George Lu

Subcutaneous Tissue Reapproximation, Alone or in Combination With Drain, in Obese Women Undergoing Cesarean Delivery

OBJECTIVE: To compare the efficacy of subcutaneous suture reapproximation alone with suture plus subcutaneous drain for the prevention of wound complications in obese women undergoing cesarean delivery. METHODS: We conducted a multicenter randomized trial of women undergoing cesarean delivery. Consenting women with 4 cm or more of subcutaneous thickness were randomized to either subcutaneous suture closure alone (n = 149) or suture plus drain (n = 131). The drain was attached to bulb suction and removed at 72 hours or earlier if output was less than 30 mL/24 h. The primary study outcome was a composite wound morbidity rate (defined by any of the following: subcutaneous tissue dehiscence, seroma, hematoma, abscess, or fascial dehiscence). RESULTS: From April 2001 to July 2004, a total of 280 women were enrolled. Ninety-five percent of women (268/280) had a follow-up wound assessment. Both groups were similar with respect to age, race, parity, weight, cesarean indication, diabetes, steroid/antibiotic use, chorioamnionitis, and subcutaneous thickness. The composite wound morbidity rate was 17.4% (25/144) in the suture group and 22.7% (28/124) in the suture plus drain group (relative risk 1.3, 95% confidence interval 0.8–2.1). Individual wound complication rates, including subcutaneous dehiscence (15.3% versus 21.8%), seroma (9.0% versus 10.6%), hematoma (2.2% versus 2.4%), abscess (0.7% versus 3.3%), fascial dehiscence (1.4% versus 1.7%), and hospital readmission for wound complications (3.5% versus 6.6%), were similar (P > .05) between women treated with suture alone and those treated with suture plus drain, respectively. CONCLUSION: The additional use of a subcutaneous drain along with a standard subcutaneous suture reapproximation technique is not effective for the prevention of wound complications in obese women undergoing cesarean delivery. LEVEL OF EVIDENCE: I

Vaginal fetal fibronectin levels and spontaneous preterm birth in symptomatic women

Objective To relate vaginal fetal fibronectin levels in women with symptoms of preterm labor to subsequent spontaneous preterm birth. Methods Quantitative fetal fibronectin values were calculated from women who participated in two prospective multicenter trials relating fetal fibronectin to subsequent spontaneous preterm birth. The study populations consisted of women who presented with symptoms of preterm labor between 240/7 and 346/7 weeks, a singleton pregnancy, intact membranes, no prior tocolysis, and cervical dilation less than 3 cm. Results The characteristics of the two study populations were similar. In both populations, the rates of delivery within 7, 14, and 21 days after sampling were clustered into three distinct fetal fibronectin groups (less than 40, 40–100, and 100 ng/mL or more). As fetal fibronectin values increased, the risk of subsequent spontaneous preterm birth also increased. Delivery within 7 days of sampling was 0.4%, 3.3%, and 18.2% (trial A) and 1.4%, 8.0%, 30.0% (trial B) as the fetal fibronectin levels increased from less than 40 ng/mL, to 40–100 ng/mL, and to at least 100 ng/mL, respectively. Conclusion In women with symptoms of preterm labor, an increase in fetal fibronectin from under 40 ng/mL, to 40–100 ng/mL, to at least 100 ng/mL was associated with a progressive increase in the risk of subsequent spontaneous preterm birth. The use of a single fetal fibronectin cutoff of 50 ng/mL for defining a positive test in women with symptoms of preterm labor should be reevaluated.

Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial.

