19%)
0.41
11 25 17 9 2 1
(17%) (38%) (26%) (14%) (3%) (2%)
10 15 19 18 4 2
(15%) (22%) (28%) (26%) (6%) (3%)
0.24
24 18 21 2
(37%) (28%) (32%) (3%)
23 21 24 0
(34%) (31%) (35%) (0%)
5 45 14 1
(8%) (69%) (21%) (2%)
11 41 16 0
(16%) (60%) (24%) (0%)
34 2 7 15 7
(52%) (3%)⁎ (11%) (23%) (11%)
33 13 5 10 7
(49%) 0.04 (19%)⁎ (7%) (15%) (10%)
0.61
0.31
⁎ Community clinic serves women with medical assistance or no insurance
sites of prenatal care (13/15 vs 40/63, p=.04). At the time of the 6 month follow-up call, 34% of subjects contacted reported they did not attend their PP visit. Of the women contacted, 89% still had the original contraceptive in place. A provider removed one implant. Nine IUDs had spontaneously expelled by 6 months (16%) and one participant reported self-removal. Five of 9 women underwent IUD replacement following expulsion. Excluding subjects lost to follow-up from the analysis, the implant had a higher 6-month continuation rate than IUDs (98% vs 82%, p=.02) (Table 3). When counting replacement of an expelled IUD as continuation, the difference between groups was smaller
(98% vs. 91%, p=.12). Satisfaction with both LARC methods was high at 6 months PP, with a median score of 9/10 for the implant group (N= 41), and 8/10 for the IUD group (N= 55) (p=.42). Forty percent of subjects contacted reported gynecologic symptoms within 6 months; the most common complaints were bothersome bleeding (26%), pain (24%), and discharge (4%). In the IUD group, 15% of the subjects reported that their partners complained of feeling the IUD strings, 13% reported having imaging for IUD localization due to absent strings, and 32% had the strings trimmed. No serious adverse events were reported. At the time of telephone contact, a minority of subjects expressed desire for device removal (7 (17%) implant users, 5 (10%) of IUD users, p=.7). More than half of these women were uninsured and subsequently lost to follow-up; of those with known outcome, half ultimately discontinued the device. Of those with telephone follow-up at 1 year, 82% had an implant or IUD in place (84% for implants, 81% for IUDs, p=.96; see Table 3). The only detected difference between those who continued or discontinued the LARC device was ethnicity: white Hispanic women had the highest continuation rate, 92%(p=0.02). Satisfaction was similarly high for both devices with a median score of 8/10 in both groups at 1 year. No pregnancies were reported and the groups reported similar side effects during telephone follow-up.
4. Discussion In this study, women with etonogestrel implants reported a higher continuation rate at 6 months than women with IUDs when considering the original device. When accounting for IUDs replaced after expulsion, however, continuation rates were more similar. Due to the small sample size and higher-than-expected subject attrition, this study had limited power to identify differences in continuation between implants and IUDs at 1 year. Our one-year continuation rate for both immediate PP devices at 82% is consistent with the previous studies regarding IUD and implant continuation, even when inserted outside of the PP time period (83%) [15–19]. Satisfaction was high at 6 months and 1 year. The PP period represents a window of opportunity to initiate contraception: motivation to prevent pregnancy is high, but so is the risk of non-attendance at a follow-up visit.
