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Postplacental placement of intrauterine devices: A randomized clinical trial
Journal Pre-proofs Original Research Article Postplacental placement of intrauterine devices: A randomized clinical trial Montas Laporte, Marcos Marangoni Jr., Fernanda Surita, Cassia T. Juliato, Mariana Miadaira, Luis Bahamondes PII: DOI: Reference:
S0010-7824(19)30495-0 https://doi.org/10.1016/j.contraception.2019.12.006 CON 9369
To appear in:
Contraception
Received Date: Revised Date: Accepted Date:
8 July 2019 2 December 2019 4 December 2019
Please cite this article as: M. Laporte, M. Marangoni Jr., F. Surita, C.T. Juliato, M. Miadaira, L. Bahamondes, Postplacental placement of intrauterine devices: A randomized clinical trial, Contraception (2019), doi: https:// doi.org/10.1016/j.contraception.2019.12.006
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Postplacental placement of intrauterine devices: A randomized clinical trial
Montas Laporte, Marcos Marangoni Jr., Fernanda Surita, Cassia T. Juliato, Mariana Miadaira, Luis Bahamondes Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. Word count of abstract: 250 Word count of Implications: 32 Word count of manuscript: 2,716
Trial registration: Registered as REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under number RBR-67H649. Conflict of interest: LB is a member without remuneration of the Board of the International Contraceptive Access Foundation and received an honorarium from Bayer. The other authors do not have any conflict. Corresponding author: Luis Bahamondes, MD Caixa Postal 6181 13084-971 Campinas, SP, Brazil Telephone: +55-19-3289-2856; Fax: +55-19-3289-2440 E-mail: [email protected]
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Abstract Objective: To compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52mg intrauterine system (IUS) up to 90 days after postplacental placement (10 minutes after delivery of the placenta).
Study design: Randomized trial (1:1) of women aged 18-43 years and >37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion.
Results: We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08-15.10; P< .00) and higher among women with one (OR 4.38; 95% CI 1.33-14.43; P .00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78–20.77; P .00) than those with two deliveries. Conclusions: Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days.
Keywords: copper IUD; levonorgestrel intrauterine system, postpartum placement.
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Implications: Policy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.
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1. Introduction The first year after childbirth is a period when a new pregnancy will present high maternal and infant risks [1]. Nevertheless, many women are discharged from care after delivery without contraceptive counseling or method provision (even in the West, where many women deliver at hospital), and this deficit increases the high rate of unplanned short-interval pregnancy worldwide [2-4]. Furthermore, despite the advice given to new mothers in many healthcare settings about the need to return to obtain contraceptive methods by 6 weeks after delivery, many women do not do so [5]. The immediate postpartum period is thus a good opportunity to offer long-acting reversible contraceptive (LARC) methods.
The copper-bearing intrauterine device (Cu IUD) and the levonorgestrel (LNG) 52mg intrauterine system (IUS) are highly effective and safe, and easy to insert in the immediate postpartum period, especially within 10 minutes of delivery of the placenta [6], and they provide immediate pregnancy protection. In addition, postplacental placement is associated with less discomfort during the procedure, less risk of perforation and fewer side-effects [7]; however, it is associated with higher expulsion rates than interval placement [8-12]. The higher expulsion rate is a key barrier to the increased use of these methods in the postpartum period. Because few randomized trials have compared expulsion of the TCu380A IUD and the LNG IUS after postplacental insertion [10-12], we conducted a randomized trial to compare the expulsion rates of the TCu380A IUD and LNG IUS up to 90 days after postplacental placement.
2. Materials and methods
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2.1. Trial design We performed an open-label, parallel-group (1:1), randomized trial. We registered the trial in the REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under No. RBR-67H649.
2.2. Participants We invited pregnant women at admission in the early or prodromal stage of labor and those who were admitted for elective Cesarean delivery to participate in the study. All potential participants were counseled about all the contraceptive methods available at our hospital, and also about the hospital’s policy of providing contraceptive methods at 42 days after childbirth. In addition, they were counseled on the efficacy, bleeding patterns and potential side-effects of both the IUD and the IUS before they were asked to join the study. We invited those who reported interest in these forms of contraception to participate. We included women if they were healthy, aged 18-43 years, >37 weeks pregnant, willing to return to the outpatient clinic for 2 follow-up visits (at 42 and 90 days after childbirth), and willing to be randomized to the use of a TCu380A IUD (Pregna, Mumbai, India) or an LNG IUS (Mirena®, Bayer Oy, Turku, Finland). None of the women wished to conceive within the next 12 months. We excluded women with contraindications to either device according to the World Health Organization criteria [14], and those who had multiple gestations, placenta previa, rupture of membranes for >24 hours, intrapartum fever, postpartum hemorrhage, uterine malformation or uterine fibromas, anemia (hemoglobin level, <8.0 mg/dL), or active untreated lower genital tract infection. 2.3. Study setting
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The study was conducted at the Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil, from May 2018 to May 2019. The university ethics committee approved the study protocol, and all women signed an informed consent form before entry to the study.
2.4. Procedures Before participant enrollment, three senior faculty members trained six Obstetrics and Gynecology residents in postplacental IUD and IUS placement using a pelvic model. During the study, if the resident had any doubt or difficulty at the time of insertion, one of the teachers helped. All the insertions were performed within 10 minutes of delivery of the placenta [9], in the delivery room. No ultrasound scan was performed during or after IUD or IUS insertion. In the case of vaginal deliveries, the healthcare provider inserted a Cu IUD with a long inserter tube (35 cm) developed by the manufacturer (Figure 1) and a LNG IUS using modified Kelley forceps for postplacental placement. We clamped the anterior lip of the cervix with Collin forceps. The non-dominant hand of the physician fixed the uterine fundus externally and then placed the IUD. The inserter tube or the forceps was then slowly removed. We cut the IUD or IUS strings at 1 cm from the cervical os. For Cesarean deliveries, either the Cu IUD or the LNG IUS was inserted manually. At Cesarean delivery, the healthcare provider directed the uncut IUD or IUS strings towards the lower uterine segment and through the cervix. All participants were scheduled for follow-up at 42 and 90 (± 5) days after childbirth to evaluate for expulsion. At the 42-day visit we cut the strings flush with the external cervical os. At the 42- and 90-day visits, we evaluated the IUD or IUS location in all
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women using transvaginal ultrasound (Core Vision PRO Ultrasound with a 5-7 MHz endovaginal probe; Toshiba, Japan).
