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1.
Obstet Gynecol ; 142(3): 641-651, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37535968

RESUMO

OBJECTIVE: The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making. METHODS: APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding. RESULTS: Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs. CONCLUSION: Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion. FUNDING SOURCE: Bayer AG. CLINICAL TRIAL REGISTRATION: EU PAS register, EUPAS33461.


Assuntos
Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos , Menorragia , Perfuração Uterina , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/efeitos adversos , Dispositivos Intrauterinos de Cobre/efeitos adversos , Levanogestrel , Menorragia/etiologia , Estudos Retrospectivos , Perfuração Uterina/epidemiologia , Perfuração Uterina/etiologia , Pessoa de Meia-Idade
2.
JAMA ; 329(11): 910-917, 2023 03 21.
Artigo em Inglês | MEDLINE | ID: mdl-36943214

RESUMO

Importance: The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits. Objective: To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit. Design, Setting, and Participants: In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum. Interventions: Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum. Main Outcomes and Measures: The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome. Results: Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group. Conclusions and Relevance: Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement. Trial Registration: ClinicalTrials.gov Identifier: NCT03462758.


Assuntos
Anticoncepção , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos , Período Pós-Parto , Adulto , Feminino , Humanos , Cesárea , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/efeitos adversos , Parto , Fatores de Tempo , Anticoncepção/instrumentação , Anticoncepção/métodos , Adulto Jovem
3.
Contraception ; 119: 109913, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36473509

RESUMO

OBJECTIVE: To evaluate infectious outcomes following postplacental intrauterine device (PPIUD) placement in patients with suspected chorioamnionitis. STUDY DESIGN: This retrospective cohort study identified individuals desiring PPIUD who subsequently developed suspected chorioamnionitis, treated with antibiotics. We followed 12-month infectious outcomes amongst two cohorts: (1) those who received PPIUD and (2) those with placement deferred. RESULTS: Of 55 followed, 18 of 22 PPIUDs were placed before chorioamnionitis was suspected; 33 placements were deferred. Neither group experienced acute infectious complications. Notably, IUDs were more often deferred when chorioamnionitis was more clearly diagnosed (20/33, 60.6% vs 4/22, 18.2% p < 0.01). Overdiagnosis of chorioamnionitis prevented IUD uptake in 10 of 55 (18.2%) individuals in this sample. CONCLUSIONS: PPIUD placement in individuals with early signs of chorioamnionitis may not result in severe morbidity, in a study limited by sample size. Larger, prospective studies are needed in well-defined cohorts. IMPLICATIONS: Incidental, immediate postplacental IUD placement in individuals with treated, suspected chorioamnionitis was not associated with severe morbidity within 1-year postpartum. Larger-scale, prospective studies are needed to guide the management of incidentally-placed, postplacental IUDs in the setting of mild chorioamnionitis.


Assuntos
Dispositivos Intrauterinos , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Estudos Retrospectivos , Dispositivos Intrauterinos/efeitos adversos , Anticoncepção , Período Pós-Parto
4.
Int J Gynaecol Obstet ; 157(1): 67-75, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34197636

RESUMO

OBJECTIVE: To identify clinical and demographic factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices (TCu380A IUD). METHODS: This is a secondary analysis of an implementation study. We followed participants who had a postplacental TCu380A IUD insertion, at two postpartum visits: 45-90 days (visit 1) and 6-9 months (visit 2). We used multiple log-binomial regression models to evaluate the demographic and clinical variables associated with missing strings and with IUD expulsion. RESULTS: We included 705 participants who had a postplacental IUD insertion. We observed missing strings in 275 (47.9%) participants at visit 1, and in 127 (34.2%) participants at visit 2. We identified 61 expulsions (8.9%) by visit 2. In the multiple regression models, only the delivery type was associated with missing strings and expulsion. Compared with vaginal delivery, cesarean delivery increased the risk of missing strings (adjusted relative risk [aRR] 6.21; 95% confidence interval [CI] 4.29-8.99) but reduced the risk of IUD expulsion (aRR 0.24; 95% CI 0.13-0.43). CONCLUSION: The delivery mode was the only factor associated with missing strings and expulsion after postplacental IUD insertion. Cesarean section was associated with an increased risk of missing strings but decreased risk of expulsion after postplacental TCu380A IUD insertion.


