Victoria Jauk

Surgical Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery A Randomized Controlled Trial

OBJECTIVE: To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture. METHODS: Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3–4 for low transverse incisions and days 7–10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3–4) and 4–6 weeks postoperatively. The primary outcome was a composite of wound disruption or infection within 4–6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score, and patient scar satisfaction score. Analyses were by intent to treat. RESULTS: Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean delivery, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture (P<.001, relative risk 14.1, 95% confidence interval [CI] 1.9–106). Of 350 (87.9%) with follow-up at 4–6 weeks, the cumulative risk of the primary outcome at 4–6 weeks was 14.5% for staples and 5.9% for suture (P=.008, relative risk 2.5, 95% CI 1.2–5.0). Operative time was longer with suture closure (median time of 58 versus 48 minutes; P<.001). Pain scores at 72–96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group. CONCLUSION: Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01008449. LEVEL OF EVIDENCE: I

Incontinence outcomes in women undergoing primary and repeat midurethral sling procedures.

OBJECTIVE: To assess stress urinary incontinence (SUI) and other lower urinary tract symptom outcomes in women undergoing repeat midurethral sling procedures compared with those undergoing primary midurethral sling procedures. METHODS: Cure was defined as responses of “not at all” or “somewhat” to both questions of the SUI subscale of the Urogenital Distress Inventory-6; symptom effect was assessed using the Incontinence Impact Questionnaire-7. Multivariable models were created controlling for baseline Medical Epidemiologic and Social Aspects of Aging questionnaire urge score and Urogenital Distress Inventory-6 stress subscale score. RESULTS: One thousand three hundred sixteen patients had charts available for review: 135 of 1,316 (10.2%) had undergone prior midurethral sling procedures; 799 of 1,316 (61%) questionnaires were returned, with 92 from those having undergone prior midurethral sling procedures. Median follow-up time was 36.4 months with a range of 11.4–71.5 months. Cure rates were 71% (95% confidence interval [CI] 67.7–74.3%) in the primary midurethral sling group and 54% (95% CI 43.8–64.2%) in the repeat midurethral sling group (P<.001). Women undergoing repeat midurethral sling procedures experienced significantly greater improvement in symptom-specific quality of life (QOL) compared with those undergoing primary midurethral sling procedures (−28.87±37.6 compared with −18.42±32.73, P=.01). Multivariable analyses revealed that women in the repeat midurethral sling group had increased risk of SUI failure (odds ratio 1.7, 95% CI 1.1–2.8). CONCLUSION: Women undergoing repeat midurethral sling procedures had almost two times the odds of SUI treatment failure but greater improvement in symptom effect on QOL than did those undergoing a primary midurethral sling procedure. This information can help counsel patients regarding their expectations of repeat midurethral sling surgery for recurrent SUI . LEVEL OF EVIDENCE: II

Risk of adverse pregnancy outcomes in women with mild chronic hypertension before 20 weeks of gestation

OBJECTIVE: To evaluate whether blood pressure (BP) less than 140/90 mm Hg is associated with lower risk of adverse pregnancy outcomes in women with mild chronic hypertension. METHODS: This was a secondary analysis of women with chronic hypertension diagnosed before 20 weeks of gestation (either BP 140/90 mm Hg or greater on two occasions at least four hours apart or previously diagnosed and on antihypertensive therapy) enrolled in the Maternal-Fetal Medicine Units Networks High-risk Aspirin preeclampsia prevention trial. Outcomes including a primary composite (perinatal death, severe preeclampsia, placental abruption, and indicated preterm birth less than 35 weeks of gestation) and small for gestational age (SGA) were compared by study preenrollment BP analyzed as a categorical (less than 140/90, 140–150/90–99, or 151–159/100–109 mm Hg) and as a continuous variable. RESULTS: Among 759 women with singleton pregnancy and preenrollment BP less than 160/110 mm Hg, the incidence of the primary composite outcome (10.7%, 19.0%, 30%) and SGA (8.8%, 12.3%, 23.7%) increased with increasing BP category (P values ⩽.001). The adjusted odds ratio (95% confidence interval) for the primary composite was 2.0 (1.3–3.2) for 140–150/90–99 mm Hg and 3.2 (1.6–6.3) for 151–159/100–109 mm Hg compared with BP less than 140/90 mm Hg. The results for SGA were 1.6 (0.9–2.8) and 3.8 (1.8–7.9), respectively. Models including continuous systolic and diastolic BP revealed increasing adverse outcomes per 5-mm Hg rise in diastolic but not systolic BP: primary composite (19% per 5 mm Hg) and SGA (22% per 5 mm Hg). CONCLUSION: The risks of adverse pregnancy outcomes in women with chronic hypertension are lower with preenrollment BP less than 140/90 mm Hg as compared with higher BP categories and increase with increasing BP. LEVEL OF EVIDENCE: II

