Publications by authors named "Justin R Lappen"

31 Publications

Society for Maternal-Fetal Medicine Special Statement: Maternal-fetal medicine subspecialist survey on abortion training and service provision.

Am J Obstet Gynecol 2021 Apr 10. Epub 2021 Apr 10.

Following a collaborative workshop at the 39th Annual Pregnancy Meeting, the Society for Maternal-Fetal Medicine Reproductive Health Advisory Group identified a need to assess attitudes of maternal-fetal medicine subspecialists about abortion services and available resources at the local and regional levels. The purpose of this study was to identify trends in attitudes, beliefs, and behaviors of practicing maternal-fetal medicine subspecialists in the United States regarding abortion. An online survey was distributed to Associate and Regular members of the Society for Maternal-Fetal Medicine assessing their personal training experience, abortion practice patterns, factors that influence their decision to provide abortion care, and their responses to a series of scenarios about high-risk maternal or fetal medical conditions. Frequencies were analyzed and univariable and multivariable analyses of survey responses were conducted. Of the 2,751 members contacted, 546 SMFM members who completed all (448 of 546, 82.1%) or some (98 of 546, 17.9%) of the survey. Over 80% of respondents reported availability of abortion in their state, 70% reported availability in their primary institution, and 44% reported provision as part of their personal medical practice. Ease of referral to family planning subspecialists or other abortion providers, institutional restrictions, and the lack of training or continuing education were identified as the most significant factors in respondent's limiting their scope of abortion services or not performing abortion. In univariable analysis, exposure to formal family planning training programs, fewer years since residency completion, current practice setting not being religiously affiliated, and current state categorized as supportive by the Guttmacher Institute's abortion policy landscape were associated with abortion provision (all P < 0.01). After controlling for these factors in a multivariable regression, exposure to formal family planning training programs was no longer associated with current abortion provision (P = 0.20, adjusted odds ratio 1.34, 95% CI 0.85-2.10), whereas a favorable state policy environment and fewer years from residency retained their association. The results of this survey suggest factors at the individual, institution, and state level impact provision of abortion care by maternal-fetal medicine subspecialists. The subspecialty of maternal-fetal medicine should be active in ensuring adequate training and education to create a community of maternal-fetal medicine physicians able to provide comprehensive reproductive healthcare.
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http://dx.doi.org/10.1016/j.ajog.2021.04.220DOI Listing
April 2021

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Am J Obstet Gynecol MFM 2021 01 21;3(1):100236. Epub 2020 Sep 21.

Division of Maternal-Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

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http://dx.doi.org/10.1016/j.ajogmf.2020.100236DOI Listing
January 2021

Delivery dose of methadone, but not buprenorphine, is associated with the risk and severity of neonatal opiate withdrawal syndrome.

Am J Obstet Gynecol MFM 2020 02 10;2(1):100075. Epub 2019 Dec 10.

Division of Maternal-Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

Background: Data on the relationship between the dose of opioid replacement therapy in pregnancy and the risk and severity of neonatal opioid withdrawal syndrome are conflicting and have methodological limitations.

Objective: To assess the association of methadone and buprenorphine dose at delivery with neonatal opioid withdrawal syndrome in a large cohort.

Study Design: We performed a retrospective cohort study using data from a comprehensive perinatal opioid dependency program from 2000 through 2016. Women with a history of opioid use disorder enrolled in a medication-assisted treatment program were included. Strict neonatal opioid withdrawal syndrome case definition and neonatal treatment guidelines were utilized throughout the study epoch. Comparisons were made between women on methadone and buprenorphine. The dose of opioid replacement at delivery and the risk and severity of neonatal opioid withdrawal syndrome were assessed with univariable analysis and multivariable logistic regression. In all analyses, methadone and buprenorphine dosing were evaluated as a continuous variable.

