Heavy menstrual bleeding in women with inherited bleeding disorders in use of LNG-IUS: A systematic review and single-arm meta-analysis.

OBJECTIVES: Inherited bleeding disorders may cause heavy menstrual bleeding in women, impacting quality of life and impairing daily and social activities. The levonorgestrel-releasing intrauterine system is a potential treatment for these women, which might reduce menstrual blood loss. STUDY DESIGN: We performed a systematic review and single-arm meta-analysis to examine the levonorgestrel-releasing intrauterine system in women with inherited bleeding disorders and heavy menstrual bleeding. RESULTS: A systematic search on PubMed, Embase and Cochrane yielded 583 results, of which six observational studies (n = 156) met inclusion criteria. Levonorgestrel-releasing intrauterine system use in patients with inherited bleeding disorders and heavy menstrual bleeding was associated with amenorrhea in 60% of patients and a significant increase of 1.40 g/dL in hemoglobin and of 19.75 ng/mL in ferritin levels when comparing post- and pre-treatment levels. The post-treatment mean hemoglobin was 13.32 g/dL and the mean ferritin was 43.22 ng/dL. The rate of intrauterine device expulsion or removal due to mal position was low (13%), as was the need for intrauterine device removal due to lack of efficacy (14%). CONCLUSION: The levonorgestrel-releasing intrauterine system may improve bleeding patterns and quality of life in patients with inherited bleeding disorders and heavy menstrual bleeding. IMPLICATIONS: Women with inherited bleeding disorders could benefit from levonorgestrel-releasing intrauterine system, so its use should be an option for this women.

Body Mass Index and Levonorgestrel Device Expulsion in Adolescents and Young Adults.

STUDY OBJECTIVE: To evaluate the relationship between body mass and levonorgestrel intrauterine device (LNG-IUD) expulsion in adolescents and young adults (AYA). DESIGN, SETTING, PARTICIPANTS & INTERVENTIONS: A retrospective chart review was conducted of nulliparous females aged 10-24 years who had a 52-milligram LNG-IUD placed between November 2017 and May 2021 by pediatric and adolescent gynecology providers at a tertiary children's hospital, including those who underwent metabolic and bariatric surgery (MBS). Primary analysis focused on 10-19 year olds as they had comparable anthropometrics (namely BMI percentile [BMIP] as defined by the Centers for Disease Control). Descriptive statistics included means, standard deviations (SD), and ranges for continuous variables counts and percentages for categorical variables. Chi-square or Fisher's exact tests were used to assess associations. Logistic regressions were fit to test the associations between BMIP, MBS, and the odds of expulsion. MAIN OUTCOME MEASURES & RESULTS: A total of 588 patients were included in the primary analysis (10-19 years). Mean age was 15.8 years (±2.0). Using BMIP, 15.5% (n = 91) of the sample was overweight and 22.3% (n = 131) were obese. Within 12 months, 33 patients (5.6%) experienced expulsion. Every one-unit increase in BMIP was associated with a 3% increase in the odds of expulsion (P = .008), and each increase in BMIP category (eg, overweight vs average/underweight) was significantly associated with increased odds of expulsion (OR = 2.77-4.28). Patients who had LNG-IUD placement during MBS (n = 43) had higher odds of expulsion (OR = 3.23; P = .024) than other patients. CONCLUSION: AYA with higher BMIP and/or who undergo MBS are at increased risk of LNG-IUD expulsion within one year of placement.

Menstrual cup use and intrauterine device expulsion in a copper intrauterine device randomized trial.

