Copper Intrauterine Device Insertion Research Articles

Statement of Retraction [Ultrasound-guided versus uterine sound-sparing approach during copper intrauterine device insertion: a randomised clinical trial

Statement of Retraction [Ultrasound-guided versus uterine sound-sparing approach during copper intrauterine device insertion: a randomised clinical trial

Knowledge, Attitude, and Practice of Brazilian Physicians about Immediate Postpartum and Postabortion Intrauterine Device Insertion.

To assess the knowledge, attitude, and practice of Brazilian physicians about immediate postpartum and postabortion intrauterine device insertion. Cross-sectional online survey involving physicians on duty in public Brazilian hospitals. Participants answered an anonymous questionnaire with close-ended questions to assess their knowledge, attitude, and experience on the immediate postpartum and postabortion insertion of copper intrauterine devices. One hundred twenty-seven physicians working in 23 hospitals in the 5 geographic regions of Brazil completed the questionnaire. Most were female (68.5%) and worked in teaching hospitals (95.3%). The mean (standard deviation) knowledge score (0-10 scale) was 5.3 (1.3); only 27.6% of the participants had overall scores ≥ 7.0. Most physicians (73.2%) would insert a postpartum intrauterine device in themselves/family members. About 42% of respondents stated that they had not received any training on postpartum or postabortion intrauterine device insertion. In the past 12 months, 19.7%, 22.8%, and 53.5% of respondents stated they had not inserted any intrauterine device during a cesarean section, immediately after a vaginal delivery, or after an abortion, respectively. Most study participants have a positive attitude toward the insertion of intrauterine devices in the immediate postpartum period, but they have limited knowledge about the use of this contraceptive method. A large percentage of respondents did not have previous training on postpartum and postabortion intrauterine device insertion and had not performed any such insertions in the last 12 months. Strategies are needed to improve the knowledge, training, and experience of Brazilian physicians on immediate postpartum and postabortion intrauterine device insertion.

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

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)

Vaginal misoprostol versus dinoprostone before copper IUD application in women with anticipated difficult loop application

Background: Intrauterine device (IUD) are safe, reliable and highly effective forms of long-acting reversible contraception. (1) The major advantage of LARC compared with other reversible contraceptive methods is that they do not require ongoing effort on the part of the patient for long-term and effective use. In addition, after the device is removed, the return of fertility is rapidAim and Objectives: The aim of this study was to compare the effect of Vaginal Misoprostol versus vaginal Dinoprostone to facilitate loop application in women with anticipated difficult loop application.Subjects and Methods: About 270 of women were assessed to select of 100 women were randomized to two groups using simple randomization and classified into: Group A: (Misoprostol group): Include 50 patients who received one tablet (200mcg misoprostol in posterior fornix of vagina 3 to 4 hour before IUD insertion.Group B: (Dinoprostone group): Include 50 patients who received one tablet (3mg dinoprostone in posterior fornix of vagina 3 to 4 hour before IUD insertion.Result: Side effect between two study drugs there is more side effects in group A (Misoprostol) than group B (Dinoprostone)but there is no significant difference between two group p value in all side effect is >0.05. Significance difference between two studied group regarding to satisfaction level p value s.002 where p value >0.05Conclusion: Both Dinoprostone and Misoprostol were effective in decreasing pain and easing insertion of Copper IUD in women with anticipated difficult insertion. However, more satisfaction lesser, adverse effects in dinoprostone group, we recommend misoprostol as is less cost than dinoprostone and stable at room temperature. This study further supports the clinical using of dinoprostone in an additional-obstetric indication.

Immediate Postpartum Insertion of Copper Intrauterine Device in a Brazilian University Hospital: Expulsion and Continuation Rates.

To evaluate the expulsion and continuation rates of the copper intrauterine device (IUD) inserted in the immediate postpartum period in a Brazilian public university hospital. In the present cohort study, we included women who received immediate postpartum IUD at vaginal delivery or cesarean s March 2018 to December 2019. Clinical data and the findings of transvaginal ultrasound (US) scans performed 6-weeks postpartum were collected. The expulsion and continuation rates were assessed 6-months postpartum using data from the electronic medical records or by telephone contact. The primary outcome was the proportion of IUDs expelled at 6 months. For the statistical analysis, we used the Student t-test, the Poisson distribution, and the Chi-squared test. There were 3,728 births in the period, and 352 IUD insertions were performed, totaling a rate of 9.4%. At 6 weeks postpartum, the IUD was properly positioned in 65.1% of the cases, in 10.8% there was partial expulsion, and in 8.5% it had been completely expelled. At 6 months postpartum, information was obtained from 234 women, 74.4% of whom used IUD, with an overall expulsion rate of 25.6%. The expulsion rate was higher after vaginal delivery when compared with cesarean section (68.4% versus 31.6% respectively; p = 0.031). There were no differences in terms of age, parity, gestational age, final body mass index, and newborn weight. Despite the low insertion rate of copper IUDs in the postpartum period and a higher expulsion rate, the rate of long-term continuation of intrauterine contraception was high, indicating that it is a useful intervention to prevent unwanted pregnancies and to reduce short-interval birth.

