Copper T380A Intrauterine Device Research Articles

One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial

Recent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied. This study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device. This participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups. The levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users. The pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

P060Utilization of larc methods at the time of emergency contraception visit: A prospective observational study

<h3>Objectives</h3> To compare long-acting reversible contraceptive (LARC) method initiation by device at time of emergency contraception (EC) request. <h3>Methods</h3> All clients who presented to four Planned Parenthood Association of Utah clinics for EC from February 2021 to April 2022 received printed information about three LARC options for EC in addition to oral options. LARC options included the copper T380A intrauterine device (IUD), 52 mg levonorgestrel (LNG) IUD, and the guideline-supported option for oral LNG with same-day etonogestrel (ENG) implant. Participants were aged 18–35, who reported unprotected intercourse within five days with negative pregnancy testing. We assessed demographic variables associated with method selection and reasons for method choice. LARC methods were available at no cost. <h3>Results</h3> A total of 194 EC clients (18% of 1,086 approached) requested LARC and 187 qualified: 24% (n=44) selected a copper IUD, 23% (n=43) a 52 mg LNG IUD, and 54% (n=100) an ENG implant and oral LNG. ENG implant users were younger (22.9) than those selecting the LNG IUD (25.4) or copper IUD (25.9, p<0.01). Copper IUD users had a lower mean BMI (24.0) than those selecting an LNG IUD (27.0) or ENG implant and oral LNG (27.1, p=0.01). Commonly cited reasons for choosing ENG implant and oral LNG included having friends using the same method (30.0%), wanting fewer side effects (20.0%), and wanting lighter or no bleeding (18.0%). <h3>Conclusions</h3> In this observational study of EC clients desiring LARC, participants more frequently selected the ENG implant with oral LNG over either IUD, despite a lack of EC efficacy data for the ENG implant with oral LNG.

A randomized double blinded clinical trial to explore the clinical outcomes of vaginal isonicotinic acid hydrazide (INH) administration six hours prior to T380A intrauterine device insertion in persons delivered only by cesarean delivery

ObjectiveTo compare insertion pain and ease of insertion in participants with a prior caesarean delivery having copper intrauterine device (IUD) after pretreatment with isonicotinic acid hydrazide (INH) 900 mg vaginally or placebo. Study designFrom September 2020 to September 2021, we conducted a randomized, double-blind, placebo-controlled experiment at Aswan University Hospital in Egypt with participants who were delivered solely by caesarean delivery and desired copper T380A IUD insertion. The participants were randomly assigned to either vaginal INH or placebo six hours before IUD insertion in a 1:1 ratio. The primary objective of the research was the individuals' self-reported pain during cervical tenaculum placement, sound insertion, IUD insertion, and 5 minutes after the placement, as measured by a 10-cm visual analogue scale (VAS). Our secondary outcomes were ease of insertion, satisfaction, the need for analgesics, and adverse effects. IUD insertion ease was graded from 0 to 10 on a 10-cm VAS scale, with 0 suggesting very easy insertion and 10 denoting extremely difficult insertion. ResultsWhen compared to the placebo group, the INH group experienced considerably less pain during IUD insertion (2.9±0.85vs.5.11±0.82;p<0.01), lower median ease of insertion score (3(1−4)vs.5(3−6);p<0.01), and better satisfaction (8.17±0.69vs.5.57±0.75). The two groups had comparable side effects. ConclusionsVaginal INH administered before IUD insertion reduce the amount of discomfort participants feel throughout the process in individuals who had previously only been delivered via CD. It also has the potential to make insertion easier. ImplicationsIn participants who were delivered solely by CD before, vaginal INH given prior to IUD placement reduces the amount of discomfort participants experience throughout the procedure. Furthermore, it could increase the ease of insertion.

Factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices.

To identify clinical and demographic factors associated with missing strings and expulsion after postplacental insertion of copper T380A intrauterine devices (TCu380A IUD). This is a secondary analysis of an implementation study. We followed participants who had a postplacental TCu380A IUD insertion, at two postpartum visits: 45-90days (visit 1) and 6-9months (visit 2). We used multiple log-binomial regression models to evaluate the demographic and clinical variables associated with missing strings and with IUD expulsion. 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). 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.

Pregnancy Risk by Frequency and Timing of Unprotected Intercourse Before Intrauterine Device Placement for Emergency Contraception.