OBJECTIVE: To evaluate menstrual cup use and intrauterine device (IUD) expulsion. STUDY DESIGN: We performed a secondary analysis of a 3-year contraceptive efficacy trial comparing two copper 380 mm2 IUDs. Investigators randomized participants approximately 1:4 to the TCu380A or NTCu380-Mini IUD. Approximately 12 months after enrollment began, we advised participants against menstrual cup use due to observed IUD expulsions in cup users. We evaluated IUD expulsion (including spontaneous partial and complete expulsion and accidental self-removal) at 12 and 36 months. We used multivariable logistic regression to evaluate IUD expulsion by age, baseline menstrual volume, body mass index, IUD type, menstrual cup use, parity, and uterine length. RESULTS: This analysis included 1046 participants (203 TCu380A and 843 NTCu380-Mini), with 879 (84.0%) nulliparas. Through 12 and 36 months, expulsion occurred in 74 (7.1%, 95% CI 5.5-8.6%) and 133 (12.7%, 95% CI 10.7-14.7%) participants, respectively. Overall, 250 (23.9%) reported menstrual cup use. More menstrual cup users than non-users experienced expulsion through 12 months (32/203 [15.8%] vs. 42/843 [5.0%]) and 36 months (58/250 [23.2%] vs. 75/796 [9.4%]). Through 36 months, NTCu380-Mini menstrual cup users had higher expulsion odds, while TCu380A cup users did not. Menstrual cup users more frequently experienced accidental self-removal than non-users in participants using the TCu380A (3/53 [5.7%] vs. 0/150 [0.0%]) and the NTCu380-Mini (20/197 [10.2%] vs. 7/646 [1.1%]). In multivariable regression, we found increased odds of expulsion through 36 months in participants using menstrual cups with the NTCu380-Mini (aOR 3.13, 95% CI 1.16-8.46) and <25 years (aOR 1.59, 95% CI 1.07-2.34). CONCLUSIONS: We found higher odds of IUD expulsion with menstrual cup and concurrent NTCu380-Mini IUD use over 36 months of use, but not with concurrent TCu380A IUD use. Menstrual cup users experienced higher likelihood of accidental self-removal regardless of IUD type. IMPLICATIONS: Menstrual cup and NTCu380-Mini use may increase IUD expulsion risk and may increase accidental self-removal risk with TCu380A and NTCu380-Mini use. Clinicians should advise patients of these risks and consider warning patients using an IUD shaped like the NTCu380-Mini (Nova-T frames) of expulsion risk with menstrual cup use.

Longitudinal impact of a residency-based postplacental levonorgestrel intrauterine device insertion program: Expulsion rates in years 1, 2, and 3.

OBJECTIVE: To evaluate expulsion rates in the first 3 years of an academic postplacental levonorgestrel intrauterine device (LNG-IUD) insertion program. STUDY DESIGN: Retrospective case series, January 2016 to December 2018. We measured LNG-IUD expulsion rates by 12 weeks postpartum. RESULTS: Of 235 LNG-IUD insertions, in years 1, 2, and 3, expulsion rates were 11/39 (28%), 9/94 (10%), and 15/102 (15%) (p = 0.03). After vaginal delivery, manual insertion was associated with a higher expulsion rate than ring-forceps (10/28 [36%] vs 17/105 [16%], p = 0.04). CONCLUSIONS: LNG-IUD expulsion rates decreased after program year 1, suggesting program maturity may be associated with a lower expulsion risk.

Intrauterine Device Placement Success for Adolescents and Young Adults at Community-Based Reproductive Health Clinics.

