Copper Intrauterine Device Research Articles

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices.

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. 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. 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. 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. Bayer AG. EU PAS register, EUPAS33461.

Statement of Retraction [Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial

Statement of Retraction [Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial

Reproductive Planning and the Choice of Long-acting Reversible Contraceptive Primary to Health: A Cross-Sectional Study.

Evaluate the different perspectives that involve the choice of long-acting reversible contraceptives (LARCs), the issues related to this process and the consequences of deciding one method in the women's in the primary health care (PHC) center in Sousas, a district in Campinas, SP (Brazil). This is an analytical cross-sectional study, it was performed at the PHC in Sousas. Data were collected through the analysis of medical records and interviews with women who live in Sousas and had the insertion of the copper intrauterine device (IUD) (D) from April 2021 to April 2022 or the etonogestrel implant (I) from May to December 2022. The study was approved by the Research Ethics Committee of the Medical Science School at the State University of Campinas (UNICAMP). Reason for choosing this LARC: medical (D: 52%; I: 100%), easy adhesion (D: 71%; I: 67%), effectiveness (D: 55%; I: 100%). Indication by health professionals (D: 65%; I: 100%). And improvement of clinical characteristics: mood (D: 77%; I: 67%), body mass index (BMI; D: 52%; I: 33%), and libido (D: 84%; I: 67%). It is suggested that women tend to decide between LARCs when guided by their doctor or PHC health professionals, and they select LARCs because of the ease of use and low failure rates. Therefore, this study highlights how LARCs can positively interfere in the aspects that pervade contraception, such as BMI, libido, and mood.

Spherical Ball-Shaped Intrauterine Device Long-Acting Reversible Contraception: Post-marketing Pharmacovigilance Assessment

Objective: Pharmacovigilance assessment of a novel intrauterine spherical ball-shaped copper intrauterine device (Spherical Copper 300 mm2 intrauterine device [IUD]; OCON Medical Ltd., Modiin, Israel]) using data collected from both users and healthcare providers. Study Design: Pharmacovigilance reports of undesirable side effects (events) were collected and evaluated based on healthcare providers who completed pharmacovigilance reporting related to device insertion and outcomes. Results: Data was reviewed from 111,022 insertions from 23 countries. Insertions were performed by multiple types of providers: nurse practitioners, midwives, general practitioners, and obstetrician-gynaecologists. Out of 111,022 insertions, a total of 496 accumulative pregnancies were reported over a period of 70 months, for an effectiveness of 99.6% (n=110,706) over the reported period. Few complications were reported. Of those reported, expulsion rate was 3.30% (n=3,619), with median time from insertion to expulsion of 7 weeks (0–60 weeks), perforation rate of 0.05% (n=60), and pelvic inflammatory disease rate of 0.02% (n=23). Conclusions: The Spherical Copper 300 mm2 IUD was used in a diverse group of women by a variety of medical providers. Spherical Copper 300 mm2 IUD use suggests high efficacy and safety with infrequent complications. The Spherical Copper 300 mm2 IUD is an additional option for women desiring reliable, reversible, long-acting, and non-hormonal contraception. Implications: Females interested in a safe and highly effective, long-acting, reversible contraceptive method would benefit from additional options. Currently, the T-shaped Copper 380 mm2 IUD is the most prevalent, non-hormonal, long-acting, reversible contraceptive method for females, with over 99% effectiveness. The Spherical Copper 300 mm2 IUD offers an alternative contraceptive option for females who do not desire exogenous oestrogen or progestin exposure.

Non-Hormonal Contraception.

While hormonal contraceptives are efficacious and available in several forms for women, perception of safety and concern over side effects are a deterrent for many. Existing non-hormonal contraceptives include permanent sterilization, copper intrauterine devices (IUDs), chemical/physical barriers such as spermicides and condoms, as well as traditional family planning methods including withdrawal and the rhythm method. Individuals who wish to retain their fertility in the future can achieve highest adherence and efficacy with long-acting, reversible contraceptives (LARCs), though there is only one, the copper IUD, that is non-hormonal. As rates of unintended pregnancies remain high with existing contraceptive options, it is becoming increasingly attractive to develop novel pregnancy prevention methods for both women and men. Non-hormonal contraceptives can target a variety of critical reproductive processes discussed here. This review focuses on identified non-hormonal contraceptive targets and subsequent drug candidates in development.