Table 3 Six-month and 1-year follow up. 6 Months
Patients that followed up Original LACRC device in place LARC device in place Device removed upon request Satisfaction on 10-point scale (median)
1 Year
Intrauterine Device
Implant
p Value
Intrauterine Device
Implant
p Value
72% (N=55/76) 82% (N=45/55) 91% (n= 50/55) 2% (n= 1/55) 8
72% (n=41/57) 98% (n=40/41) 98% (n=40/41) 2% (n=1/41) 9
0.96 0.02 0.12 0.89 0.42
57% (n= 43/76) 74% (n= 32/43) 81% (n= 35/43) 12% (n= 5/43) 8
44% (n=25/57) 84% (n=21/25) 84% (n=21/25) 16% (n=4/25) 8
0.15 0.36 0.96 0.61 0.87
I. Woo et al. / Contraception 92 (2015) 532–535
In this study, 34% of women did not return for their routine PP visit, thus precluding their opportunity for LARC initiation after hospital discharge. Many of these women had limited health insurance coverage that expired after the immediate PP period. For those who may not return for follow-up, the benefits of placing a LARC immediately PP greatly outweigh the risks of device expulsion or early removal. Immediate postpartum implant insertion may have the highest rate of continuation up to 3 years in the population who are most vulnerable to rapid repeat and unintended pregnancy [20]. The primary limitation of this study was the attrition rate of subjects (28% at 6 months and 49% at 1 year). It is possible that those lost to follow-up presented to other health centers with device complications or for device removal; thus, we may have overestimated the continuation rates. A further limitation is that we cannot calculate a study participation rate. Due to resource constraints, we could only approach patients for this study when an investigator was available, and thus the women enrolled are an unknown subset of all women receiving PP LARC. We recruited our subjects from two large academic medical centers serving a mostly urban population. Due to lack of stable housing or consistent telephone service among many of these women, long-term follow-up is often a challenge. LARC methods are more cost effective than other forms of contraception [21,22]. Further studies to evaluate cost effectiveness of immediate postpartum insertion of LARC devices in the US are warranted. A cost benefit analysis must consider both the high no show rate for interval insertion and the higher rate of IUD expulsion after immediate PP placement [8]. We found high continuation and satisfaction rates at 6 and 12 months following immediate PP LARC insertion. One-year continuation rates were comparable to rates when LARC devices are placed outside of the immediate PP period. The PP period is a window of opportunity for women and providers to ensure women are provided with the most effective contraceptive methods. Acknowledgement Funding for this research was provided by the Department of Family Planning, Johns Hopkins Bayview Medical Center. References [1] Blumenthal PD, Voedisch A, Gemzell-Danielsson K. Strategies to prevent unintended pregnancy: increasing use of long-acting reversible contraception. Hum Reprod Update 2011;17(1):121–37. [2] Stuart JE, Secura GM, Zhao Q, Pittman ME, Peipert JF. Factors associated with 12-month discontinuation among contraceptive pill, patch, and ring users. Obstet Gynecol 2013;121(2 Pt 1):330–6.
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[3] Lewis LN, Doherty DA, Hickey M, Skinner SR. Implanon as a contraceptive choice for teenage mothers: a comparison of contraceptive choices, acceptability and repeat pregnancy. Contraception 2010;81(5):421–6. [4] Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15–44: United States, 2011–2013. National Health Statistics Reports, No. 173. Hyattsville, MD: National Center for Health Statistics; 2014. [5] Gemmill A, Lindberg LD. Short interpregnancy intervals in the United States. Obstet Gynecol 2013;122(1):64–71. [6] Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception 2009;80(6):519–26. [7] Ogburn JA, Espey E, Stonehocker J. Barriers to intrauterine device insertion in postpartum women. Contraception 2005;72(6):426–9. [8] Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol 2010;116(5):1079–87. [9] Celen S, Moroy P, Sucak A, Aktulay A, Danisman N. Clinical outcomes of early postplacental insertion of intrauterine contraceptive devices. Contraception 2004;69(4):279–82. [10] Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev 2010(5):Cd003036, http://dx.doi.org/10.1002/ 14651858.CD003498.pub3. [11] Kaneshiro B, Aeby T. Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device. Int J Womens Health 2010;2:211–20. [12] Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception 2009;80(4):327–36. [13] Xu JX, Rivera R, Dunson TR, et al. A comparative study of two techniques used in immediate postplacental insertion (IPPI) of the Copper T-380A IUD in Shanghai, People's Republic of China. Contraception 1996;54:33–8 [United States]. [14] 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(2):169–79. [15] Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol 2011;117(5):1105–13. [16] Jensen JT, Nelson AL, Costales AC. Subject and clinician experience with the levonorgestrel-releasing intrauterine system. Contraception 2008;77:22–9 [United States]. [17] Sivin I, el Mahgoub S, McCarthy T, et al. Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study. Contraception 1990;42(4):361–78. [18] Short M, Dallay D, Omokanye S, Hanisch JU, Inki P. Acceptability of the levonorgestrel releasing-intrauterine system and etonogestrel implant: one-year results of an observational study. Eur J Contracept Reprod Health Care 2012;17(1):79–88. [19] Teunissen AM, Grimm B, Roumen FJ. Continuation rates of the subdermal contraceptive Implanon((R)) and associated influencing factors. Eur J Contracept Reprod Health Care 2014;19(1):15–21. [20] Wilson S, Tennant C, Sammel MD, Schreiber C. Immediate postpartum etonogestrel implant: a contraception option with longterm continuation. Contraception 2014;90(3):259–64. [21] Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception 2009;79(1):5–4. [22] Trussell J, Hassan F, Lowin J, Law A, Filonenko A. Achieving cost-neutrality with long-acting reversible contraceptive methods. Contraception 2014;91(1):49–56.