BACKGROUND: Despite the endorsement of intrauterine device (IUD) use in adolescents and young adults (AYAs) by leading professional organizations and demonstrated acceptance and desirability by AYAs, clinicians may worry about the procedural difficulty of IUD device placement in younger patients. OBJECTIVE: The aim of this study was to evaluate the clinical outcomes of first-attempt IUD placement in an AYA population by vaginal delivery (VD) history. STUDY DESIGN: We performed a retrospective cohort study of patients under 25 years old at reproductive health clinics with an IUD placement attempt between January 1 and August 31, 2017. We abstracted sociodemographic characteristics, pregnancy history, and procedural characteristics including complications. Bivariate analyses compared successful first-attempt IUD placement by VD history. We also assessed the frequency of secondary clinical outcomes including ancillary measures used, provider type, symptoms reported during the procedure, and complications. RESULTS: We included 1325 participants (median age = 21.3 years), including 42 (3.2%) with a previous VD. Nearly all IUD placements were successful on the first attempt (n = 1301, 98.2%) and performed by advanced practice clinicians (n = 1314, 99.2%). First-attempt IUD placement success was similar in those participants with and without VD (P > .999). Ancillary measures other than nonsteroidal anti-inflammatory drugs were used infrequently (n = 16, 3.6%). Among participants with an unsuccessful placement, 66.7% returned, and all had a successful IUD placement on the second attempt. Documented complications within 6 months of placement were rare (n = 29) and mostly comprised expulsions (n = 27, 93.1%). CONCLUSION: IUD placement success among AYAs at community-based reproductive health clinics is high and is not associated with a history of VD.

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices.

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.

Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial.

BACKGROUND: Inserting IUDs during cesarean section reduces the need for more manipulation and discomfort. The current conventional manual technique for IUD insertion during cesarean section is not standardized with many modifications and high rates of expulsion, displacement, missed threads, and discontinuation. This study aims to find a standard technique for IUD insertion during cesarean section with the least possible problems, especially displacement and missed threads. METHODS: A randomized controlled study was conducted at Kasr Al-Ainy Maternity Hospital, Cairo University, Egypt. The study was performed over 12 months, from September 2020 to September 2021. Two groups of patients were selected; each group included 420 patients with a desire for IUD insertion during cesarean section. Group (A) (Control group) was subjected to a post-placental intrauterine device (Copper T380) during cesarean section using a conventional manual method; Group (B) (Study group): the IUD (Copper T380) was placed at the top of the uterine fundus using a new technique (intra-cesarean post placental introducer withdrawal IUD insertion technique). RESULTS: There was a significant statistical difference between the two groups regarding displacement of the IUDs at the end of puerperium, at 6 months, non-visibility of IUD threads, and continuation of use with p-value < 0.05. There was no significant statistical difference in the term of duration of surgery. CONCLUSION: The new technique of post-placental IUD insertion can be the standard technique of intra-cesarean section IUD insertion as it is associated with more favorable outcomes among the included women in the form of lower incidence of IUD displacement, non-visibility of IUD threads, and higher rates of continuation without increasing the duration of surgery as compared with the conventional manual technique. TRIAL REGISTRATION: ClinicalTrial.gov ID: NCT05788354, registration date: 28/03/2023 (retrospectively registered).

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.

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.

Does change in the shape of intrauterine contraceptive device Cu 375 and Cu T 380A affect the expulsion after post-partum insertion - a prospective randomized control trial.

PURPOSE: The objective of the study was to see the difference in expulsion rates of two types of Copper containing intrauterine contraceptive devices (IUCDs): Cu 375 & CuT 380 A, within or at 6 weeks after insertion. METHODS: It was a randomised control trial. A total of 396 pregnant women were recruited. Ultrasonography was done to look for the position of the IUCD at the time of discharge and at six weeks follow-up and the expulsion rate was calculated. RESULTS: Amongst 396 participants, 22 PPIUCDs were expelled completely at 6 weeks (modified intention to treat analysis [ITA]), 10 (5.3%) and 12 (6.7%) in the Cu 375 and CuT 380 A groups respectively. The expulsion rate was 6.02%. However, this difference was not statistically significant. When ultrasonologically assessed partial expulsions were also considered, the total expulsion rate in both groups (14.3% and 14.1% respectively) was also not significantly different. The expulsion rate was higher in the vaginal delivery group (10.7%) than in the caesarean section (3.6%) group (p = 0.007) and early postpartum insertion 12.3% than in the immediate post-placental insertion group, 3.7% (p = 0.002). CONCLUSIONS: The study concluded that the altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.SHORT CONDENSATIONThe altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.