2.5. Outcomes Our primary outcome was expulsion up to 90 days after placement of the TCu380A IUD or the LNG IUS. We also compared the expulsion rates after vaginal birth and after Cesarean delivery; we collected data at 42 and 90 days after IUD placement. We considered total expulsion to have occurred if the IUD or IUS was not in the uterine cavity and partial expulsion to have occurred if part of the IUD or IUS was below the internal os. Where the IUD or IUS was not visualized in situ on the ultrasonography scan, we performed an abdominal radiograph of the pelvis to exclude uterine perforation. Women with partial or complete expulsion were offered removal and replacement of the IUD or the IUS.
2.6. Randomization We randomized all the women to receive either the TCu380A IUD or the LNG IUS. The randomization sequence was generated using a computer program by a hospital statistician and stratified in a permuted block size of six. The treatment information was kept inside a sealed numbered opaque enveloper. The envelope was opened after the participant signed an informed consent form.
2.7. Statistical analysis A literature review suggested the expulsion rate after postpartum insertion was 15% to 25% for the LNG IUS [10,15-17] and 5% to 7% for the Cu-IUD [8,10,18]. To observe a 20% difference in expulsion rate between the IUD and IUS, with a two-sided alpha value of 0.05 and power equal to 80%, would require a sample size of 114 women in the final
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analysis. Because we anticipated that 15% of the women would be lost to follow-up, we enrolled 140 women. We present demographic and clinical characteristics of the women as means and standard deviations if the data normally are distributed. The characteristics of the Cu IUD and the LNG IUS users are compared using the Fisher exact test for categorical variables or the Mann-Whitney test when the variables are not normally distributed. Bivariate and multivariate logistic regression analyses (with stepwise variable selection; including those with P< .05) were performed to quantify the association between the expulsion rates by device type (IUD or IUS) after controlling for potential confounding variables differences between the groups. These variables included: age, years of schooling, ethnicity, cohabitation status, number of pregnancies and deliveries (including the present one), weight, height, body mass index (kg/m2), mode of delivery, and gestational age. We estimated the odds ratio (OR) with the 95% confidence interval (CI).
3. Results
We enrolled 140 women, who were allocated to use either the TCu380A IUD (n = 70) or the LNG IUS (n = 70). Seventy-four women had a vaginal delivery. Among the 66 women who had a Cesarean delivery, 35 and 31 were elective and emergency procedures, respectively. The TCu380A IUD was placed in 39 women after vaginal delivery and 31 women after Cesarean delivery, whereas the LNG IUS was inserted in 35 women after vaginal delivery and 35 women after Cesarean delivery (Figure 2). No perforations occurred nor any other complications during placement or follow-up. Table 1 presents the participant sociodemographic characteristics.
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By the 90-day visit, four women in the TCu380A IUD group had requested removal of the device and six had been lost to follow-up, while in the LNG IUS group six women had requested removal and four women had been lost to follow-up. The Table 2 showed the cumulative number of expulsions by the 90-day visit. Of the expulsions, 13 and 10 were total expulsions of the TCu380A IUD and LNG IUS devices, respectively, and nine and two were partial expulsions of the TCu380A IUD and LNG IUS devices, respectively. For the 23 complete expulsions; 13 were not recognized by the women and we suspected given absence of strings on clinical exam. We removed all IUDs and IUSs with partial expulsion. After counseling about other contraceptive options, six of the women chose to undergo a new IUD insertion and the remaining 28 women accepted other contraceptive methods. The bivariate analysis revealed that the variables associated with expulsion of were one delivery (namely the present one) (P< .01), vaginal delivery (P< .01) and use of the TCu380A IUD (P< .03; Table 2). Further, the Table 3 showed the multivariate logistic analysis which demonstrated that the OR of expulsion was higher after vaginal delivery when compared with Cesarean delivery and was higher among women with one or ≥3 deliveries when compared with those with two deliveries.
4. Discussion
We observed that the cumulative partial or complete expulsion rate at 90 days after childbirth was 36.7% for the postplacental TCu380A IUD, and 20% for the postplacental LNG IUS. In adjusted multivariate logistic analysis we found that the odds of expulsion was higher among women with vaginal compared with Cesarean delivery, and among women with 1 or ≥3 deliveries when compared with those with 2 deliveries. Our results add to those of two recent trials in which the authors also compared the TCu380A IUD and
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the LNG IUS [11,12], and thus do contribute to the small body of evidence on postplacental LNG IUS insertion [10]. The differences between our study and that of Hinz et al [11], which also compared the TCu380A and the LNG IUS, are that they did not randomize the participants, that all the devices were inserted with ring forceps (for both vaginal and Cesarean deliveries), that the last study visit was at 6 months postpartum, and that almost two-thirds of women selected the LNG IUS. In that study, the authors observed that the median time to expulsion was 23 days [interquartile range (IQR): 7– 52.5], and similar for both the IUD and IUS. The expulsion rate at 6 months was also similar for the LNG IUS (26.7%) and for the Cu IUD (20.5%; P= .38); however, the expulsion rate was higher after vaginal delivery than after Cesarean delivery (as we too observed). Goldthwaite et al [12] reported results from a cohort study in which 55 women received a postplacental Cu IUD and 68 women received a postplacental LNG IUS following vaginal delivery. Within 12 weeks, 38.2% of LNG IUS users and 19.5% of Cu IUD users experienced complete or partial expulsion (OR 2.55; 95% CI, 0.99-6.55; P < .05). As in our study, most (86%) of the expulsions occurred at <6 weeks postpartum, and the only variable associated with expulsion was type of device. Our finding of a higher expulsion rate for the TCu380A IUD compared with the LNG IUS differs from the results of other studies [11,12]. This could be explained by the fact that we inserted the TCu380A IUDs with a new long inserter tube and the LNG IUS with a forceps, which is different from what other authors did, which was to avoid using the manufacturer’s inserters [11,12]. In our subanalysis of the insertions performed at Cesarean delivery (all of which were performed manually), the expulsion rates for the TCu380A IUD (12.9%) and the LNG IUS (11.4%) were similar, which is in line with prior studies [11].
