Cold Compress for Intrauterine Device Insertional Pain: A Randomized Control Trial.
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SUBMITTER: Hylton J
PROVIDER: S-EPMC7784818 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background:This study evaluates oral naproxen and intrauterine instillation of lidocaine for analgesia with intrauterine device (IUD) placement as compared to placebo. Methods:This 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. Results:From 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. Conclusion:Naproxen with or without intrauterine lidocaine does not reduce pain with IUD placement. Clinical trial registration:Clinicaltrials.gov, NCT02769247. Registered May 11, 2016, Retrospectively registered.
| S-EPMC6734494 | biostudies-literature
Project description:OBJECTIVE:To investigate whether a 20-mL buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement. METHODS:In a randomized, single-blind, placebo-controlled trial, women were assigned to receive either a 20-mL buffered 1% lidocaine paracervical block or no block before IUD placement. The primary outcome was pain with IUD placement measured on a 100-mm visual analog scale. Our sample size had 80% power (?=0.05) to detect a 20-mm difference in visual analog scale scores with a SD of 28 mm. Secondary outcomes included pain with speculum placement, paracervical block administration, tenaculum placement, 5 minutes postprocedure, and overall pain perception. RESULTS:From October 7, 2014, through October 26, 2017, 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). There were no differences in baseline demographics between the groups. Women who received the paracervical block reported less pain with IUD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=.002). Pain was significantly less in the intervention group for uterine sounding (30 mm vs 47 mm, P=.005), 5 minutes after placement (12 mm vs 27 mm, P=.005), and overall pain perception (30 mm vs 51 mm, P=.015). Participants who received the paracervical block experienced more pain with block administration compared with placebo (30 mm vs 8 mm, P=.003). There was no perceived pain difference for speculum insertion (10 mm vs 6 mm, P=.447) or tenaculum placement (15 mm vs 10 mm, P=.268). CONCLUSION:A 20-mL buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 minutes after placement (secondary outcome). Although paracervical block administration can be painful, perception of pain for overall IUD placement procedure is lower compared with no block. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02219308.
| S-EPMC6438819 | biostudies-literature
Project description:BackgroundTo study the effectiveness of an aromatase inhibitor (Anastrozole) associated with levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.MethodsProspective, randomized clinical trial.SettingUniversity Hospital (single center). Elegibility criteria: Endometriomas > 3 × 4 cm, CA-125 > 35 U/mL and endometriosis symptoms.PatientsThirty-one women randomized to anastrozole + Mirena® + Conservative Surgery(CS) (n = 8), anastrozole + Mirena® + transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n = 7), Mirena® + CS (n = 9), or Mirena® + TUGPA (n = 7).InterventionsAnastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment.Main outcome measuresVisual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.ResultsA significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients including anastrozole in their treatment (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed in patients not taking anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena® + anastrozole). After CS for endometriosis, a reduction of ultrasound findings of endometriomas and long-term recurrence occurred, with or without anastrozole. At 4.2 ± 1.7 years (95% CI 3.57-4.85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p = 0.019).ConclusionsDosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces significantly the painful symptoms and delays recurrence, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Trial registrationEudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.
| S-EPMC8138989 | biostudies-literature
Project description:BackgroundImmediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes.ObjectiveThis study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes.Study designWe conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18-40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4-12 weeks' postpartum. Prespecified exclusion criteria included delivery <37.0 weeks' gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast-feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention.ResultsWe met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70-86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76-91%). The 5% difference in breast-feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, -5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, -4.8 to 8.2 hours), noninferior by log-rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group.ConclusionOur results of noninferior breast-feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast-feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast-feeding women planning to use the levonorgestrel intrauterine device.
| S-EPMC6040814 | biostudies-literature
Project description:To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device (IUD) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6-8 weeks postpartum.We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD. Patients were randomly assigned when admitted in labor to postplacental or delayed IUD insertion. The women followed up in person at 6-8 weeks and 6 months and were contacted by telephone at 3 months. Women were ineligible for a study IUD postenrollment for intrapartum events including infection, hemorrhage, and cesarean delivery; these women were contacted by phone at 3 and 6 months. Expelled IUDs were replaced per patient preference.Successful IUD placement occurred in 50 of 51 participants (98.0%) and 46 of 51 participants (90.2%) in the postplacental and delayed groups, respectively (P=.2). Expulsion within 6 months occurred in 12 of 50 (24.0%; 95% confidence interval [CI], 13.1-38.2) and two of 46 (4.4%; 95% CI 0.5-14.8) participants, respectively (P=.008). Intrauterine device use at 6 months was 43 of 51 (84.3%; 95% CI 71.4-93.0) and 39 of 51 (76.5%; 95% CI 62.5-87.2), respectively (P=.32). For ineligible patients, only 11 of 41 (26.8%) women were using IUDs at 6 months and two (4.9%) had become pregnant.Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs. Expulsions are significantly higher with postplacental compared with delayed IUD placement. Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00476021.I.
