Objective The random urine protein-to-creatinine ratio (UPCR) is a screening test used for predicting clinically significant proteinuria (urine protein >= 300 mg) during pregnancy. No consensus exists on the optimal random UPCR cutoff for performing follow-up 24 hour urine (24H) total protein collection. We aim to evaluate the test performance of random UPCR in predicting proteinuria in a contemporary cohort. Study Design This was a retrospective cohort study of pregnant patients at our institution from 2014 to 2018 with a random UPCR and follow-up 24H protein collection. The primary analysis estimated the test characteristics (sensitivity, specificity, positive and negative predictive values) of using random UPCR for the detection of proteinuria defined as urine protein >= 300 mg on 24H protein collection. UPCR cutoffs from 0.10 to 0.30 mg/dL were evaluated, receiver operator characteristic (ROC) curve was constructed, and area under the curve (AUC) was determined. A secondary analysis examined the correlation between UPCR and 24H protein using least squares regression and Pearson correlation. Results Paired UPCR and 24H collection results were available for 1,120 patients. Mean gestational age at time of UPCR was 31.1 +/- 5.1 weeks and 687 (61.3%) of patients had a 24H >= 300 mg. UPCR <0.10 mg/dL effectively excluded proteinuria >= 300 mg on 24H collection, while UPCR >= 0.18 mg/dL correctly classifies proteinuria with 91% sensitivity, 57% specificity, 77% positive predictive value, and 79% negative predictive value. UPCR >= 1.07 mg/dL had 100% specificity for 24 hour proteinuria. The area under ROC curve was 0.86. UPCR and 24H collection were highly correlated with a Pearson correlation coefficient of 0.85. After our institution lowered the threshold to obtain a 24H from UPCR >= 0.20 mg/dL to >= 0.10 mg/dL in May 2017, the percentage of patients meeting criteria for 24H collection increased from 57.8 to 84.4%. Conclusion The AUC and Pearson correlation suggest random UPCR is a high performance test for the prediction of proteinuria on 24H. Optimal test performance is dependent upon clinical consideration and upon the implications of the disease or condition. A random UPCR screen positive threshold of 0.18 mg/dL maximizes sensitivity to identify clinically significant proteinuria. Key Points Random urine protein to creatinine ratio is a high performance test for proteinuria. A random UPCR threshold of 0.18 mg/dL maximizes sensitivity to identify proteinuria.
Abstract Objectives To identify if there is an increased risk for spontaneous preterm birth (sPTB) across the continuum of measured, normal cervical lengths (CL) in low-risk women. Methods Retrospective cohort study of women with singleton pregnancies and no history of prior sPTB. Women were included if they underwent mid-trimester transvaginal CL measurement between February 2016 and August 2018 and had a measured, normal CL ≥25mm. Women were excluded for progesterone exposure, fetal anomalies, or an unmeasurable CL due to a poorly developed lower uterine segment. The primary study outcome was sPTB <37 weeks. Secondary outcomes included: sPTB <35 weeks, birth gestational age (GA), and the number of hospital evaluations for suspected preterm labor (PTL). Cervical length was considered in interval groups 25–29mm, 30–34mm, 35–39mm, 40–44mm, and ≥45mm. Outcomes were analyzed with χ2 test of trend and as a continuum (linear models, logistic regression and ROC curve), where appropriate. Results 985 women were included. The incidence of sPTB <37 weeks was 3.7%, with a mean birth GA of 38.7 ± 2.4 weeks. The odds of sPTB <37 weeks decreased with increasing cervical length, considered in 5 mm intervals (odds ratio = 0.67; 95% confidence interval 0.49–0.90) and an increasing birth GA of 1 additional day for each CL increase of 3mm (p = .0002). Conversely, sPTB <35 weeks (p = .49) and mean hospital evaluations for PTL (p = .26) were similar across groups. The ROC curve area-under-the-curve for sPTB <37 weeks of 0.64 showed poor predictive value. Conclusions Among women without a history of sPTB, there was an association of decreased risk of sPTB <37 weeks and advanced delivery GA with increasing, but normal-range CL measurements. However, the association was poor and was not associated with spontaneous preterm birth <35 weeks, or the number of hospital evaluations for PTL.