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Jatlaoui et al [10] stated that many studies of postpartum IUD insertion [10-12;15-17] include confounders, and often the patient characteristics and procedures are not well defined or controlled. Among these characteristics are age, parity, breastfeeding status, healthcare provider experience, insertion technique, diagnostic criteria for total and partial expulsions, time after insertion, and use of ultrasound to assess IUD position. All of these factors can influence expulsion. We did not control for breastfeeding status, did not examine timing of expulsion after insertion and did not use ultrasound. We used a long inserter tube for the TCu380A IUD insertions, which is a new procedure in our clinical facility. This method was pilot tested in a previous study of 80 women, and those authors reported an expulsion rate that was almost half that we found (17.5%) at 6-8 weeks after delivery [19]. We do not have any plausible explanation for the high expulsion rate observed with the TCu380A IUD compared with the LNG IUS, other than the use of the new inserter tube. Low expulsion rates have previously been described when using the operator’s hand or ring forceps for postplacental Cu IUD insertions (13.3% and 12.7% at 6 months, respectively) [20]. Henceforth we will use ring forceps for all IUD insertions [10] because manual insertion without any regional anesthesia [12] can be more painful. We did not use ultrasound guidance during IUD insertion or before hospital discharge because it is not routine procedure in our hospital (as in many other settings) [12]. However, we examined all the women at the 42- and 90-day visits with transvaginal ultrasonography to assess IUD position, and we removed all IUDs that had been partially expelled. We consider these women to be at risk for unplanned pregnancy due to the possibility of undetected total expulsion. However, if the LNG IUS is positioned below the internal os (intracervical position), the device may still be effective [21].
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Postplacental IUD or IUS placement is an excellent form of contraception. Because many women do not return for postpartum visits, they are at risk of unplanned pregnancy if IUD insertion is only offered at that time [5]. Postpartum IUD or IUS placement is safe and cost-effective, even if 1 of 4 women are expected to expel the device [10,22], although reported rates of expulsion vary widely in the literature [10, 18]. Consequently, the benefit of postpartum IUD or IUS placement outweighs the risk of expulsion [10-12,15-18 In the year 2014, we estimated the cost for the public sector of 1.8 million unplanned pregnancies in Brazil [23], which would result in 1.58 million live births. Even taking into account that, in Brazil, the LNG IUS costs more than the TCu380A IUD, postplacental placement is cheaper than an unplanned pregnancy, which was estimated at that time to cost more than US$1,000 for the direct costs of labor and childbirth alone. The strengths of our study were that we randomized the women to the TCu380A IUD and LNG IUS; we ascertained both total and partial expulsions through ultrasound examination; and the low rate of loss to follow-up (7% of women), similar in both study groups. The limitations of our study were that parity was imbalanced; consequently the apparent expulsion difference by parity is only because they got different IUDs or unbalanced allocation, the different technique of insertion for the TCu380A IUD and the LNG IUS, that we were unable to identify expulsion timing, and the imbalance between groups regarding age and number of deliveries. Another criticism might be that the 90 days of follow-up after childbirth is shorter than in other studies [10,11]; however, after that time, the number of expulsions is likely to be similar to that for interval insertions, because the involution of the uterus is complete [18]. In fact, we observed that 97% of the expulsions occurred within 42 days. In our opinion, due to different outcomes, future studies are needed and must focus on type of device, type of delivery and technique of insertion. In conclusion, our results
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showed that postplacental insertion of the TCu380A had a higher expulsion rate than the LNG IUS, and that Cu IUD placements in women with vaginal delivery presented higher expulsion rates than placements after Cesarean delivery, as described previously [10]. Because almost all the expulsions occurred within 42 days of childbirth, we suggest that healthcare providers pay special attention during this period to identify premature expulsions, as these could compromise effectiveness and pose a risk of unplanned pregnancy.
Funding: ML is PhD student with a fellowship funded by the Organization of American States. This study received partial financial support from the Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP) award No. 2015/20504-9 and from the Brazilian National Research Council (CNPq) grant No. 573747/2008-3. The TCu380A IUDs were donated by Pregna, Mumbai, India. Since 2007, the LNG-IUSs used at our clinic have been donated by the International Contraceptive Access Foundation, Turku, Finland, under an unrestricted grant. References [1] Conde-Agudelo A, Rosas-Bermudez A, Castaño F, Norton MH. Effects of birth spacing on maternal, perinatal, infant, and child health: a systematic review of causal mechanisms. Stud Fam Plann 2012;43:93-114. [2] Rossier C, Bradley SE, Ross J, Winfrey W. Reassessing unmet need for family planning in the postpartum period. Stud Fam Plann 2015;46:355-67. [3] Bahamondes L, Villarroel C, Frías Guzmán N, Oizerovich S, Velázquez-Ramírez N, Monteiro I. The use of long-acting reversible contraceptives in Latin America and the Caribbean: current landscape and recommendations. Hum Reprod Open 2018;2018:hox030. [4] Theme-Filha MM, Baldisserotto ML, Fraga AC, Ayers S, da Gama SG, Leal MD. Factors associated with unintended pregnancy in Brazil: cross-sectional results from the Birth in Brazil National Survey, 2011/2012. Reprod Health 2016;13(Suppl 3):118. [5] Darroch JE, Singh S. Trends in contraceptive need and use in developing countries in 2003, 2008, and 2012: an analysis of national surveys. Lancet 2013;381:1756-62.