Original research article
Six-month and 1-year continuation rates following postpartum insertion of implants and intrauterine devices☆ Irene Woo a,⁎, Sara Seifert a , Dacia Hendricks c , Roxanne M. Jamshidi b , Anne E. Burke b , Michelle C. Fox b a b
Gynecology and Obstetrics, Johns Hopkins Institution, 600 North Wolfe Street, Phipps 279 Baltimore, MD, USA, 21287 Department of Family Planning, John Hopkins Bayview Medical Center, 4940 Eastern Ave Baltimore, MD, USA, 21224 c Howard University College of Medicine, 520 W St North West, Washington DC, USA, 20059 Received 30 December 2014; revised 19 September 2015; accepted 21 September 2015
Abstract Objective: Studies show immediate postpartum (PP) insertion increases use of contraceptive implants and intrauterine devices (IUDs). Our objective was to compare the satisfaction and continuation rates of the two types of devices at 6 months and 1 year following PP insertion. Study Design: We enrolled 133 women in a prospective cohort study following immediate PP insertion of an implant or IUD at two academic hospitals during 8 months of 2011. Subjects completed an enrollment survey during hospital admission and a follow-up phone survey 6 months and 1 year PP. Results: At 6 months PP, 72% of subjects provided follow-up information. Implant users were more likely to be using the originally-placed device (40/41, 98% vs. 45/55, 82%, p=0.02); nine women reported IUD expulsions. When accounting for replacement of expelled IUDs, IUD continuation at 6 months was 89% yielding similar continuation rates between groups (p=0.12). At 1 year PP, 51% provided follow-up. Of those, 82% still had a LARC method in place with similar continuation by device type (84% for implants, 81% for IUDs, p=0.96). Overall, satisfaction was similarly high in both groups. Conclusion: Due to IUD expulsion, implants had a higher continuation rate than IUDs six months following immediate PP insertion. After replacement of expelled IUDs, continuation and satisfaction were similar for both devices at 6 months and 1 year. Implications: Placement of implants and IUDs immediately PP can lead to high satisfaction. Despite early IUD expulsions, continuation rates were similar to those placed outside of the immediate PP period. © 2015 Elsevier Inc. All rights reserved. Keywords: Long acting reversible contraception; postpartum contraception; contraception continuation; contraception compliance
1. Introduction Long-acting reversible contraceptive (LARC) methods, defined here as implants and IUDs, are highly effective methods of birth control in large part because they do not rely on the user for compliance or continuation after device placement. LARC devices are more effective than other forms ☆ Conflicts of Interest: Dr. Michelle Fox is currently employed by Merck pharmaceuticals, the manufacturer of the contraceptive implant used in this study; this research was completed prior to her association with the company. The opinions expressed in this publication are those of the authors and not of Merck. ⁎ Corresponding author at: Department of Gynecology and Obstetrics, Johns Hopkins Institution, 600 North Wolfe Street, Phipps 279 Baltimore, MD, USA, 21287. Tel.: + 1 610 659 8417. E-mail address: [email protected] (I. Woo).
http://dx.doi.org/10.1016/j.contraception.2015.09.007 0010-7824/© 2015 Elsevier Inc. All rights reserved.