Assuntos
Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos , Cesárea , Cobre , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos de Cobre/efeitos adversos , Período Pós-Parto , Gravidez , Fatores de Tempo
6.
Int J Gynaecol Obstet ; 149(2): 154-159, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32037531

RESUMO

OBJECTIVE: To evaluate the delivery-to-insertion interval for copper postpartum intrauterine devices (PPIUDs). METHODS: Secondary analysis of two related studies at five academic sites in India from March 2015 to July 2016. IUDs were inserted within 48 hours of vaginal delivery. Women (n=560) were grouped by whether they underwent postplacental (≤10 minutes) or immediate (>10 minutes) insertion. Outcomes were complete expulsion at the 6-8-week follow-up (primary), and IUD-to-fundus distance, as assessed by postinsertion ultrasound (secondary). RESULTS: Overall, 93 (16.6%) women received a postplacental PPIUD and 467 (83.4%) received an immediate PPIUD. Complete expulsion at follow-up was 3.2% (n=3) in the postplacental and 7.5% (n=35) in the immediate postpartum group (P=0.176; difference in proportions, 4.3%; 95% confidence interval, -2.0 to 8.1). Distance from the fundus did not differ between the two groups (P=0.107); high fundal placement (≤10 mm from the internal endometrial verge) was achieved for most women. CONCLUSION: The present data challenge previous guidance on the timing of PPIUD insertion. The 10-minute insertion window is a barrier to uptake and should be reassessed for inclusion in service delivery guidelines. A flexible interval would accommodate the multiple post-delivery tasks of providers and increase access to PPIUD.


Assuntos
Parto Obstétrico/estatística & dados numéricos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos de Cobre/efeitos adversos , Adulto , Feminino , Humanos , Índia , Dispositivos Intrauterinos de Cobre/estatística & dados numéricos , Pessoa de Meia-Idade , Período Pós-Parto , Gravidez , Fatores de Tempo
7.
Eur J Contracept Reprod Health Care ; 24(5): 368-372, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31335218

RESUMO

Purpose: To gather preliminary data about menstrual hygiene product use and associated risk of intrauterine device (IUD) expulsion. Materials and methods: We conducted an Internet-based survey using the Amazon Mechanical Turk (MTurk) platform and Researchmatch.org. Eligible participants were women at least 18 years old and self-identified as current or previous IUD users. Results: Of 902 survey responses, 71% reported current or previous IUD use and 19.7% reported menstrual cup use. IUD users were significantly more likely than non-IUD users to use a menstrual cup or tampons. Among all IUD users, 56 individuals reported experiencing at least one expulsion (8.8%). We found a positive association between concurrent menstrual cup use and IUD expulsion (OR: 2.75, 95% CI: 1.40-5.42, p = .002), but no association with concurrent tampon or pad use. Of concurrent IUD and cup users who experienced an expulsion, one reported it occurring 'while using a menstrual cup', with others reporting the expulsion during other events. Conclusions: Menstrual cup use may be higher than previously reported, particularly in IUD users. Concurrent menstrual cup use may increase the risk of IUD expulsion. Prospective research is necessary to fully explore the relationship between menstrual hygiene product use and IUD expulsions.


Assuntos
Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/estatística & dados numéricos , Produtos de Higiene Menstrual/efeitos adversos , Produtos de Higiene Menstrual/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , Dispositivos Intrauterinos/efeitos adversos , Fatores de Risco , Autorrelato , Estados Unidos , Adulto Jovem
8.
Contraception ; 100(2): 101-105, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31108053