BACKGROUND: Preeclampsia with severe features when diagnosed at less than 34 weeks is associated with maternal morbidity and is managed by immediate delivery or inpatient expectant management. OBJECTIVE: This study aimed to compare maternal morbidity in women with preeclampsia with severe features in whom the American College of Obstetricians and Gynecologists recommends immediate delivery versus those eligible for expectant management. STUDY DESIGN: This was a retrospective cohort study of women with preeclampsia with severe features delivered between 23 to 34 weeks of gestation from 2013 to 2017 at a single tertiary center. Women were categorized into 2 groups: (1) those recommended by the American College of Obstetricians and Gynecologists for immediate delivery, that is, ineligible for expectant management, and (2) those eligible for expectant management. The primary outcome was composite postpartum maternal morbidity, which included maternal intensive care unit admission, stroke, death, and other severe morbidities. The secondary outcomes included select adverse perinatal outcomes. Groups were compared and adjusted odds ratios (95% confidence intervals) calculated. RESULTS: Of the 1172 women with preeclampsia identified during the study period, 543 with preeclampsia with severe features were included for analysis: 211 (39%) were ineligible for expectant management and 332 (61%) were eligible for expectant management. Baseline characteristics, including age, body mass index, race and ethnicity, parity, marital status, and gestational age at preeclampsia diagnosis, were similar between the 2 groups. Women ineligible for expectant management had significantly higher composite postpartum maternal morbidity (adjusted odds ratio, 5.02 [95% confidence interval, 1.35-18.69]). In addition, those ineligible for expectant management were more likely to have postpartum intensive care unit admission (adjusted odds ratio, 4.19 [95% confidence interval, 1.09-16.16]) and postpartum hemoglobin level of >7 g/dL (adjusted odds ratio, 5.07 [95% confidence interval, 1.35-19.08]). There was no demonstrable difference in neonatal outcomes between the 2 groups. CONCLUSION: Women with preeclampsia with severe features who were ineligible for expectant management per the American College of Obstetricians and Gynecologists guidelines had a 5-fold increased risk of maternal morbidity, confirming the need for escalation of care and delivery without delay.
Early amniotomy (AROM) during induction (IOL) shortens labor in term patients, but optimal timing of AROM has not been prospectively studied in preterm IOL. A prior retrospective study in preterm patients showed early AROM may be associated with increased risk of cesarean delivery (CD). We tested the hypothesis that late AROM compared to early decreases the risk of CD in preterm IOL. RCT (NCT03504670) of singleton pregnancies undergoing IOL between 23w0d and 35w6d gestation with reassuring fetal status and vertex presentation. Women were excluded for planned CD, labor contraindications, dilation >= 4cm, signs of spontaneous labor, ruptured membranes, chorioamnionitis, IUFD, major fetal anomaly, HIV, Hepatitis B or C, or plan for no fetal intervention. Women were randomized 1:1 to late (>= 4cm dilation) vs early (< 4cm) AROM. Both groups underwent IOL according to institutional protocol with combinations of cervical foley, oxytocin, and/or misoprostol. Primary outcome was CD. Secondary outcomes included labor duration, composite maternal morbidity and composite neonatal morbidity. Based on historical data, we powered to detect a 2.5-fold relative risk with a cross-over of 7.5% and a baseline CD risk of 62.5%. A sample size of 43 per group was required for 80% power and alpha=0.05. Intention-to-treat analysis was performed. Of 695 screened, 43 women were randomized per group (Figure). There were no differences in BMI (41.3 vs 39.1 kg/m2), gestational age (32.9 vs 32.8 wks), delivery indication (preeclampsia: 100% vs 95.4%), parity (1.05 vs 1.09), prior CD, comorbidities, cervical exam, or other baseline characteristics. CD did not significantly differ between groups (58.1 vs 53.5%, p=0.664; RR 1.11, 95% CI 0.69-1.79), nor did duration of labor (Table) or indications for CD. Composite maternal and neonatal morbidity did not differ based on timing of AROM (Table). In women undergoing preterm induction, late AROM did not reduce the risk of CD. Larger studies are needed to further evaluate whether early AROM reduces CD, length of labor, and maternal and neonatal morbidity.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
To identify whether a poorly developed lower uterine segment (PDLUS) observed during cervical length (CL) screening affects the duration of gestation in women with no prior spontaneous preterm birth (sPTB).