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[6] Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care 2016;42:93-8. [7] Eluwa GIE, Atamewalen R, Odogwu K, Ahonsi B. Success providing postpartum intrauterine devices in private-sector health care facilities in Nigeria: Factors associated with uptake. Glob Health Sci Pract 2016;4:276-83. [8] Lopez LM, Bernholc A, Hubacher D, Stuart G, Van Vliet HA. Immediate postpartum insertion of intrauterine device for contraception. The Cochrane Database of Systematic Reviews 2015;6:CD003036. [9] Whitaker AK, Chen BA. Society of Family Planning Guidelines: Postplacental insertion of intrauterine devices. Contraception 2018;97:2-13. [10] Jatlaoui TC, Whiteman MK, Jeng G, Tepper NK, Berry-Bibee E, Jamieson DJ, et al. Intrauterine device expulsion after postpartum placement: a systematic review and metaanalysis. Obstet Gynecol 2018;132:895–905. [11] Hinz EK, Murthy A, Wang B, Ryan N, Ades V. A prospective cohort study comparing expulsion after postplacental insertion: the levonorgestrel versus the copper intrauterine device. Contraception 2019; in press. [12] Goldthwaite LM, Sheeder J, Hyer J, Tocce K, Teal SB. Postplacental intrauterine device expulsion by 12 weeks: a prospective cohort study. Am J Obstet Gynecol 2017;217:674.e1-674.e8. [13] CONSORT. Available at http://www.consort-statement.org/downloads/extensions. Accessed June 9 2019. [14] World Health Organization. Medical eligibility criteria for contraceptive use. In: Reproductive Health and Research, 5th edn, Geneva, World Health Organization, 2015. [15] 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;116:1079-87. [16] Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel intrauterine system at three time periods: a prospective randomized pilot study. Contraception 2011;84:244-8. [17] Jatlaoui TC, Marcus M, Jamieson DJ, Goedken P, Cwiak C. Postplacental intrauterine device insertion at a teaching hospital. Contraception 2014;89:528-33. [18] Sonalkar S, Kapp N. Intrauterine device insertion in the postpartum period: a systematic review. Eur J Contracept Reprod Health Care 2015;20:4–18.
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[19] Singh S, Das V, Agarwal A, et al. A Dedicated postpartum intrauterine device inserter: pilot experience and proof of concept. Glob Health Sci Pract 2016;4:132-40.
[20] 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. [21] Pakarinen P, Luukkainen T. Five years’ experience with a small intracervical/intrauterine levonorgestrel-releasing device. Contraception 2005;72:342-5.
[22] Washington CI, Jamshidi R, Thung SF, Nayeri UA, Caughey AB, Werner EF. Timing of postpartum intrauterine device placement: a cost effectiveness analysis. Fertil Steril 2015;103:131–7. [23] Le HH, Connolly MP, Bahamondes L, Cecatti JG, Yu J, Hu HX. The burden of unintended pregnancies in Brazil: a social and public health system cost analysis. Int J Womens Health 2014;6:663-70.
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Table 1. Main demographic and clinical characteristics of participant randomized to postplacental insertion of the TCu380A IUD or the LNG IUS at the University of Campinas, Brazil (N=140).
Type of IUD inserted Variables
TCu380A IUD (n= 70)
LNG IUS (n = 70)
<25
28 (40.0)
19 (27.1)
25-29
23 (32.9)
18 (25.8)
>30
19 (27.1)
33 (47.1)
White
41(58.6)
29 (41.4)
Black
7 (10.0)
10 (14.3)
Mixed
22 (31.4)
31 (44.3)
P-value
Age (years) .04
Ethnicity .13
Number of deliveries (including the present one) 1
35 (50.0)
20 (28.6)
2
18 (25.7)
33 (47.1)
>3
17 (24.3)
17 (24.3)
With a partner
60 (85.7)
60 (85.7)
Without a partner
10 (14.3)
10 (14.3)
1-8
13 (18.6)
7 (10.0)
9-12
45 (64.2)
54 (77.1)
13 or more
12 (17.1)
9 (12.9)
Vaginal delivery
39 (55.7%)
35 (50.0%)
Cesarean delivery
31 (44.2%)
35 (50.0%)
.01
Cohabitation status 1.0
Years of schooling 0.20
Delivery type
Gestational age (weeks completed)
.049
17
37-38
19 (27.1)
23 (32.9)
39-40
47 (67.1)
45 (64.3)
41-42
4 (5.8)
2 (2.8)
.59
All data are presented as n (%); IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
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Table 2. Number of cases and reasons for discontinuation by 42- and 90-days visits after childbearing according to type of IUC (n=140). TCu380A IUD (n=70)
LNG IUS (n=70)
P-value
Events
By 42-days visit Total and partial expulsions
Vaginal delivery (n=39)
Cesarean delivery (n=31)
Vaginal delivery (n=35)
Cesarean delivery (n=35)
17
4
8
4
.05
By 90-days visit Total and partial expulsions
1
.69
Cumulative expulsions by 90-day visit
18
4
8
4
IUD use, original or new
17
20
21
31
IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
.12
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Table 3. Bivariate and multivariate logistic regression of expulsion of the TCu380A IUD and the LNG IUS at 90 days after childbirth. Variable
Age (years)
Parity (including the present one)
BMI (kg/m2)
Ethnicity
Type of IUD Mode of delivery
Category
P-value
OR
95% CI
<25 (ref.)
---
1.00
---
25-29
.86
0.91
0.33 – 2.55
≥30
.86
1.09
0.43 – 2.76
One
.05
2.79
0.97 – 8.01
Two deliveries (ref.)
---
1.00
---
Three or more deliveries
.00
4.84
1.57 – 14.90
≤29.9 (ref.)
---
1.00
---
30-39.9
.43
1.39
0.61 – 3.15
≥40.0
.60
0.65
0.13 – 3.36
Mixed (ref.)
---
1.00
---
White
.07
2.32
0.91 – 5.88
Black
.10
2.85
0.80 – 10.12
LNG IUS (ref.)
---
1.00
---
TCu380A IUD
.04
2.35
1.04 – 5.33
Cesarean delivery (ref)
---
1.00
---
Vaginal
.00
4.17
1.70 – 10.21
LNG IUS (ref.) TCu380A IUD
--.416
1.00 1.47
--0.58 – 3.71
Cesarean (ref.) Vaginal
--<.00
1.00 5.60
--2.08 – 15.10
One Two (ref.) Three or more
.01 --.00
4.38 1.00 6.08
1.33 – 14.43 --1.78 – 20.77
Multivariate logistic regression analysis Type of IUD Mode of delivery Parity (including the present one)
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OR: Odds ratio; CI: Confidence interval; BMI: body mass index; IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
21
Figure 1. Photo of the long inserter tube and the TCu380A intrauterine device.
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Figure 2. Flow diagram of study enrollment and follow-up of participants choosing postplacental insertion of the TCu380A IUD or LNG IUS in a randomized trial at the University of Campinas, Brazil.
IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system
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Conflict of interest: Luis Bahamondes is member without remuneration of the Board of the ICA Foundation and received an honorarium from Bayer. Other co-authors do not have any conflict of interest.
