Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial.

Background Postcesarean wound morbidity is a costly complication of cesarean delivery for which preventative strategies remain understudied. Objective We compared surgical site occurrences (SSOs) in cesarean patients receiving closed-incision negative-pressure therapy (ciNPT) or standard-of-care (SOC) dressing. Study Design A single-center randomized controlled trial compared ciNPT (5-7 days) to SOC dressing (1-2 days) in obese women (body mass index [BMI] ≥ 35), undergoing cesarean delivery between 2012 and 2014. Participants were randomized 1:1 and monitored 42 ± 10 days postoperatively. The primary outcome SSOs included unanticipated local inflammation, wound infection, seroma, hematoma, dehiscence, and need for surgical or antibiotic intervention. Results Of the 92 randomized patients, 82 completed the study. ciNPT and SOC groups had similar baseline characteristics. Mean BMI was 46.5 ± 6.5 and no treatment-related serious adverse events. Compared with SOC, the ciNPT group had fewer SSOs (7/43 [16.3%] vs. 2/39 [5.1%], respectively; p = 0.16); significantly fewer participants with less incisional pain both at rest (39/46 [84.8%] vs. 20/46 [43.5%]; p < 0.001) and with incisional pressure (42/46 [91.3%] vs. 25/46 [54.3%]; p < 0.001); and a 30% decrease in total opioid use (79.1 vs. 55.9 mg morphine equivalents, p = 0.036). Conclusion A trend in SSO reduction and a statistically significant reduction in postoperative pain and narcotic use was observed in women using ciNPT.

Thrombin-Induced Inflammation in Human Decidual Cells Is Not Affected By Heparin.

OBJECTIVE: Thrombin (Thr) generation at the uteroplacental interface induces inflammation and weakens fetal membranes. Tissue factor (TF) is a powerful procoagulant that is increased by Thr in decidual cells (DCs). The TF expression may play an important role in modulating Thr-induced inflammation. The purpose of this study was to assess the effect of heparin, including nonanticoagulant (desulfated) heparins, on basal and Thr-induced expression of TF and inflammatory cytokines in DCs. METHODS: Fetal membranes were collected from term pregnancies undergoing unlabored cesarean delivery and then DCs were isolated and cultured. Third passage DCs were conditioned in defined media for 1 week and then treated with 1 of the 4 heparins (enoxaparin, unfractionated heparin, and 2 desulfated heparins) with and without Thr (2.5 U/mL) for 24 hours. Supernatant levels of interleukin (IL) 6, IL-8, IL-10, tumor necrosis factor α, and interferon γ (IFN-γ) were determined by enzyme-linked immunosorbent assay. Western blots were performed on cell lysates to determine TF expression. A Kruskal-Wallis test was used to compare cytokine concentrations and normalized TF expression among treatments. RESULTS: Treatment of DCs with Thr alone increased the expression of TF, IL-6, IL8, IL-10, and IFN-γ compared to basal levels ( P < .05 for each). Cotreatment of DCs with Thr and any of the tested heparins did not decrease the expression of TF or inflammatory cytokines compared to treatment with Thr alone. DISCUSSION: Heparins do not appear to affect basal or Thr-induced expression of TF or inflammatory cytokines in human term DCs. Additional work is needed to determine whether nonanticoagulant heparins can reduce inflammation and membrane weakening due to bleeding in pregnancy.

Increase in Cesarean Operative Time Following Institution of the 80-Hour Workweek.

BACKGROUND: In 2003, the Accreditation Council for Graduate Medical Education limited resident duty hours to 80 hours per week. More than a decade later, the effect of the limits on resident clinical competence is not fully understood. OBJECTIVE: We sought to assess the effect of duty hour restrictions on resident performance of an uncomplicated cesarean delivery. METHODS: We reviewed unlabored primary cesarean deliveries at Duke University Hospital after 34 weeks gestation, between 2003 and 2011. Descriptive statistics and linear regression were used to compare total operative time with incision to delivery time as a function of years since institution of the 80-hour workweek. Resident training level, subject body mass index, estimated blood loss, and skin closure method were controlled for in the regression model. RESULTS: We identified 444 deliveries that met study criteria. The mean (SD) total operative time in 2003-2004 was 43.3 (14.3) minutes and 59.6 (10.7) minutes in 2010-2011 (P < .001). Multivariable regression demonstrated an increase in total operative time of 1.9 min/y (P < .001) but no change in incision to delivery time (P = .05). The magnitude of increased operative time was seen among junior residents (2.0 min/y, P < .001) compared to that of senior residents (1.2 min/y, P = .06). CONCLUSIONS: Since introduction of the 2003 duty hour limits, there has been an increase of nearly 20 minutes in the time required for a routine cesarean delivery. It is unclear if the findings are due to a change in residency duty hours or to another aspect of residency training.

The effects of intermittent pneumatic compression during cesarean delivery on fibrinolysis.