of contraception due to fewer opportunities for user error and high long-term continuation rates [1–3]. LARC methods remain underutilized in the United States (US). Only 6.4% of US women of reproductive age surveyed in 2011-2013 reported current use of an IUD within the last month [4]. Because 35% of pregnancies in the US are conceived within 18 months of a previous birth, PP contraceptive provision is crucial to prevent short interpregnancy intervals and the associated risks of preterm birth, low birth weight and preeclampsia [5]. In one study, nearly 50% of women instructed to abstain from sexual intercourse until 6 weeks PP reported having unprotected sex earlier [6]. Women who express intention to use IUDs for contraception during prenatal care frequently do not receive the method during the PP period [7]. The immediate PP period is increasingly seen
I. Woo et al. / Contraception 92 (2015) 532–535
as a particularly favorable time for implant or IUD insertion because motivation for contraception is high and access to care is already assured. The study objectives were to assess the continuation rate and satisfaction with the etonogestrel implant compared to IUDs at 6 months and 1 year following immediate PP placement. We hypothesized that implant continuation would be higher than IUD continuation, given the known risk of IUD expulsion following immediate PP insertion (14-20%, compared to 3% for interval insertion) [8–14]. We also compared our PP LARC continuation rates with expected continuation following standard interval insertion, using published literature for comparison [11,14].
2. Materials and methods Women were eligible for this prospective cohort study if they delivered a live infant at greater than or equal to 24 0/7 weeks gestation and received an immediate PP LARC method at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Medical Center (JHMBC) from January 1, 2011 to August 31, 2011. Implant insertion anytime between delivery and hospital discharge qualified for this study. IUD insertion qualified if it had occurred within 10 minutes of the expulsion of the placenta. We only enrolled women who could provide a telephone contact number for study follow-up. Investigators recruited women after device placement and prior to hospital discharge; after obtaining informed consent, we asked them to complete an enrollment survey. Recruitment was dependent on investigator availability. We did not collect information regarding women who declined participation and have no information regarding the number of eligible women who we did not have the opportunity to invite to participate. The enrollment survey covered demographic and reproductive characteristics and past use of implants and IUDs. At 6 months and 1 year PP, we attempted to reach each subject by telephone with a maximum of 3 calls per listed phone number. If we were unable to reach a subject, we mailed a recall letter encouraging her to contact our research office. The 6- and 12-month telephone surveys assessed device continuation, satisfaction, side effects, potential LARC complications, and pregnancies. We measured satisfaction using a 10-point scale from 0 (unsatisfied) to 10 (completely satisfied). This study enrolled a convenience sample based on investigator availability for 8 months of recruitment. The planned convenience sample size of 50 subjects completing follow-up in each arm (implant vs. IUD) had 80% power to detect a 25% difference in continuation rates. The primary outcome was continuation of implants compared with IUDs at 6 months and 1 year PP. We compared continuation rates using Chi-square and Fisher’s exact method, when appropriate. We also assessed satisfaction rates for both types of devices. Statistical analysis was performed using Stata 12.1 (College Station, TX, USA). The Johns Hopkins Medical Institute (JHMI) IRB approved this study.