Results: Four hundred eighty two of 709 women (68.0%) met inclusion criteria including 344 on methadone (71.4%) and 138 on buprenorphine (28.6%). Nonopioid polysubstance abuse, body mass index, medication-assisted treatment compliance, birthweight, and other characteristics were similar between groups. Overall, the frequency of neonatal opioid withdrawal syndrome was not significantly different between the methadone and buprenorphine groups (56.8% vs 52.0%, P = .35). Dose at delivery ranged at 0-165 mg for methadone and 0-30 mg for buprenorphine. In a univariable analysis, methadone dose at delivery was associated with neonatal opioid withdrawal syndrome (83.0 ± 34.2 mg vs 71.9 ± 35.8 mg for neonatal opioid withdrawal syndrome vs nonneonatal opioid withdrawal syndrome neonates, P < .001), but buprenorphine dose at delivery was not (8.4 ± 4.4 vs 7.6 ± 4.8 mg for neonatal opioid withdrawal syndrome vs nonneonatal opioid withdrawal syndrome neonates, P = .30). Peak neonatal opioid withdrawal syndrome score, duration of neonatal opioid withdrawal syndrome treatment, and cumulative neonatal morphine exposure were significantly associated with delivery methadone dose but not buprenorphine dose. The association between delivery methadone dose and neonatal opioid withdrawal syndrome persisted in multivariable regression.

Conclusion: The dose of methadone at the time of delivery is associated with the frequency and severity of neonatal opioid withdrawal syndrome, with higher doses associated with more severe neonatal opioid withdrawal syndrome when analyzed continuously. These data may inform future prospective studies on methadone dosing in pregnancy. While medication-assisted treatment agent and dose may have an impact on pertinent neonatal outcomes related to neonatal opioid withdrawal syndrome, the provision of medication-assisted treatment in pregnancy should reflect the goal of prevention of recidivism and maternal mortality and utilize an approach that balances fetal and maternal risk to optimize outcomes.
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http://dx.doi.org/10.1016/j.ajogmf.2019.100075DOI Listing
February 2020

Society for Maternal-Fetal Medicine Consult Series #54: Assessing the risk of maternal morbidity and mortality.

Am J Obstet Gynecol 2021 04 9;224(4):B2-B15. Epub 2020 Dec 9.

Society for Maternal-Fetal Medicine, 409 12 St. SW, Washington, DC 20024, USA.

The rates of maternal morbidity and mortality in the United States demand a comprehensive approach to assessing pregnancy-related risks. Numerous medical and nonmedical factors contribute to maternal morbidity and mortality. Reducing the number of women who experience pregnancy morbidity requires identifying which women are at greatest risk and initiating appropriate interventions early in the reproductive life course. The purpose of this Consult is to educate all healthcare practitioners about factors contributing to a high-risk pregnancy, strategies to assess maternal health risks due to pregnancy, and the importance of risk assessment across the reproductive spectrum in reducing maternal morbidity and mortality.
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http://dx.doi.org/10.1016/j.ajog.2020.12.006DOI Listing
April 2021

Term Labor Outcomes after Cerclage Placement in a Multi-institutional Cohort.

Am J Perinatol 2020 01 6;37(1):119-126. Epub 2020 Jan 6.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, MetroHealth Medical Center, University Hospitals Cleveland Medical Center, Cleveland, Ohio.

Objective: The placement of a cervical cerclage in early pregnancy could influence subsequent labor outcomes at term. Prior studies have yielded conflicting results regarding the potential association with adverse labor outcomes such as cesarean delivery (CD), cervical laceration, and prolonged labor. Our objective was to evaluate rate of CD and adverse maternal outcomes in women who labored at term with and without a cerclage within the Consortium on Safe Labor (CSL) cohort. We hypothesize that women with a cerclage in the incident pregnancy will have an increased frequency of CD and other adverse term labor outcomes.

Study Design: A retrospective cohort study was performed using data from the CSL. Women with live nonanomalous singleton gestations≥ 37 weeks with induced or spontaneous labor were identified. The risk of CD and other maternal and neonatal outcomes were compared between women with and without cerclage placement during pregnancy. Univariable and multivariable analyses were performed with adjustment for confounding factors. Planned subgroup analysis by history of CD was performed.

Results: A total of 374 of the 147,463 patients who met study inclusion criteria in the CSL (0.25%) had a cerclage. In univariable analysis, cerclage placement was associated with a significant increase in the frequency of CD (17.1 vs. 12.8%,  = 0.016, odds ratio: 1.4, 95% CI: 1.07-1.84), cervical lacerations, infectious morbidity, and blood loss. The association with CD persisted in multivariable regression. Cerclage placement was not associated with an increased risk of neonatal morbidity.

Conclusion: Cerclage placement in pregnancy is associated with an increased risk of CD, cervical laceration, and infectious morbidity among women delivering at term. These findings suggest that cerclage placement may impact labor progression and outcomes. However, the magnitude of the association may not alter clinical decisions regarding cerclage placement in appropriate candidates.
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http://dx.doi.org/10.1055/s-0039-3401851DOI Listing
January 2020

Starting Health Disparities Education During Resident Orientation: Our Patients, Our Community.