Mode of delivery in women with class III obesity: planned cesarean compared with induction of labor

OBJECTIVE To compare maternal and neonatal outcomes between planned cesarean delivery and induction of labor in women with class III obesity (body mass index ≥40 kg/m(2)). STUDY DESIGN In this retrospective cohort study, we identified all women with a body mass index ≥40 kg/m(2) who delivered a singleton at our institution from January 2007 to February 2013 via planned cesarean or induction of labor (regardless of eventual delivery route) at 37-41 weeks. Patients in spontaneous labor were excluded. The primary outcome was a composite of maternal morbidity including death as well as operative, infection, and thromboembolic complications. The secondary outcome was a neonatal morbidity composite. Additional outcomes included individual components of the composites. Student t, χ(2), and Fisher exact tests were used for statistical analysis. To calculate adjusted odds ratios, covariates were analyzed via multivariable logistic regression. RESULTS There are 661 mother-infant pairs that met enrollment criteria-399 inductions and 262 cesareans. Groups were similar in terms of prepregnancy weight, pregnancy weight gain, and delivery body mass index. Of the 399 inductions, 258 had cervical ripening (64.7%) and 163 (40.9%) had a cesarean delivery. After multivariable adjustments, there was no significant difference in the maternal morbidity composite (adjusted odds ratio, 0.98; 95% confidence interval, 0.55-1.77) or in the neonatal morbidity composite (adjusted odds ratio, 0.81; 95% confidence interval, 0.37-1.77) between the induction and cesarean groups. CONCLUSION In term pregnant women with class III obesity, planned cesarean does not appear to reduce maternal and neonatal morbidity compared with induction of labor.

Selective uptake of influenza vaccine and pregnancy outcomes

Abstract Objective: To describe the characteristics of pregnant women who accept the influenza vaccine and evaluate the relationship between vaccination and adverse pregnancy outcomes. Methods: Retrospective cohort study of women receiving prenatal care during the 2009–2011 influenza seasons. Vaccination status was ascertained through our perinatal record system and clinic vaccination logs. Pregnancy outcomes included a primary composite of miscarriage, fetal demise, preterm birth (PTB) <37 weeks and neonatal demise. Stratification and logistic regression were used to adjust for potential confounders. Results: Of 3104 eligible pregnant women, 1094 (35%) received the influenza vaccine. Women vaccinated were more likely to be older, obese, primiparae, and have medical complications or a prior PTB. In univariable analyses, flu vaccination was associated with increased adverse composite outcome and PTB. After multivariable adjustments, vaccination was no longer associated with adverse outcomes in women with medical complications but remained associated with adverse outcomes among those without known co-morbidity. Conclusions: Vaccination was associated with an increased adverse composite outcome in pregnant women without identified co-morbidity but not those with co-morbidities. This association is likely due to selection bias, which should be considered in planning of observational studies of the impact of vaccination on pregnancy outcomes.

Impact of sickle hemoglobinopathies on pregnancy-related venous thromboembolism

OBJECTIVE The aim of the study is to examine the relationship between sickle cell trait (Hb AS) and other sickle hemoglobinopathies and the risk of thromboembolism during pregnancy or the puerperium. STUDY DESIGN Retrospective cohort study of African American women receiving prenatal care from 1991 to 2006. Sickle cell status was ascertained by routine hemoglobin electrophoresis. Venous thromboembolism (VTE) was defined as one or more episodes of deep venous and/or pulmonary thromboembolism during pregnancy or the puerperium according to discharge diagnoses based on International Classification of Diseases, Ninth Revision codes. RESULTS Among 22,140 women with hemoglobin (Hb) AA status, 20 women (0.09%) experienced pregnancy-related VTE compared with 3 women (0.15%) of 2,037 women with Hb AS; relative risk (RR) for the association with AS status = 1.6; 95% confidence interval (CI) 0.5 to 5.5. Of 103 women, 3 women (2.9%) with sickle cell disease conditions (Hb SS, Hb SC, or Hb S,beta-thalassemia) experienced thromboembolism. Compared with women with Hb AA status, the RR = 32.2, 95% CI 9.7 to 107. CONCLUSION Sickle cell trait may be associated with a modest increase in VTE in the setting of pregnancy; sickle cell disease conditions are strongly associated with this rare but potentially fatal outcome.