OBJECTIVE: To compare the efficacy of transcervical Foley catheter alone (Foley) to transcervical Foley catheter with extraamniotic saline infusion for labor induction and cervical ripening in women with an unfavorable cervix. METHODS: This was a multicenter, randomized, controlled trial of women presenting for labor induction with a singleton, cephalic fetus, intact membranes, and unfavorable cervix (Bishop score 6 or less). Eligible women were randomly assigned to receive either Foley catheter alone or Foley catheter with extraamniotic saline infusion. All women received concurrent oxytocin administration. The primary study outcome was the induction-to-delivery interval. Secondary outcomes included cesarean delivery, maternal infectious outcomes, and immediate neonatal outcomes. Analysis was by intent to treat. RESULTS: One hundred eighty-eight women met eligibility criteria and were randomly assigned (Foley plus extraamniotic saline infusion, n=97; Foley, n=91). Baseline demographic characteristics, including parity, gestational age, and Bishop score were similar between the study groups. The median induction-to-delivery interval in the extraamniotic saline infusion arm (12.6 hours, interquartile range 9.3–18.8 hours) was similar to that in the Foley arm (13.4 hours, interquartile range 9.6–17.5 hours) (P=. 70). The proportion of women delivered by 24 hours was comparable between groups (delivery 24 hours, extraamniotic saline infusion 89.7%, Foley 87.9%, P=.70), as was the rate of cesarean delivery (Foley 18.7%, extraamniotic saline infusion 27.8%, P=.14). No significant differences were noted between the study groups with respect to rate of chorioamnionitis, endometritis, or immediate birth outcomes. CONCLUSION: In women with an unfavorable cervix, the addition of extraamniotic saline infusion to a transcervical Foley catheter does not improve efficacy for labor induction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00442663 LEVEL OF EVIDENCE: I

CURRENT CONCEPTS ON THE PATHOGENESIS AND MARKERS OF PRETERM BIRTHS

Preterm births remain a major cause of neonatal morbidity and mortality despite our efforts over the past several decades. Our improved understanding of the complex mechanisms surrounding preterm labor, however, has resulted in the development of numerous biologic and clinical predictors of spontaneous preterm births. These developments offer the exciting prospect for the creation of specific interventions that are directed toward the various pathways involved with preterm births.

Is there a preferred gestational age threshold of viability?: a survey of maternal-fetal medicine providers.

Objective. To characterize variation and factors associated with the perceived gestational age for the threshold of viability among maternal-fetal medicine (MFM) providers. Methods. We performed a web-based online survey of 1375 MFM providers. For this secondary analysis, a subset of survey questions targeted toward perceptions of the limit of viability was analyzed to identify how the respondents viewed the optimal threshold of viability gestational age. Comparative statistics were performed to assess various characteristics that influence the perceived threshold of viability. Results. Five hundred and eight providers (37%), representing all 50 states and 13 countries, responded to the survey. The reported threshold of viability varied among survey respondents: 22 weeks, 2.0%; 23 weeks, 37.2%; 24 weeks, 55.3%; 25 weeks, 3.4%; and 26 weeks, 2.2%. No significant differences were noted in the reported threshold of viability with respect to practitioner age (<50 years old vs. ≥50 years old, p = 0.42), nursery availability (level III vs. other, p = 0.46), and years in practice (<10 years vs. ≥10 years, p = 0.86). Significant differences in the reported threshold of viability were noted with respect to practitioner gender with males tending to have a lower gestational age threshold than females (p = 0.005). Significant differences were also noted among practitioners from academic vs. community/private practice settings (p = 0.008). A logisitic regression model, adusting for both gender and practice setting, revealed that male gender was independently associated with selection of a threshold of viability less than 24 weeks of gestation: male gender OR 1.8 (95% CI 1.3–2.7, p = 0.002); academic practice setting OR 1.1 (95% CI 0.8–1.6, p = 0.50). Conclusions. Perceived threshold of viability among MFM providers varies with the majority of practitioners identifying 23–24 weeks of gestation. Significant difference, however, exists between practitioner genders.