Obstet Gynecol 2018 11;132(5):1153-1157

Department of Obstetrics and Gynecology, Division of Reproductive Biology, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, Ohio.

Disparities in women's reproductive health outcomes are persistent and prevalent. Cultural competency education of trainees is central to reducing patient-, system-, and practitioner-level factors that promote disparate health outcomes. Such issues include health literacy, access to health care, and unconscious bias. We suggest that recognizing and reducing health disparities should be a longitudinal theme in resident education, first introduced during intern orientation and continued with dedicated didactics, experiential learning opportunities, grand rounds, and journal clubs built into the residency curricula. In this commentary, we present various methods of introducing health disparities education and commencing a larger conversation about inequity and race in medicine. We hope to encourage other training programs to incorporate this important topic earlier into their educational curriculum.
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http://dx.doi.org/10.1097/AOG.0000000000002911DOI Listing
November 2018

Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status.

Obstet Gynecol 2018 10;132(4):1011-1017

Division of Maternal-Fetal Medicine, University Hospitals Cleveland Medical Center, and the Division of Maternal-Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Objective: To define and characterize a maternal contraction-associated heart rate deceleration pattern and evaluate its association with maternal volume status.

Methods: We performed a prespecified secondary analysis of a prospectively collected cohort from a randomized controlled trial of maternal pulse pressure, epidural coload volume, and postepidural complications. Participants were healthy intrapartum women with nonanomalous singleton gestations at 35 weeks of gestation or greater and a category 1 fetal heart rate (FHR) pattern from admission to epidural placement. Those lacking continuous maternal pulse oximetry data before epidural placement were excluded. Maternal heart rate tracings were evaluated for the presence of a contraction-associated heart rate deceleration pattern before epidural placement. Women with and without a contraction-associated heart rate deceleration pattern were compared using univariable and multivariable analyses. The primary outcome was the frequency of a contraction-associated heart rate deceleration pattern in hypovolemic compared with euvolemic women as defined by admission pulse pressure (less than 45 and 50 mm Hg or greater, respectively). Secondary outcomes included the association of a contraction-associated heart rate deceleration pattern with postepidural complications related to maternal volume status including new-onset category 2 and 3 FHR abnormalities, maternal hypotension, and the need for resuscitative obstetric interventions.

Results: Of 414 trial participants, 388 (93.7%) met inclusion criteria, and 124 of these (32.0%) had a contraction-associated heart rate deceleration pattern before epidural placement. The presence of a contraction-associated heart rate deceleration pattern was more frequent among hypovolemic compared with euvolemic women as defined by admission pulse pressure (41.1% vs 13.6%, relative risk [RR] 3.0, 95% CI 1.9-4.8, P<.001). A contraction-associated heart rate deceleration pattern was associated with more frequent postepidural FHR abnormalities (43.5% vs 31.1%, RR 1.4, 95% CI 1.1-1.8, P=.02), diastolic hypotension (63.7% vs 50.0%, RR 1.3, 95% CI 1.1-1.5, P=.01), and the need for resuscitative interventions (33.9% vs 23.1%, RR 1.5, 95% CI 1.1-2.0, P=.03). In multivariable analysis with adjustment for baseline differences between groups, the associations between a contraction-associated heart rate deceleration pattern and abnormal FHR patterns, diastolic hypotension, and the need for resuscitative interventions persisted and were slightly strengthened.

Conclusion: The maternal contraction-associated heart rate deceleration pattern is a pragmatic, bedside visual indicator of intrapartum maternal volume status. A contraction-associated heart rate deceleration pattern is threefold more frequent among hypovolemic compared with euvolemic women as defined by admission pulse pressure and is associated with postepidural complications including abnormal FHR patterns, diastolic hypotension, and the need for resuscitative interventions. The contraction-associated heart rate deceleration pattern highlights a novel role for intrapartum maternal heart rate assessment and may inform the individualization of intrapartum fluid management.
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http://dx.doi.org/10.1097/AOG.0000000000002808DOI Listing
October 2018

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Am J Obstet Gynecol 2018 11 11;219(5):513-514. Epub 2018 Jul 11.

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University Hospitals, Cleveland, OH.

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http://dx.doi.org/10.1016/j.ajog.2018.07.007DOI Listing
November 2018

Cervical ripening balloon with and without oxytocin in multiparas: a randomized controlled trial.

Am J Obstet Gynecol 2018 09 12;219(3):294.e1-294.e6. Epub 2018 May 12.