TEMPORARILY WITHDRAWN: Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12

This article has been temporarily withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal

Emergency contraception: society of family planning clinical recommendation (2023)

Emergency contraception (EC) refers to several contraceptive options that can be used within a few days after unprotected or under protected intercourse or sexual assault to reduce the risk of pregnancy. Current EC options available in the United States include the copper intrauterine device (IUD), levonorgestrel (LNG) 52 mg IUD, oral LNG, and oral ulipristal acetate (UPА).
 These clinical recommendations review the indications, effectiveness, safety, and side effects of emergency contraceptive methods; considerations for the use of EC by specific patient populations and in specific clinical circumstances and current barriers to emergency contraceptive access. Further research is needed to evaluate the effectiveness of LNG IUDs for emergency contraceptive use; address the effects of repeated use of UPА at different times in the same menstrual cycle; assess the impact on ovulation of initiating or reinitiating different regimens of regular hormonal contraception following UPА use; and elucidate effective emergency contraceptive pill options by body mass indices or weight.

Retraction.

Rezk, M., Elshamy, E., Shaheen, A.-E., Shawky, M. and Marawan, H. (2019). Effects of a levonorgestrel intrauterine system versus a copper intrauterine device on menstrual changes and uterine artery Doppler. Int J Gynecol Obstet, 145: 18-22. https://doi.org/10.1002/ijgo.12778. The above article, published online on 1 February 2019 on Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal's Editor-in-Chief, Professor Michael Geary, the International Federation of Gynecology and Obstetrics and John Wiley & Sons Ltd. The journal's Editor-in-Chief was contacted by a third party who raised concerns regarding the authenticity of the data presented within the article. The authors were unable to provide a satisfactory explanation and could not provide the original data. Following review by the journal's research integrity team, it was found that the data were unlikely to be genuine. As such, the conclusions can no longer be relied upon and the journal is issuing this retraction.

Knowledge, beliefs and practices of nurses with long-acting reversible contraception, Cape Town.

Implanon and copper intrauterine contraceptive device (IUCD) are long-acting reversible contraceptives (LARC) available in public primary health care (PHC) South Africa. These methods are the most effective forms of contraception. To evaluate the knowledge, beliefs and practices on provision of LARC. Primary health care facilities within the Khayelitsha Eastern Substructure, Cape Town. A descriptive survey of all permanent nurses who provided contraception. Data were collected from 72/90 (80% response rate) via a validated questionnaire and evaluated using Statistical Package for Social Sciences (SPSS). Knowledge of eligibility for LARC was tested. The mean knowledge scores for Implanon were 8.56/11 (s.d. 1.42) for the trained and 7.16/11 (s.d. 2.83) for the untrained (p = 0.007). The mean knowledge scores for IUCD were 10.42/12 (s.d. 1.80) for the trained and 8.03/12 (s.d. 3.70) for the untrained (p = 0.019). Participants believed that inaccessibility to training courses (29%), no skilled person available (24%) and staff shortages (35%) were barriers. Less than 50% of women were routinely counselled for LARC. Forty-one percent of nurses were trained and performed IUCD insertion, and 64% were trained and performed Implanon insertion, while 61% and 45% required further training. Confidence was low, with 32% trained and confident in IUCD and 56% trained and confident in Implanon insertion. Lack of training, poor confidence and deficient counselling skills were barriers to effective LARC provision. The identified system-specific barriers must be addressed to improve uptake.Contribution: The first study to evaluate knowledge, beliefs and practices on LARC in providers in the Western Cape.

Novel Concepts for Intrauterine Device Placement at Caesarean Delivery: Description of Technique and Video Recording.

The International Federation of Gynaecology and Obstetrics recommend digital insertion of the copper intrauterine device (IUD) during caesarean delivery and note the risk of thread inclusion in the uterotomy closure and nonvisibility of threads at follow-up. We describe a novel method of inserting the IUD with the insertion straw and directing the lower end of the straw through the cervix for retrieval after the operation, to protect and ensure alignment of the threads. We also describe a simple method of lengthening one thread with part of the other thread, to avoid risks associated with braided suture extensions.

Study Participants' and Clinicians' Experiences With Placement of a Novel Low-Dose Copper Intrauterine Device With a Nitinol Frame in Nulliparous Versus Parous Participants [ID: 1374840