RESUMO

OBJECTIVES: To compare the expulsion rate at 6 months after postplacental insertion by intrauterine device (IUD) type. STUDY DESIGN: This prospective cohort included participants with a postplacental IUD inserted after vaginal or cesarean delivery, aged 18-45 and ≥24 weeks' gestation. Study enrollment took place after IUD selection and insertion. Participants returned for a postpartum visit and received a short message service survey regarding IUD expulsion, removal, vaginal bleeding and breastfeeding weekly from weeks 0 to 5 and on weeks 12 and 24 postpartum. Multivariable logistic regression examined 6-month expulsion rate by IUD type adjusting for variables that differed between the groups at baseline and in the bivariate analyses. RESULTS: Of 114 participants, 75 (65.8%) chose a levonorgestrel 52-mg IUD and 39 (34.2%) chose a copper IUD; 58 (50.9%) had a vaginal delivery, and 56 (49.1%) had a cesarean delivery. Groups were similar except that copper IUD users had a higher median parity (3 vs. 2, p=.03) and a higher proportion of senior residents compared to junior residents had performed insertion (46.2% vs. 22.7%, p=.02). The expulsion rate at 6 months was similar between the levonorgestrel and copper groups (26.7% and 20.5%, respectively; p=.38). Multivariable logistic regression also demonstrated that the odds of expulsion did not differ by IUD type (adjusted odds ratio 0.98, 95% confidence interval 0.22-4.48). CONCLUSION: The expulsion rate at 6 months after postplacental insertion did not differ between the levonorgestrel and copper IUD type. IMPLICATIONS: Prior studies demonstrate a wide range of expulsion after postplacental insertion, and recent data suggest a higher expulsion rate for the levonorgestrel compared to the copper intrauterine device. However, many studies did not control for patient-level factors or delivery route. We found that when controlling for these confounding variables, the expulsion rate at 6 months postpartum did not differ by intrauterine device type.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos de Cobre/efeitos adversos , Levanogestrel/efeitos adversos , Cuidado Pós-Natal , Adulto , Cesárea/estatística & dados numéricos , Anticoncepcionais Femininos/administração & dosagem , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/tendências , Levanogestrel/administração & dosagem , Modelos Logísticos , Análise Multivariada , Cidade de Nova Iorque , Gravidez , Estudos Prospectivos , Fatores de Tempo
9.
Contraception ; 100(1): 85-87, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30981842

RESUMO

Although reproductive-aged women use both menstrual cups and intrauterine devices (IUDs) simultaneously, it is unknown whether concomitant use reduces contraceptive effectiveness. We report seven cases wherein IUD expulsion occurred during concomitant menstrual cup use. Further research is needed to determine mechanisms of expulsion, predictors and strategies to avoid expulsions.


Assuntos
Expulsão de Dispositivo Intrauterino/etiologia , Produtos de Higiene Menstrual/efeitos adversos , Adolescente , Adulto , Colorado , Feminino , Humanos , Dispositivos Intrauterinos/efeitos adversos , Adulto Jovem
10.
Eur J Contracept Reprod Health Care ; 24(2): 97-101, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30870042

RESUMO

OBJECTIVES: In some settings women are advised to return to the clinic after intrauterine contraceptive (IUC) placement, for a follow-up visit to check the strings and identify any expulsions. Our objective was to evaluate whether the number of follow-up visits to check the strings at the external cervical os after IUC placement predicts or prevents future expulsions. METHODS: This was a retrospective study conducted at the University of Campinas Medical School, Brazil. We reviewed the medical records of all women who used an IUC between January 1980 and December 2017, to identify women who had experienced IUC expulsion (N = 1974). We excluded women whose IUC was expelled more than once (n = 331) or after 10 years of use (n = 31). We fitted a generalised linear model of the time between IUC placement and expulsion, adjusting for several variables at expulsion. Significance was established at p < .05. RESULTS: Most expulsions (843/1612; 52.3%) occurred within the first 6 months after IUC placement and 691/1612 (42.9%) were within the first three months after placement. The adjusted model showed that the number of visits, the woman's age, and complaints of pain and bleeding during use were not significantly associated with and had no influence on expulsion. CONCLUSIONS: Our results indicate that after IUC insertion more than one follow-up visit within the first four to six months after placement is not necessary, as additional visits to check for IUC strings do not appear to reduce or predict future expulsion.