Division of Maternal-Fetal Medicine, University Hospitals, Cleveland, OH; Department of Obstetrics and Gynecology, University Hospitals, Cleveland, OH.

Background: The optimal method for induction of labor for multiparous women with an unfavorable cervix is unknown.

Objective: We sought to determine if induction of labor with simultaneous use of oxytocin and a cervical ripening balloon, compared with sequential use, increases the likelihood of delivery within 24 hours in multiparous women.

Study Design: We performed a randomized controlled trial from November 2014 through June 2017. Eligible participants were multiparous women with a vertex presenting, nonanomalous singleton gestation ≥34 weeks undergoing induction of labor. Women were excluded for admission cervical examination >2 cm, ruptured membranes, chorioamnionitis or evidence of systemic infection, placental abruption, low-lying placenta, >1 prior cesarean delivery, or contraindication to vaginal delivery. Patients were randomly allocated to the following cervical ripening groups: simultaneous (oxytocin with cervical ripening balloon) or sequential (oxytocin following cervical ripening balloon expulsion). The primary outcome was delivery within 24 hours of cervical ripening balloon placement. Secondary outcomes included induction-to-delivery interval, time to cervical ripening balloon expulsion, mode of delivery, and adverse maternal or neonatal outcomes.

Results: In all, 180 patients were randomized (90 simultaneous, 90 sequential). Baseline demographic and obstetric characteristics were similar between study groups. Women in the simultaneous group were significantly more likely to deliver within 24 hours of cervical ripening balloon placement compared to the sequential group (87.8% vs 73.3%, P = .02). The simultaneous group also had a significantly shorter induction-to-delivery interval and greater cervical dilation at cervical ripening balloon expulsion. There were no differences in mode of delivery, chorioamnionitis, or adverse maternal or neonatal outcomes.

Conclusion: In multiparous women with an unfavorable cervix, the simultaneous use of cervical ripening balloon and oxytocin results in an increased frequency of delivery within 24 hours and a shorter induction-to-delivery interval.
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http://dx.doi.org/10.1016/j.ajog.2018.05.009DOI Listing
September 2018

Pulse Pressure and Carotid Artery Doppler Velocimetry as Indicators of Maternal Volume Status: A Prospective Cohort Study.

Anesth Analg 2018 08;127(2):457-464

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Background: Narrow pulse pressure has been demonstrated to indicate low central volume status. In critically ill patients, volume status can be qualitatively evaluated using Doppler velocimetry to assess hemodynamic changes in the carotid artery in response to autotransfusion with passive leg raise (PLR). Neither parameter has been prospectively evaluated in an obstetric population. The objective of this study was to determine if pulse pressure could predict the response to autotransfusion using carotid artery Doppler in healthy intrapartum women. We hypothesized that the carotid artery Doppler response to PLR would be greater in women with a narrow pulse pressure, indicating relative hypovolemia.

Methods: Intrapartum women with singleton gestations ≥35 weeks without acute or chronic medical conditions were recruited to this prospective cohort study. Participants were grouped by admission pulse pressure as <45 mm Hg (narrow) or ≥50 mm Hg (normal). Maternal carotid artery Doppler assessment was then performed in all patients before and after PLR using a standard technique where carotid blood flow (mL/min) = π × (carotid artery diameter/2) × (velocity time integral) × (60 seconds). The velocity time integral was calculated from the Doppler waveform. The primary outcome was the change in the carotid Doppler parameters (carotid artery diameter, velocity time integral, and carotid blood flow) after PLR. Outcomes were compared between study groups with univariable and multivariable analyses with adjustment for potential confounding factors.

Results: Thirty-three women consented to participation, including 18 in the narrow and 15 in the normal pulse pressure groups (mean and standard deviation initial pulse pressure, 38.3 ± 4.4 vs 57.3 ± 4.1 mm Hg). The 2 groups demonstrated similar characteristics except for initial pulse pressure, systolic and diastolic blood pressure, and race. In response to PLR, the narrow pulse pressure group had a significantly greater increase in carotid artery diameter (0.08 vs 0.02 cm; standardized difference, 2.0; 95% confidence interval [CI], 1.16-2.84), carotid blood flow (79.4 vs 16.0 mL/min; standardized difference, 2.23; 95% CI, 1.36-3.10), and percent change in carotid blood flow (47.5% vs 8.7%; standardized difference, 2.52; 95% CI, 1.60-3.43) compared with the normal pulse pressure group. In multivariable analysis with adjustment for potential confounding factors, women with narrow admission pulse pressure had a significantly larger carotid diameter (0.66 vs 0.62 cm; P < .0001) and greater carotid flow (246.7 vs 219.3 cm/s; P = .001) after PLR compared to women with a normal pulse pressure. Initial pulse pressure was strongly correlated with the change in carotid flow after PLR (r = 0.60; P < .0001).