OBJECTIVE: Pregnancy is associated with increased risk for thromboembolic events. Intermittent pneumatic compression (IPC) devices are the method of thromboprophylaxis in a nonpregnant population. The aim of this study was to examine the effects of IPC on markers of fibrinolysis during cesarean delivery. STUDY DESIGN: We conducted a randomized controlled trial from April 2009 to March 2010 of women undergoing scheduled elective cesarean delivery. Forty-nine women were randomized to IPCs or usual care. All participants had three blood samples obtained: (1) baseline, (2) 1 hour after randomization, and (3) 30 minutes after cesarean delivery. Tissue-type plasminogen activator (tPA), urokinase-type plasminogen activator (uPA), thrombin-antithrombin complex (TAT), plasminogen activator inhibitor-1 (PAI-1), and plasminogen activator inhibitor-2 (PAI-2) levels were analyzed in each sample using an enzyme-linked immunosorbent assay. Statistical analysis was performed using repeated measures two-way analysis of variance with α = 0.05. RESULTS: There was a time-dependent change in tPA, uPA, and PAI-1 levels following delivery but no difference in TAT and PAI-2 levels with time. There were no differences between women randomized to IPCs or usual care. CONCLUSION: Markers of fibrinolysis were not significantly altered by IPCs in this study of low-risk pregnant women. Further research regarding the mechanism and efficacy of IPCs in pregnant women is warranted.

Predictors of failed trial of labor among women with an extremely obese body mass index.

OBJECTIVE: The purpose of this study was to examine predictors associated with cesarean delivery (CD) among extremely obese women undergoing a trial of labor (TOL). STUDY DESIGN: Using a delivery database, we identified all pregnant women delivering at our institution from Jan. 1, 2008, through July 31, 2010, weighing >275 lb at the time of delivery who attempted a TOL with a singleton gestation >34 weeks' gestation. Demographic and obstetrical factors were compared for those having a successful vaginal delivery to those having a CD. RESULTS: During the study period, there were 357 pregnant women who weighed >275 lb (all with body mass index [BMI] >40 kg/m(2)), and among these, 248 (69.5%) attempted a TOL. Women having a CD had a greater BMI (51.6 vs 49.9 kg/m(2), P = .038), were less likely to be parous (32.2% vs 65.8%, P < .0001), and were more likely to be induced (80.5% vs 57.8%) compared to those having a vaginal delivery. Using a multivariable logistic regression model, among nulliparous women, maternal age, parity, and cervical dilation at time of admission were independent predictors for CD. Furthermore, an increase in BMI of 10 kg/m(2) was associated with a 3.5 increased odds (P = .002) for CD. CONCLUSION: Among nulliparous extremely obese women attempting a TOL, BMI was an independent predictor of CD, with the rate of CD increasing further with increasing BMI. The underlying mechanisms for failed TOL in the setting of maternal obesity remain largely unknown.

Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers.

OBJECTIVE: Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states. METHODS: We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics. RESULTS: Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE. CONCLUSIONS: This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Improving the management of an advanced extrauterine pregnancy using pelvic arteriography in a hybrid operating suite.

Advanced extrauterine pregnancy is an extremely rare, life-threatening pregnancy complication. Management of these pregnancies presents significant challenges, especially when they have progressed to an advanced stage of fetal viability. With high rates of maternal and fetal mortality associated with this complication, delivery or pregnancy interruption should be expedited following diagnosis. Localization of the placenta and its blood supply is critical to preoperative planning. Hybrid operating suites that can accommodate a multidisciplinary team of subspecialists may improve the chance of a successful outcome with this rare complication.

Utility scores and treatment preferences for clinical early-stage cervical cancer.

OBJECTIVES: To determine utility scores for health states relevant to the treatment of early-stage, high-risk cervical cancer. METHODS: Seven descriptive health states incorporating the physical and emotional aspects of medical treatment, recovery, and prognosis were developed. Forty-five female volunteers valuated each health state using the visual analogue score (VAS) and time trade off (TTO) methods. Treatment options were ranked by mean and median TTO scores. The 95% confidence intervals were calculated to determine the statistical significance of ranking preferences. The Wilcoxon rank-sum test was used to compare central tendencies related to age, race, parity, and subject history of abnormal cervical cytology. RESULTS: VAS and TTO scores were highly correlated. Volunteers ranked minimally invasive radical hysterectomy with low-risk features as most preferred (mean TTO = 0.96; median TTO = 1.00) and aborted radical hysterectomy followed by chemoradiation as least preferred (mean TTO = 0.69; median TTO = 0.83). Health states that included radical surgery were ranked higher than those that included chemoradiation, either in the adjuvant or primary setting. When survival was comparable, volunteers rated radical hysterectomy with high-risk pathology followed by adjuvant chemoradiation (mean TTO = 0.78; median TTO = 0.92; 95% CI: 0.69-0.87) similarly to chemoradiation alone (mean TTO = 0.76; median TTO 0.90; 95% CI: 0.66-0.86; p = NS). Utility scores for the majority of health states were not significantly associated with age, race, parity, or subject history of abnormal cervical cytology. CONCLUSION: Subjects consistently preferred surgical excision to treat early-stage, high-risk cervical cancer and chose a minimally invasive approach. Such utility scores can be used to incorporate quality-of-life effects into comparative-effectiveness models for cervical cancer.