To assess pregnancy risk after intrauterine device (IUD) placement by the number and timing of unprotected intercourse episodes in the prior 14 days. This was a secondary analysis of a randomized trial that compared the copper T380A IUD and levonorgestrel 52-mg intrauterine system for emergency contraception. At enrollment, participants had a negative urine pregnancy test result and reported the frequency and timing of any unprotected intercourse in the preceding 14 days. We assessed pregnancies 1 month after IUD placement and compared pregnancy risk by single or multiple unprotected intercourse episodes and by timing (5 or fewer days before IUD placement or 6 or more days before). Among the 655 participants, one pregnancy occurred in a patient who reported intercourse once 48 hours before IUD placement. Multiple unprotected intercourse episodes were reported by 286 participants (43.7%), and 95 participants (14.4%) reported at least one unprotected intercourse episode 6 or more days before IUD placement. No pregnancies occurred among those with multiple unprotected intercourse episodes (0%, 97.5% CI 0-1.3%) or with any unprotected intercourse episode 6-14 days before IUD placement (0.0%, 97.5% CI 0.0-3.8%). Pregnancy risk difference did not significantly differ by single compared with multiple unprotected intercourse episodes (0.3%, 95% CI -0.3% to 0.8%), nor by unprotected intercourse 5 or fewer days before IUD placement or 6 or more days before (0.2%, 95% CI -0.2% to 0.5%). With a negative urine pregnancy test result at IUD placement, 1-month pregnancy risk remains low, regardless of frequency or timing of unprotected intercourse in the prior 14 days. ClinicalTrials.gov, NCT02175030.

Ex-vivo forces associated with intrauterine device placement and perforation: a biomechanical evaluation of hysterectomy specimens

BackgroundThis biomechanical analysis of hysterectomy specimens assesses the forces associated with intrauterine device placement. These include compressive forces required to cause uterine perforation with two commonly available commercial intrauterine device placement instruments and a metal uterine sound.MethodsWe obtained hysterectomy specimens at a single academic center. All specimens resulted from excision for benign conditions in premenopausal women by any operative method. Within one hour of excision, we stabilized uterine specimens in an apparatus specifically designed for this analysis. A single, experienced clinician performed all experimental maneuvers and measured forces with a Wagner FDIX-25 force gauge. The investigator applied traction on a tenaculum to approximate force used during an intrauterine device placement. The maximum compressive force to the uterine fundus was determined by using manufacturers’ placement instruments for two commercially available products and a metal sound.ResultsSixteen individuals provided hysterectomy specimens. No complete perforations occurred while using loaded intrauterine devices; in a single observation the LNG IUS entered the myometrium. The plastic intrauterine device placement rod bowed in all attempts and did not perforate the uterine serosa at the fundus. A metal uterine sound created a complete perforation in all specimens (p < .001). The lowest mean maximum force generated occurred with the levonorgestrel intrauterine system placement instrument 12.3 N (SD ± 3.8 N), followed by the copper T380A intrauterine device placement instrument 14.1 N (SD ± 4.0 N), and highest for the metal sound 17.9 N (SD ± 7.6 N) (p < 0.01).ConclusionsIn this ex-vivo model, metal uterine sounds caused complete perforation and intrauterine device placement instruments did not.This study received Institutional Review Board (IRB0059096) approval.

Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception

BackgroundIn the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose.MethodsThis randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points.ResultsAmong the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, −0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group.ConclusionsThe levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.)

A comparative study between the efficacy of tranexamic acid and ibuprofen for treatment of menorrhagia induced by copper T-380A intrauterine device

Background Menorrhagia is menstrual blood loss, which interferes with a woman’s physical, emotional, social, and material quality of life, and which can occur alone or in combination with other symptoms. Ibuprofen is one of the most common NSAIDs used for treatment of heavy menstrual bleeding. Tranexamic acid is the best option for those who experience irregular uterine bleeding and plan to become pregnant in the near future.Objective To evaluate and compare the efficacy of tranexamic acid and ibuprofen in controlling menorrhagia induced by copper T-380A intrauterine device (IUD).Patients and methods This prospective randomized comparative parallel study between tranexamic acid and ibuprofen for treating copper-IUD-induced menorrhagia included 100 women who attend outpatient clinic at Al-Hussein University Hospital from October 2019 to March 2020.Results Mean menstrual days in both group 1 and group 2 decreased significantly from the first month after IUD insertion to 6 months after treatment.Conclusion Tranexamic acid as an antifibrinolytic agent and Ibuprofen as an NSAID, at a dosage of 500 mg capsules of tranexamic acid three times a day and 400-mg tablet of ibuprofen three times a day orally, have the same significant effects on copper T-380A IUD-induced menorrhagia. Their effects are on both the volume of blood loss and the duration of menses.

Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India

ObjectivesEvaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20–35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD) during the first postpartum year. Study designWe conducted a one-year multicenter, non-randomized, non-inferiority, open-label, comparative trial at 20 centers in India and compared efficacy, safety, continuation and LA plus feeding patterns and growth/well-being of participants’ infants. Women used four 3-month PVRs consecutively (lost PVRs were not replaced) and were to breastfeed at least four times/day. We used Pearl Index (PI) and Kaplan Meier (K-M) rates to analyze pregnancy and K-M for continuation. ResultsWe enrolled 789 women (459 PVR, 330 IUD). Neither PI nor K-M one-year pregnancy rates differed significantly between groups (PI: PVR-0.62; IUD-0.35); (K-M: PVR-0.7; IUD-0.4, p = 0.58). Continuation rates at 12 months were 78.5% (IUD) vs. 56.9% (PVR) (p < 0.001). Ring expulsions and menorrhagia were the most common discontinuation among PVR/IUD users respectively. The median duration of LA among PVR vs. IUD users was 405 vs. 120 days (p < 0.001). Both groups reported similar adverse events (PVR: 24.2%; IUD: 23.0%); there were no serious adverse events among PVR users. Infants from both groups fed 12–7 times/day and grew at expected rates. ConclusionsEfficacy and safety outcomes were comparable among women in both groups. Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users. Infant breastfeeding and growth patterns/well-being were favorable in both groups. ImplicationsPVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.

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.

Prophylactic vaginal dinoprostone administration six hours prior to copper-T380A intrauterine device insertion in nulliparous women: A randomized controlled trial

ObjectiveTo determine the effectiveness of 3 mg vaginal dinoprostone administered six hours prior to copper intrauterine device (IUD) insertion compared to placebo in increasing ease of insertion and reducing insertion pain among nulliparous women. Study design. This was a single-center double-blinded randomized controlled trial (RCT). We randomly divided the two hundred nulliparous women requesting a copper T380A IUD to receive 3 mg vaginal dinoprostone or placebo six hours before IUD insertion. The primary outcome was provider ease of insertion. Patients reported their perceived insertion pain using a 10 cm visual analog scale (VAS). We also reported number of failed IUD insertions. ResultsBaseline characteristics were similar between groups. Ease of insertion score was lower in dinoprostone group than placebo group (3.6 ± 2.5 vs. 5.4 ± 2.8; p < 0.01) denoting easier insertion for clinicians in dinoprostone group. Mean pain score during copper IUD insertion was lower in dinoprostone group (3.7 ± 2.3 vs. 5.0 ± 2.8; p < 0.01). Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68). ConclusionsAlthough vaginal dinoprostone administration six hours prior to copper IUD insertion in nulliparous women leads to an easy IUD insertion, we do not routinely advise it as the reduction in IUD insertion pain scores with vaginal dinoprostone lacked clinical significance. ImplicationsIn settings where it is feasible to provide dinoprostone vaginally six hours before copper IUD insertion, clinicians will find insertion easier, and nulliparous women may experience somewhat less pain during the procedure. Where waiting six hours is practical, this may prove to be useful.

Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial

BackgroundThis study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo.MethodsThis was a randomized, double-blind, placebo-controlled trial. Patients desiring levonorgestrel 52 mg IUD or Copper T380A IUD were randomized into treatment groups. Patients received either oral naproxen 375 mg or placebo approximately 1 h prior to procedure in conjunction with 5 mL of 2% lidocaine or 5 mL of intrauterine saline. The primary outcome was pain with IUD insertion measured on a visual analog scale immediately following the procedure. Prespecified secondary outcomes included physician pain assessment, post procedure analgesia, satisfaction with procedure, satisfaction with IUD, and pain assessment related to IUD type.ResultsFrom June 4, 2014 to October 28, 2016 a total of 160 women desiring Copper T380A or levonorgestrel 52 mg intrauterine device insertion and meeting study criteria were enrolled and randomized in the study. Of these, 157 (78 in the Copper T380A arm, 79 in the levonorgestrel 52 mg) received study treatment medication. There were 39 in naproxen/lidocaine arm, 39 in placebo/lidocaine arm, 40 in naproxen/placebo arm, and 39 in placebo/placebo arm. There were no differences in the mean pain scores for IUD placement between treatment groups (naproxen/lidocaine 3.38 ± 2.49; lidocaine only 2.87 ± 2.13; naproxen only 3.09 ± 2.18; placebo 3.62 ± 2.45). There was no difference in self-medication post procedure or in satisfaction with the procedure and IUD among women in the treatment arms or by type of IUD.ConclusionNaproxen with or without intrauterine lidocaine does not reduce pain with IUD placement.Clinical trial registrationClinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered

Classic versus uterine sound-sparing approach for insertion of copper T380A intrauterine device: A randomized clinical trial

Abstract Objective The current study compares the efficacy of the classic approach and the uterine sounding sparing approach (a new approach) for copper intrauterine device (Cu-IUD) insertion. Study design A randomized clinical trial. Setting Woman's Health Hospital, Assiut, Egypt. Materials and methods The current study was an open parallel randomized clinical study conducted in Assiut Woman’s Health Hospital, Egypt included women requesting Copper IUD insertion. Enrolled women were randomized into 2 groups; group I included women subjected to classic approach for Cu-IUD insertion and group II included women had Cu-IUD insertion using the uterine sound-sparing approach (USSA). This approach utilized transvaginal ultrasound (TV/US) for assessment of the uterine cavity length and position before IUD insertion without using uterine sounding. The primary outcome was the successful Cu-IUD insertion. Results 46 women were analyzed in group I and 46 in group II. The pain during IUD insertion and 5 min post-insertion was significantly lower in group II than group I (p Conclusions Cu-IUD can be inserted successfully without using uterine sound provided using TV/US prior to insertion. This method associated with less pain, greater women satisfaction during insertion with shorter duration.

Rectal Indomethacin is an Effective Analgesic During Copper T380A Intrauterine Device Insertion: A Randomized Double-Blind Placebo-Controlled Trial

Rectal Indomethacin is an Effective Analgesic During Copper T380A Intrauterine Device Insertion: A Randomized Double-Blind Placebo-Controlled Trial

Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: a retrospective review

BACKGROUNDAs the popularity of long-acting reversible contraception increases, so does the need for accurate data on method continuation in diverse clinical settings. We determined 2-year continuation rates for the levonorgestrel 52-mg intrauterine device, the copper T380A intra-uterine device, and the 68-mg etonogestrel contraceptive implant in an academic healthcare system with mixed-payer reimbursement.OBJECTIVEThe purpose of this study was to examine the proportion and characteristics of women who continue intrauterine device and implant use to 2 years and to relate continuation to device type when controlling for patient characteristics.STUDY DESIGNThis retrospective chart review assessed University of Utah Healthcare System patients who had an intrauterine device or contraceptive implant inserted between January 1, 2004, and December 31, 2012. We identified users and dates of insertions and removals by querying billing, medication, and procedural data in the Electronic Data Warehouse. Multivariable Poisson regression was conducted to estimate incidence risk ratios and to relate the probability of 2-year continuous use to device type.RESULTSData on 8603 device insertions were obtained with the following distribution: levonorgestrel 52-mg intrauterine devices (6459; 75.1%), copper T380A intrauterine devices (1136; 13.2%), and 68-mg etonogestrel implant (1008; 11.7%). Two-year continuation rates were 77.8%, 73.1%, and 75.9%, respectively. There was no statistical difference in 2-year continuation between levonorgestrel 52-mg intrauterine device users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0–1.1) and 68-mg etonogestrel implant users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0–1.1) compared with copper device users, after we controlled for age, Hispanic ethnicity, payer type, and year of insertion. Older-age, self-pay, or public payer insurance (reference commercial payer) and Hispanic ethnicity were associated with 2-year continuation.CONCLUSIONThree-quarters of women with an intrauterine device or implant continue using it for 2 years. In this cohort, the 2-year continuation rates were 77.8%, 73.1%, and 75.9% for the levonorgestrel 52-mg intrauterine device, copper T380A intrauterine device, and 68-mg etonogestrel implant, respectively.

Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial

ObjectiveThe current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD). Study designThe current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion. ResultsThe ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both. ConclusionsMisoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD. ImplicationsThe use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure.