S0010-7824(19)30495-0 https://doi.org/10.1016/j.contraception.2019.12.006 CON 9369
To appear in:
Contraception
Received Date: Revised Date: Accepted Date:
8 July 2019 2 December 2019 4 December 2019
Please cite this article as: M. Laporte, M. Marangoni Jr., F. Surita, C.T. Juliato, M. Miadaira, L. Bahamondes, Postplacental placement of intrauterine devices: A randomized clinical trial, Contraception (2019), doi: https:// doi.org/10.1016/j.contraception.2019.12.006
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Postplacental placement of intrauterine devices: A randomized clinical trial
Montas Laporte, Marcos Marangoni Jr., Fernanda Surita, Cassia T. Juliato, Mariana Miadaira, Luis Bahamondes Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. Word count of abstract: 250 Word count of Implications: 32 Word count of manuscript: 2,716
Trial registration: Registered as REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under number RBR-67H649. Conflict of interest: LB is a member without remuneration of the Board of the International Contraceptive Access Foundation and received an honorarium from Bayer. The other authors do not have any conflict. Corresponding author: Luis Bahamondes, MD Caixa Postal 6181 13084-971 Campinas, SP, Brazil Telephone: +55-19-3289-2856; Fax: +55-19-3289-2440 E-mail: [email protected]
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Abstract Objective: To compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52mg intrauterine system (IUS) up to 90 days after postplacental placement (10 minutes after delivery of the placenta).
Study design: Randomized trial (1:1) of women aged 18-43 years and >37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion.
Results: We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08-15.10; P< .00) and higher among women with one (OR 4.38; 95% CI 1.33-14.43; P .00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78–20.77; P .00) than those with two deliveries. Conclusions: Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days.
Keywords: copper IUD; levonorgestrel intrauterine system, postpartum placement.
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Implications: Policy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.
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1. Introduction The first year after childbirth is a period when a new pregnancy will present high maternal and infant risks [1]. Nevertheless, many women are discharged from care after delivery without contraceptive counseling or method provision (even in the West, where many women deliver at hospital), and this deficit increases the high rate of unplanned short-interval pregnancy worldwide [2-4]. Furthermore, despite the advice given to new mothers in many healthcare settings about the need to return to obtain contraceptive methods by 6 weeks after delivery, many women do not do so [5]. The immediate postpartum period is thus a good opportunity to offer long-acting reversible contraceptive (LARC) methods.
The copper-bearing intrauterine device (Cu IUD) and the levonorgestrel (LNG) 52mg intrauterine system (IUS) are highly effective and safe, and easy to insert in the immediate postpartum period, especially within 10 minutes of delivery of the placenta [6], and they provide immediate pregnancy protection. In addition, postplacental placement is associated with less discomfort during the procedure, less risk of perforation and fewer side-effects [7]; however, it is associated with higher expulsion rates than interval placement [8-12]. The higher expulsion rate is a key barrier to the increased use of these methods in the postpartum period. Because few randomized trials have compared expulsion of the TCu380A IUD and the LNG IUS after postplacental insertion [10-12], we conducted a randomized trial to compare the expulsion rates of the TCu380A IUD and LNG IUS up to 90 days after postplacental placement.
2. Materials and methods
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2.1. Trial design We performed an open-label, parallel-group (1:1), randomized trial. We registered the trial in the REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under No. RBR-67H649.
2.2. Participants We invited pregnant women at admission in the early or prodromal stage of labor and those who were admitted for elective Cesarean delivery to participate in the study. All potential participants were counseled about all the contraceptive methods available at our hospital, and also about the hospital’s policy of providing contraceptive methods at 42 days after childbirth. In addition, they were counseled on the efficacy, bleeding patterns and potential side-effects of both the IUD and the IUS before they were asked to join the study. We invited those who reported interest in these forms of contraception to participate. We included women if they were healthy, aged 18-43 years, >37 weeks pregnant, willing to return to the outpatient clinic for 2 follow-up visits (at 42 and 90 days after childbirth), and willing to be randomized to the use of a TCu380A IUD (Pregna, Mumbai, India) or an LNG IUS (Mirena®, Bayer Oy, Turku, Finland). None of the women wished to conceive within the next 12 months. We excluded women with contraindications to either device according to the World Health Organization criteria [14], and those who had multiple gestations, placenta previa, rupture of membranes for >24 hours, intrapartum fever, postpartum hemorrhage, uterine malformation or uterine fibromas, anemia (hemoglobin level, <8.0 mg/dL), or active untreated lower genital tract infection. 2.3. Study setting
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The study was conducted at the Department of Obstetrics and Gynecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil, from May 2018 to May 2019. The university ethics committee approved the study protocol, and all women signed an informed consent form before entry to the study.
2.4. Procedures Before participant enrollment, three senior faculty members trained six Obstetrics and Gynecology residents in postplacental IUD and IUS placement using a pelvic model. During the study, if the resident had any doubt or difficulty at the time of insertion, one of the teachers helped. All the insertions were performed within 10 minutes of delivery of the placenta [9], in the delivery room. No ultrasound scan was performed during or after IUD or IUS insertion. In the case of vaginal deliveries, the healthcare provider inserted a Cu IUD with a long inserter tube (35 cm) developed by the manufacturer (Figure 1) and a LNG IUS using modified Kelley forceps for postplacental placement. We clamped the anterior lip of the cervix with Collin forceps. The non-dominant hand of the physician fixed the uterine fundus externally and then placed the IUD. The inserter tube or the forceps was then slowly removed. We cut the IUD or IUS strings at 1 cm from the cervical os. For Cesarean deliveries, either the Cu IUD or the LNG IUS was inserted manually. At Cesarean delivery, the healthcare provider directed the uncut IUD or IUS strings towards the lower uterine segment and through the cervix. All participants were scheduled for follow-up at 42 and 90 (± 5) days after childbirth to evaluate for expulsion. At the 42-day visit we cut the strings flush with the external cervical os. At the 42- and 90-day visits, we evaluated the IUD or IUS location in all
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women using transvaginal ultrasound (Core Vision PRO Ultrasound with a 5-7 MHz endovaginal probe; Toshiba, Japan).