| S-EPMC3104850 | biostudies-literature
Project description:ObjectiveTo compare intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean delivery (during cesarean delivery) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum.MethodsIn this nonblinded randomized trial, women who were undergoing a cesarean delivery and desired an IUD were randomized to intracesarean delivery or interval IUD placement. The primary outcome was IUD use at 6 months postpartum. A sample size of 112 (56 in each group) was planned to detect a 15% difference in IUD use at 6 months postpartum between groups.ResultsFrom March 2012 to June 2014, 172 women were screened and 112 women were randomized into the trial. Baseline characteristics were similar between groups. Data regarding IUD use at 6 months postpartum were available for 98 women, 48 and 50 women in the intracesarean delivery and interval groups, respectively. A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum (40/48 [83%]) compared with those in the interval group (32/50 [64%], relative risk 1.3, 95% confidence interval 1.02-1.66). Among the 56 women randomized to interval IUD insertion, 22 (39%) of them never received an IUD; 14 (25%) never returned for IUD placement, five (9%) women declined an IUD, and three (5%) had a failed IUD placement.ConclusionIntrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement.Level of evidenceI.
| S-EPMC5354629 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.MethodsA multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device.ResultsOf 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%).ConclusionIntrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality.Funding sourceAlydia Health, Inc.Clinical trial registrationClinicalTrials.gov, NCT02883673.
| S-EPMC7575019 | biostudies-literature
Project description:ObjectiveBleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection.Study designThis trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians.ResultsTwo hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01).ConclusionsParticipants reporting bleeding via text messages provided more complete data than women using paper diaries.ImplicationsDepending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes.
| S-EPMC4967589 | biostudies-literature
Project description:BackgroundKrill oil is an edible oil extracted from krill, a small red-colored crustacean found in the Antarctic Ocean. The administration of krill oil is reported to mitigate inflammation in patients with cardiac disease, rheumatoid arthritis, or osteoarthritis. However, the effect of krill oil on mild knee pain has not yet been determined.ObjectiveTo assess the effect of krill oil on mild knee pain.DesignA randomized, double-blind, parallel-group, placebo-controlled trial of fifty adults (38-85 years old) with mild knee pain attending the Fukushima Orthopedic Clinic (Tochigi, Japan) between September 2014 and March 2015.InterventionsParticipants were randomized to receive 2 g per day of either krill oil or an identical placebo for 30 days.OutcomesThe primary outcome was improvement in subjective symptoms of knee pain as assessed by the Japanese Knee Osteoarthritis Measure (JKOM) and Japanese Orthopaedic Association score (JOA). Secondary outcomes included blood and urine biochemical parameters.ResultsBoth the placebo and krill oil groups showed significant improvements in the questions in the JKOM and JOA questionnaires after administration. After the intervention, krill oil group showed more improvements than placebo group in two questions regarding the pain and stiffness in knees in JKOM. Controlling for age, sex, weight, and smoking and drinking habits, krill oil significantly mitigated knee pain in sleeping (P < 0.001), standing (P < 0.001) and the range of motion of both right and left knees (both P = 0.011) compared to placebo. Krill oil administration raised plasma EPA (P = 0.048) and EPA/AA ratio (P = 0.003).ConclusionThis study indicates that krill oil administration (2 g/day, 30 days) improved the subjective symptoms of knee pain in adults with mild knee pain.Trial registrationUMIN-CTR; ID UMIN000014413.
| S-EPMC5049853 | biostudies-literature
Project description:To evaluate contraceptive adherence to the copper intrauterine device (Cu-IUD) and the injectable depot medroxyprogesterone acetate (DMPA) among women with HIV in Lilongwe, Malawi.We randomized 200 HIV-infected women on highly active antiretroviral therapy (HAART) to either the Cu-IUD or DMPA and followed these women prospectively, evaluating adherence and factors associated with nonadherence.There was no difference in contraceptive adherence: 68% of Cu-IUD and 65% of DMPA users were adherent at 48 weeks. Receiving first-choice contraceptive was not associated with adherence. Women commonly cited partner's disapproval as an indication for discontinuation. Women who experienced heavy menstruation and first-time contraceptive users were more likely to be nonadherent. Among ongoing users at study conclusion, 95% were happy with their method, and 98% would recommend their method to a friend.Contraceptive adherence between the Cu-IUD and DMPA was similar at 1 year. With similar adherence and similar high rates of satisfaction among users of both methods at 1 year, the Cu-IUD offers a hormone-free alternative to DMPA.Adherence to the Cu-IUD and DMPA is similar at 1 year among HIV-infected women on HAART in a randomized controlled trial. Despite high method satisfaction, partner disapproval and heavy bleeding contribute to reduced adherence. Receiving a method that differs from participant's first-choice method did not influence adherence.
| S-EPMC4108248 | biostudies-literature