Guidelines for serial laboratory evaluation in women undergoing expectant management (EM) of preeclampsia (PE) are driven by expert opinion. We evaluated an optimal frequency for lab assessment in women with PE undergoing EM. Retrospective cohort study of women with EM of PE ≥23 weeks at a single tertiary care center from 2015-2018. Women not undergoing EM (by individual chart review), with lab abnormality (LA) at initial diagnosis or < 2 lab sets (platelets, aspartate aminotransferase, serum creatinine) prior to decision to deliver were excluded. Women were categorized by initial diagnosis: PE, superimposed PE (SiPE), and their forms with severe features (SPE/SiSPE). Lab testing was obtained weekly for PE/SiPE and 2x/week for SPE/SiSPE until delivery (additional labs done for blood pressures/symptoms). Logistic regression analysis modeled development of LA as a function of testing time intervals (days) for each PE type. Receiver operating characteristic (ROC) curves, areas under the curve (AUC), and optimal cutpoints were calculated. Optimal cutoffs and corresponding time intervals with highest sensitivity (SN), specificity (SP) or negative predictive value (NPV) were determined visually. 636 women were analyzed: 317 (50%) PE, 171 (27%) SiPE, 83 (13%) SPE and 65 (10%) SiSPE at presentation. Only 40 (6%) developed LA: 25 with PE, 9 SiPE, 4 SPE and 2 SiSPE. The model of all PE classes (n=636) had poor predictive value (AUC=0.63) and no clinically useful cutoff. Stratified by PE class, time intervals were most predictive for SPE and SiSPE, while least predictive for SiPE (Figure). ROC curves for each of the 4 groups revealed different cutpoints and test characteristics (Table). Optimal cutoffs were 3-4 days in the PE model (SN=0.64, NPV=0.96) and 1 day for SPE (SN=0.75, NPV= 0.98). Individual PE types should undergo serial lab evaluation based on their risk of developing LA- every 3-4 days for PE and daily for SPE. Studies should investigate the duration of this testing and the impact of utilizing optimal lab evaluation strategies on cost and perinatal outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Objective The percentage of operative vaginal deliveries (OVDs) in the United States has sharply declined. In May 2016, our institution's obstetrics and gynecology (OB/GYN) residency program implemented a twice-yearly OVD curriculum consisting of didactics and simulation. We sought to evaluate the impact of this curriculum. Study Design We performed a retrospective cohort study of all deliveries at our institution from July 2011 to May 2018. Deliveries were evaluated quarterly for the pre- (July 2011–April 2016) and postcurriculum (July 2016–May 2018) periods. Forceps-assisted vaginal delivery (FAVD), vacuum-assisted vaginal delivery (VAVD), and total OVD percentages, and the ratio of forceps to vacuums were calculated. Pre- and postcurriculum percentages were compared using Wilcoxon's rank-sum test. Cubic regression curves were fit to quarterly percentages to illustrate trends over time. Results The quarterly OVD percentage was unchanged following curriculum implementation (mean 3.2% [Q1–Q3: 2.6–3.5%] pre- vs. 3.1% [2.5–3.8%] post-, p > 0.99). The FAVD percentage was increased (1.2% [0.8–1.5%] vs. 2.0% [1.4–2.6%], p = 0.027) and the VAVD percentage was decreased (2.0% [1.6–2.2%] vs. 1.2% [0.9–1.3%], p < 0.001). This was accompanied by an increase in the ratio of FAVD to VAVD (0.6 [0.4–0.8] vs. 1.7 [1.3–2.2], p < 0.001). FAVD percentage (3.1%) was higher in the last quarter than any other quarter in the 7-year study period, and total OVD percentage (3.9%) was higher in 2018 than any other calendar year. Conclusion The implementation of an OVD curriculum in our OB/GYN residency program resulted in an increase in the percentage of FAVD and the ratio of FAVD to VAVD. Key Points
Cervical length (CL) screening is an effective adjunct to reduce recurrent spontaneous preterm birth (sPTB) in high-risk women. While the efficacy of universal screening in women with no prior sPTB is debated, studies have shown benefit to identifying low-risk women with shortened CL ≤20 mm. In high-risk women a range of normal CLs (≥25 mm) has been associated with a stable risk of recurrent sPTB; however, it is unclear how rates of sPTB vary over a range of measured-normal CLs in low-risk women. Retrospective cohort of women with singletons and no prior sPTB who had universal mid-trimester transvaginal CL screening 1/2016-8/2018 and a measured (Normal) CL ≥25mm. We excluded fetal anomalies or an unmeasurable CL due to a poorly-developed lower uterine segment. The primary outcome was sPTB < 37 wk. We considered CL in interval groups: 25-29 mm, 30-34 mm, 35-39 mm, 30-44 mm, and ≥45 mm (χ2 test of trend) and as a continuum (logistic regression and ROC curve). A secondary outcome was the number of hospital evaluations for suspected preterm labor (PTL). 