INTRODUCTION: Clinicians may perceive intrauterine device (IUD) placement to be more challenging for nulliparous versus parous users. This study assesses nulliparous versus parous study participants' and clinicians' experiences with placement of a novel, low-dose copper (175 mm2) IUD with a flexible nitinol frame. METHODS: This single-arm, IRB-approved, phase 3 clinical trial recruited pregnancy-capable people aged 17–45 at 42 U.S. centers. We compared nulliparous and parous participants' experiences for first IUD placement attempt including successful placement, participant-reported pain (on an 11-point numeric pain rating scale), investigator-reported ease of IUD placement (on a 5-point Likert scale), need for mechanical cervical dilation, and uterine perforation. RESULTS: Of 1,620 participants enrolled, 973 (60.1%) reported nulliparity and 647 (39.9%) parity. Successful IUD placement occurred at first attempt for 929 (96.0%) nulliparous versus 625 (96.6%) parous participants. Including second attempts, successful placement occurred for 1,601 (98.8%) participants. Nulliparous participants reported a mean pain score of 5.6 (±2.19) versus 4.0 (±2.55) for parous participants (P<.001), and investigators more frequently reported hard or very hard IUD placement in 81 (8.4%) nulliparous versus 22 (3.4%) parous participants (P<.001). Among nulliparous participants, 203 (21.2%) reported pain-related adverse events associated with placement versus 65 (10.1%) in parous participants (P<.001). Mechanical dilation was required for 202 (20.8%) nulliparous versus 79 (12.2%) parous participants (P<.001). Uterine perforation occurred in 1 nulliparous (0.10%) and 1 parous participant (0.15%). CONCLUSION: Despite experiencing more challenging IUD placements than parous participants, nulliparous trial participants experienced similar IUD placement success with this novel, low-dose copper IUD.

Long-Acting Reversible Contraception for Adolescents: A Review of Practices to Support Better Communication, Counseling, and Adherence.

Long-acting reversible contraception (LARC) methods, including levonorgestrel and copper intrauterine devices (IUDs) and the subdermal contraceptive implant, are the most effective reversible forms of contraception and thus are an important aspect of adolescent pregnancy prevention. While LARC efficacy, safety, and appropriateness are supported by major medical organizations and usage rates are increasing, overall LARC uptake among United States (US) adolescents remains lower than uptake of short-acting contraceptive methods. A better understanding of the barriers affecting adolescent LARC uptake and reasons for discontinuation could help facilitate effective communication. For example, learning how to improve adolescent-centered communication, shared decision-making, and motivational counseling strategies may be the first step to improving utilization rates. This narrative review includes three sections. First, this review will describe the history, mechanisms of action, and epidemiology of adolescent LARC use in the US and globally. Next, this review will describe key factors influencing adolescent LARC uptake, reasons for discontinuation, and multilevel barriers specific to adolescent LARC use. Finally, this review will characterize communication techniques and LARC counseling strategies for adolescents in the context of a reproductive justice approach set in the health belief model framework. The distinction between moving away from a presumptive counseling approach towards an adolescent-centered, shared decision-making approach to encourage parent-adolescent sexual health communication to lay the foundation of empowering adolescent reproductive autonomy should be the underpinning of all effective reproductive communication strategies.

Long-Acting Reversible Contraception Continuation After Management of a Malpositioned Intrauterine Device [ID: 1376021

INTRODUCTION: Studies have investigated risk factors for intrauterine device (IUD) malposition, but there is a paucity of data regarding patients’ contraceptive decisions after experiencing a malpositioned IUD. Therefore, we sought to investigate continued long-acting reversible contraception (LARC) usage after management of a malpositioned IUD. METHODS: After IRB approval, a retrospective cohort study was conducted, which included 541 patients who underwent IUD insertion at one institution with subsequent pelvic imaging. One hundred six had a malpositioned IUD and were age-matched to controls. Chart and imaging reports were abstracted. Long-acting reversible contraception retention was documented through 24 months from index imaging. RESULTS: Most patients had a levonorgestrel IUD (90.9%) for the indication of contraception alone (54.1%). The imaging indication of abnormal uterine bleeding (AUB) was most likely to be associated with malposition (odds ratio [OR] 1.67 [1.03–2.71], P=.038), as well as a copper IUD type (OR 5.31 [2.14–13.18], P<.001). Most patients with a malpositioned IUD did not have an IUD replaced after removal (57.8%). Of those who abandoned IUD therapy, only six chose to initiate an alternative LARC. Malposition was not an independent risk factor for LARC abandonment between the two groups over the 24 months of follow-up. Risk factors for abandonment over the follow-up period included AUB, copper IUD use, younger age, and shorter duration of use before undergoing imaging. CONCLUSION: Most patients with a malpositioned IUD did not have IUD replacement and abandoned all LARC therapy. These are important preliminary findings regarding LARC abandonment associated with IUD malposition that will help shape further studies as well as clinical counseling.

How do levonorgestrel intrauterine devices (IUDs) compare with copper IUDs for emergency contraception?

How do levonorgestrel intrauterine devices (IUDs) compare with copper IUDs for emergency contraception?

The different facets of 'experiential knowledge' in Swedish women's claims about systemic side effects of the copper intrauterine device.

