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Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Mody SK

PROVIDER: S-EPMC6438819 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

Mody Sheila K SK Farala John Paul JP Jimenez Berenice B Nishikawa Moena M Ngo Lynn L LL

Obstetrics and gynecology 20180901 3

<h4>Objective</h4>To investigate whether a 20-mL buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement.<h4>Methods</h4>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 (α=0.05) to detect a 20-mm difference ...[more]

PMID: 30095776

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Project description:BackgroundSeveral studies have investigated the effectiveness of intrauterine device placement at cesarean delivery as a contraceptive method. However, national-level use and outcomes of a postplacental intrauterine device at cesarean delivery are currently understudied in the United States.ObjectiveThis study aimed to examine the trends, characteristics, and outcomes of patients who received a postplacental intrauterine device at cesarean delivery.Study designThis retrospective cohort study used the National Inpatient Sample. The study cohort included patients who underwent cesarean delivery from October 2015 to December 2018. The exclusion criteria included hemorrhage, chorioamnionitis, uterine anomaly, hysterectomy, and permanent surgical sterilization. Eligible cases were grouped on the basis of the use of a postplacental intrauterine device at cesarean delivery. The primary outcome measures were temporal trends and characteristics associated with the use of a postplacental intrauterine device at cesarean delivery, assessed using the generalized estimating equation model in multivariable analysis. The secondary outcome measure was perioperative morbidity (leukocytosis, endometritis, myometritis, and sepsis). Propensity score matching was used to balance the baseline characteristics.ResultsAmong 2,983,978 patients who met the inclusion criteria, 10,145 patients (0.3%) received a postplacental intrauterine device at cesarean delivery. The use of a postplacental intrauterine device increased from 0.1% in the fourth quarter of 2015 to 0.6% in the fourth quarter of 2018 (P<.001). In a multivariable analysis, the use of a postplacental intrauterine device increased by 14% every quarter-year (adjusted odds ratio, 1.14; 95% confidence interval, 1.13-1.15). In addition, (1) patient characteristics of young age, non-White race, obesity, tobacco use, lowest quartile median household income, and insured with Medicaid; (2) hospital characteristics of large bed capacity and urban teaching setting in Northeast region; and (3) pregnancy characteristics of early gestational age at cesarean delivery, hypertensive disease, previous cesarean delivery, multifetal pregnancy, grand multiparity, placenta previa, and nonelective cesarean delivery represented the independent characteristics associated with the use of a postplacental intrauterine device (all P<.05). A regression tree model identified 35 discrete patterns of the use of a postplacental intrauterine device based on 8 factors (time, race or ethnicity, primary expected payer, obesity, hospital bed capacity, hospital teaching status, hospital region, and previous cesarean delivery). There were 9 patterns, representing 8.8% of the study population, exhibiting a use rate of ≥1.0%, whereas there were 7 patterns, representing 16.0% of the study population, exhibiting no use of a postplacental intrauterine device (absolute rate difference from the highest group to the lowest group, 4.7%). In a propensity score-matched model, postplacental intrauterine device placement at cesarean delivery was not associated with increased risk of measured morbidity (any, 1.8% vs 1.7%; odds ratio, 1.06; 95% confidence interval, 0.66-1.69; P=.812), including postpartum endometritis (1.2% vs 1.0%; odds ratio, 1.19; 95% confidence interval, 0.67-2.14; P=.554).ConclusionThe use of a postplacental intrauterine device at cesarean delivery increased significantly in recent years in the United States.

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.

Project description:BackgroundProlonged latent phase of labour often results in a traumatic birth experience. Prolonged labour is associated with more operative deliveries, haemorrhage, fetal asphyxia and poor birth experience. Women with prolonged labour in a former pregnancy more often demand caesarean section in the next, due to their negative birth experience. "Proactive support of labour" is an alternative method, developed to counteract prolonged labour. There are little research and no randomized controlled study that compare proactive to standard labour support.Methods/designA prospective, non-blinded, randomized, single-centre, clinical trial where we compare proactive support to standard support of labour in a university hospital setting.Inclusion criterialatent phase of labour, non-pathologic pregnancy. Robson group 1, with painful contractions, and fully effaced cervix, with 1-3 cm dilatation.Exclusion criteriainduction of labour, breech presentation, twin pregnancy, multi-parity, conditions that require extended surveillance before and/or during labour.Primary outcomespontaneous, uncomplicated vaginal delivery. After inclusion, women randomized to proactive support of labour will stay at the hospital and have one-to-one midwife support. If no progression during the next 1-2 hours, amniotomy and/or oxytocin stimulation will be started. The control group will adhere to the standard procedures for labour support: expectance until established regular contractions and 4-5 cm cervical dilatation, and then one-to-one midwife support.DiscussionThe idea of proactive support of labour is to initiate early intervention when there are signs of slow progress in order to avoid protracted labour with exhaustion of the mother, the uterus and prolonged stress of the foetus. Proactive support of labour may represent a useful method to improve labour support in nulliparous women. However, evidence based on randomized controlled trials are needed in order to know whether proactive support of labour is comparable or superior to standard care. A randomized, controlled trial is described; challenges and possible clinical implications are discussed.Trial registrationThe Proactive Support of Labor Study (PAF) ClinicalTrials, NCT03056313. Registered on February 17, 2017.

Dataset Information

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

Publications

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

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