990 low-risk women were included. The incidence of sPTB < 37 wk was 3.6%; mean CL was 39.2±6.0 mm (interdecile range=31.6, 47.0), measured at 19.4±1.1 wk. The median number of PTL evaluations was 0 (range 0-4) and mean birth gestational age was 38±2.4 wk. There was a significant decreasing trend in rates of sPTB across increasing CL groups (p=0.001; Table). Increasing CL as a continuous variable was also associated with a significantly lower odds of sPTB (OR=0.92, 95% CI 0.87, 0.98). However, the number of evaluations for suspected PTL was not associated with CL (p=0.55). The ROC (Figure) AUC for sPTB was only 0.64, suggesting that a range of normal CLs in low-risk women was a poor predictor of sPTB. Among low-risk women with a normal CL observed during mid-trimester screening, there was only a modest effect of a range of measured-normal CLs on sPTB < 37 wk and no significant association with the number of hospital evaluations for PTL.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Guidelines for serial laboratory evaluation (platelets (Plt), aspartate aminotransferase (AST), serum creatinine (Cr)) for expectant management (EM) of preeclampsia (PE) are based on expert opinion. We compared the frequency and timing of laboratory abnormalities (LA) in women with PE undergoing EM. Retrospective cohort of women with EM of PE ≥ 23 weeks at a single tertiary care center from 2015-2018. Women not undergoing EM (by individual chart review), with LA (Plt < 100K, AST > 80, or Cr > 1.1) at PE diagnosis, or < 2 lab sets prior to decision to deliver were excluded. Women were categorized by admission diagnosis (per ACOG definitions) as preeclampsia (PE), superimposed PE (SiPE), and their forms with severe features (SPE/SiSPE). Lab testing was obtained weekly for PE/SiPE and 2x/week for SPE/SiSPE until delivery (additional labs done for blood pressures/symptoms). Frequency and timing of LA were compared across categories. Kaplan-Meier (KM) curves modeled time to LA (event) with censoring for delivery; log-rank tests compared KM survival curves across PE groups. 636 women met inclusion criteria: 317 (50%) PE, 171 (27%) SiPE, 83 (13%) SPE, and 65 (10%) SiSPE at presentation. Any LA was uncommon (n=40, 6.3%). Median number of labs obtained before LA differed across groups (Table). Median time to LA in all groups was ≤ 7 days, except in stable PE/SiPE, with shortest time to LA in severe (SPE/SiSPE) groups (Table). Time to any LA differed significantly between groups, with most LAs developing < 10 days for SPE/SiSPE (Figure). Time to LA differed significantly between PE, PE that progressed to SPE (by ACOG severe criteria), and SPE; rapid events occurred < 2 and < 10 days respectively in SPE and progressing group (Figure). Superimposed disease did not alter the time to LAs (p=0.08). Although uncommon, most LAs occur within 7-10 days after diagnosis of any PE type; thus, serial lab testing after this time may be unwarranted. Studies should evaluate optimal lab frequencies by PE type within this period, as earlier and more frequent LAs develop in SPE/SiSPE.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Objective This study aimed to compare maternal and neonatal outcomes in women with severe preeclampsia before and after implementation of the American College of Obstetricians and Gynecologists (ACOG) taskforce hypertensive guidelines. Study Design Single-center retrospective cohort study of women with severe preeclampsia delivering live nonanomalous singletons 23 to 34 (2/7) weeks from 2013 to 2017. In 2015, the ACOG guidelines for expectant management of severe preeclampsia were implemented at our institution. Based on this, patients were categorized as preguideline (January 2013-December 2015) or postguideline adoption (January 2016-December 2017). Primary outcomes included composite maternal morbidity and composite neonatal morbidity; secondary outcomes included composite components, length of stay, birth weight, and delivery gestational age. Groups were compared with Student's t -test, Chi-square, and Wilcoxon's rank-sum tests; adjusted odds ratios (aOR; 95% confidence intervals [CIs]) were calculated. Yearly composite outcomes were compared using the Cochran-Armitage trend test. We estimated a sample size of 250 per group would provide 80% power at alpha = 0.05 to detect a 50% reduction in neonatal morbidity from a baseline rate of 21.5%. Results From 2013 to 2017, a total of 543 women with severe preeclampsia were identified: 278 (51%) preguideline and 265 (49%) postguideline. Baseline characteristics were overall similar between groups. There were no significant differences in maternal (aOR = 0.96, 95% CI: 0.6-1.41) or neonatal (aOR = 0.88, 95% CI: 0.61-1.28) composite morbidity between groups. Furthermore, there were no differences in composite maternal or neonatal morbidity over time. Conclusion Perinatal outcomes were similar before and after implementation of severe preeclampsia management guidelines at our institution. Studies to evaluate if benefits are limited to subsets of this population, such as earlier gestational ages, are needed.
