Dataset Information

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

ABSTRACT: The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking.We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery.Patients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12.No differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60).Although we did not identify any short-term safety concerns, HA-CMC adhesion barrier applied at cesarean delivery did not reduce adhesion formation at the subsequent cesarean delivery.

SUBMITTER: Kiefer DG

PROVIDER: S-EPMC4818004 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

Kiefer Daniel G DG Muscat Jolene C JC Santorelli Jarrett J Chavez Martin R MR Ananth Cande V CV Smulian John C JC Vintzileos Anthony M AM

American journal of obstetrics and gynecology 20151023 3

<h4>Background</h4>The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking.<h4>Objective</h4>We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) a ...[more]

PMID: 26478104

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Project description:OBJECTIVE:To estimate the contributions of patient and health care provider-hospital characteristics to the variation in the frequency of nulliparous, term, singleton, vertex cesarean delivery in a multi-institutional U.S. cohort. METHODS:We performed a secondary analysis of the multicenter Assessment of Perinatal Excellence cohort of 115,502 mother and neonatal pairs who were delivered at 25 hospitals between March 2008 and February 2011. Women met inclusion criteria if they were nulliparous and delivered a singleton in vertex presentation at term. Hospital ranks for nulliparous, term, singleton, vertex cesarean delivery frequency were determined after risk adjustment. The fraction of variation in nulliparous, term, singleton, vertex cesarean delivery frequency attributable to patient and health care provider-hospital characteristics was assessed using hierarchical logistic regression. RESULTS:Of the 115,502 deliveries in the initial cohort, 38,275 nulliparous, term, singleton, vertex deliveries met inclusion criteria. The median hospital nulliparous, term, singleton, vertex cesarean delivery frequency was 25.3% with a range from 15.0% to 35.2%. The majority of hospitals (16/25) changed rank quintiles after risk adjustment; overall the changes in rank were not statistically significant (P=.53). Patient characteristics accounted for 24% of the nulliparous, term, singleton, vertex cesarean delivery variation. The analyzed health care provider-hospital characteristics were not significantly associated with cesarean delivery frequency. CONCLUSION:Although patient characteristics accounted for some of the variation in nulliparous, term, singleton, vertex cesarean delivery frequency and accounting for case mix had implications for hospital cesarean delivery rankings, the majority of the variation was not explained by the characteristics evaluated. These findings emphasize the importance of continued efforts to understand aspects of obstetric care, including case mix, that contribute to cesarean delivery variation.

Project description:IMPORTANCE:Planned cesarean delivery comprises a significant proportion of births globally, with combined rates of planned and unscheduled cesarean delivery in a number of regions approaching 50%. Observational studies have shown that offspring born by cesarean delivery are at increased risk of ill health in childhood, but these studies have been unable to adjust for some key confounding variables. Additionally, risk of death beyond the neonatal period has not yet been reported for offspring born by planned cesarean delivery. OBJECTIVE:To investigate the relationship between planned cesarean delivery and offspring health problems or death in childhood. DESIGN, SETTING, AND PARTICIPANTS:Population-based data-linkage study of 321,287 term singleton first-born offspring born in Scotland, United Kingdom, between 1993 and 2007, with follow-up until February 2015. EXPOSURES:Offspring born by planned cesarean delivery in a first pregnancy were compared with offspring born by unscheduled cesarean delivery and with offspring delivered vaginally. MAIN OUTCOMES AND MEASURES:The primary outcome was asthma requiring hospital admission; secondary outcomes were salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, cancer, and death. RESULTS:Compared with offspring born by unscheduled cesarean delivery (n?=?56,015 [17.4%]), those born by planned cesarean delivery (12,355 [3.8%]) were at no significantly different risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, obesity at age 5 years, inflammatory bowel disease, cancer, or death but were at increased risk of type 1 diabetes (0.66% vs 0.44%; difference, 0.22% [95% CI, 0.13%-0.31%]; adjusted hazard ratio [HR], 1.35 [95% CI, 1.05-1.75]). In comparison with children born vaginally (n?=?252,917 [78.7%]), offspring born by planned cesarean delivery were at increased risk of asthma requiring hospital admission (3.73% vs 3.41%; difference, 0.32% [95% CI, 0.21%-0.42%]; adjusted HR, 1.22 [95% CI, 1.11-1.34]), salbutamol inhaler prescription at age 5 years (10.34% vs 9.62%; difference, 0.72% [95% CI, 0.36%-1.07%]; adjusted HR, 1.13 [95% CI, 1.01-1.26]), and death (0.40% vs 0.32%; difference, 0.08% [95% CI, 0.02%-1.00%]; adjusted HR, 1.41 [95% CI, 1.05-1.90]), whereas there were no significant differences in risk of obesity at age 5 years, inflammatory bowel disease, type 1 diabetes, or cancer. CONCLUSIONS AND RELEVANCE:Among offspring of women with first births in Scotland between 1993 and 2007, planned cesarean delivery compared with vaginal delivery (but not compared with unscheduled cesarean delivery) was associated with a small absolute increased risk of asthma requiring hospital admission, salbutamol inhaler prescription at age 5 years, and all-cause death by age 21 years. Further investigation is needed to understand whether the observed associations are causal.