Conclusions: The hemodynamic response of the carotid artery to autotransfusion after PLR is significantly greater in women with narrow pulse pressure. Pulse pressure correlates with the physiological response to autotransfusion and provides a qualitative indication of intravascular volume in term and near-term pregnant women.
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http://dx.doi.org/10.1213/ANE.0000000000003304DOI Listing
August 2018

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Obstet Gynecol 2018 03;131(3):601-602

Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio.

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http://dx.doi.org/10.1097/AOG.0000000000002508DOI Listing
March 2018

Maternal Pulse Pressure and the Risk of Postepidural Complications: A Randomized Controlled Trial.

Obstet Gynecol 2017 12;130(6):1366-1376

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Department of Anesthesiology, MetroHealth Medical Center, Cleveland, Ohio.

Objective: To test the hypothesis that increasing the intravenous fluid bolus volume at the time of epidural placement in women with narrow pulse pressure would reduce postepidural fetal heart rate (FHR) abnormalities, hypotension, and resuscitative obstetric interventions.

Methods: We performed a single-center randomized controlled trial. Eligible participants were normotensive with a nonanomalous singleton gestation at or after 35 weeks and with a narrow pulse pressure (less than 45 mm Hg) on admission. Enrolled patients remained eligible for randomization at epidural request if they were within 6 hours of admission and the FHR remained category 1. Patients were allocated to a 500-mL (institutional standard) or 1,500-mL intravenous fluid bolus at epidural placement. A reference group with admission pulse pressure 50 mm Hg or greater was also evaluated. The primary outcome was a category 2 or 3 FHR pattern within 60 minutes after the epidural test dose. Evaluated secondary outcomes included maternal hypotension and composite resuscitative interventions to correct FHR abnormalities or hypotension. We calculated that 276 women (138/group) would provide 80% power to detect a relative 50% reduction in the occurrence of the primary outcome from 27% in the 500-mL group to 13.5% in the 1,500-mL group (two-sided α=0.05).

Results: From October 2015 to November 2016, 276 women were allocated to receive a 500-mL (n=139) or 1,500-mL (n=137) fluid bolus. One hundred thirty-eight women were evaluated in the reference group. Demographic, obstetric, and labor characteristics were similar between groups. The 1,500-mL group had significantly fewer postepidural FHR abnormalities (38.0% compared with 51.8%, relative risk 0.73, 95% CI 0.56-0.96, P=.02). Maternal systolic hypotension (10.2% compared with 34.5%, relative risk 0.30, 95% CI 0.17-0.51, P<.001) and composite postepidural interventions (18.3% compared with 44.2%, relative risk 0.42, 95% CI 0.28-0.62, P<.001) were also less frequent in the 1,500-mL group. Fetal heart rate abnormalities remained significantly less frequent in the reference group than among women with a narrow pulse pressure on admission for delivery.

Conclusion: A 1,500-mL intravenous fluid bolus in women with a narrow pulse pressure decreases the risk of postepidural FHR abnormalities (number needed to treat=7), results in less frequent postepidural hypotension, and reduces the need for resuscitative interventions. Admission pulse pressure may be used to individualize intrapartum fluid management at the time of initiation of neuraxial labor analgesia.

Clinical Trial Registration: ClinicalTrials.gov, NCT02565485.
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http://dx.doi.org/10.1097/AOG.0000000000002326DOI Listing
December 2017

The systematic error in the estimation of fetal weight and the underestimation of fetal growth restriction.

Am J Obstet Gynecol 2017 05 13;216(5):477-483. Epub 2017 Feb 13.