Assuntos
Assistência ao Convalescente/estatística & dados numéricos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/efeitos adversos , Adolescente , Adulto , Assistência ao Convalescente/métodos , Brasil , Feminino , Humanos , Estudos Retrospectivos , Adulto Jovem
11.
Eur J Contracept Reprod Health Care ; 20(1): 4-18, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25397890

RESUMO

OBJECTIVES: Given new research on postpartum placement of levonorgestrel and copper intrauterine devices (IUDs), our objective was to update a prior systematic review of the safety and expulsion rates of postpartum IUDs. METHODS: We searched MEDLINE, CENTRAL, LILACS, POPLINE, Web of Science, and ClinicalTrials.gov databases for articles between the database inception until July 2013. We included studies that compared IUD insertion time intervals and routes during the postpartum period. We used standard abstract forms and the United States Preventive Services Task Force grading system to summarise and assess the quality of the evidence. RESULTS: We included 18 articles. New evidence suggests that a levonorgestrel releasing-intrauterine system (LNG-IUS) insertion within 48 hours of delivery is safe. Postplacental insertion and insertion between 10 minutes and 48 hours after delivery result in higher expulsion rates than insertion 4 to 6 weeks postpartum, or non-postpartum insertion. Insertion at the time of caesarean section is associated with lower expulsion rates than postplacental insertion at the time of vaginal delivery. CONCLUSIONS: This review supports the evidence that insertion of an intrauterine contraceptive within the first 48 hours of vaginal or caesarean delivery is safe. Expulsion rates should be further studied in larger randomised controlled trials.


Assuntos
Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/efeitos adversos , Feminino , Humanos , Período Pós-Parto , Fatores de Tempo
12.
Contraception ; 89(6): 528-33, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24565735

RESUMO

OBJECTIVE: To determine whether postplacental intrauterine device (IUD) insertion can be safely and effectively performed within a teaching program. STUDY DESIGN: This was a prospective cohort of 177 subjects planning vaginal delivery enrolled antenatally who desired postplacental IUD insertion of either the copper T380A IUD or levonorgestrel IUS. Insertions were performed primarily by resident physicians following a training session. Follow-up included a 4- to 8-week visit and telephone calls at 3 and 6 months. RESULTS: Ninety-nine subjects underwent successful postplacental IUD insertion of 100 attempts. Seventeen expulsions (17%) were noted: 10 complete and 7 partial. The study identified no differences in outcome by training level; however, the study lacked statistical power to evaluate anything other than large differences. CONCLUSION: Postplacental IUD insertions can be safely and effectively performed within a training program. IMPLICATIONS: A training protocol may safely and feasibly be initiated among physicians, advanced practice clinicians or trainees with no prior experience with postplacental IUD insertion. By initiating this practice, access to highly effective contraception may increase for patients who have difficulty returning for a visit or otherwise receiving effective methods.


Assuntos
Competência Clínica , Hospitais de Ensino , Internato e Residência , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Unidade Hospitalar de Ginecologia e Obstetrícia , Cuidado Pós-Natal , Adolescente , Adulto , Estudos de Coortes , Estudos de Viabilidade , Feminino , Seguimentos , Georgia/epidemiologia , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Migração de Dispositivo Intrauterino/etiologia , Satisfação do Paciente , Infecção Pélvica/epidemiologia , Infecção Pélvica/prevenção & controle , Estudos Prospectivos , Fatores de Risco , Recursos Humanos , Adulto Jovem
13.
Arch Gynecol Obstet ; 290(1): 99-105, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24573506

RESUMO

PURPOSE: Approximately 21 days after an abortion, ovulation occurs in 50 % of women. Installation of an IUD directly after induced or spontaneous abortion offers immediate contraceptive protection. The purpose of the present study was to weigh up contraceptive safety and adverse reactions of IUD inserted directly after first-trimester abortion under general or paracervical anesthesia as against the fitting of IUD in the days of the next menstrual cycle without anesthesia. METHOD: During the period May 1987 to October 2010, 73 women (Group A) underwent an immediate post-abortion insertion IUD after a first-trimester spontaneous or induced abortion under general or local paracervical anesthesia and 69 participants (Group B) received IUD during the next menstrual cycle without anesthesia. Questionnaires were completed by all the women of the study with respect to the effects of IUD. The women were examined every 3 months for 1 year after the fitting of the IUD in the out-patient department of the University Obstetrics Gynecological Department of Alexandroupolis, Democritus University of Thrace, Greece. RESULTS: The demographic characteristics of the women of the two groups were similar. The age of the women ranged between 19 and 44 years, while 61.98 % were women with one or two children and 38.02 % were women with three or more children. During the first menstrual cycles, with the exception of vaginal hemorrhages (5 %) and adnexitis (1 %), no serious adverse reactions were noted. During the transvaginal ultrasonography checks in both groups, no observation was made of any dislocation of the IUD, except for two cases in the subgroup of those women with paracervical anesthesia and one case in the women of Group B. As concerns the questionnaire with regard to the women's subjective evaluation of IUD, satisfactory answers were given. CONCLUSIONS: There were no differences between the two groups either with respect to the security of the supplied contraceptive methods or to the development of side effects.