Effect of cervical lidocaine–prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial

ObjectiveThe objective was to investigate the analgesic effect of cervical lidocaine–prilocaine (LP) cream in alleviating pain during copper T380A intrauterine device (IUD) insertion among parous women. Study designWe conducted a randomized, double-blind, placebo-controlled trial at Assiut Women's Health Hospital, Egypt, from October 2015 to April 2016 of parous women desiring copper IUD insertion. We randomized the subjects in a 1:1 ratio to LP cream or placebo. Seven minutes prior to IUD insertion, women received 2 ml of LP cream or placebo to the anterior cervical lip, followed by 2 ml placed in the cervical canal using a Q-tip applicator. The study end point was the subjects' self-reported pain using a 10-cm visual analog scale (VAS) during cervical tenaculum placement, sound insertion, IUD insertion and 5 min postprocedure. We considered a 2-cm difference in VAS scores between study groups as clinically significant. Also, the difference in the ease of insertion score using a 10-cm VAS with 0=very easy insertion and 10=terribly difficult insertion was assessed. ResultsThe study included 120 women (n=60 in each group). LP cream reduces the median VAS pain scores during tenaculum placement (2 vs. 4), sound insertion (3 vs. 6) and IUD insertion (3 vs. 6.5) with p=.0001 at all steps. A lower ease of insertion score was also determined among LP women (2.5±0.98 vs. 4.5±2.7, p=.001). Participants reported no side effects. ConclusionsUse of cervical LP cream prior to copper T380A IUD insertion may alleviate the IUD insertion pain among parous women. ImplicationsCervical LP cream could be effective as an analgesic prior to copper T380A IUD insertion with no side effects. Further studies are needed to assess the women's satisfaction from lying with a speculum in place for 7 min while waiting for the cream to be effective.

Non-visualisation of strings after postplacental insertion of Copper-T 380A intrauterine device

AimTo assess the incidence of visible strings of intrauterine contraceptive devices (IUDs) after postplacental insertion following vaginal or caesarean delivery and to establish a management protocol of follow-up visits when...

Diclofenac plus lidocaine gel for pain relief during intrauterine device insertion. A randomized, double-blinded, placebo-controlled study

ObjectiveTo determine the effectiveness of diclofenac potassium combined with 2% lidocaine gel in reducing the pain of intrauterine device (IUD) insertion. Study designWe randomized 90 parous women requesting copper T380A IUD insertion in a 1:1 ratio to active or placebo treatment. Active treatment included administration of two 50-mg diclofenac potassium tablets 1h before IUD insertion, application of 3mL of 2% lidocaine gel on the anterior cervical lip 3min before IUD insertion and placement of a cotton swab soaked in 2% lidocaine gel in the cervical canal 3min before IUD insertion. Women in the placebo group received placebo tablets and gel. Participants assessed pain intensity using a 10-cm visual analog scale (VAS). We considered a 2-cm difference in VAS pain score between both groups during IUD insertion to be a clinically significant difference. ResultsSubjects receiving active treatment, as compared to placebo, experienced less pain during tenaculum placement (1.66±0.85 vs. 2.33±1.19, p=.003) and IUD insertion (3.14±0.92 vs. 3.94±1.3, p=.001). Women who delivered only by cesarean section had higher pain scores with IUD insertion compared with women with previous vaginal deliveries (4.41±1.24 vs. 3.29±1.05, p=.001). ConclusionDiclofenac potassium combined with 2% lidocaine gel slightly reduced pain scores during tenaculum application and copper IUD insertion in parous women; however, the reduction in pain scores lacked clinical significance. ImplicationsAlthough we found a statistically significant lowering of pain scores with pretreatment with diclofenac potassium and lidocaine gel in parous women having copper IUD placement, the reduction is not clinically relevant. These findings may be more relevant for nulliparous women who experience more pain than parous women with IUD insertion and support studies of diclofenac potassium and lidocaine gel in this population.

Contraceptive failure with Copper T380A intrauterine device (IUD): A single tertiary center experience.

Objective:The objective of this study was to assess the risk factors of pregnancy with Copper (Cu)T380A IUD and pregnancy outcomes.Methods:A retrospective study evaluating the risk factors and pregnancy outcomes of 81 patients who conceived with CuT380A IUD in situ.Results:Four ectopic pregnancies and 77 intrauterine pregnancies were detected. Twenty-six pregnancies (33.76%, 26/77) were terminated according to maternal desire. Twenty-five patients (32.46%, 25/77) whose IUDs were removed constituted the Removed IUD Group, and the remaining 26 patients constituted IUD Left in situ Group. Term pregnancy rates (76% vs. 20.8%, p=0.002) were significantly higher in the Removed IUD Group compared with the IUD Left in situ Group. Abortion rates (16% vs. 53.84%, p=0.008) were detected significantly higher in the IUD Left in situ Group.Conclusion:The main result of our study was that pregnancy with CuT380A in situ is a significant risk factor for adverse perinatal outcome. Adjusting the scheduled follow-ups for checking the IUD seems to be important in order to prevent accidental pregnancy.