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Effectiveness of a novel device in the reduction of cesarean deliveries.

ABSTRACT: Objective. To test the hypothesis that the use of the HEM-AVERT Perianal Stabilizer will result in a reduction of cesarean births and shorter duration of second-stage labor. Study Design. In a prospective controlled trial, 102 women scheduled for vaginal delivery were randomized to either the HEM-AVERT investigational device or control group. Ninety eight (98) patients completed the study. A chi-square test was used to evaluate the difference in the number of cesarean deliveries between the investigational and control groups. Duration of second-stage labor was assessed as a secondary outcome. Results. Six (6) of the 50 patients in the investigational group (12%) failed to deliver vaginally and required cesarean delivery. Comparatively, 19 of the 48 control patients (39.6%) required cesarean delivery. Duration of second-stage labor was shorter in the investigational group, but the difference was not statistically significant. Results from 4 patients were excluded due to protocol violations. Conclusion. The HEM-AVERT device effectively reduced the incidence rate of cesarean deliveries in the investigational group when compared to women who delivered without use of the device. This trial is registered with ClinicalTrials.gov NCT01739543.

SUBMITTER: Burns DA

PROVIDER: S-EPMC3773949 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Effectiveness of a novel device in the reduction of cesarean deliveries.

Burns Daniel A DA

ISRN obstetrics and gynecology 20130901

Objective. To test the hypothesis that the use of the HEM-AVERT Perianal Stabilizer will result in a reduction of cesarean births and shorter duration of second-stage labor. Study Design. In a prospective controlled trial, 102 women scheduled for vaginal delivery were randomized to either the HEM-AVERT investigational device or control group. Ninety eight (98) patients completed the study. A chi-square test was used to evaluate the difference in the number of cesarean deliveries between the inve ...[more]

PMID: 24078876

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Project description:Background:Delayed cord clamping (DCC) results in decreased iron deficiency in infancy. The American College of Obstetrics and Gynecology has called for research on the optimal time to clamp the cord during cesarean deliveries (CD). Our objective was to conduct a pilot trial examining the safety of delayed cord clamping (DCC) for maternal-infant dyads during elective cesarean delivery (CD). Methods:We enrolled 39 dyads [23 at 90 s, 16 at 120 s; (DCC Pilot)] between 10/2013 and 9/2014. We abstracted data from the electronic medical record (EMR) for historical controls (HC) birthing between 1/2012-6/2013 for whom DCC was not performed (n?=?112). Results:Available data for 37 mothers and 30 infants compared to HC revealed 174 (95% CI: 61-286) mL lower mean estimated maternal blood loss [(EBL) mean (SD) mL]: DCC Pilot 691(218) vs. HC 864(442), p =?0.003 and lower incidence of maternal transfusions, DCC Pilot 2.7% vs. HC 18.8%, p =?0.016. There was no significant between group difference between DCC Pilot and HC in other a priori definitions of excess maternal blood loss: a) EBL?>?800 ml, 21.6% vs. 38.8%, p =?0.07 or b) post-op hgb/pre-op hgb?<?80%, 16.7% vs. 20.6%, p =?0.81. There were also no statistically significant between group differences in rates of NICU admission DCC Pilot 8.1% vs. HC 7.1%, p =?1.0., but there was a higher rate of newborn cold stress or hypothermia ?36.2 °C in study subjects, DCC Pilot 27.0% vs. HC 11.9%, p =?0.038.Prevalence of newborn anemia was decreased [DCC pilot 3.3% (1 of 30) vs. HC 40.0% (4 of 10 infants with data), p =?0.012. No infants were polycythemic. Conclusions:These pilot data suggest cord clamping can be delayed to 120 s during elective CD without increased risk of excessive maternal blood loss. More aggressive prevention of infant heat loss may be warranted. A randomized trial to evaluate long-term maternal and infant outcomes is indicated. Trial registration:Clinical trials.gov, NCT02229162; registered: 1 September, 2014.