2.5. Outcomes Our primary outcome was expulsion up to 90 days after placement of the TCu380A IUD or the LNG IUS. We also compared the expulsion rates after vaginal birth and after Cesarean delivery; we collected data at 42 and 90 days after IUD placement. We considered total expulsion to have occurred if the IUD or IUS was not in the uterine cavity and partial expulsion to have occurred if part of the IUD or IUS was below the internal os. Where the IUD or IUS was not visualized in situ on the ultrasonography scan, we performed an abdominal radiograph of the pelvis to exclude uterine perforation. Women with partial or complete expulsion were offered removal and replacement of the IUD or the IUS.
2.6. Randomization We randomized all the women to receive either the TCu380A IUD or the LNG IUS. The randomization sequence was generated using a computer program by a hospital statistician and stratified in a permuted block size of six. The treatment information was kept inside a sealed numbered opaque enveloper. The envelope was opened after the participant signed an informed consent form.
2.7. Statistical analysis A literature review suggested the expulsion rate after postpartum insertion was 15% to 25% for the LNG IUS [10,15-17] and 5% to 7% for the Cu-IUD [8,10,18]. To observe a 20% difference in expulsion rate between the IUD and IUS, with a two-sided alpha value of 0.05 and power equal to 80%, would require a sample size of 114 women in the final
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analysis. Because we anticipated that 15% of the women would be lost to follow-up, we enrolled 140 women. We present demographic and clinical characteristics of the women as means and standard deviations if the data normally are distributed. The characteristics of the Cu IUD and the LNG IUS users are compared using the Fisher exact test for categorical variables or the Mann-Whitney test when the variables are not normally distributed. Bivariate and multivariate logistic regression analyses (with stepwise variable selection; including those with P< .05) were performed to quantify the association between the expulsion rates by device type (IUD or IUS) after controlling for potential confounding variables differences between the groups. These variables included: age, years of schooling, ethnicity, cohabitation status, number of pregnancies and deliveries (including the present one), weight, height, body mass index (kg/m2), mode of delivery, and gestational age. We estimated the odds ratio (OR) with the 95% confidence interval (CI).
3. Results
We enrolled 140 women, who were allocated to use either the TCu380A IUD (n = 70) or the LNG IUS (n = 70). Seventy-four women had a vaginal delivery. Among the 66 women who had a Cesarean delivery, 35 and 31 were elective and emergency procedures, respectively. The TCu380A IUD was placed in 39 women after vaginal delivery and 31 women after Cesarean delivery, whereas the LNG IUS was inserted in 35 women after vaginal delivery and 35 women after Cesarean delivery (Figure 2). No perforations occurred nor any other complications during placement or follow-up. Table 1 presents the participant sociodemographic characteristics.
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By the 90-day visit, four women in the TCu380A IUD group had requested removal of the device and six had been lost to follow-up, while in the LNG IUS group six women had requested removal and four women had been lost to follow-up. The Table 2 showed the cumulative number of expulsions by the 90-day visit. Of the expulsions, 13 and 10 were total expulsions of the TCu380A IUD and LNG IUS devices, respectively, and nine and two were partial expulsions of the TCu380A IUD and LNG IUS devices, respectively. For the 23 complete expulsions; 13 were not recognized by the women and we suspected given absence of strings on clinical exam. We removed all IUDs and IUSs with partial expulsion. After counseling about other contraceptive options, six of the women chose to undergo a new IUD insertion and the remaining 28 women accepted other contraceptive methods. The bivariate analysis revealed that the variables associated with expulsion of were one delivery (namely the present one) (P< .01), vaginal delivery (P< .01) and use of the TCu380A IUD (P< .03; Table 2). Further, the Table 3 showed the multivariate logistic analysis which demonstrated that the OR of expulsion was higher after vaginal delivery when compared with Cesarean delivery and was higher among women with one or ≥3 deliveries when compared with those with two deliveries.
4. Discussion
We observed that the cumulative partial or complete expulsion rate at 90 days after childbirth was 36.7% for the postplacental TCu380A IUD, and 20% for the postplacental LNG IUS. In adjusted multivariate logistic analysis we found that the odds of expulsion was higher among women with vaginal compared with Cesarean delivery, and among women with 1 or ≥3 deliveries when compared with those with 2 deliveries. Our results add to those of two recent trials in which the authors also compared the TCu380A IUD and
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the LNG IUS [11,12], and thus do contribute to the small body of evidence on postplacental LNG IUS insertion [10]. The differences between our study and that of Hinz et al [11], which also compared the TCu380A and the LNG IUS, are that they did not randomize the participants, that all the devices were inserted with ring forceps (for both vaginal and Cesarean deliveries), that the last study visit was at 6 months postpartum, and that almost two-thirds of women selected the LNG IUS. In that study, the authors observed that the median time to expulsion was 23 days [interquartile range (IQR): 7– 52.5], and similar for both the IUD and IUS. The expulsion rate at 6 months was also similar for the LNG IUS (26.7%) and for the Cu IUD (20.5%; P= .38); however, the expulsion rate was higher after vaginal delivery than after Cesarean delivery (as we too observed). Goldthwaite et al [12] reported results from a cohort study in which 55 women received a postplacental Cu IUD and 68 women received a postplacental LNG IUS following vaginal delivery. Within 12 weeks, 38.2% of LNG IUS users and 19.5% of Cu IUD users experienced complete or partial expulsion (OR 2.55; 95% CI, 0.99-6.55; P < .05). As in our study, most (86%) of the expulsions occurred at <6 weeks postpartum, and the only variable associated with expulsion was type of device. Our finding of a higher expulsion rate for the TCu380A IUD compared with the LNG IUS differs from the results of other studies [11,12]. This could be explained by the fact that we inserted the TCu380A IUDs with a new long inserter tube and the LNG IUS with a forceps, which is different from what other authors did, which was to avoid using the manufacturer’s inserters [11,12]. In our subanalysis of the insertions performed at Cesarean delivery (all of which were performed manually), the expulsion rates for the TCu380A IUD (12.9%) and the LNG IUS (11.4%) were similar, which is in line with prior studies [11].