Assuntos
Aborto Induzido , Aborto Espontâneo , Dispositivos Intrauterinos/efeitos adversos , Menstruação/fisiologia , Adulto , Anticoncepção/métodos , Feminino , Seguimentos , Grécia , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/estatística & dados numéricos , Período Pós-Operatório , Gravidez , Primeiro Trimestre da Gravidez , Estudos Retrospectivos , Fatores de Risco , Fatores Socioeconômicos , Inquéritos e Questionários , Fatores de Tempo , Hemorragia Uterina/complicações , Adulto Jovem
14.
Contraception ; 89(6): 534-9, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24457061

RESUMO

OBJECTIVE: This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4-8 weeks after delivery. STUDY DESIGN: This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4-8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery. RESULTS: Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment. CONCLUSIONS: Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion. IMPLICATIONS: Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.


Assuntos
Cesárea , Anticoncepcionais Femininos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/efeitos adversos , Cuidado Pós-Natal , Centros Médicos Acadêmicos , Adulto , Chicago , Anticoncepcionais Femininos/administração & dosagem , Término Precoce de Ensaios Clínicos , Feminino , Seguimentos , Hospitais Urbanos , Humanos , Análise de Intenção de Tratamento , Expulsão de Dispositivo Intrauterino/etiologia , Levanogestrel/administração & dosagem , Perda de Seguimento , Satisfação do Paciente , Gravidez , Fatores de Tempo , Adulto Jovem
15.
PLoS One ; 7(11): e48948, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23155432

RESUMO

BACKGROUND: Today, a large proportion of early abortions are medical terminations, in accordance to the woman's choice. Intrauterine contraceptives (IUC) provide highly effective, reversible, long-acting contraception. However, the effects of timing of IUC insertion after medical abortion are not known. METHODS: Women undergoing medical abortion with mifepristone and misoprostol up to 63 days gestation and opting for IUC were randomised to early insertion (day 5-9 after mifepristone) or delayed (routine) insertion (at 3-4 weeks after mifepristone). The primary outcome was the rate of IUC expulsion at six months after IUC insertion. RESULTS: A total of 129 women were randomized, and 116 women had a successful IUC insertion. There was no difference in expulsion rate between early (9.7%) vs. delayed (7.4%) IUC insertion (risk difference -9.2-13.4). Furthermore, 1.5% of women randomized to early and 11.5% to delayed insertion did not attend the follow up (proportion difference 10.0%, 95% CI: 1.8-20.6%, p = 0.015), and a higher proportion of women (41%) had had unprotected intercourse prior to returning for insertion in the delayed group compared with the early group (16%) (p = 0.015). Adverse events were rare and did not differ between the groups. CONCLUSIONS: Early insertion of IUC after medical abortion was safe and well tolerated with no increased incidence for expulsions or complications. Women were more likely to return for the IUC insertion if scheduled early after the abortion, and less likely to have had an unprotected intercourse prior to the IUC insertion. Early insertion should be offered as a routine for women undergoing first trimester medical abortion. TRIAL REGISTRATION: ClinicalTrials.gov NCT01537562.