Project description:To evaluate the association between documentation of estimated fetal weight, and its value, with cesarean delivery.This was a secondary analysis of a multicenter observational cohort of 115,502 deliveries from 2008 to 2011. Data were abstracted by trained and certified study personnel. We included women at 37 weeks of gestation or greater attempting vaginal delivery with live, nonanomalous, singleton, vertex fetuses and no history of cesarean delivery. Rates and odds ratios (ORs) were calculated for women with ultrasonography or clinical estimated fetal weight compared with women without documentation of estimated fetal weight. Further subgroup analyses were performed for estimated fetal weight categories (less than 3,500, 3,500-3,999, and 4,000 g or greater) stratified by diabetic status. Multivariable analyses were performed to adjust for important potential confounding variables.We included 64,030 women. Cesarean delivery rates were 18.5% in the ultrasound estimated fetal weight group, 13.4% in the clinical estimated fetal weight group, and 11.7% in the no documented estimated fetal weight group (P<.001). After adjustment (including for birth weight), the adjusted OR of cesarean delivery was 1.44 (95% confidence interval [CI] 1.31-1.58, P<.001) for women with ultrasound estimated fetal weight and 1.08 for clinical estimated fetal weight (95% CI 1.01-1.15, P=.017) compared with women with no documented estimated fetal weight (referent). The highest estimates of fetal weight conveyed the greatest odds of cesarean delivery. When ultrasound estimated fetal weight was 4,000 g or greater, the adjusted OR was 2.15 (95% CI 1.55-2.98, P<.001) in women without diabetes and 9.00 (95% CI 3.65-22.17, P<.001) in women with diabetes compared to those with estimated fetal weight less than 3,500 g.In this contemporary cohort of women attempting vaginal delivery at term, documentation of estimated fetal weight (obtained clinically or, particularly, by ultrasonography) was associated with increased odds of cesarean delivery. This relationship was strongest at higher fetal weight estimates, even after controlling for the effects of birth weight and other factors associated with increased cesarean delivery risk.

Project description:BACKGROUND:Policy consensus in high-income countries supports offering pregnant women with previous cesarean section a choice between planning an elective repeat cesarean section (ERCS) or attempting a vaginal birth, known as a planned vaginal birth after previous cesarean (VBAC), provided they do not have contraindications to planned VBAC. However, robust comprehensive information on the associated outcomes to counsel eligible women about this choice is lacking. This study investigated the short-term maternal and perinatal outcomes associated with planned mode of delivery after previous cesarean section among women delivering a term singleton and considered eligible to have a planned VBAC. METHODS AND FINDINGS:A population-based cohort of 74,043 term singleton births in Scotland between 2002 and 2015 to women with one or more previous cesarean sections was conducted using linked Scottish national datasets. Logistic or modified Poisson regression, as appropriate, was used to estimate the effect of planned mode of delivery on maternal and perinatal outcomes adjusted for sociodemographic, maternal medical, and obstetric-related characteristics. A total of 45,579 women gave birth by ERCS, and 28,464 had a planned VBAC, 28.4% of whom went on to have an in-labor nonelective repeat cesarean section. Compared to women delivering by ERCS, those who had a planned VBAC were significantly more likely to have uterine rupture (0.24%, n = 69 versus 0.04%, n = 17, adjusted odds ratio [aOR] 7.3, 95% confidence interval [CI] 3.9-13.9, p < 0.001), a blood transfusion (1.14%, n = 324 versus 0.50%, n = 226, aOR 2.3, 95% CI 1.9-2.8, p < 0.001), puerperal sepsis (0.27%, n = 76 versus 0.17%, n = 78, aOR 1.8, 95% CI 1.3-2.7, p = 0.002), and surgical injury (0.17% versus 0.09%, n = 40, aOR 3.0, 95% CI 1.8-4.8, p < 0.001) and experience adverse perinatal outcomes including perinatal death, admission to a neonatal unit, resuscitation requiring drugs and/or intubation, and an Apgar score < 7 at 5 minutes (7.99%, n = 2,049 versus 6.37%, n = 2,570, aOR 1.6, 95% CI 1.5-1.7, p < 0.001). However, women who had a planned VBAC were more likely than those delivering by ERCS to breastfeed at birth or hospital discharge (63.6%, n = 14,906 versus 54.5%, n = 21,403, adjusted risk ratio [aRR] 1.2, 95% CI 1.1-1.2, p < 0.001) and were more likely to breastfeed at 6-8 weeks postpartum (43.6%, n = 10,496 versus 34.5%, n = 13,556, aRR 1.2, 95% CI 1.2-1.3, p < 0.001). The effect of planned mode of delivery on the mother's risk of having a postnatal stay greater than 5 days, an overnight readmission to hospital within 42 days of birth, and other puerperal infection varied according to whether she had any prior vaginal deliveries and, in the case of length of postnatal stay, also varied according to the number of prior cesarean sections. The study is mainly limited by the potential for residual confounding and misclassification bias. CONCLUSIONS:Among women considered eligible to have a planned VBAC, planned VBAC compared to ERCS is associated with an increased risk of the mother having serious birth-related maternal and perinatal complications. Conversely, planned VBAC is associated with an increased likelihood of breastfeeding, whereas the effect on other maternal outcomes differs according to whether a woman has any prior vaginal deliveries and the number of prior cesarean sections she has had. However, the absolute risk of adverse outcomes is small for either delivery approach. This information can be used to counsel and manage the increasing number of women with previous cesarean section, but more research is needed on longer-term outcomes.

Dataset Information

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

Publications

Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

Similar Datasets

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