Faculty Bibliography

BACKGROUND:While elevated second trimester maternal serum alpha fetoprotein (msAFP) has been associated with adverse pregnancy outcomes, the utility of first trimester msAFP in predicting these outcomes is limited. Some laboratories have been including msAFP as part of the first trimester analyte screening for aneuploidy and preeclampsia, offering its potential utility in predicting pregnancy outcomes. OBJECTIVE:Our primary objective was to determine the association between elevated first trimester msAFP and preeclampsia, as well as ischemic placental disease (a composite of preeclampsia, fetal growth restriction and/or placental abruption). Secondary outcomes included early onset preeclampsia requiring delivery at <34 weeks gestation, fetal growth restriction, placental abruption, preterm delivery, fetal demise, and spontaneous abortion. STUDY DESIGN/METHODS:An IRB-approved multi-site retrospective cohort study was performed including all patients with first trimester msAFP as part of routine first trimester aneuploidy screening from April 2015-January 2017. Pregnancies with multiple gestations, known structural or chromosomal abnormalities, known malignancy, and incomplete delivery records were excluded. Delivery records were reviewed for baseline characteristics and adverse pregnancy outcomes. The optimal cut-off point for first trimester msAFP to predict these outcomes was assessed and an elevated msAFP was considered > 2.0 MoM. Fisher exact test and odds ratios were used to determine the association between elevated first trimester msAFP and adverse pregnancy outcomes. Spearman correlation coefficient assessed the relationship between first and second trimester msAFP. RESULTS:Of 1478 patients with first trimester msAFP, 1280 had complete records available for review (86.6%). There was no association demonstrated between elevated first trimester msAFP (> 2.0 MoM) and the primary outcome, overall preeclampsia (5.8% vs. 4.6%, OR 1.29, 95% CI 0.58, 2.91). However, there was an increased incidence of ischemic placental disease, 15.8% vs 7.7% (OR 2.26, 95% CI 1.33-3.87) in those with an elevated AFP. Also, elevated first trimester msAFP was associated with a higher incidence of fetal growth restriction (7.5% vs 2.3%, OR 3.40, 95% CI 1.56-7.42) and preterm birth (18.3% vs 10.3%, OR 1.95, 95% CI 1.18-3.21). Also, a positive correlation between first and second trimester msAFP was demonstrated (rho = 0.46, P< 0.0001). CONCLUSIONS:Elevated first trimester msAFP is associated with ischemic placental disease, fetal growth restriction, and preterm birth. This suggests that elevated msAFP may help to identify high risk pregnancies as early as the first trimester of pregnancy. Future studies are necessary to determine if addition of first trimester msAFP to existing algorithms can improve the early detection of ischemic placental disease.

INTRODUCTION: Early identification of PPH is difficult. Shock index (SI) (SI=HR/SBP) of (.0.9) has demonstrated good prediction of PPH, and identify identification of patients requiring massive transfusion. Our objective is to determine if there is a change in SI on admission to postpartum or at time of transfusion after which there is an increased transfusion requirement or morbidity.
METHOD(S): IRB approved, retrospective cohort of patients who received blood transfusion at a University based hospital, 2017-2018. SI calculated; at time of admission, after delivery, and prior to transfusion. Patients with invasive carcinoma, with fetus of non-viable gestational age, and incomplete charts were excluded. Spearman correlate coefficient, univariable logistic regression, and ROC analyses were performed.
RESULT(S): 160 patients; 117/160 (73%) delivered by cesarean, 37/ 160 (23%) vaginally, and 6/160 (4%) operative vaginal delivery. Mean admission hemoglobin was 10.8 (6 1.5). Median EBL was 1320 mL (250-6000 mL). 77/160 (48%) of patients received 2 units of PRBC, 26/ 160 (17%) received 3 units of PRBC, 24/160 (15%) received 4 units of PRBC and 33/160 (20%) received >=5 units of PRBC. Change in SI from admission to postpartum had a correlation coefficient of 0.022 and a P value of .78. Change in SI from admission to pre-transfusion had a correlation coefficient of 0.128 and a P value of .11.
CONCLUSION(S): Changes in SI from admission to immediately postpartum or pre-transfusion do not show any correlation or predictive value for increasing morbidity, or transfusion requirements. This demonstrates change in SI is a poor predictor of morbidity and transfusion requirements