Assuntos
Aborto Induzido/efeitos adversos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos , Abortivos/uso terapêutico , Adulto , Feminino , Humanos , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Fatores de Tempo , Resultado do Tratamento
16.
Trials ; 13: 147, 2012 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-22920273

RESUMO

BACKGROUND: We describe the rationale and protocol for a randomized noninferiority controlled trial (RCT) to determine if the Flexi-T380(+) copper intrauterine contraceptive device (IUD) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use, NovaT-200, when placed immediately after a first-trimester abortion. METHODS/DESIGN: Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380(+) IUD, a device for which no current evidence on expulsion or effectiveness rates is available, or the Nova-T200 IUD, the only other brand of copper IUD available in Canada at the time of study initiation. The primary outcome measure is IUD expulsion rate at 1 year. Secondary outcomes include: pregnancy rate, method continuation rate, complication rates (infection, perforation), and satisfaction with contraceptive method. A non-intervention group of consenting women choosing a range of other post-abortion contraception methods, including no contraception, will be included for comparison of secondary outcomes. Web-based contraception satisfaction questionnaires, clinical records, and government-linked health administrative databases will be used to assess primary and secondary outcomes. DISCUSSION: The RCT design, combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry, and hospital records, offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada, in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options. We highlight considerations of design, implementation, and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01174225.


Assuntos
Aborto Induzido , Dispositivos Intrauterinos de Cobre , Primeiro Trimestre da Gravidez , Projetos de Pesquisa , Colúmbia Britânica , Desenho de Equipamento , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos de Cobre/efeitos adversos , Satisfação do Paciente , Gravidez , Taxa de Gravidez , Gravidez não Planejada , Gravidez não Desejada , Estudos Prospectivos , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
17.
Contraception ; 86(2): 119-21, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22464406

RESUMO

BACKGROUND: Many intrauterine device (IUD) users utilize intravaginal menstrual cups or tampons during menses, but no studies have investigated the impact this practice may have on IUD expulsions. STUDY DESIGN: Retrospective chart survey. RESULTS: Of the 930 women having IUDs placed and reporting menstrual protection, 10.3% (96) used menstrual cups, 74.2% (690) used tampons, and 43.2% (402) used pads (many women reported using more than one method). In the 743 women with adequate follow-up information, there was a full or partial expulsion (i.e., part of the IUD in the cervical canal) rate of 2.5% (27) during the first 6 weeks after insertion. There was no difference in the women using cups, tampons or pads (confidence intervals overlap). CONCLUSIONS: From this study, there is no evidence that women who report using menstrual cups or tampons for menstrual protection had higher rates of early IUD expulsion.


Assuntos
Expulsão de Dispositivo Intrauterino/etiologia , Produtos de Higiene Menstrual/efeitos adversos , Adulto , Canadá , Anticoncepcionais Femininos , Feminino , Seguimentos , Humanos , Dispositivos Intrauterinos Medicados , Levanogestrel , Prontuários Médicos , Serviços de Saúde Reprodutiva , Estudos Retrospectivos
18.
Eur J Contracept Reprod Health Care ; 16(2): 135-41, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21281098

RESUMO

BACKGROUND: To shed additional light on various aspects of intrauterine contraception discussed recently in a comprehensive review article and on the continued development of frameless copper intrauterine devices (IUDs). CONTENT: An essential feature of intrauterine contraceptives is their long duration of action. However, this only applies in the absence of side effects. The importance of dimensional compatibility of the IUD or intrauterine system (IUS) with the uterine cavity should be stressed: IUD/IUS designs that fit will lead to high acceptability, a prerequisite with regard to continuation of use. Dimensional incompatibility, on the other hand, is a cause of cramping pain, erratic bleeding or menorrhagia, dislocation or expulsion and, as a result thereof, pregnancy. The size of the intrauterine foreign body, in relation to that of the uterine cavity, determines its acceptability and influences menstrual bleeding. Abnormal and heavy menstrual bleeding is an issue which has not been fully resolved. It is the most common cause of discontinuation of this contraceptive modality. The size of the IUD can be reduced without jeopardizing its effectiveness provided the effective copper surface is sufficiently large. CONCLUSION: Properly designed and fitting IUDs and IUSs are associated with fewer side effects and greater user satisfaction. This, in turn, could increase usage of intrauterine contraception and thus reduce further the number of unintented pregnancies and induced abortions.