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

Fetal growth restriction (FGR) is associated with an increased risk of perinatal morbidity and mortality and has lifetime implications for the risk of chronic medical conditions. Antenatal diagnosis of FGR remains poor, with the majority of cases remaining undiagnosed. Although several factors contribute to the underdiagnosis of FGR, the error in ultrasound estimation of fetal weight (EFW) generally is not considered in clinical practice. In this commentary, we suggest that the intrinsic, or systematic, error in ultrasound EFW is a significant factor contributing to the underestimation of fetuses predicted to have FGR and should be incorporated into screening and surveillance recommendations. To illustrate this point, we present an analytic model of published data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Growth Studies characterizing and quantifying the impact of the systematic error in ultrasound EFW on the underdiagnosis of FGR. Independent of the centile at which the risk of adverse outcome related to FGR begins, whether the 10th, 5th or 3rd percentile, our analysis suggests the need to modify to the current paradigm for identifying and responding to fetuses estimated to be at risk.
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http://dx.doi.org/10.1016/j.ajog.2017.02.013DOI Listing
May 2017

Does pregnancy increase the risk of abdominal hernia recurrence after prepregnancy surgical repair?

Am J Obstet Gynecol 2016 Sep 10;215(3):390.e1-5. Epub 2016 May 10.

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, OH.

Background: By increasing intraabdominal pressure, pregnancy may increase the risk of abdominal hernia recurrence. Current data are limited to studies with small sample size and thus the impact of pregnancy on recurrence is unclear.

Objective(s): The objective of this analysis was to evaluate the impact of pregnancy on clinically significant abdominal hernia recurrence in a large multicenter cohort.

Study Design: A multiinstitution deidentified electronic health record database, EPM: Explore (Explorys Inc, Cleveland, OH) was utilized to perform a retrospective cohort study of women aged 18-45 years with a history of an abdominal hernia repair from 1999 through 2013. Abdominal hernia was defined to include ventral and incisional hernias, and other types were excluded. The presence or absence of a pregnancy following primary hernia repair was elucidated from the database. Subjects were excluded if a hernia repair occurred during pregnancy. The rate of hernia recurrence, defined as reoperation, was calculated. The association between pregnancy and hernia recurrence was evaluated with logistic regression, both unadjusted and adjusted for diabetes, obesity (body mass index >30 kg/m(2)), tobacco abuse, and wound complication at the time of initial hernia repair.

Results: A total of 11,020 women with a history of hernia repair were identified, of whom 840 had a subsequent pregnancy. Overall, 915 women in the cohort had a hernia recurrence (8.3%). Women with a history of pregnancy following primary hernia repair were more likely to have a body mass index >30 kg/m(2), a history of tobacco abuse, and a wound complication at the time of primary repair. In an unadjusted analysis, pregnancy was associated with an increase in the risk of hernia recurrence (13.1% vs 7.1%, odds ratio, 1.96, 95% confidence interval, 1.60-2.42). The association between pregnancy and hernia recurrence was attenuated but persisted after adjusting for confounding factors (adjusted odds ratio, 1.73, 95% confidence interval, 1.40-2.14).

Conclusion: Pregnancy is associated with an increased risk of abdominal hernia recurrence after adjusting for confounding factors. The magnitude of this association is likely underestimated, given that the risk of recurrence was defined as reoperation, which captures only the most clinically significant group of recurrences. This information will facilitate counseling for reproductive-aged women planning elective ventral or incisional hernia repair. The risk of recurrence and subsequent reoperation should be balanced against the risk of incarceration and emergent surgery during pregnancy. As such, the desire for future pregnancy and/or contraception should be considered when planning asymptomatic hernia repair for women of reproductive age.
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http://dx.doi.org/10.1016/j.ajog.2016.05.003DOI Listing
September 2016

Intravenous Sedation Without Intubation and the Risk of Anesthesia Complications for Obese and Non-Obese Women Undergoing Surgical Abortion: A Retrospective Cohort Study.

Anesth Analg 2016 06;122(6):1957-62

From the *Case Western Reserve University School of Medicine, Cleveland, Ohio; †Division of Family Planning, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, Ohio; and ‡Department of Anesthesiology, Magee Women's Hospital, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

Background: The primary objective of this study was to assess the risk of perioperative anesthesia-related complications in a cohort of obese and non-obese women undergoing outpatient surgical abortion under IV sedation without tracheal intubation.

Methods: We performed a retrospective cohort study of all surgical abortions through 22 6/7 weeks' gestation at an outpatient clinic from 2012 to 2013. Women receiving IV sedation were included. Obesity status was defined by the World Health Organization criteria. The primary outcome was the rate of perioperative anesthesia complications defined as tracheal intubation, pulmonary aspiration, hospital transfer for an anesthesia indication, or anesthesia-related adverse events (persistent hypoxemia and allergic reaction). The use of opioid reversal (naloxone) was assessed as a secondary outcome measure. Multivariate analysis for the secondary outcome measure was performed with adjustment for confounding factors.

