Dataset Information

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

ABSTRACT: To evaluate the effectiveness of four commonly used induction methods.This randomized trial compared four induction methods: misoprostol alone, Foley alone, misoprostol-cervical Foley concurrently, and Foley-oxytocin concurrently. Women undergoing labor induction with full-term (37 weeks of gestation or greater), singleton, vertex-presenting gestations, with no contraindication to vaginal delivery, intact membranes, Bishop score 6 or less, and cervical dilation 2 cm or less were included. Women were enrolled only once during the study period. Our primary outcome was time to delivery. Neither patients nor health care providers were blinded to assigned treatment group because examinations are required for placement of all methods; however, research personnel were blinded during data abstraction. A sample size of 123 per group (n=492) was planned to compare the four groups pairwise (P?.008) with a 4-hour reduction in delivery time considered clinically meaningful.From May 2013 through June 2015, 997 women were screened and 491 were randomized and analyzed. Demographic and clinical characteristics were similar among the four treatment groups. When comparing all induction method groups, combination methods achieved a faster median time to delivery than single-agent methods (misoprostol-Foley: 13.1 hours, Foley-oxytocin: 14.5 hours, misoprostol: 17.6 hours, Foley: 17.7 hours, P<.001). When censored for cesarean delivery and adjusting for parity, women who received misoprostol-Foley were almost twice as likely to deliver before women who received misoprostol alone (hazard ratio 1.92, 95% confidence interval [CI] 1.42-2.59) or Foley alone (hazard ratio 1.87, 95% CI 1.87 1.39-2.52), whereas Foley-oxytocin was not statistically different from single-agent methods.After censoring for cesarean delivery and adjusting for parity, misoprostol-cervical Foley resulted in twice the chance of delivering before either single-agent method.ClinicalTrials.gov, https://clinicaltrials.gov, NCT01916681.

SUBMITTER: Levine LD

PROVIDER: S-EPMC5127406 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

Levine Lisa D LD Downes Katheryne L KL Elovitz Michal A MA Parry Samuel S Sammel Mary D MD Srinivas Sindhu K SK

Obstetrics and gynecology 20161201 6

<h4>Objective</h4>To evaluate the effectiveness of four commonly used induction methods.<h4>Methods</h4>This randomized trial compared four induction methods: misoprostol alone, Foley alone, misoprostol-cervical Foley concurrently, and Foley-oxytocin concurrently. Women undergoing labor induction with full-term (37 weeks of gestation or greater), singleton, vertex-presenting gestations, with no contraindication to vaginal delivery, intact membranes, Bishop score 6 or less, and cervical dilation ...[more]

PMID: 27824758

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Project description:Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction.1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants.541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters.While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care.

Project description:BACKGROUND:Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. METHODS:A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score???5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. RESULTS:Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72?±?1.85 vs. 2.25?±?0.55?min p?=?0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p?=?0.72 and failure 2/42 (5%) vs. 0/44 (0%) p?=?0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7?±?9.4 vs 29.6?±?11.5?h p?=?0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p?=?0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p?=?0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. CONCLUSION:Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. TRIAL REGISTRATION:This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.

Project description:BackgroundBlinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments.Methods and findingsWe undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events.ConclusionsThis review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.

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Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

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Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

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