Assuntos
Anticoncepção/instrumentação , Anticoncepção/métodos , Dispositivos Intrauterinos/normas , Saúde da Mulher , Remoção de Dispositivo , Desenho de Equipamento , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/etiologia , Migração de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos/efeitos adversos , Ajuste de Prótese
19.
Int J Gynaecol Obstet ; 113(1): 50-3, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21272883

RESUMO

OBJECTIVE: To evaluate the correlation between endometrial cavity length and expulsion rate in acceptors of the TCu380A intrauterine device (IUD) or the levonorgestrel-releasing intrauterine system (LNG-IUS). METHODS: The study included 235 nulligravida and parous women who received a TCu380A IUD or LNG-IUS and who were observed for up to 1 year. The length of the uterine cavity was measured by uterine sounding and ultrasonography. RESULTS: The endometrial cavity was shorter than 3.2 cm in 2 LNG-IUS users and at least 3.2 cm long in 87 LNG-IUS users, with expulsions occurring in 0 (0.0%) and 2 (2.3%) of these women, respectively (P>0.999). Among the TCu380A IUD users, the endometrial cavity was shorter than 3.6 cm in 63 women and at least 3.6 cm long in 83 women, with expulsions occurring in 3 (4.8%) and 5 (6.0%) of these women, respectively (P>0.999). The mean length of the endometrial cavity-evaluated via ultrasonography-among the 10 women whose devices were expelled was 3.9 ± 0.3 cm, compared with 3.9 ± 0.0 cm in those who retained their devices (P=0.799). CONCLUSION: The present results do not support the hypothesis of an association between uterine length and risk of intrauterine contraceptive expulsion.


Assuntos
Endométrio/anatomia & histologia , Expulsão de Dispositivo Intrauterino/etiologia , Dispositivos Intrauterinos Medicados/efeitos adversos , Dispositivos Intrauterinos/efeitos adversos , Adulto , Anticoncepcionais Femininos/administração & dosagem , Endométrio/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Levanogestrel/administração & dosagem , Pessoa de Meia-Idade , Ultrassonografia , Adulto Jovem
20.
Fertil Steril ; 94(7): 2732-5, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20451183

RESUMO

OBJECTIVE: To assess the accuracy of three-dimensional (3D) ultrasound to determine the position of Essure microinserts. DESIGN: Prospective observational study. SETTING: Gynecology department in a teaching hospital. PATIENT(S): Forty women who underwent hysteroscopic sterilization from March through October 2008. INTERVENTION(S): Both 3D ultrasound and hysterosalpingography (HSG) were performed 3 months after the procedure to verify device position. Positions seen on 3D ultrasound were classified in four categories: a perfect position (1 + 2 + 3), a proximal position (1 + 2), a distal position (2 + 3), and a very distal position (3-only). MAIN OUTCOME AND MEASURE(S): Microinsert position on 3D ultrasound and correlation with HSG. RESULT(S): Overall, 93% of the devices for 40 patients were found to have been placed successfully. The final sample comprised 64 Essure devices. HSG showed tubal patency for only three devices, all classified as 3-only. No tubal permeability was noted for the other 61 positions. This 3-only location on 3D ultrasound was statistically associated with a failure of sterilization in comparison with the other locations (3/16 [18%] vs. 0/48 [0%]). CONCLUSION(S): 3D ultrasound is a simple and reproducible technique to assess the position of the Essure microinsert and appears to protect most patients from the negative aspects of pelvic radiography and of HSG. Using the 3D ultrasound classification presented in this study appears to make it possible to use HSG for backup confirmation only when Essure is found to be in the 3-only position on 3D ultrasound.


Assuntos
Endossonografia/métodos , Tubas Uterinas/diagnóstico por imagem , Tubas Uterinas/cirurgia , Imageamento Tridimensional , Dispositivos Intrauterinos , Esterilização Tubária/métodos , Adulto , Algoritmos , Falha de Equipamento/estatística & dados numéricos , Feminino , Humanos , Histerossalpingografia/métodos , Histeroscopia/métodos , Imageamento Tridimensional/métodos , Expulsão de Dispositivo Intrauterino/etiologia , Migração de Dispositivo Intrauterino/etiologia , Modelos Biológicos , Esterilização Tubária/instrumentação
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