Results: During the study period, 9348 abortions were performed. Of the 5579 patients who received IV sedation, 1438 (25.8%) were obese, 1707 (30.6%) were in the second trimester, and 851 (15.3%) were ≥17 weeks' gestation. No patients experienced a primary outcome measure. Based on the upper 95% confidence interval (CI) for the sample size, the maximal risk of an anesthesia-related complication is 1 in 1860 procedures. Naloxone use occurred in 13 (0.2%) patients and was not more frequent among obese patients (0.14% vs 0.27%; 95% CI of odds ratio [OR], 0.12-2.36; P = 0.54) or procedures at ≥17 weeks' gestation (0.47% vs 0.19%; 95% CI of OR, 0.76-8.06; P = 0.12). These negative findings should be interpreted with caution, given the limitations of the sample size to assess these secondary outcome measures. Naloxone use was associated with fentanyl doses >200 μg (0.82% vs 0.13%; P = 0.002), an association that remained significant when we controlled for confounding factors (adjusted OR, 5.51; 95% CI, 1.61-18.91). Further analysis revealed that fentanyl dose >200 μg was associated with naloxone use for procedures in the first trimester (incident rate ratio, 9.02; 95% CI, 3.73-21.80) but not in the second trimester (incident rate ratio, 0.92; 95% CI, 0.23-3.70).

Conclusions: Among women receiving IV sedation without tracheal intubation for surgical abortion, anesthesia complications are rare and may not be greater for obese women or procedures at gestational age ≥17 weeks. IV sedation without tracheal intubation may be considered for women undergoing first- and second-trimester surgical abortion; however, the rarity of anesthesia-related complications in our cohort precludes a definitive conclusion regarding the overall safety of IV sedation without tracheal intubation.
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http://dx.doi.org/10.1213/ANE.0000000000001335DOI Listing
June 2016

Maternal and neonatal outcomes of attempted vaginal compared with planned cesarean delivery in triplet gestations.

Am J Obstet Gynecol 2016 10 7;215(4):493.e1-6. Epub 2016 May 7.

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

Background: The prevailing obstetric practice of planned cesarean delivery for triplet gestations is largely empiric and data on the optimal route of delivery are limited.

Objective: The primary objectives of this study are to determine the likelihood of success in an attempted vaginal delivery and assess maternal and neonatal outcomes of attempted vaginal vs planned cesarean delivery of triplets using a multiinstitution obstetric cohort.

Study Design: We performed a retrospective cohort study using data from the Consortium on Safe Labor, identifying triplet pregnancies with delivery at a gestational age ≥28 weeks. Women with a history of cesarean delivery and pregnancies complicated by chromosomal or congenital anomalies, twin-twin transfusion syndrome, or a fetal demise were excluded. The attempted vaginal group included all women with spontaneous or induced labor and excluded all women delivering by prelabor cesarean delivery, including those coded as elective or for fetal malpresentation. Primary maternal outcomes included infection (composite of chorioamnionitis, endometritis, wound separation, and wound infection), blood transfusion, or transfer to the intensive care unit. Primary neonatal outcomes included neonatal asphyxia, mechanical ventilation, and composite neonatal morbidity, consisting of ≥1 of the following: birth injury, 5-minute Apgar <4, arterial pH <7.0 or base excess <-12.0, neonatal asphyxia, or neonatal death. For neonatal outcomes, Poisson regression was performed with clustering to account for correlation between neonates within a triplet pregnancy, controlling for confounders as outcome rates allowed. A sensitivity analysis was performed in the subcohort delivering at gestational age ≥34 weeks in which the attempted vaginal delivery group was restricted to include only women with evidence of induction or augmentation or labor.

Results: 188 triplet sets were identified of which 80 sets (240 neonates) met inclusion criteria and 24 sets (30%) had an attempted vaginal delivery. The rate of successful attempted vaginal delivery was 16.7% (4 triplet sets; 12 neonates). No women had a combined mode of delivery. Women attempting vaginal delivery were more likely to have preterm labor (45.8 vs 12.5%, P < .001) and receive antenatal corticosteroids (45.8 vs 21.4%, P = .03), however gestational age at delivery did not differ by mode of delivery. Attempted vaginal delivery was associated with a higher risk of maternal transfusion (20.8% vs 3.6%, P = .01) and neonatal mechanical ventilation (26.4% vs 7.7%; adjusted incidence rate ratio, 1.12; 95% confidence interval, 1.01-1.24). There was no significant difference in the risk of asphyxia or composite neonatal morbidity by mode of delivery. In the subcohort sensitivity analysis, attempted vaginal delivery was associated with an increased risk of composite neonatal morbidity (adjusted incidence rate ratio, 12.44; 95% confidence interval, 1.22-127.20) but not maternal transfusion (22.2% vs 3.5%, P = .06) or neonatal mechanical ventilation (adjusted incidence rate ratio, 1.02; 95% confidence interval, 0.89-1.17).