Outcomes of Intrauterine Device Insertion by Certified Midwives and Obstetric Nurse Practitioners.

to evaluate the outcomes of Interval Copper Intrauterine Device (IUD) insertion performed by certified midwives and obstetric nurse practitioners at a Peri-Hospital Birth Center. a cross-sectional study was conducted involving 75 women who underwent IUD insertion between January 2018 and February 2020. Data collection was carried out using medical records and telephone interviews. no instances of uterine perforation were observed. Expulsion rates of the devices were 1.3% within 30 to 45 days of use and 5.3% within the first year of use. The follow-up removal rate was 4.0%. The average pain score reported was 4.2 (SD = 3.3). Among those who continued using the device, 93.1% expressed satisfaction. the findings demonstrate that IUD insertion by certified midwives and obstetric nurse practitioners is a safe procedure, yielding outcomes comparable to those reported in the existing literature.

Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth—a protocol for a randomized clinical trial

BackgroundEnsuring effective and long-term contraception in the immediate postpartum period is an effective strategy for reducing unplanned pregnancies. In the meantime, the intrauterine device (IUD) is an excellent option. The aim of our study was to evaluate the best way to insert post-placental IUDs in the immediate postpartum period. Discomfort during insertion, expulsion rate, uterine perforation rate, and proper positioning 40–60 days postpartum will be analyzed.MethodsRandomized, controlled, open clinical trial. The study group will be composed of women between 18 and 43 years old who are admitted for vaginal birth at the Women’s Hospital of the State University of Campinas and who wish to use the IUD as a contraceptive method. The sample will be randomized into two insertion groups: manual and forceps. To calculate the sample size, the method of comparing the proportion between 2 groups was used, setting the level of significance alpha at 5% (alpha=0.05) and the power of the sample at 80% (beta=0.20). Based on the results, it was estimated that a sample of n=186 women (n=93 with manual insertion and n=93 with forceps) would be representative for comparison of expulsion between the 2 groups. All participants will undergo a postpartum consultation 40–60 days after birth with transvaginal ultrasound to assess the proper placement of the IUD.DiscussionInsertion of an IUD in the immediate postpartum period has been considered a good option to increase coverage and access to contraception, and its benefit outweighs the inconvenience of a higher expulsion rate.Trial registrationThis study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 50497321.4.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC) (number RBR-4j62jv6). This is the first version of the study protocol approved on 11/12/2021 prior to the start of participant recruitment.

Whole-exome sequencing reveals novel variants associated with abnormal uterine bleeding caused by copperintrauterine device.

Aim: This study aimed to explore the genetic risk factors and validate variants of abnormal uterine bleeding after copperintrauterine deviceinsertion. Methods: Whole-exome sequencing was performed and several variants were validated by Sequenom MassARRAY. Results: Eight variants showed potential clinical damage according to American College of Medical Genetics and Genomics criteria. By combined analysis of screening and validation, NFASC RS2802808 C>G p.Ile971Met (Pallele=0.009 and Pgenotype=0.027) and PIGR RS2275531 C>T p.Gly365Ser (Pallele=0.009 and Pgenotype=0.013) variants were identified as significantly associated with abnormal uterine bleeding with a false discovery rate <0.05. NFASC and PIGR may play a role in abnormal uterine bleeding by regulating coagulation fibrinolysis and endometrial epithelium inflammation functions. Conclusion: These findings provide a genetic basis for clinical individualization and precision of intrauterine device implantation.

Clinical Outcome of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Before T380A Copper Intrauterine Device Insertion in Adolescent and Young Women: A Double-Blind Randomized Controlled Study

Clinical Outcome of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Before T380A Copper Intrauterine Device Insertion in Adolescent and Young Women: A Double-Blind Randomized Controlled Study

Retroperitoneal Migration of an Intrauterine Device

This patient presented with pelvic pain and intrauterine pregnancy following insertion of copper intrauterine device, whose strings had previously been palpable by the patient. We performed medical abortion followed by laparoscopy, which identified intrauterine device in the retroperitoneum overlying the ureter and iliac vessels. This location suggests migration of the device, as device strings were previously palpable by the patient. After intact removal, the patient opted for a replacement copper intrauterine device.