Effectiveness, safety, and acceptability of postplacental insertion of GyneFix postpartum intrauterine device among women undergoing cesarean section: A multicenter prospective cohort study in China.

OBJECTIVES: To assess the effectiveness, safety, and acceptability of postplacental insertion of GyneFix postpartum intrauterine device (PPIUD) in women undergoing cesarean section (C-section). STUDY DESIGN: We conducted a prospective cohort study at 14 hospitals in four eastern coastal provinces of China between September 2017 and November 2020. A total of 470 women who underwent C-section and consented to the postplacental insertion of GyneFix PPIUD were enrolled, and 400 completed the 12-month follow-up. Participants were interviewed in the wards after delivery and followed up at 42 days, and months 3, 6, and 12 after delivery. We used Pearl Index (PI) to measure the rate of contraceptive failure, life-table method to measure the rate of PPIUD discontinuation, including IUD expulsion, and Cox regression model to explore the risk factors associated with discontinuation of the device. RESULTS: Nine pregnancies were detected during the first year after GyneFix PPIUD insertion: seven were due to device expulsion and two occurred with PPIUD in situ. The PIs for overall 1-year pregnancy rate and pregnancies with IUD in situ were 2.3 (95% CI: 1.1-4.4) and 0.5 (95% CI: 0.1-1.9), respectively. The 6- and 12-month cumulative expulsion rates for PPIUD expulsion were 6.3% and 7.6%, respectively. The overall 1-year continuation rate was 86.6% (95% CI: 83.3-89.8). We did not identify any patient with insertion failure, uterine perforation, pelvic infection, or excess bleeding due to GyneFix PPIUD insertion. Women's age, education, occupation, previous history of C-section, parity, and breastfeeding were not associated with removal of GyneFix PPIUD in the first year of use. CONCLUSIONS: Postplacental insertion of GyneFix PPIUD is effective, safe, and acceptable for women undergoing C-section. Expulsion is the most common reason for GyneFix PPIUD discontinuation and pregnancy. The expulsion rate for GyneFix PPIUD is lower than that for framed IUDs, but more evidence is needed for a firm verdict.

Placement of an intrauterine device within 48 hours after early medical abortion-a randomized controlled trial.

BACKGROUND: Intrauterine devices are safe, well-tolerated, and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception. OBJECTIVE: This study aimed to investigate if placement of an intrauterine device within 48 hours of completed medical abortion at up to 63 days' gestation leads to higher user rates at 6 months after the abortion compared with placement at 2 to 4 weeks after abortion. Furthermore, we aimed to compare continued use of intrauterine devices, safety, and patient satisfaction between groups. STUDY DESIGN: We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion at up to 63 days' gestation and opting for an intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2 to 4 weeks after abortion (control group). We defined the abortion as complete after bleeding with clots and cessation of heavy bleeding following the use of misoprostol. Patients answered questionnaires at 3, 6, and 12 months. The primary outcome was use of intrauterine device at 6 months postabortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in nonparametric continuous variables were analyzed with the Mann-Whitney U test and differences in dichotomous variables with the chi square or Fisher exact tests. A P value of <.05 was considered statistically significant. RESULTS: In the intervention group, 91 of 111 (82%) participants used an intrauterine device at 6 months after the abortion vs 87 of 112 (77.7%) in the control group, with a difference in proportion of 4.3% (95% confidence interval, -0.062 to 0.148; P=.51). Attendance rate and rate of successful intrauterine device placement were similar between the groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score [visual analogue scale], 32.3; standard deviation, 29) compared with the control group (mean pain score [visual analogue scale], 43.4; standard deviation, 27.9; P=.002). Patients preferred their allocated time of placement significantly more often in the intervention group (83/111, 74.8%) than in the control group (70/114, 61.4%; P=.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) than in the control group (15/101, 14.9%; P<.001), and in one patient in the control group a retained gestational sac was found. Three patients in the intervention group and 2 in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. Expulsion during the first 6 months after abortion was experienced by 9 of 97 (9.3%) patients in the intervention group and 4 of 89 (4.5%; P=.25) in the control group. There were no perforations or infections requiring antibiotic treatment. CONCLUSION: Placement of an intrauterine device within 48 hours after medical abortion at ≤63 days' gestation does not lead to higher user rates at 6 months after the abortion compared with intrauterine device placement at 2 to 4 weeks after abortion. When compared with placement at a follow-up visit after 2 to 4 weeks, intrauterine device placement within 48 hours after early medical abortion seems safe, is preferred by patients, and is associated with lower pain scores.