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Jatlaoui et al [10] stated that many studies of postpartum IUD insertion [10-12;15-17] include confounders, and often the patient characteristics and procedures are not well defined or controlled. Among these characteristics are age, parity, breastfeeding status, healthcare provider experience, insertion technique, diagnostic criteria for total and partial expulsions, time after insertion, and use of ultrasound to assess IUD position. All of these factors can influence expulsion. We did not control for breastfeeding status, did not examine timing of expulsion after insertion and did not use ultrasound. We used a long inserter tube for the TCu380A IUD insertions, which is a new procedure in our clinical facility. This method was pilot tested in a previous study of 80 women, and those authors reported an expulsion rate that was almost half that we found (17.5%) at 6-8 weeks after delivery [19]. We do not have any plausible explanation for the high expulsion rate observed with the TCu380A IUD compared with the LNG IUS, other than the use of the new inserter tube. Low expulsion rates have previously been described when using the operator’s hand or ring forceps for postplacental Cu IUD insertions (13.3% and 12.7% at 6 months, respectively) [20]. Henceforth we will use ring forceps for all IUD insertions [10] because manual insertion without any regional anesthesia [12] can be more painful. We did not use ultrasound guidance during IUD insertion or before hospital discharge because it is not routine procedure in our hospital (as in many other settings) [12]. However, we examined all the women at the 42- and 90-day visits with transvaginal ultrasonography to assess IUD position, and we removed all IUDs that had been partially expelled. We consider these women to be at risk for unplanned pregnancy due to the possibility of undetected total expulsion. However, if the LNG IUS is positioned below the internal os (intracervical position), the device may still be effective [21].
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Postplacental IUD or IUS placement is an excellent form of contraception. Because many women do not return for postpartum visits, they are at risk of unplanned pregnancy if IUD insertion is only offered at that time [5]. Postpartum IUD or IUS placement is safe and cost-effective, even if 1 of 4 women are expected to expel the device [10,22], although reported rates of expulsion vary widely in the literature [10, 18]. Consequently, the benefit of postpartum IUD or IUS placement outweighs the risk of expulsion [10-12,15-18 In the year 2014, we estimated the cost for the public sector of 1.8 million unplanned pregnancies in Brazil [23], which would result in 1.58 million live births. Even taking into account that, in Brazil, the LNG IUS costs more than the TCu380A IUD, postplacental placement is cheaper than an unplanned pregnancy, which was estimated at that time to cost more than US$1,000 for the direct costs of labor and childbirth alone. The strengths of our study were that we randomized the women to the TCu380A IUD and LNG IUS; we ascertained both total and partial expulsions through ultrasound examination; and the low rate of loss to follow-up (7% of women), similar in both study groups. The limitations of our study were that parity was imbalanced; consequently the apparent expulsion difference by parity is only because they got different IUDs or unbalanced allocation, the different technique of insertion for the TCu380A IUD and the LNG IUS, that we were unable to identify expulsion timing, and the imbalance between groups regarding age and number of deliveries. Another criticism might be that the 90 days of follow-up after childbirth is shorter than in other studies [10,11]; however, after that time, the number of expulsions is likely to be similar to that for interval insertions, because the involution of the uterus is complete [18]. In fact, we observed that 97% of the expulsions occurred within 42 days. In our opinion, due to different outcomes, future studies are needed and must focus on type of device, type of delivery and technique of insertion. In conclusion, our results
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showed that postplacental insertion of the TCu380A had a higher expulsion rate than the LNG IUS, and that Cu IUD placements in women with vaginal delivery presented higher expulsion rates than placements after Cesarean delivery, as described previously [10]. Because almost all the expulsions occurred within 42 days of childbirth, we suggest that healthcare providers pay special attention during this period to identify premature expulsions, as these could compromise effectiveness and pose a risk of unplanned pregnancy.
Funding: ML is PhD student with a fellowship funded by the Organization of American States. This study received partial financial support from the Fundação de Apoio à Pesquisa do Estado de São Paulo (FAPESP) award No. 2015/20504-9 and from the Brazilian National Research Council (CNPq) grant No. 573747/2008-3. The TCu380A IUDs were donated by Pregna, Mumbai, India. Since 2007, the LNG-IUSs used at our clinic have been donated by the International Contraceptive Access Foundation, Turku, Finland, under an unrestricted grant. References [1] Conde-Agudelo A, Rosas-Bermudez A, Castaño F, Norton MH. Effects of birth spacing on maternal, perinatal, infant, and child health: a systematic review of causal mechanisms. Stud Fam Plann 2012;43:93-114. [2] Rossier C, Bradley SE, Ross J, Winfrey W. Reassessing unmet need for family planning in the postpartum period. Stud Fam Plann 2015;46:355-67. [3] Bahamondes L, Villarroel C, Frías Guzmán N, Oizerovich S, Velázquez-Ramírez N, Monteiro I. The use of long-acting reversible contraceptives in Latin America and the Caribbean: current landscape and recommendations. Hum Reprod Open 2018;2018:hox030. [4] Theme-Filha MM, Baldisserotto ML, Fraga AC, Ayers S, da Gama SG, Leal MD. Factors associated with unintended pregnancy in Brazil: cross-sectional results from the Birth in Brazil National Survey, 2011/2012. Reprod Health 2016;13(Suppl 3):118. [5] Darroch JE, Singh S. Trends in contraceptive need and use in developing countries in 2003, 2008, and 2012: an analysis of national surveys. Lancet 2013;381:1756-62.