Evaluation the Role Uterine Artery Doppler Indices in Prediction of Abnormal Uterine Bleeding In Intrauterine Contraceptive Device Users

Contraceptive intrauterine device (IUD) is a successful method of contraception which has been used for more than 30 years. The objectives of our study were to evaluate the correlation between abnormal uterine bleeding in IUD users and uterine artery Doppler [pulsitility index (PI); Resistant index (RI)] using transvaginal ultrasound and Doppler. The study included 120 women from obstetrics and gynecology department Hospital. ,divided into three groups: Group I included forty female using coipper intrauterine device withbleeding Group II included forty female using CIUD without bleeding. Group III included forty ladies as a control group. All fullfil the inclusion and exclusion criteria History was obtained. Examination was done: Routine investigations: The Results Of This Work Were:- As regard to Doppler findings, it was noted that RI was significantly lower in group I in comparison to group II and group III and Pulsitility index (PI) followed the same pattern as RI. We can conclude that detection of PI and RI in the uterine artery could be used to identify patients at risk of developing excessive bleeding after copper IUD insertion.

Ultrasound-guided versus uterine sound-sparing approach during copper intrauterine device insertion: a randomised clinical trial

Objective To compare the outcomes of trans-abdominal ultrasound (TAS) guided approach and uterine sound-sparing approach (USSA) during copper intrauterine device (IUD) insertion Study design A randomised open-label clinical trial (Clinical Trials.Gov: NCT03383432) included multiparous women requesting Copper IUD insertion for birth control were invited to participate. The eligible women were randomised into two groups (44 women in each group); group I (TAS-guided IUD insertion) and group II: USSA. The primary outcome was to measure the satisfaction score of IUD insertion in both methods. Secondary outcomes included the easiness score (ES), the difference in pain scores during IUD insertion, the duration of insertion, and the successful device placement after one week and one month evaluated by transvaginal ultrasound (TVS). Results Eighty-eight women were analysed in both groups. The VAS for satisfaction was significantly higher in the USSA group than the TAS-guided group (7.80 ± 1.27 vs. 5.45 ± 1.42, p = .0001). There was significantly lower VAS of pain scores during IUD insertion in the USSA group as compared with the TAS-guided IUD (p = .001). A lower ES and a significantly shorter duration of IUD insertion were also determined among the USSA group (p = .0001). Conclusions USSA is associated with higher satisfaction and less pain during insertion than the TAS-guided IUD insertion approach. However, both techniques have optimal intra-uterine device positioning.

Uterine artery Doppler indices: pulsatility index and resistance index as predictive tools for the incidence of heavy menstrual bleeding related to copper intrauterine contraceptive device.

ObjectivesTo assess the predictive value of the initial uterine artery Doppler indices, the pulsatility index (PI), and resistance index (RI) in the prediction of heavy menstrual bleeding before and after copper intrauterine contraceptive device (IUCD) insertion.MethodsThe current prospective clinical study included 100 women who intended to use a copper IUCD (Cu T-380A) and met the inclusion criteria. Uterine artery Doppler PI and RI indices were calculated before IUCD insertion and at three and six months after insertion. Based on the presence or absence of menorrhagia, all women were classified into two groups: non-bleeding (n=52) and extreme menstrual bleeding (n=48). Receiver operating curve analysis was used to determine the predictive value of uterine artery PI and RI in patients with menorrhagia relevant to IUCD.ResultsThe PI and RI indices displayed a highly significant difference between the IUCD groups at three and six months after insertion (P<0.001). Uterine artery PI ≤2.02 (sensitivity of 95.8%, specificity of 100%, and area below the curve [AUC] of 0.97 at P-value<0.001) and RI ≤0.83 (sensitivity of 93.8%, specificity of 100%, and AUC of 0.949 at P-value<0.001) were correlated with significant menstrual bleeding following insertion of IUCD.ConclusionThe presented results confirmed our assumption that the initial studies of uterine artery Doppler can predict heavy-menstrual bleeding associated with IUCD and therefore, should be conducted in women pursuing reversible long-acting contraception.