17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial

BackgroundProgestational agents may reduce the risk of preterm birth in women with various risk factors. We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate (17P) given to women with preterm rupture of the membranes (PROM) will prolong pregnancy and thereby reduce neonatal morbidity.MethodsDouble-blind, placebo-controlled randomized clinical trial. Women with PROM at 23.0 to 31.9 weeks of gestation were randomly assigned to receive a weekly intramuscular injection of 17P (250 mg in 1 mL castor oil) or placebo (1 mL castor oil). The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation. Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity. Enrollment of 111 participants per group, 222 total, was planned to yield 80% power to detect an increase in the primary outcome from 30% with placebo to 50% with 17P.ResultsTwelve women were enrolled of whom 4 were randomly assigned to receive 17P and 8 to receive placebo. The trial was terminated prematurely because of two separate issues related to the supply of 17P. No adverse events attributable to 17P were identified.ConclusionBecause of premature termination, the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM. Nonetheless, ethical principles dictate that we report the results, which may contribute to possible future metaanalyses and systematic reviews.Trial RegistrationClinicalTrials.gov: NCT01119963Supported by a research grant from the Center for Research, Education, and Quality, Pediatrix Medical Group, Sunrise, FL

The impact of lower threshold values for the detection of gestational diabetes mellitus

Abstract Objective: To compare the 4th International Workshop-Conference on Gestational Diabetes Mellitus (GDM) 100-g OGTT (NEW) criteria to the current ACOG criteria. Methods: An analysis of a comprehensive perinatal database (1991–1998) identified women with singletons who underwent a 100-g OGTT after an abnormal 50-g GCT performed at 24 weeks or more. Women were classified into three groups for comparison: those who met the ACOG criteria and received diet or insulin therapy or both; those who did not meet ACOG criteria, but did meet the NEW criteria; and those who met neither criteria (non-GDM). Results: Of 3,253 women, 478 women met ACOG criteria, 319 women would have been reclassified as GDM by the NEW criteria, and 2,456 women met neither criteria. The selected characteristics and outcomes (%) for the three groups are as follows: legend . legend Cesarean LGA BWT ≥4,000 g Shoulder dystocia Non-GDM 17.5 18.4 9.7 5.5 NEW 21.8 28.1 17.0 7.3 ACOG 26.5 29.0 16.5 8.7 P value NS legend LGA indicates large for gestational age; BWT, birth weight. After controlling for confounders (including maternal weight, age, race, parity, and smoking status), the adjusted odds ratios and 95% CI, compared with non-GDM women are as follows: Cesarean LGA BWT ≥4,000 g Shoulder dystocia NEW 1.4 (1.0, 1.9) 1.3 (0.98, 1.8) 1.6 (1.1, 2.3) 1.7 (0.6, 4.6) ACOG 1.5 (1.1, 1.9) 1.5 (1.2, 2.0) 1.4 (1.0, 2.0) 2.5 (1.1, 5.5) Conclusions: At our institution, utilization of the NEW criteria would increase the diagnosis of GDM by 40% and identify gravidas with similar risks of cesarean delivery and macrosomia as those with GDM diagnosed by ACOG criteria. Whether or not standard GDM therapy in women with the disease diagnosed by the NEW criteria can reduce the incidence of cesarean delivery and macrosomia to rates comparable with non-GDM women remains to be verified by well-designed randomized controlled studies.

17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial.

OBJECTIVE Preterm rupture of membranes (PROM) is associated with an increased risk of preterm birth and neonatal morbidity. Prophylactic 17-hydroxyprogesterone caproate (17OHP-C) reduces the risk of preterm birth in some women who are at risk for preterm birth. We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes. STUDY DESIGN This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. The study included singleton pregnancies with gestational ages from 23(0/7) to 30(6/7) weeks at enrollment, documented PROM, and no contraindication to expectant management. Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C (250 mg) or placebo. The primary outcome was continuation of pregnancy until a favorable gestational age, which was defined as either 34(0/7) weeks of gestation or documentation of fetal lung maturity at 32(0/7) to 33(6/7) weeks of gestation. The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome. The planned sample size was 222 total women. RESULTS From October 2011 to April 2014, 152 women were enrolled; 74 women were allocated randomly to 17OHP-C, and 78 were allocated randomly to placebo. The trial was stopped when results of a planned interim analysis suggested that continuation was futile. The primary outcome was achieved in 3% of the 17OHP-C group and 8% of the placebo group (P = .18). There was no significant between-group difference in the prespecified secondary outcomes, randomization-to-delivery interval (17.1 ± 16.1 vs 17.0 ± 15.8 days, respectively; P = .76) or composite adverse perinatal outcome (63% vs 61%, respectively; P = .93). No significant differences were found in other outcomes, which included rates of chorioamnionitis, postpartum endometritis, cesarean delivery, individual components of the composite outcome, or prolonged neonatal length of stay. CONCLUSION Compared with placebo, weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial.