The operative vaginal delivery (OVD) rate in the US has sharply declined – with the average OVDs performed by each graduating resident at our institution dropping from 82 in 2009 to just 22 in 2014. In response, our institution's OBGYN residency program implemented a yearly OVD curriculum (didactics + simulation twice yearly) in May 2016. We sought to evaluate the rate of total OVDs, forceps- (FAVD), and vacuum-assisted (VAVD) deliveries performed before and after the introduction of this OVD curriculum. We performed a retrospective cohort study of all deliveries at our institution from July 2011 - May 2018. Deliveries were evaluated quarterly for the pre- (July 2011-April 2016) and post-curriculum (July 2016-May 2018) time periods. FAVD, VAVD, total OVD rates and the ratio of forceps-to-vacuums were calculated for each time period. Pre- and post-curriculum rates were compared using Wilcoxon rank sum test. Cubic regression curves were fit to quarterly rates to illustrate trends over time. From July 2011-April 2016, our institution averaged 4154 ± 907 deliveries annually (68% spontaneous vaginal deliveries, 29% cesareans, and 3% OVDs. The OVD rate was unchanged following curriculum implementation (median 3.1% [2.6-3.5% IQR] Pre- vs 3.2% [2.5-3.8%] Post-, p>0.99). However, the FAVD rate was significantly increased (1.0% [0.8-1.5%] vs 2.2% [1.4-2.6%], p=0.027) and the VAVD rate decreased (1.8% [1.6-2.2%] vs 1.1% [0.9-1.3%], p<0.001) between the pre- and post-curriculum groups. This was accompanied by a significant increase in the ratio of forceps-to-vacuum deliveries in the period post-curriculum (0.6 [0.4-0.8] vs 1.8 [1.3-2.2], p<0.001). These trends were demonstrated graphically in cubic regression curves fit to quarterly data over the study period – with FAVD rate higher in the last quarter than any other quarter in the 7 year study period (Figures 1 and 2). The OVD rate at our institution has remained stable from July 2011 - May 2018; however, in the 2 years following the implementation of an OVD curriculum, the rate of FAVD and ratio of forceps-to-vacuum deliveries has significantly increased beyond values seen for the 5 years prior to this initiative. The implementation of an OVD curriculum in resident education increases the rate of FAVD performed.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
To compare maternal morbidity in women with preeclampsia with severe features (SPE) in whom ACOG recommends immediate delivery compared to those eligible for expectant management (EM). Retrospective cohort of women with SPE and liveborn, non-anomalous singletons between 23–34 weeks at a single tertiary care center from 1/2013-12/2017. Women in whom ACOG recommended and had immediate delivery (EM INappropriate) were compared to those eligible for EM per ACOG regardless of management (EM appropriate). EM INappropriate included women with eclampsia, pulmonary edema, disseminated intravascular coagulation, uncontrolled severe hypertension, anomalous/nonviable fetus, abruption, fetal demise, platelet < 100,000, liver function >2x normal, serum creatinine >1.1, severe persistent right upper quadrant/epigastric pain, or new-onset cerebral/visual disturbances. Primary outcome was a composite of maternal morbidity including ICU admission, stroke, other severe morbidities (see Table), and death. Secondary outcomes included postpartum hemoglobin (PP Hgb) < 7 g/dL, maternal hospitalization length, and neonatal outcomes (Table). Chi-square and Student's t-tests were used to compare outcomes between groups; adjusted odds ratios (95% CIs) were calculated. Of 543 women with SPE included in this analysis, 332 (61%) were EM appropriate and 211 (39%) were EM INappropriate. Age, race, BMI, parity, and gestational age at diagnosis were similar between groups. EM INappropriate women were significantly more likely to have composite maternal morbidity (4.7% vs 1.2%; aOR 5.0 [95% CI 1.4–18.7]). Specifically, they were more likely to be admitted to the ICU (3.8% vs 0.9%; aOR 4.2 [1.1–16.2]) and have PP Hgb < 7g/dL (4.3% vs 0.9%; aOR 5.1 (1.4–19.1)(Table). Neonatal outcomes were similar between groups (Table). Women with SPE whom ACOG identifies as ineligible for EM have a 5-fold increased risk of maternal morbidity despite immediate delivery at a tertiary care center. Thus, escalation of care and immediate delivery is essential among these women to reduce maternal morbidity and mortality.