RETRACTED ARTICLE: 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

We, the Editor and Publisher of the European Journal of Contraception & Reproductive Health Care, have retracted the following article: Ahmed M. Abbas, Noura H. Abd Ellah, Maryt A. Hosny, Mohamed S. Abdellah & Mohammed K. Ali (2021) 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, The European Journal of Contraception & Reproductive Health Care, 26:2, 132–138, DOI: 10.1080/13625187.2020.1868427 Following the article’s publication, significant concerns were raised about the integrity of the data and reported results in the article. When approached for an explanation, the authors kindly provided their data, but they have not sufficiently addressed the concerns raised. We contacted the authors’ institution to evaluate the statistical concerns, and the institution’s statistician found no significant concerns regarding the data. However, the journal’s editorial team and three external statisticians’ findings did not agree. As verifying the validity of published work is core to the integrity of the scholarly record, we are therefore retracting the article. The authors do not agree with the retraction. We have been informed in our decision-making by our policy on publishing ethics and integrity and COPE guidelines The retracted article will remain online to maintain the scholarly record, but it will be digitally watermarked on each page as ‘Retracted’.

Postplacental Insertion of Levonorgestrel Intrauterine System Versus Copper Intrauterine Device: A Prospective Study.

To compare between postplacental insertion of levonorgestrel intrauterine system versus copper intrauterine device regarding expulsion rates, patient satisfaction, complications, and continuation rates. This prospective observational study was conducted on 1100 participants divided in to two groups: group (1) CU-IUD group and group (2) LNG-IUS group where women were assigned for postplacental insertion of either CU-IUD or LNG-IUS, respectively. Follow-up at 6weeks, 3 and 6months postpartum and data were collected and analyzed to evaluate outcomes. No statistical difference between both groups regarding patients' characteristics, the overall expulsion rate was higher in LNS-IUS group than CU-IUD group; 77 patients (14%) and 50 patients (9%), respectively, (P value < 0.05), odds ratio: 1.63 at CI: (1.12-2.37). No significant difference between the two groups regarding pain intensity, perforation, abnormal uterine bleeding, and clinical endometritis (P > 0.05). Overall satisfaction rate at six months was 478(87%) in the CU-IUD group and 472(85.8%) in the LNS-IUS group (P value > 0.05), odds ratio: 1.1 at CI: (0.78-1.55). Continuation rate at s6 months was comparable between the two groups 485 (88.2%) and 480 (87.3%) in CU-IUD group and LNS-IUS group respectively, (P value < 0.05), odds ratio: 1.09 at CI: (0.76-1.56). The rate of expulsion of LNG-IUS is higher than copper IUD when inserted postplacental, yet the continuation and acceptability rates were comparable between the two groups.

Comparison of Intrauterine Device Insertion-Related Pain and Ease of Procedure at Different Times During Menstruation.

ObjectiveFear of pain during the copper intrauterine device (Cu-IUD) insertion may lead patients to reject this highly effective birth control method. The aim of this study was to investigate the pain scores associated with IUD insertion and the ease of procedure at different times during menstruation.MethodIn this prospective cohort trial, eligible women received IUD at three-time segments of menstruation: Group I, at 0.5 to 0.69-time segment (n=53); Group II, at 0.7 to 0.89-time segment (n=67); and Group III, at 0.9 to 1-time segment (n=72). The time segments during menstruation were calculated for each participant by dividing the menstrual cycle day of IUD insertion to total number of menses days. The score of pain experienced at different steps of IUD insertion during and five min. after the procedure measured by Wong-Baker FACES Pain Rating Scale (WBS) and the ease of insertion were compared among groups.ResultsThere were significant differences in age (p=0.011) and time since the last delivery (p=0.017). After adjusting for potential confounding factors, the mean WBS score and the ease of insertion were not statistically significant among groups, respectively (p=0.664 and p=0.149). The most painful step was observed as uterine sounding (median, 4 [interquartile range {IQR}, 2]). No significant correlation was observed between WBS scores, the ease of insertion, and main characteristics of the participants.ConclusionThe most painful step of IUD insertion was observed as uterine sounding. IUD insertion-related pain and the ease of procedure do not appear to be different at any time in the second half of menstruation.