533
3. Results We enrolled one hundred and thirty three women in the study — 57 who received an implant and 76 who received IUDs. Table 1 shows the baseline characteristics of participants. Women who received implants were younger than women receiving IUDs (mean age 26 years vs. 28 years, p=.02). Implant users were less likely to report completion of childbearing (32% vs. 51%, p=.02) and less likely to have previously used a LARC method (2% vs. 13%, p=.04). Implant and IUD users were similar with regard to other baseline characteristics. Three-fourths of our cohort had expressed intention to use a LARC method for PP contraception during prenatal visits. At 6 months PP, 72% (96/133) of subjects completed the follow-up survey. At 1 year PP, we were able to contact 51% (68/133) of participants for follow-up. Those lost to follow-up at six months were more likely to have had a prior elective abortion (43% vs. 22%, p=.05) and more likely to be single (57% vs. 33%, p=.04). Demographics of subjects with and without 1 year follow-up were similar with regard to type of device they received, prior LARC use, education, insurance and marital status (Table 2). The few women (15 of the total) who received prenatal care at the faculty practice had higher rate of 1-year follow-up than women with other
Table 1 Enrollment demographics. Demographics
Intrauterine Device Implant p value N=76 (57%) N=57 (43%)
Age (mean) Prior births (median) Prior elective abortions (median) Prior use of any LARC methods Race/Ethnicity Nonhispanic White Hispanic White Nonhispanic Black Hispanic Black Asian Other Relationship Status Single Married Long-term partner Divorced Education b 8th grade Some high school High school graduate Some college College graduate Beyond college Insurance Private Medical assistance Uninsured (device provided by grant)
27 2 0 10 (13%)
25 2 0 1 (2%)
0.02 0.58 0.42 0.04
19 (25%) 23 (30%) 29 (38%) 1 (1%) 2 (3%) 2 (3%)
18 (31%) 20 (35%) 16 (28%) 0 (0%) 2 (4%) 1 (2%)
0.76
24 (32%) 24 (32%) 27 (36%) 1 (1%)
23 (40%) 38 (26%) 18 (32%) 1 (2%)
0.75
9 (12%) 24 (32%) 18 (24%) 19 (25%) 3 (4%) 3 (4%)
12 (21%) 16 (28%) 18 (32%) 8 (14%) 3 (5%) 0 (0%)
0.23
11 (14%) 49 (65%) 15 (21%)
5 (9%) 37 (65%) 15 (26%)
0.52
534
I. Woo et al. / Contraception 92 (2015) 532–535
Table 2 Demographics of those that did and did not follow up at 12 months. No follow up Follow up p value N=65 N=68 Type of Device IUD Implant Prior LARC No Yes Education b8th grade Some high school High school graduate Some college College graduate Beyond college Relationship Status Single Married Long-term partner Divorced Insurance Private Medical assistance Uninsured (device provided by grant) Clinic site Academic hospital clinic Private clinic/faculty practice Center for addiction and pregnancy Community clinic⁎ Other
0.34 33 (51%) 32 (49%)
43 (63%) 25 (37%)
56 (86%) 9 (14%)
55 (81%) 13 (19%)
0.41
11 25 17 9 2 1
(17%) (38%) (26%) (14%) (3%) (2%)
10 15 19 18 4 2
(15%) (22%) (28%) (26%) (6%) (3%)
0.24
24 18 21 2
(37%) (28%) (32%) (3%)
23 21 24 0
(34%) (31%) (35%) (0%)
5 45 14 1
(8%) (69%) (21%) (2%)
11 41 16 0
(16%) (60%) (24%) (0%)
34 2 7 15 7
(52%) (3%)⁎ (11%) (23%) (11%)
33 13 5 10 7
(49%) 0.04 (19%)⁎ (7%) (15%) (10%)
0.61
0.31
⁎ Community clinic serves women with medical assistance or no insurance
sites of prenatal care (13/15 vs 40/63, p=.04). At the time of the 6 month follow-up call, 34% of subjects contacted reported they did not attend their PP visit. Of the women contacted, 89% still had the original contraceptive in place. A provider removed one implant. Nine IUDs had spontaneously expelled by 6 months (16%) and one participant reported self-removal. Five of 9 women underwent IUD replacement following expulsion. Excluding subjects lost to follow-up from the analysis, the implant had a higher 6-month continuation rate than IUDs (98% vs 82%, p=.02) (Table 3). When counting replacement of an expelled IUD as continuation, the difference between groups was smaller
(98% vs. 91%, p=.12). Satisfaction with both LARC methods was high at 6 months PP, with a median score of 9/10 for the implant group (N= 41), and 8/10 for the IUD group (N= 55) (p=.42). Forty percent of subjects contacted reported gynecologic symptoms within 6 months; the most common complaints were bothersome bleeding (26%), pain (24%), and discharge (4%). In the IUD group, 15% of the subjects reported that their partners complained of feeling the IUD strings, 13% reported having imaging for IUD localization due to absent strings, and 32% had the strings trimmed. No serious adverse events were reported. At the time of telephone contact, a minority of subjects expressed desire for device removal (7 (17%) implant users, 5 (10%) of IUD users, p=.7). More than half of these women were uninsured and subsequently lost to follow-up; of those with known outcome, half ultimately discontinued the device. Of those with telephone follow-up at 1 year, 82% had an implant or IUD in place (84% for implants, 81% for IUDs, p=.96; see Table 3). The only detected difference between those who continued or discontinued the LARC device was ethnicity: white Hispanic women had the highest continuation rate, 92%(p=0.02). Satisfaction was similarly high for both devices with a median score of 8/10 in both groups at 1 year. No pregnancies were reported and the groups reported similar side effects during telephone follow-up.