Current postpartum (PP) venous thromboembolism (VTE) prophylaxis (ppx) recommendations are based on consensus and expert opinion. PP VTE can result in morbidity and mortality, but it is a rare event. We compare the cost-effectiveness of three PP VTE ppx strategies in a general obstetric population.
OBJECTIVE: To analyze the labor curves of nulliparous and multiparous women between 23.0 and 34.0 weeks of gestation who underwent induction of labor and achieved vaginal delivery. METHODS: This is a retrospective cohort study of all live singletons delivered vaginally after medically indicated induction of labor between 23.0 and 34.0 weeks of gestation from 2011 through 2014 at our institution. We excluded those with one or no cervical examinations available during labor. Prior cesarean delivery, 5-minute Apgar score less than 5, and arterial cord pH less than 7.0 were exclusions. The course of cervical dilation was modeled using repeated measures analysis, and smoothed curves for nulliparous and parous women were generated separately. Estimates of the median (5th-95th percentile) traverse times between two dilations were computed using interval censored regression. Traverse times (ie, the elapsed time between two given dilation measures) were compared between nulliparous and parous women. RESULTS: Sixty-seven nulliparous and 69 multiparous women were included. Each group exhibited similar rates of change from 1 to 3 cm of dilation (median 3.6 hours nulliparous and 3.4 hours multiparous, P=.90). Nulliparous women progressed from 3 to 6 cm more slowly than multiparous women (median 10 hours vs 4.4 hours, P<.001). After 6 cm, both groups rapidly progressed to 10 cm (median 0.3 hours vs 0.3 hours, P=.64). Although the 95th percentile traverse time from 6 to 10 cm was about 2 hours in each group, progression from 1 to 6 cm at the 95th percentile was much longer (64.0 vs 42.2 hours). CONCLUSION: Early preterm labor induction takes less time in multiparous women owing to more rapid progression from 3 to 6 cm. At the 95th percentile, both nulliparous and multiparous women delivered vaginally, even with latent labor lasting well longer than 24 hours.
ACOG revised its guidelines for managing preeclampsia with severe features (SPE) in 2013 to recommend expectant management (EM) as opposed to immediate delivery (ID) in appropriate women given evidence that EM improved neonatal outcomes without significant maternal harm. We sought to pragmatically compare maternal and neonatal outcomes in women with SPE before and after implementation of these guidelines. We conducted a retrospective cohort study of all women with SPE delivering non-anomalous live singletons 23- 34 weeks at a single tertiary care center from 2013-2017. Patients were categorized as pre-guideline (1/2013- 12/2015) or post-guideline adoption (1/2016-12/2017 – managed per ACOG guidelines). Primary outcomes included maternal and neonatal composite morbidity; secondary outcomes included composite components (Table), length of stay, birthweight, and delivery gestational age (GA). Groups were compared with Student's t- test, Chi-square, and Wilcoxon rank sum tests; odds ratios (95% CIs) were calculated and adjusted for covariates. Yearly composite outcome rates were compared using Cochran-Armitage trend test. Subgroup analysis of pre- and post-guideline cohorts excluding women ineligible for EM by ACOG guidelines was planned. We estimated a sample size of 250 per group would provide 80% power at a = 0.05 to detect a 50% reduction in neonatal morbidity from a 21.5% pre-guideline rate. From 2013-2017, 543 women with SPE were identified: 278 (51%) pre-guideline and 265 (49%) post-guideline change. Baseline characteristics were similar between groups except marital status and higher admission blood pressures in the post-guideline group (Table). There were no significant differences in delivery GA, maternal or neonatal composite morbidity between groups (Table). There were no significant differences in composite maternal or neonatal morbidity over time (Figure). Subgroup analysis excluding women ineligible for EM was consistent with the primary analysis. Overall perinatal outcomes were similar before and after implementation of new SPE management guidelines at our institution. Prospective studies are needed to evaluate guideline compliance or if benefits are limited to subsets of this population, e.g. earlier or later GAs.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
ACOG recommends expectant management (EM) of preeclampsia with severe features (SPE) for neonatal benefit in select women; but this may come with maternal harm. We compared maternal and neonatal outcomes in women with SPE managed with immediate delivery (ID) versus EM. Retrospective cohort study of women with SPE delivering viable singletons at 23-34 wks from 2013–2018 at a single tertiary care center (24hr MFM/Neonatology access) where EM was widely adopted in 2016 (ID standard pre-2016). We defined EM by time from SPE diagnosis to decision for delivery (ID≤2 days, EM >2 days). An alternate analysis evaluated EM by intent - defining women initiated/titrated on oral anti-hypertensives as EM. Patients ineligible for EM (i.e. abnormal labs, eclampsia, pulmonary edema) were excluded from both groups. Primary outcomes were composites of maternal and