Project description:BackgroundCesarean delivery rates are increasing globally with almost half of them occurring due to a previous Cesarean delivery. A trial of labor after Cesarean (TOLAC) is considered a safe procedure, but most eligible women instead undergo Cesarean before 39 weeks of gestation. Lack of education about TOLAC is often associated with increased repeat Cesarean. To reveal the safety and feasibility of TOLAC, we conducted this observational, prospective study with women's independent decisions. We aimed to clarify the relationship between their chosen mode of delivery and the reason for their previous Cesarean. Additionally, we have tried to identify maternal and obstetric factors associated with failed TOLAC to improve its success rate.MethodsThis was a prospective, observational study of 1086 pregnant women with at least one previous Cesarean delivery. Of these, 735 women met our TOLAC criteria (Table 1), and then, could choose TOLAC or repeat Cesarean after receiving detailed explanations regarding the risks and benefits of both procedures. The primary outcomes were the number of successful TOLAC procedures and 5-min Apgar scores < 7 for the trial of labor after Cesarean group and elective Cesarean group. We collected the maternal and neonatal data including the reasons of previous Cesarean.ResultsIn total, 64.1% of women chose TOLAC. The success rate was 91.3%. The uterine rupture rate was 0.6%. There were no significant differences in the rate of Apgar scores at 5 min < 7 between both groups. Histories of experience of labor in previous Cesarean delivery were observed in 30 and 50% of women who chose TOLAC and repeat Cesarean, respectively (p < 0.05). Factors related to failed TOLAC included ≥40 weeks of gestation (odds: 5.47, 95% CI: 2.55-11.70) and prelabor rupture of membranes (PROM) (odds: 4.47, 95% CI: 2.07-9.63).ConclusionsTOLAC is a favorable delivery option for both mothers and neonates when women meet criteria and choose after receiving detailed explanations. Women who experience PROM or ≥ 40 weeks of gestation, their modes of delivery should be reconsulted.

Project description:ObjectiveTrial of labor after cesarean delivery has been mostly studied in the setting of one prior cesarean delivery; controversy remains regarding the risks and benefits of trial of labor for women with two prior cesarean deliveries. This study aimed to examine utilization, success rate, and maternal and neonatal outcomes of trial of labor in this population.MethodsUsing linked hospital discharge and birth certificate data, we retrospectively analyzed a cohort of mothers with nonanomalous, term, singleton live births in California between 2010-2012 and had two prior cesarean deliveries and no clear contraindications for trial of labor. We measured whether they attempted labor and, if so, whether they delivered vaginally. Association of patient and hospital characteristics with the likelihood of attempting labor and successful vaginal birth was examined using multivariable regressions. We compared composite severe maternal morbidities and composite severe newborn complications in those who underwent trial of labor as opposed to planned cesarean delivery using a propensity score-matching approach.ResultsAmong 42,771 women who met sample eligibility criteria, 1,228 (2.9%) attempted labor, of whom 484 (39.4%) delivered vaginally. There was no significant difference in the risk of composite severe maternal morbidities, but there was a modest increase in the risk of composite severe newborn complications among women who attempted labor compared with those who did not (2.0% vs 1.4%, P=.04). After accounting for differences in patient and hospital characteristics, propensity score-matched analysis showed no significant association between trial of labor and the risk of composite severe maternal morbidities (odds ratio [OR] 1.16, 95% CI 0.70-1.91), but trial of labor was associated with a higher risk for the composite of severe newborn complications (OR 1.78, 95% CI 1.04-3.04).ConclusionAmong women with two prior cesarean deliveries, trial of labor was rarely attempted and was successful in 39.4% of attempts. Trial of labor in this population was associated with a modest increase in severe neonatal morbidity.

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Effectiveness of a novel device in the reduction of cesarean deliveries.

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Effectiveness of a novel device in the reduction of cesarean deliveries.

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