A Meta-Analysis of Postpartum Copper IUD Continuation Rates in Low- and Middle-Income Countries

Long-acting reversible contraception (LARC) initiated immediately postpartum can reduce unintended or mistimed pregnancies, and contribute to proper pregnancy spacing. Data on use and continuation of postpartum LARC in low- and middle-income countries (LMIC) is limited.We searched PubMed, OVID, Embase, Google Scholar, Cochrane, POPLINE, Global Health (CABI), and LILACS databases for relevant terms. Studies of any design, published in English, were screened for relevance based on six-month continuation rates of postpartum LARC, location of study, and LARC insertion within 48 hours after vaginal or cesarean birth. We found no relevant studies of implant or hormonal intrauterine device (IUD). Therefore, analysis was limited to studies of the copper IUD only. Two authors used the Cochrane Public Health Group Data Extraction and Assessment Template to guide data extraction to estimate pooled six-month continuation rates, and the Cochrane Risk of Bias Tool for Randomized Controlled Trials and the National Heart, Lung, and Blood Institute (NHLBI) Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies to rate the quality of the studies. A random-effects meta-analysis of proportions was performed.Immediate-postpartum copper IUDs have a six-month continuation rate of 87% (95% CI 80-92%) in LMIC. The pooled estimated rates of six-month adverse outcomes were 6% (95% CI 5-9%) for expulsion, 5% (95% CI 4-7%) for removal, and 0.2% (95% CI 0.0-0.9%) for infection.High six-month continuation rates and a low rate of adverse outcomes suggest immediate postpartum copper IUD insertion is a feasible and acceptable postpartum contraceptive option for women living in LMIC.

Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial

To assess efficacy and safety of self-administered 3 mg dinoprostone vaginally in reducing pain during copper intrauterine device (IUD) insertion in parous women. Randomized, double-blinded, placebo-controlled trial. Family planning clinic in a tertiary referral hospital. Multiparous women who were attending a family planning clinic and requesting copper IUD insertion. We randomly assigned 160 participants into two groups: The dinoprostone group (n = 80) received 3 mg dinoprostone vaginally, and the placebo group (n = 80) received placebo vaginally. Our primary outcome was mean pain scores during IUD insertion. Our secondary outcomes were mean pain scores during tenaculum application, during uterine sounding, and 15 minutes after insertion, ease of insertion, satisfaction score, need for additional analgesics, and side-effects. Both groups showed no significant difference in anticipated pain score (P=.41), pain during tenaculum placement (P=.22), and pain during sound insertion (P=.07). The dinoprostone group had significantly lower pain scores during IUD insertion (34.8 ± 10.1 vs. 57.8 ± 11.8) and 15 minutes after insertion (20.6 ± 6.4 vs. 29.6 ± 6.2), easier IUD insertion (43.6 ± 21.9 vs. 64.7 ± 18.1), and higher satisfaction (83.9 ± 11.6 vs. 63.0 ± 9.1) compared with the placebo group. Fewer patients required additional analgesics in the dinoprostone group compared with the placebo group (P=.01). Side-effects were similar between the groups. Self-administered 3 mg dinoprostone vaginally before copper IUD insertion in parous women reduces pain scores during IUD insertion, making insertion easier and increasing women's satisfaction, with tolerable side-effects. NCT04046302.

Comparative Efficacy of Vaginal Misoprostol vs Vaginal Dinoprostone Administered 3 Hours Prior to Copper T380A Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial.

To compare the effectiveness of misoprostol and dinoprostone tablets administered vaginally 3hours before copper intrauterine device (IUD) insertion vs placebo in reducing pain and increasing ease of insertion among nulliparous women. Randomized controlled trial. Tertiary referral hospital. A total of 129 nulliparous women requesting a Copper T380A IUD insertion. Women were randomized to receive 200μg misoprostol or 3mg dinoprostone or placebo 3hours before IUD insertion. Primary outcome was patient-reported pain during IUD insertion using a 10-cm visual analog scale (VAS). Secondary outcomes include provider ease of insertion, women satisfaction level, and side effects. Participants' baseline characteristics were comparable between the study groups. Mean pain score during IUD insertion was lower with misoprostol than placebo (3.1±2.3 vs 4.4±2.2; P=.02) and dinoprostone compared to placebo (2.4±1.8 vs 4.4±2.2; P<.001). Clinicians reported easier IUD insertion with misoprostol than placebo (2.4±1.7 vs 4.0±2.4; P=.001) and dinoprostone compared to placebo (2.0±1.5 vs 4.0±2.4; P<.001). Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo (P<.001). Side effects did not differ among the 3 study groups. Premedication with vaginal misoprostol or dinoprostone effectively lowered pain during copper IUD insertion. However, the reduction in pain scores was clinically significant only in women who received dinoprostone. In both the misoprostol and dinoprostone groups, clinicians found the procedure easier, and women were more satisfied with IUD insertion. Side effects and complications were similar in all groups.