'Experiential knowledge' has been identified as a key epistemic resource used by lay people to contest medical authorities and build new knowledge related to health. The Internet has created unprecedented opportunities for such experience-based epistemic projects. This article contributes to understandings of the as yet under-theorised concept of experiential knowledge by analysing accounts of a group of Swedish women who claim that their use of contraceptive copper IUDs has led to systemic side effects not recognised by health care providers. Based on digital group interviews and written essays, we distinguish between three components or stages of experiential knowledge at work in the women's use of experience as an epistemic resource: somatic knowing, collective validation and self-experimentation. Drawing on a critical realist framework, we defend a notion of experiential knowledge as crucially, while only partially, based on a bodily and practical access to aspects of reality organised by extra-discursive principles. By providing theoretical complexity to the notion of experiential knowledge, we contribute resources for discriminating between and evaluating various experience-based claims, something that is particularly needed in the current 'post-truth' era where experience-based knowledge claims pointing in divergent directions flourish.

Real-World Experience Using the Iub Ballerine Midi Copper Iud: A Multicenter, Multinational Observational Study

Objective: The aim of the study was to assess efficacy, safety and patient acceptability of the intrauterine ball (IUB) Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians. Study design: Retrospective analysis of two cross-sectional survey studies conducted in seven private clinics in Israel or Switzerland, and in one Swiss hospital between January and October 2018. Participants were healthy women who had the non-hormonal IUB Ballerine MIDI inserted >12 months before enrolment. In total, 382 participants and their 19 physicians completed questionnaires relating to device insertion, user experience and performance. Results: Mean age at insertion was 31.8±7.1 years, the survey was answered 16.0±4.7 months following IUB insertion. Most women were married (56.8%) and multigravid (83.5%). In 20 (5.2%) cases premature removal was due to desire to conceive. Excluding these women, the >12-month continuation rate was 71%. The expulsion rate was 17 (4.5%) and pregnancy rate was 4 (1.1%). The IUB was associated with high tolerability, 31% of current users reported no menstrual cramps/pain or light (34%) to moderate (20%) dysmenorrhea. The majority of women (69%) reported moderate to high satisfaction with the device, and 79% said they would recommend it to friends and relatives. Physicians reported in 87% of procedures the device was simple to deploy, with no difficulties encountered. Conclusions: The IUB Ballerine MIDI was demonstrated to be safe, effective and highly accepted in a cohort of women in different clinical settings and among a socioeconomically and demographically diverse population of contraception seekers

Evaluation of Immediate Post-placental Insertion of the Copper Intrauterine Contraceptive Device during Caesarean Delivery

Evaluation of Immediate Post-placental Insertion of the Copper Intrauterine Contraceptive Device during Caesarean Delivery

Lidocaine Spray 10% versus Oral Ibuprofen Tablets in Pain Control during Copper Intrauterine Device Insertion (A Randomized Controlled Trial)

Lidocaine Spray 10% versus Oral Ibuprofen Tablets in Pain Control during Copper Intrauterine Device Insertion (A Randomized Controlled Trial)

Intrauterine contraceptive discontinuation reasons among female trial participants living with HIV in Cape Town, South Africa: A qualitative analysis.

While young women in South Africa may navigate both HIV infection and pregnancy risks, intrauterine contraceptive (IUC) use is low. Though IUCs have low failure rates, concerns exist about whether the IUC is an appropriate method choice for women living with HIV (WLHIV). In this qualitative study, we explore WLHIVs' experiences of using IUC and reasons for discontinuation. This qualitative study included in-depth interviews (IDIs) with 17 WLHIV who electively discontinued their allocated IUC while participating in a randomized controlled trial comparing the safety of the levonorgestrel intrauterine system (LNG-IUS) and the copper intrauterine device (C-IUD) in Cape Town, South Africa. The transcripts were coded and emergent themes were grouped to examine women's experiences with IUC use and reasons for discontinuation, highlighting experiential differences between the two methods. Women's experience with the allocated IUC related most commonly to bleeding and/or abdominal pain just after insertion. Most C-IUD discontinuers, but only one LNG-IUS discontinuer, complained of pain and/or increased bleeding as the main reason for removal. Three women (two LNG-IUS, one C-IUD) requested removal because they desired pregnancy, while two others discontinued due to fears the IUC was exacerbating non-gynecologic conditions (hypertension, diabetes). Generally, women acknowledged advantages of IUC use and many expressed their desire to continue use if not for the side effects. In the South African context, IUC use for WLHIV should be promoted with specific counseling considerations. Both providers and potential users should receive specific information about potential menstrual-related side effects and countering common misperceptions to enable informed contraceptive decision-making.

Correction to: Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.

Correction to: Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.