Dana Figueroa

Relationship between 1-hour glucose challenge test results and perinatal outcomes

OBJECTIVE: To estimate the relationship between 1-hour 50 g glucose challenge test values and perinatal outcomes. METHODS: This was a secondary analysis of data from a multicenter treatment trial of mild gestational diabetes mellitus. Women with glucose challenge test values of 135–199 mg/dL completed a 3-hour oral glucose tolerance test. Mild gestational diabetes mellitus was defined as fasting glucose less than 95 mg/dL and two or more abnormal oral glucose tolerance test values: 1-hour 180 mg/dL or more; 2-hour 155 mg/dL or more; and 3-hour 140 mg/dL or more. Our study included untreated women with glucose challenge test values of 135–139 mg/dL and 140–199 mg/dL and a comparison group with values less than 120 mg/dL. Primary outcomes included a perinatal composite (stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia, and birth trauma), large for gestational age (LGA, birth weight above the 90th percentile based on sex-specific and race-specific norms), and macrosomia (greater than 4,000 g). RESULTS: There were 436 women with glucose challenge test values less than 120 mg/dL and 1,403 with values of 135 mg/dL or more (135–139, n=135; 140–199, n=1,268). The composite perinatal outcome occurred in 25.6% of those with glucose challenge test values less than 120 mg/dL compared with 21.1% for values of 135–139 mg/dL and 35.3% for values of 140–199 mg/dL. Rates of LGA by group were 6.6%, 6.8%, and 12.4%, respectively. Rates of macrosomia by group were 7.8%, 6.1%, and 12.1%, respectively. Compared with glucose challenge test values less than 120 mg/dL, the adjusted odds ratios (ORs) (95% confidence intervals [CIs]) for values of 140–199 mg/dL were 1.48 (1.14–1.93) for the composite outcome, 1.97 (1.29–3.11) for LGA, and 1.61 (1.07–2.49) for macrosomia. For glucose challenge test values of 135–139 mg/dL, adjusted ORs and 95% CIs were 0.75 (0.45–1.21), 1.04 (0.44–2.24), and 0.75 (0.30–1.66), respectively. The subcategories with glucose challenge test values of 140–144 mg/dL and 145–149 mg/dL also were associated with an increase in selected outcomes when compared with those with values less than 120 mg/dL. CONCLUSIONS: Glucose challenge test values of 135–139 mg/dL were not associated with adverse outcomes compared with values less than 120 mg/dL; however, glucose challenge test values of 140 mg/dL or more were associated with an increase in odds of the composite perinatal outcome, LGA, and macrosomia. LEVEL OF EVIDENCE: II

Higher-Dose Oxytocin and Hemorrhage After Vaginal Delivery: A Randomized Controlled Trial

OBJECTIVE: Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally. METHODS: In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups. RESULTS: Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62–1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61–1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19–0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69–0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups. CONCLUSION: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062. LEVEL OF EVIDENCE: I

Does midtrimester Nugent score or high vaginal pH predict gestational age at delivery in women at risk for recurrent preterm birth

OBJECTIVE To estimate whether bacterial vaginosis, as defined by either Nugent score or vaginal pH, predicts gestational age at delivery in women at risk for recurrent preterm birth. STUDY DESIGN Planned secondary analysis of a randomized cerclage trial in women with prior spontaneous preterm birth 17⁰(/)⁷-33⁶(/)⁷ weeks. Vaginal Gram stain and pH were collected at the initial study visit. Women not assigned to cerclage, either because they did not experience cervical shortening <25 mm or because they were randomly assigned to no cerclage, were studied. RESULTS Seven hundred eighty-six women had complete delivery gestational age, Gram stain, and pH results. The diagnosis of bacterial vaginosis by either Nugent score ≥ 7 or by pH ≥ 5 was not associated with earlier birth. CONCLUSION The presence of bacterial vaginosis at 16-21⁶(/)⁷ weeks does not predict gestational age at birth in women at risk for recurrent preterm birth.

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.

Wound morbidity with staples compared with suture for cesarean skin closure by diabetic status

Abstract Objective: To determine if the risk of post-cesarean wound morbidity in patients undergoing staple versus suture closure is modified by diabetic status. Methods: Secondary analysis of a randomized trial of skin closure with subcuticular 4-0 monocryl suture or surgical staples after cesarean delivery. The primary outcome was a composite of wound disruption or infection within 4–6 weeks. We compared the association between this outcome and skin closure method by diabetic status (also stratified by gestational or pregestational) using the Breslow–Day test for interaction. Results: Of 350 patients, 179 were randomized to staples and 171 to suture. Of the 67 (19.1%) diabetic patients, 35 were gestational and 32 pregestational. The incidence of composite wound morbidity in non-diabetics was 16.7% for staples and 3.6% for suture (p ≤ 0.001, RR: 4.6, 95% CI: 1.8–11.8); it was 5.7% for staples and 15.6% for sutures in diabetics (p = 0.25, RR: 0.4, 95% CI: 0.1–1.7). The corresponding Breslow–Day p value indicated a significant difference between diabetics and non-diabetics (p = 0.002). Stratified further by gestational and pregestational diabetes, the RRs were 0.3 (95% CI: 0.03–2.4) and 0.5 (95% CI: 0.05–5.0) compared to non-diabetics, respectively. Each diabetic sub-group was significantly different from non-diabetics (Breslow–Day p values for homogeneity p = 0.005 and p = 0.045, respectively). Conclusions: The use of staples compared with subcuticular suture for cesarean skin closure is associated with increased wound morbidity. While this is true for non-diabetics, further studies of diabetics are needed to evaluate for a null or opposite effect of closure type.