4. Discussion In this study, women with etonogestrel implants reported a higher continuation rate at 6 months than women with IUDs when considering the original device. When accounting for IUDs replaced after expulsion, however, continuation rates were more similar. Due to the small sample size and higher-than-expected subject attrition, this study had limited power to identify differences in continuation between implants and IUDs at 1 year. Our one-year continuation rate for both immediate PP devices at 82% is consistent with the previous studies regarding IUD and implant continuation, even when inserted outside of the PP time period (83%) [15–19]. Satisfaction was high at 6 months and 1 year. The PP period represents a window of opportunity to initiate contraception: motivation to prevent pregnancy is high, but so is the risk of non-attendance at a follow-up visit.
Table 3 Six-month and 1-year follow up. 6 Months
Patients that followed up Original LACRC device in place LARC device in place Device removed upon request Satisfaction on 10-point scale (median)
1 Year
Intrauterine Device
Implant
p Value
Intrauterine Device
Implant
p Value
72% (N=55/76) 82% (N=45/55) 91% (n= 50/55) 2% (n= 1/55) 8
72% (n=41/57) 98% (n=40/41) 98% (n=40/41) 2% (n=1/41) 9
0.96 0.02 0.12 0.89 0.42
57% (n= 43/76) 74% (n= 32/43) 81% (n= 35/43) 12% (n= 5/43) 8
44% (n=25/57) 84% (n=21/25) 84% (n=21/25) 16% (n=4/25) 8
0.15 0.36 0.96 0.61 0.87
I. Woo et al. / Contraception 92 (2015) 532–535
In this study, 34% of women did not return for their routine PP visit, thus precluding their opportunity for LARC initiation after hospital discharge. Many of these women had limited health insurance coverage that expired after the immediate PP period. For those who may not return for follow-up, the benefits of placing a LARC immediately PP greatly outweigh the risks of device expulsion or early removal. Immediate postpartum implant insertion may have the highest rate of continuation up to 3 years in the population who are most vulnerable to rapid repeat and unintended pregnancy [20]. The primary limitation of this study was the attrition rate of subjects (28% at 6 months and 49% at 1 year). It is possible that those lost to follow-up presented to other health centers with device complications or for device removal; thus, we may have overestimated the continuation rates. A further limitation is that we cannot calculate a study participation rate. Due to resource constraints, we could only approach patients for this study when an investigator was available, and thus the women enrolled are an unknown subset of all women receiving PP LARC. We recruited our subjects from two large academic medical centers serving a mostly urban population. Due to lack of stable housing or consistent telephone service among many of these women, long-term follow-up is often a challenge. LARC methods are more cost effective than other forms of contraception [21,22]. Further studies to evaluate cost effectiveness of immediate postpartum insertion of LARC devices in the US are warranted. A cost benefit analysis must consider both the high no show rate for interval insertion and the higher rate of IUD expulsion after immediate PP placement [8]. We found high continuation and satisfaction rates at 6 and 12 months following immediate PP LARC insertion. One-year continuation rates were comparable to rates when LARC devices are placed outside of the immediate PP period. The PP period is a window of opportunity for women and providers to ensure women are provided with the most effective contraceptive methods. Acknowledgement Funding for this research was provided by the Department of Family Planning, Johns Hopkins Bayview Medical Center. References [1] Blumenthal PD, Voedisch A, Gemzell-Danielsson K. Strategies to prevent unintended pregnancy: increasing use of long-acting reversible contraception. Hum Reprod Update 2011;17(1):121–37. [2] Stuart JE, Secura GM, Zhao Q, Pittman ME, Peipert JF. Factors associated with 12-month discontinuation among contraceptive pill, patch, and ring users. Obstet Gynecol 2013;121(2 Pt 1):330–6.
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