The effect of omega-3 supplementation on pregnancy outcomes by smoking status.

BACKGROUND: Smoking during pregnancy is associated with adverse maternal and neonatal outcomes such as preterm delivery, intrauterine growth restriction, stillbirth, and low birth weight. Because smoking causes oxidative stress, some have suggested using antioxidants to counteract the effects of oxidative stress. Smokers have lower serum levels of omega‐3 fatty acids, an important antioxidant, and thus, investigating whether omega‐3 supplementation in smokers reduces adverse maternal and neonatal outcomes represents an important area of research. OBJECTIVE: To investigate whether the antioxidant effect of omega‐3 fatty acid supplementation on the incidence of adverse pregnancy outcomes differs between smokers and nonsmokers. STUDY DESIGN: Secondary analysis of a multicenter randomized controlled trial of omega‐3 supplementation for preterm delivery prevention in women with a singleton pregnancy and a history of a previous singleton spontaneous preterm delivery. Subjects were randomized to begin omega‐3 or placebo before 22 weeks, which was continued until delivery. All women received 17 alpha‐hydroxyprogesterone caproate intramuscularly weekly beginning between 16 and 20 weeks of gestation and continued until 36 weeks of gestation or delivery, whichever occurred first. The primary outcome was spontaneous preterm delivery. Secondary outcomes were indicated preterm delivery, any preterm delivery (spontaneous and indicated), pregnancy‐associated hypertension (gestational hypertension and preeclampsia), a neonatal composite (retinopathy of prematurity, intraventricular hemorrhage grade III or IV, patent ductus arteriosus, necrotizing enterocolitis, sepsis, respiratory morbidity, or perinatal death), low birth weight (<2500 g), small for gestational age (less than the 10th percentile), and neonatal intensive care unit or intermediate nursery admission. The study population was stratified into smokers and nonsmokers, and the incidence of each outcome was compared by omega‐3 supplementation versus placebo in each subgroup. Zelen tests were performed to test for homogeneity of effect in smokers and nonsmokers. RESULTS: Of 851 subjects included in the analysis, 136 (16%) smoked. Baseline characteristics between omega‐3 and placebo groups did not differ in smokers or nonsmokers. Omega‐3 supplementation was associated with a lower risk of spontaneous preterm delivery in smokers (relative risk, 0.56, 95% confidence interval, 0.36–0.87) but not in nonsmokers (relative risk 1.04, 95% confidence interval 0.84–1.29); P value for interaction = 0.013. Low birth weight was also less frequent in smokers receiving omega‐3 supplementation (relative risk 0.57, 95% confidence interval 0.36–0.90) compared with nonsmokers (relative risk 0.93, 95% confidence interval 0.71–1.24); P value for interaction = 0.047. The effect on other secondary outcomes did not differ significantly between smokers and nonsmokers. CONCLUSION: Omega‐3 supplementation in smokers may have a protective effect against recurrent spontaneous preterm delivery and low birth weight.

Risk Factors for Postcesarean Maternal Infection in a Trial of Extended-spectrum Antibiotic Prophylaxis

OBJECTIVE To identify maternal clinical risk factors for postcesarean maternal infection in a randomized clinical trial of preincision extended-spectrum antibiotic prophylaxis. METHODS We conducted a planned secondary analysis of a randomized clinical trial. Patients were 24 weeks of gestation or greater and delivered by cesarean after a minimum of 4 hours of ruptured membranes or labor. All participants received standard preincision prophylaxis and were randomized to receive azithromycin or placebo. The primary outcome for this analysis is maternal infection: a composite outcome of endometritis, wound infection (superficial or deep), or other infections occurring up to 6 weeks postpartum. Maternal clinical characteristics associated with maternal infection, after controlling for azithromycin assignment, were identified. These maternal factors were included in a multivariable logistic regression model for maternal infection. RESULTS Of 2,013 patients, 1,019 were randomized to azithromycin. Overall, 177 (8.8%) had postcesarean maternal infection. In the final adjusted model, compared with the reference groups, women of black race-ethnicity, with a nontransverse uterine incision, with duration of membrane rupture greater than 6 hours, and surgery duration greater than 49 minutes, were associated higher odds of maternal infection (all with adjusted odds ratios [ORs] of approximately 2); azithromycin was associated with lower odds of maternal infection (adjusted OR 0.4, 95% confidence interval 0.3-0.6). CONCLUSION Despite preincision azithromycin-based extended-spectrum antibiotic prophylaxis, postcesarean maternal infection remains a significant source of morbidity. Recognition of risk factors may help guide innovative prevention strategies. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov, NCT012235546.