Infectious outcomes following immediate postplacental intrauterine device placement in the setting of chorioamnionitis: An exploratory, retrospective study.

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.

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

BACKGROUND: Ensuring 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. METHODS: Randomized, 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. DISCUSSION: Insertion 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 REGISTRATION: This 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.

Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion.

OBJECTIVE: To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors. METHODS: The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders. RESULTS: In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding. CONCLUSION: Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly. FUNDING SOURCE: Bayer AG. CLINICAL TRIAL REGISTRATION: EU PAS register, EUPAS33461.

Ultrasound-Guided Compared With Non-Ultrasound-Guided Placement of Immediate Postpartum Intrauterine Contraceptive Devices.

Immediate postpartum placement of intrauterine devices (IUDs) can help reduce unintended short-interval pregnancy; however, the rate of spontaneous device expulsion is increased. The objective of this study is to evaluate the risk of expulsion with ultrasound-guided placement of immediate postpartum IUDs. Retrospective review of all patients receiving immediate postpartum IUDs after vaginal delivery at Prisma Health Richland Hospital from 2018 to 2020 was performed. Outcomes were available for 78 patients in the ultrasound-guided cohort and for 226 in the control cohort. The expulsion rate was 15.4% (95% CI 8.2-25.3%) for the ultrasound-guided cohort and 14.2% (95% CI 9.9-19.4%) for the control cohort. Our data suggest that using ultrasonography to guide placement of IUDs immediately after vaginal delivery is not associated with the risk of expulsion.

Intrauterine Device Outcomes in Young Women with Heavy Menstrual Bleeding: Comparing Patients with and without Inherited Bleeding Disorders.

STUDY OBJECTIVE: To evaluate the use of intrauterine devices (IUDs) in two young women's hematology clinics and compare adverse events in adolescents with and without inherited bleeding disorders (BDs) DESIGN: Retrospective multicenter cohort study from February 2014 through February 2020 SETTING: Young women's hematology clinics at Nationwide Children's Hospital in Columbus, Ohio, and Children's Medical Center in Dallas, Texas PARTICIPANTS: Female patients evaluated for heavy menstrual bleeding (HMB) who underwent IUD placement INTERVENTIONS AND MAIN OUTCOME MEASURES: Rates of IUD expulsion, malposition, and ongoing HMB requiring additional medical treatment RESULTS: We identified 43 patients with BDs and 35 patients without BDs who underwent placement of an IUD for HMB. The mean age was 14.9 years (range 11.0-21.4 years) at the time of presentation and 15.8 years (range 11.0-21.4 years) at IUD placement. Those with BDs were younger at the time of IUD insertion. Most patients (90%) had previously failed other methods to control HMB. The annual rate of IUD adverse events was 0.25 per year of use, and all adverse events occurred in the first 20 months after placement. There were no significant differences in adverse IUD events in patients with and without BDs, although those without BDs requested IUD removal more frequently. CONCLUSIONS: In this cohort of adolescent females, the presence of a BD was not associated with a higher IUD expulsion rate. IUD placement should be considered a first-line option for adolescents with BDs who experience HMB.