neonatal morbidity (Table). Groups were compared using appropriate tests, odds ratios (OR) were calculated (ID as reference) and adjusted for confounders. Neonatal outcomes were compared across delivery gestational age (GA) ranges. Of 664 women with SPE, 418 women met study criteria; 122 had EM and 296 ID. With the exception of GA at SPE diagnosis (29wks EM vs 31wks ID p< 0.001), baseline characteristics were similar between groups. Maternal hospitalization was extended by 5 days in the EM group (ID median 6 days (IQR 5-8) vs EM 11 (8-19), p< 0.001). There was no difference in composite maternal morbidity (or components) between EM versus ID (Table). While nonsignificant, there was reduced composite neonatal morbidity (and components) after adjusting for earlier GA at SPE diagnosis in the EM group (Table). With EM defined by antihypertensive use (n=203 EM, n=215 ID), maternal outcomes were still not compromised and neonatal outcomes significantly benefited (Table). There was no difference in neonatal outcomes when stratified by GA range at delivery (p=NS, Figure) EM of SPE is associated with neonatal benefit without increased maternal harm. Larger studies should evaluate if these results are limited to certain GAs.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
The random urine protein-to-creatinine ratio (UPCR) is a commonly used screening test for predicting significant proteinuria (≥300mg) during pregnancy. Yet, no consensus exists on the optimal UPCR cutoff for performing follow-up 24-hour urine total protein (24H) collection. This leads to wide variation in practice habits across institutions. We aim to determine the test performance of UPCR in predicting significant proteinuria (≥300mg) during pregnancy. This was a retrospective cohort study of all pregnant women at our institution from Jan 2014 to May 2018 with a UPCR and follow-up 24Hcollection completed prior to delivery. Our institution decreased the UPCR cutoff for which to perform a 24H collection from ≥0.19 to ≥0.10 in May 2017. The primary outcome was to determine the test characteristics (sensitivity, specificity, positive and negative predictive values) of UPCR cutoffs from 0.10 to 0.30 for the detection of ≥300mg proteinuria on 24H collection. The secondary outcome was the Pearson correlation coefficient between UPCR and 24H collection after development of a least-squares regression line. A receiver operator characteristic (ROC) curve was constructed from sensitivity and specificity analyses of escalating UPCR thresholds. 1120 women had paired UPCR and 24H collection results with 93.4% collected within 72 hours. Mean gestational age at time of UPCR was 31 ± 5 weeks. Table 1 shows test performance of various UPCR cutoffs. A UPCR <0.10 effectively excludes ≥300mg proteinuria on 24H collection. UPCR and 24H collection are highly correlated, with a Pearson correlation coefficient of 0.85 (Figure 1). The area under ROC curve was 0.86 (Figure 2). A UPCR cutoff of ≥0.18 correctly classifies significant proteinuria with 91% sensitivity, 57% specificity, 77% PPV, and 79% NPV. Prior to the UPCR cutoff change, 58% of women with a UPCR had a 24H collection. This increased to 84% of women after the change. UPCR and 24H collection are highly correlated. UPCR cutoffs at least ≥0.18 provide test characteristics that can be used to balance the likelihood of false negative diagnosis of preeclampsia against the burden of 24H collection considering the clinical presentation.View Large Image Figure ViewerDownload Hi-res image Download (PPT)
Objective: The objective of this study was to report the tolerability and toxicity of a regimen consisting of intravenous (IV) docetaxel and intraperitoneal (IP) cisplatin and paclitaxel with granulocyte colony-stimulating factor support. Materials and Methods: We conducted a retrospective cohort study of patients with surgical stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma treated with an outpatient IP chemotherapy regimen consisting of docetaxel 75 mg/m(2) IV and cisplatin 75 mg/m(2) IP day 1 followed by paclitaxel 60 mg/m(2) IP day 8 every 21 days. Grade 3 and 4 toxicity, dose delays and reductions, port complications, and tolerability are reported. Outcomes, including response rate, progression-free survival (PFS), overall survival (OS) are also reported. Results: A total of 60 patients received this IP regimen. Most common toxicities included neutropenia (47%), gastrointestinal (28%), and anemia (25%). Most patients (85%) experienced no IP port complications. Dose delay or reduction was required in 30% of patients. Two-thirds completed all prescribed cycles, with 80% of total planned cycles completed. Complete response was achieved for 88%, and 43% are currently without evidence of disease. Median PFS for all patients was 25.5 months (95% confidence interval [CI], 20.4-30.5 mo) while OS for all patients was 56.8 months (95% CI, 47.7-65.9 mo). For the 44 patients with stage III disease, median PFS was 22.1 months (95% CI, 16.3-28.0 mo), while median OS was 56.8 months (95% CI, 47.3-66.3 mo). Conclusions: This docetaxel-based IP chemotherapy regimen demonstrates an improved tolerability profile compared with GOG172. Additional evaluations on alternative IP regimens remain warranted. Short follow-up time limits survival assessment, but results are encouraging.
