Jolene Muscat

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

BACKGROUND 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. OBJECTIVE 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. STUDY DESIGN 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. RESULTS 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). CONCLUSION 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.

Down-regulation of placental neuropilin-1 in fetal growth restriction.

BACKGROUND Fetal growth restriction (FGR) is associated with adverse outcomes extending from fetal to adult life, and thus, constitutes a major health care challenge. Fetuses with progressive growth restriction show increasing impedance in the umbilical artery flow, which may become absent during end-diastole. Absent end-diastolic flow (AEDF) is associated with adverse perinatal outcomes including stillbirths and perinatal asphyxia. Placentas from such pregnancies demonstrate deficient fetoplacental vascular branching. Current evidence, moreover, indicates an antiangiogenic state in maternal circulation in several pregnancy complications including preeclampsia, small-for-gestational-age births, fetal death, and preterm labor. The angiogenic mediators in maternal circulation are predominantly of placental origin. Information, however, on the role of specific proangiogenic and antiangiogenic mechanisms operating at the placental level remains limited. Elucidation of these placenta-specific angiogenic mechanisms will not only extend our understanding of the causal pathway for restricted fetal growth but may also lead to the development of biomarkers that may allow early recognition of FGR. OBJECTIVE We sought to test the hypothesis that fetoplacental angiogenic gene expression is altered in pregnancies complicated with FGR and umbilical artery Doppler AEDF. STUDY DESIGN Placental samples were collected from FGR pregnancies complicated with umbilical artery Doppler AEDF (study group, n = 7), and from uncomplicated pregnancies (control group, n = 7), all delivered by cesarean during the last trimester of pregnancy. Angiogenic oligonucleotide microarray analysis was performed and was corroborated by quantitative real-time polymerase chain reaction, Western blot analysis, and immunohistochemistry. The Student t test with Bonferroni correction was used with P < .05 considered statistically significant. Independent groups t test was used to analyze the immunostain intensity scores with a P < .05 considered statistically significant. RESULTS Our microarray results showed that among several differentially expressed angiogenic genes in the growth-restricted group, only the down-regulation of neuropilin (NRP)-1 was most significant (P < .0007). Quantitative real-time polymerase chain reaction confirmed a significantly lower NRP-1 gene expression in the FGR group than in the control group (mean ± SD (ˆ)cycle threshold: 0.624 ± 0.55 and 1.325 ± 0.84, respectively, P = .04). Western blot validated significantly lower NRP-1 protein expression in the FGR group than in the control group (mean ± SD NRP-1/β-actin ratio: 0.13 ± 0.04 and 0.34 ± 0.05, respectively, P < .001). Finally, immunohistochemistry of placental villi further corroborated a significantly decreased expression of NRP-1 in the FGR group (P = .006). CONCLUSION The study demonstrated significant down-regulation of placental NRP-1 expression in FGR pregnancies complicated with AEDF in umbilical artery. As NRP-1 is known to promote sprouting angiogenesis, its down-regulation may be involved in the deficient vascular branching observed in FGR placentas suggesting the presence of an antiangiogenic state. Further studies may elucidate such a causal role and may lead to the development of novel diagnostic and therapeutic tools.

A Randomized Controlled Trial Evaluating Safety and Efficacy of Sodium Hyaluronate and Carboxymethylcellulose at Cesarean Delivery

INTRODUCTION: To determine if placement of a sodium hyaluronate and carboxymethylcellulose adhesion barrier at cesarean delivery reduces adhesion formation at subsequent cesarean delivery. We previously reported data showing no increase in short-term complications. METHODS: Seven hundred fifty-three patients were evaluated in this multicenter, randomized study. Patients undergoing primary and repeat cesarean deliveries were randomized into either sodium hyaluronate and carboxymethylcellulose (n=380) or a no-treatment group (n=373). The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which has a score from 0 to 12. Secondary outcomes included safety and operative times. Sixty-five patients returning for a subsequent delivery from each arm were required to show a 50% reduction in adhesions. RESULTS: No differences in baseline characteristics, postoperative course, or incidence of complications between the groups after randomization were noted. Eighty patients from the sodium hyaluronate and carboxymethylcellulose group and 92 patients in a control group returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the sodium hyaluronate and carboxymethylcellulose group and 75.9% of the women in the control group (P=.99). There was no significant difference in the median adhesion score: 2 (range 0–10) for the sodium hyaluronate and carboxymethylcellulose group compared with 2 (range 0–8) for the control group (P=.65). There were no significant differences in the time from incision to delivery (P=.56). Uterine dehiscence in the next pregnancy was reported in two patients in the sodium hyaluronate and carboxymethylcellulose group compared with one woman in the control group (P=.60). CONCLUSION: Sodium hyaluronate and carboxymethylcellulose adhesion barrier applied at cesarean delivery does not reduce adhesion formation at the subsequent cesarean delivery. Although we did not demonstrate efficacy for improving adhesion formation, we did not identify safety concerns.