Traditional Dressing Compared With an External Negative Pressure System in Preventing Wound Complications

INTRODUCTION: The cesarean delivery rate has increased and accounts for 32.8% of all births. Wound complications are one of the most frequent risks of cesarean delivery. Our objective is to determine whether the use of a Prevena negative pressure dressing can reduce the incidence of wound complications after cesarean delivery when compared with traditional dressings. METHODS: We performed a retrospective review of all patients undergoing cesarean delivery at our institution between November 2011 and March 2013. Information was obtained regarding demographics, indication for cesarean delivery, duration of labor, infections, incision and dressing type, and postoperative course. Comparisons were made between traditional dressing and those who had a Prevena placed. RESULTS: Wound complications occurred in 50 patients (5.2%). Comparisons of the Prevena (n=103) and traditional dressing (n=867) groups revealed higher wound complications for the Prevena dressing with an odds ratio (OR) of 3.37 (confidence interval [CI] 1.68–6.39). Prevena was more commonly used in patients who are obese and have preexisting diabetes. After controlling for body mass index and preexisting diabetes in logistic regression, Prevena was equivalent to traditional dressing for risk of wound complications with an adjusted OR of 1.70 (CI 0.76–3.84). CONCLUSIONS: Prevena dressing is equivalent to traditional dressing for preventing any wound complications after controlling for the higher-risk population selected for its use. A randomized clinical trial and cost analysis should be performed before the adoption of the routine use of Prevena™ in clinical practice.

Removal versus retention of cerclage in preterm premature rupture of membranes: a randomized controlled trial

OBJECTIVE The decision of whether to retain or remove a previously placed cervical cerclage in women who subsequently rupture fetal membranes in a premature gestation is controversial and all studies to date are retrospective. We performed a multicenter randomized controlled trial of removal vs retention of cerclage in these patients to determine whether leaving the cerclage in place prolonged gestation and/or increased the risk of maternal or fetal infection. STUDY DESIGN A prospective randomized multicenter trial of 27 hospitals was performed. Patients included were those with cerclage placement at ≤23 weeks 6 days in singleton or twin pregnancies, with subsequent spontaneous rupture of membranes between 22 weeks 0 days and 32 weeks 6 days. Patients were randomized to retention or removal of cerclage. Patients were then expectantly managed and delivered only for evidence of labor, chorioamnionitis, fetal distress, or other medical or obstetrical indications. Management after 34 weeks was at the clinicians discretion. RESULTS The initial sample size calculation determined that a total of 142 patients should be included but after a second interim analysis, futility calculations determined that the conditional power for showing statistical significance after randomizing 142 patients for the primary outcome of prolonging pregnancy was 22.8%. Thus the study was terminated after a total of 56 subjects were randomized with complete data available for analysis, 32 to removal and 24 to retention of cerclage. There was no statistical significance in primary outcome of prolonging pregnancy by 1 week comparing the 2 groups (removal 18/32, 56.3%; retention 11/24, 45.8%) P = .59; or chorioamnionitis (removal 8/32, 25.0%; retention 10/24, 41.7%) P = .25, respectively. There was no statistical difference in composite neonatal outcomes (removal 16/33, 50%; retention 17/30, 56%), fetal/neonatal death (removal 4/33, 12%; retention 5/30, 16%); or gestational age at delivery (removal mean 200 days; retention mean 198 days). CONCLUSION Statistically significant differences were not seen in prolongation of latency, infection, or composite neonatal outcomes. However, there was a numerical trend in the direction of less infectious morbidity, with immediate removal of cerclage. These findings may not have met statistical significance if the original sample size of 142 was obtained, however they provide valuable data suggesting that there may be no advantage to retaining a cerclage after preterm premature rupture of membranes and a possibility of increased infection with cerclage retention.