Objective Compare outcomes in women with chronic hypertension who remain normotensive, experience exacerbation, or meet laboratory criteria for superimposed preeclampsia. Study Design This is a retrospective cohort study of singleton pregnancies with chronic hypertension from 2000 to 2014. Delivery admission records were used to categorize women into three groups: stable chronic hypertension, exacerbated hypertension, and superimposed preeclampsia. The primary outcomes were a neonatal composite of death, respiratory support, umbilical arterial pH < 7, 5-minute Apgar ≤3, and seizures, in addition to maternal severe hypertension requiring intravenous (IV) antihypertensives. Results In total, 270 women (31.3%) had stable hypertension, 429 (49.8%) had exacerbated hypertension, and 163 (18.9%) had superimposed preeclampsia. Neonatal composite (10.7 vs. 11.2 vs. 21.5%; p < 0.01) and preterm birth <35 weeks (8.8 vs. 18.3 vs. 35.7%; p < 0.01) were highest in the superimposed preeclampsia group. Severe hypertension requiring the use of IV antihypertensives increased across groups (0 vs. 15.6 vs. 23.3% p < 0.01). With the exception of severe hypertension requiring IV antihypertensive use, outcomes in women with exacerbations were unchanged compared with those with stable hypertension. Conclusion Superimposed preeclampsia is associated with an increased risk of adverse neonatal outcomes compared with stable chronic hypertension, whereas exacerbation of chronic hypertension is not.
Prior studies of cervical ripening agents have not examined outcomes specifically for preterm gestations. We evaluate the efficacy of different methods of cervical ripening less than 34 weeks. Secondary analysis of an observational cohort of 115,502 mother/infant pairs that delivered at 25 hospitals from March 2008 to February 2011. We included women with an unscarred uterus if they underwent cervical ripening for an induction of labor (IOL) of a singleton without major anomalies between 23.0 and 33.6 weeks' gestation. We excluded women with rupture of membranes, chorioamnionitis, or fetal demise prior to the start of ripening. Women with oxytocin before ripening or oxytocin only were also excluded. Methods of ripening included: 1) Foley + prostaglandins (F+PG), 2) Foley + oxytocin within 1hr (F+Ox), 3) Foley without oxytocin within 1hr (F), and 4) prostaglandins alone (PG). The primary outcome was vaginal delivery (VD). Secondary outcomes included percentage of women delivered within 24hrs of initiation of ripening, and composites of maternal and neonatal morbidity (Table 1). Covariates were compared by group using χ2, Fisher's exact, or Kruskal-Wallis tests. Logistic regression was used to adjust for the significant covariates, followed by Bonferroni adjustment of p-values for multiple comparisons. Of the 115,502 deliveries in the cohort, 270 met inclusion criteria. Race/ethnicity, GBS status, and IOL indication differed by method; all other demographics including age, BMI and parity were similar (Table 1). In bivariable analysis, the frequency of VD was highest after F+Ox (67.2%), although this did not reach statistical significance (p=0.08). Time to delivery and length of hospital stay were significantly different across methods and shortest after F+Ox. Delivery within 24 hours was least likely after F+PG. In multivariable analysis, with PG as the referent (Table 2), VD was significantly higher after F+Ox (aOR 2.64; 95% CI 1.03-6.74) and delivery within 24hrs was significantly lower with F+PG (aOR 0.24; 95% CI 0.09-0.66). Maternal or neonatal composite outcomes did not differ by group. Cervical ripening with F+Ox prior to 34 weeks was most likely to result in VD and should be further investigated in larger studies.View Large Image Figure ViewerDownload Hi-res image Download (PPT)