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[6] Heller R, Cameron S, Briggs R, Forson N, Glasier A. Postpartum contraception: a missed opportunity to prevent unintended pregnancy and short inter-pregnancy intervals. J Fam Plann Reprod Health Care 2016;42:93-8. [7] Eluwa GIE, Atamewalen R, Odogwu K, Ahonsi B. Success providing postpartum intrauterine devices in private-sector health care facilities in Nigeria: Factors associated with uptake. Glob Health Sci Pract 2016;4:276-83. [8] Lopez LM, Bernholc A, Hubacher D, Stuart G, Van Vliet HA. Immediate postpartum insertion of intrauterine device for contraception. The Cochrane Database of Systematic Reviews 2015;6:CD003036. [9] Whitaker AK, Chen BA. Society of Family Planning Guidelines: Postplacental insertion of intrauterine devices. Contraception 2018;97:2-13. [10] Jatlaoui TC, Whiteman MK, Jeng G, Tepper NK, Berry-Bibee E, Jamieson DJ, et al. Intrauterine device expulsion after postpartum placement: a systematic review and metaanalysis. Obstet Gynecol 2018;132:895–905. [11] Hinz EK, Murthy A, Wang B, Ryan N, Ades V. A prospective cohort study comparing expulsion after postplacental insertion: the levonorgestrel versus the copper intrauterine device. Contraception 2019; in press. [12] Goldthwaite LM, Sheeder J, Hyer J, Tocce K, Teal SB. Postplacental intrauterine device expulsion by 12 weeks: a prospective cohort study. Am J Obstet Gynecol 2017;217:674.e1-674.e8. [13] CONSORT. Available at http://www.consort-statement.org/downloads/extensions. Accessed June 9 2019. [14] World Health Organization. Medical eligibility criteria for contraceptive use. In: Reproductive Health and Research, 5th edn, Geneva, World Health Organization, 2015. [15] 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;116:1079-87. [16] Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel intrauterine system at three time periods: a prospective randomized pilot study. Contraception 2011;84:244-8. [17] Jatlaoui TC, Marcus M, Jamieson DJ, Goedken P, Cwiak C. Postplacental intrauterine device insertion at a teaching hospital. Contraception 2014;89:528-33. [18] Sonalkar S, Kapp N. Intrauterine device insertion in the postpartum period: a systematic review. Eur J Contracept Reprod Health Care 2015;20:4–18.
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[19] Singh S, Das V, Agarwal A, et al. A Dedicated postpartum intrauterine device inserter: pilot experience and proof of concept. Glob Health Sci Pract 2016;4:132-40.
[20] 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. [21] Pakarinen P, Luukkainen T. Five years’ experience with a small intracervical/intrauterine levonorgestrel-releasing device. Contraception 2005;72:342-5.
[22] Washington CI, Jamshidi R, Thung SF, Nayeri UA, Caughey AB, Werner EF. Timing of postpartum intrauterine device placement: a cost effectiveness analysis. Fertil Steril 2015;103:131–7. [23] Le HH, Connolly MP, Bahamondes L, Cecatti JG, Yu J, Hu HX. The burden of unintended pregnancies in Brazil: a social and public health system cost analysis. Int J Womens Health 2014;6:663-70.
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Table 1. Main demographic and clinical characteristics of participant randomized to postplacental insertion of the TCu380A IUD or the LNG IUS at the University of Campinas, Brazil (N=140).
Type of IUD inserted Variables
TCu380A IUD (n= 70)
LNG IUS (n = 70)
<25
28 (40.0)
19 (27.1)
25-29
23 (32.9)
18 (25.8)
>30
19 (27.1)
33 (47.1)
White
41(58.6)
29 (41.4)
Black
7 (10.0)
10 (14.3)
Mixed
22 (31.4)
31 (44.3)
P-value
Age (years) .04
Ethnicity .13
Number of deliveries (including the present one) 1
35 (50.0)
20 (28.6)
2
18 (25.7)
33 (47.1)
>3
17 (24.3)
17 (24.3)
With a partner
60 (85.7)
60 (85.7)
Without a partner
10 (14.3)
10 (14.3)
1-8
13 (18.6)
7 (10.0)
9-12
45 (64.2)
54 (77.1)
13 or more
12 (17.1)
9 (12.9)
Vaginal delivery
39 (55.7%)
35 (50.0%)
Cesarean delivery
31 (44.2%)
35 (50.0%)
.01
Cohabitation status 1.0
Years of schooling 0.20
Delivery type
Gestational age (weeks completed)
.049
17
37-38
19 (27.1)
23 (32.9)
39-40
47 (67.1)
45 (64.3)
41-42
4 (5.8)
2 (2.8)
.59
All data are presented as n (%); IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
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Table 2. Number of cases and reasons for discontinuation by 42- and 90-days visits after childbearing according to type of IUC (n=140). TCu380A IUD (n=70)
LNG IUS (n=70)
P-value
Events
By 42-days visit Total and partial expulsions
Vaginal delivery (n=39)
Cesarean delivery (n=31)
Vaginal delivery (n=35)
Cesarean delivery (n=35)
17
4
8
4
.05
By 90-days visit Total and partial expulsions
1
.69
Cumulative expulsions by 90-day visit
18
4
8
4
IUD use, original or new
17
20
21
31
IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
.12
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Table 3. Bivariate and multivariate logistic regression of expulsion of the TCu380A IUD and the LNG IUS at 90 days after childbirth. Variable
Age (years)
Parity (including the present one)
BMI (kg/m2)
Ethnicity
Type of IUD Mode of delivery
Category
P-value
OR
95% CI
<25 (ref.)
---
1.00
---
25-29
.86
0.91
0.33 – 2.55
≥30
.86
1.09
0.43 – 2.76
One
.05
2.79
0.97 – 8.01
Two deliveries (ref.)
---
1.00
---
Three or more deliveries
.00
4.84
1.57 – 14.90
≤29.9 (ref.)
---
1.00
---
30-39.9
.43
1.39
0.61 – 3.15
≥40.0
.60
0.65
0.13 – 3.36
Mixed (ref.)
---
1.00
---
White
.07
2.32
0.91 – 5.88
Black
.10
2.85
0.80 – 10.12
LNG IUS (ref.)
---
1.00
---
TCu380A IUD
.04
2.35
1.04 – 5.33
Cesarean delivery (ref)
---
1.00
---
Vaginal
.00
4.17
1.70 – 10.21
LNG IUS (ref.) TCu380A IUD
--.416
1.00 1.47
--0.58 – 3.71
Cesarean (ref.) Vaginal
--<.00
1.00 5.60
--2.08 – 15.10
One Two (ref.) Three or more
.01 --.00
4.38 1.00 6.08
1.33 – 14.43 --1.78 – 20.77
Multivariate logistic regression analysis Type of IUD Mode of delivery Parity (including the present one)
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OR: Odds ratio; CI: Confidence interval; BMI: body mass index; IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system.
21
Figure 1. Photo of the long inserter tube and the TCu380A intrauterine device.
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Figure 2. Flow diagram of study enrollment and follow-up of participants choosing postplacental insertion of the TCu380A IUD or LNG IUS in a randomized trial at the University of Campinas, Brazil.
IUD: intrauterine device; LNG IUS: levonorgestrel intrauterine system
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Conflict of interest: Luis Bahamondes is member without remuneration of the Board of the ICA Foundation and received an honorarium from Bayer. Other co-authors do not have any conflict of interest.