Randomized controlled trials (RCT)s of surgery are fundamentally different from RCTs of medications because it is difficult to blind or mask a surgical procedure or perform "sham' operations. An additional challenge is the variation in skills and surgical proficiency of participating centers and surgeons. Addressing heterogeneity in surgical proficiency remains of paramount importance, especially when RCTs involve a new or complex procedure such as minimally invasive radical surgery. In the presence of such heterogeneity, it is very cumbersome to objectively evaluate and monitor surgical skills so that most trials simply report associations that are averaged across surgeons and hospitals/centers. Such reporting is non-transparent because the rates of complications and adverse outcomes are reported only as averages, and these averages may not apply to the individual participating surgeons or centers. These factors, coupled with the inherent non-generalizability of findings from such RCTs - due to the strict inclusion and exclusion criteria for enrollment - may lead to conclusions that no longer apply to real life for individual surgeons or centers. Case in point is a recently published non-inferiority RCT that reported that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival (86% versus 96.5% at 4.5 years) and overall survival (93.8% versus 99% at 3 years) than open abdominal radical hysterectomy in patients with cervical cancer. However, RCTs involving two competing complex or new procedures may be affected by tremendous confounding due to variations in surgical proficiency and also non-standardization for other confounding factors such as patient selection categories (i.e. stage of cancer) and adjuvant post-operative therapies that may affect long-term survival. The purpose of this Viewpoint is not to provide an exhaustive review of the trial but to use it as an illustration to focus on two challenging areas that most RCTs of a new complex surgical procedure suffer from: un-adjusting or not correcting for surgical skill variability and non-transparent reporting of averaged results. We provide suggestions to overcome these deficiencies through robust methodological and statistical approaches.

BACKGROUND:Prior studies have reported an increased risk for preterm delivery following a term cesarean delivery. However, these studies did not adjust for high risk conditions related to the first cesarean delivery and are known to recur. OBJECTIVE:To determine if there is an association between term cesarean delivery in the first pregnancy and subsequent spontaneous or indicated preterm delivery. STUDY DESIGN/METHODS:This was a retrospective cohort study of women with the first two consecutive singleton deliveries (2007-2014) identified through a linked pregnancy database at a single institution. Women with a first pregnancy that resulted in cesarean delivery at term were compared to women whose first pregnancy resulted in vaginal delivery at term. Exclusion criteria were known to recur medical or obstetrical complications during the first pregnancy. A propensity score analysis was performed by matching women that underwent a cesarean delivery with those that underwent a vaginal delivery in the first pregnancy. The association between cesarean delivery in the first pregnancy and preterm delivery in the second pregnancy in this matched set was examined using conditional logistic regression. The primary outcome was overall preterm delivery <37 weeks in the second pregnancy. Secondary outcomes included type of preterm delivery (spontaneous versus indicated), late preterm delivery (34-36 6/7 weeks), early preterm delivery (< 34 weeks), and small for gestational age (SGA) birth. RESULTS:percentile for gestational age (3.6% versus 2.2%; aOR 1.26, 95% CI 0.52 - 3.06). CONCLUSION/CONCLUSIONS:After robust adjustment for confounders through a propensity score analysis related to the indication for the first cesarean delivery at term, cesarean delivery is not associated with an increase in preterm delivery, spontaneous or indicated, in the subsequent pregnancy.

We report a rare case of a 30-year-old female who had a long-standing history of middle aortic syndrome that was being managed nonsurgically. She presented with hypertension and buttock pain with plans to become pregnant. She underwent an aortoiliac bypass.