Second trimester marginal cord insertion is associated with adverse perinatal outcomes

Abstract Objectives: To determine the feasibility in visualizing placental cord insertion (PCI) during second-trimester fetal anatomical survey and the association between marginal cord insertion (MCI) and preterm delivery (PTD) and low birth weight (LBW). Our secondary objectives were to evaluate the association of MCI with adverse composite obstetrical and neonatal outcomes. Methods: A prospective cohort study was performed over a 28-month period. Women with singleton pregnancies presenting for routine anatomical survey between 18 and 22 weeks’ gestation were included. PCI site was visualized on 2D grayscale and color Doppler and the shortest distance from the sagittal and transverse planes to the placental edge were recorded. MCI was diagnosed when any of measured distances was ≤2 cm. Correlations were assessed via bivariate chi-squared, independent t-test analyses and Fisher’s exact tests. Regression models evaluated associations between MCI and adverse composite outcomes. Results: Three hundred one women were included and PCI was feasible in all cases. The incidence of MCI was 11.3% (n = 34). Baseline characteristics between those with and without MCI were similar, except for story of prior PTD, which was greater among those with MCI (17.65 versus 7.17%, p = .04). MCI was associated with increased likelihood of LBW (RR four; 95%CI, 1.46–10.99) and PTD (RR 3.2; 95%CI, 1.53–6.68); in multivariate analysis, we found associations between MCI and composite adverse obstetrical (RR 2.33; 95%CI, 1.30–4.19) and neonatal (RR 2.46; 95%CI, 1.26–4.81) outcomes. Conclusions: Evaluation of PCI is feasible in all cases. Second-trimester MCI is associated with increased likelihood for LBW, PTD, and composite adverse obstetrical and neonatal outcomes.

Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study

Objective Due to poor adherence for glucose testing at 6‐ to 12‐week postpartum among women with gestational diabetes, we sought to determine whether a 2‐hour glucose tolerance test (GTT) during postpartum hospitalization is predictive of 6‐ to 12‐week postpartum glucose testing. Study Design An institutional review board‐approved prospective cohort study was performed over 3 years. Patients underwent an inpatient fasting 75‐g, 2‐hour GTT on either postpartum days 2 through 4 and instructed to follow up in 6‐ to 12‐weeks for postpartum glucose testing. Sensitivity, specificity, positive predictive value (PPV), and negative predictive values (NPV) of the immediate GTT to predict abnormal 6‐ to 12‐week postpartum glucose testing were determined. Results Eighty women enrolled in the study completed the immediate GTT; of these, only 35 (44%) underwent 6‐ to 12‐week postpartum glucose testing. The sensitivity, specificity, PPV, and NPV of the immediate GTT were 100, 42.8, 30.4, and 100%, respectively. Conclusion More than 50% of our study patients did not undergo recommended postpartum glucose testing, coinciding with similar poor follow‐up reported in the literature. With a high NPV and high sensitivity, a negative immediate GTT may obviate the need for the 6‐ to 12‐week GTT, while a positive GTT may identify women who should follow up closely.

Factors Influencing Adhesion Formation After Primary Cesarean Delivery [26C]

INTRODUCTION: To determine the association, if any, between obstetrical and surgical factors and adhesion formation after a primary cesarean delivery (CD). METHODS: This is retrospective cohort of patients at a single institution who underwent a primary CD between 2008 and 2010, with a repeat CD by 12/2013. At the time of each CD, an adhesion assessment form was completed, as per the standard of care. The form evaluates the character of adhesions (none [score 0], filmy [score 1], dense [score 2]) in five locations (bowel, fascia to uterus, omentum to uterus, omentum to fascia, bladder to uterus). Patients with an adhesion score greater than or equal to 4 were compared to those patients with fewer adhesions. 38 possible obstetrical and surgical predictors of adhesions were entered into a univariable analysis; then, all significant variables were entered into an adjusted model to determine independent predictors of adhesion formation. RESULTS: 851 patients met inclusion criteria for the study. After multivariable analyses, patients with peritoneal closure (OR 0.25, 95% CI 0.14–0.43, P<.001) or rectus muscle closure (OR 0.57, 95% CI 0.37–0.89, P<.01) at primary CD are less likely to have an adhesion score greater than or equal to 4. No difference was seen with adhesion barrier use (OR 1.19, 95% CI 0.76–1.89, P<.45). CONCLUSION: Our study suggests that peritoneal and/or rectus muscle closure at the time of CD should be routinely performed, as these are safe, cost-effective surgical techniques that reduce adhesion formation and may decrease long term risks of operative morbidity.

A novel approach to teaching placement of a B-lynch suture: description of technique and validation of teaching model.

INTRODUCTION Postpartum hemorrhage is a major cause of maternal morbidity and mortality throughout the world and uterine atony is the leading cause of postpartum hemorrhage. The B-Lynch brace suture is a fertility-sparing approach to treating intractable uterine atony at the time of cesarean delivery. However, many obstetricians lack confidence to perform this procedure, which they may not have performed during residency. In order to train all residents to perform the B-Lynch brace suture, we developed a realistic model by using a flank steak to imitate a gravid uterus. METHODS A convenience sample of obstetrics-gynecology faculty and residents at different levels of training at a single large hospital participated in this pilot project. Each physician reported self-perceived understanding of and confidence in performing the B-Lynch procedure before and immediately after practicing the technique using the flank-steak model, via a Likert-type survey (scale 1  =  low, 5  =  high). A Wilcoxon matched-pairs signed rank test was used to compare the before and after responses. RESULTS Thirty-four participants completed the flank-steak model training and pretraining/posttraining surveys. The median score (range) for self-perceived understanding was 4 (2-5) and increased to 5 (4-5) (P < .01) after exposure to the training model. The confidence scores rose from 3 (1-5) to 5 (4-5) (P < .01) after training. CONCLUSION The flank-steak model for teaching the B-Lynch suture significantly improved resident and faculty self-perceived understanding of and confidence in performing this procedure, which is otherwise rarely practiced in residency.