Predictors of vaginal delivery in medically indicated early preterm induction of labor

Background When delivery is indicated prior to 34 weeks, many providers perform a cesarean delivery rather than induce labor based on perceptions of a high failure rate. Given the morbidity of cesarean delivery, an accurate estimate of the success rate and factors associated with success in preterm induction of labor is important in management decisions. Objective We sought to develop a prediction model for successful induction of labor in preterm patients using factors known at the time the decision is made to deliver. Study Design A retrospective cohort study of all live singletons undergoing an indicated induction of labor between 23 and 34 0/7 weeks from 2011 through 2015. Pregnancies with major fetal anomalies or no intrapartum fetal monitoring were excluded. Successful induction of labor was defined as vaginal delivery. The cohort was randomly split into a training cohort to develop a prediction model for vaginal delivery and a validation cohort to test the model. Factors significantly associated with vaginal delivery were identified using univariate analyses, and candidate factors were used in the multivariate logistic regression model. Only factors known at the start of the induction of labor were used in the model. Receiver‐operating characteristic curves were created to estimate the predictive value of the model. Sensitivity and specificity of the model were assessed. Results Of 331 patients who underwent induction of labor, 208 (62.8%) delivered vaginally and 123 (37.1%) by cesarean delivery. Of the factors significantly associated with cesarean delivery, the final model included gestational age, simplified Bishop score, suspected intrauterine growth retardation, chronic hypertension, and body mass index. In the training cohort, the model correctly classified 72.3% of subjects with a sensitivity (cesarean delivery predicted/cesarean delivery performed) of 56.7% and a specificity (vaginal delivery predicted/vaginal delivery performed) of 84.1%. When applied to the validation cohort, 73.9% of subjects were correctly classified, with a sensitivity of 44.6% and specificity of 89.0%. Receiver‐operating characteristic curves had an area under the curve of 0.75 for the training cohort and 0.77 for the validation cohort. Conclusion More than 60% of women undergoing induction of labor at <34 0/7 weeks deliver vaginally. For women undergoing induction of labor at <34 0/7 weeks, this prediction model rarely classifies individuals who can have a vaginal delivery as needing a cesarean delivery. This model may provide an accurate assessment tool to evaluate which patients will likely deliver vaginally to avoid the morbidity of cesarean delivery while conversely identifying subjects at high risk of cesarean delivery <34 0/7 weeks.

Risk factors for wound disruption following cesarean delivery.

Abstract Objective: Risk factors for post-cesarean wound infection, but not disruption, are well-described in the literature. The primary objective of this study was to identify risk factors for non-infectious post-cesarean wound disruption. Methods: Secondary analysis was conducted using data from a single-center randomized controlled trial of staple versus suture skin closure in women ≥24 weeks’ gestation undergoing cesarean delivery. Wound disruption was defined as subcutaneous skin or fascial dehiscence excluding primary wound infections. Composite wound morbidity (disruption or infection) was examined as a secondary outcome. Patient demographics, medical co-morbidities, and intrapartum characteristics were evaluated as potential risk factors using multivariable logistic regression. Results: Of the 398 randomized patients, 340, including 26 with disruptions (7.6%) met inclusion criteria and were analyzed. After multivariable adjustments, African-American race (aOR 3.9, 95% CI 1.1–13.8) and staple – as opposed to suture – wound closure (aOR 5.4, 95% CI 1.8–16.1) remained significant risk factors for disruption; non-significant increases were observed for body mass index ≥30 (aOR 2.1, 95% CI 0.6–7.5), but not for diabetes mellitus (aOR 0.9, 95% CI 0.3–2.9). Results for composite wound morbidity were similar. Conclusions: Skin closure with staples, African-American race, and considering the relatively small sample size, potentially obesity are associated with increased risk of non-infectious post-cesarean wound disruption.