Conclusion: In a multicenter US cohort, attempted vaginal delivery of triplets is associated with higher risks of maternal transfusion and neonatal mechanical ventilation. Composite severe neonatal morbidity may be higher with attempted vaginal delivery although studies with greater power are required. The low probability of successful vaginal delivery raises questions regarding the utility of attempted vaginal delivery in triplet gestations. Our data support planned prelabor cesarean delivery as the preferred mode of delivery for triplet gestations.
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http://dx.doi.org/10.1016/j.ajog.2016.04.054DOI Listing
October 2016

In Reply.

Obstet Gynecol 2016 Apr;127(4):804-805

Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, Ohio.

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http://dx.doi.org/10.1097/AOG.0000000000001369DOI Listing
April 2016

Intravenous drug use is associated with alloimmunization in pregnancy.

Am J Obstet Gynecol 2016 09 17;215(3):344.e1-6. Epub 2016 Mar 17.

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

Background: Anecdotal evidence has suggested an association of intravenous drug abuse with alloimmunization; however, published data are limited to case reports.

Objective: The purpose of this study was to determine whether women with a history of intravenous drug abuse have an increased risk of alloimmunization.

Study Design: A retrospective cohort study was performed with the use of data from a single-center blood bank and perinatal database from 2008-2014. Blood bank data were used to identify women with alloimmunization, which was defined as a positive antibody screen in pregnancy not due to naturally occurring antibodies, agglutinins, autoantibodies, or Rh immunoglobulin administration. Intravenous drug abuse was ascertained from a comprehensive database that has captured all drug abuse in pregnancy since 2008. For women who contributed >1 pregnancy to the database, only the most recent pregnancy was included. The rates of alloimmunization among women with a history of intravenous drug abuse and general obstetric populations were calculated and compared. The distribution of alloantibody types, proportion of Rh-group alloantibodies, and patient Rh status were assessed for intravenous and non-intravenous drug abuse-associated alloimmunization. Characteristics and outcomes between intravenous and non-intravenous drug abuse-associated alloimmunization were assessed for women with clinically significant alloantibodies.

Results: Alloimmunization was more common in women with a history of intravenous drug abuse (11/305 women; 3.6%) compared to women without a history of intravenous drug abuse (288/16,022 women; 1.8%; relative risk, 2.00; 95% confidence interval, 1.11-3.62). Needle-sharing was present in 7 and suspected in 4 women with an intravenous drug abuse history. Among women with a history of intravenous drug abuse, none had a history of transfusion or traditional risk factor for alloimmunization. The distribution of alloantibodies was different between intravenous drug abuse- and non-intravenous drug abuse-associated alloimmunization. Rh group alloantibodies and Rh-negative status were more common in women with a history of intravenous drug abuse. Among Rh-negative women with a history of intravenous drug abuse, 50% of RhD alloimmunization cases occurred in nulliparous women. The rate of multiple alloantibodies was not different between intravenous drug abuse- and non-intravenous drug abuse-associated alloimmunization.

Conclusion: Maternal history of intravenous drug abuse is associated with an increased risk of alloimmunization. Approximately 1 in 30 intravenous drug abuse women may be diagnosed with an alloantibody in pregnancy. Given the current US opioid epidemic, increased vigilance in screening is required. Needle-sharing represents a possible mechanism for intravenous drug abuse-associated alloimmunization; however, limited obstetric care, failure to obtain Rh immunoglobulin, or failure to identify early pregnancy loss cannot be excluded.
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http://dx.doi.org/10.1016/j.ajog.2016.03.019DOI Listing
September 2016

Stillbirth and the 39-Week Rule: Can We Be Reassured?

Obstet Gynecol 2015 Dec;126(6):1131-1132

Dr. Bailit and Dr. Lappen are from the Department of Obstetrics and Gynecology at MetroHealth Medical Center, Cleveland, Ohio; e-mail: and

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http://dx.doi.org/10.1097/AOG.0000000000001117DOI Listing
December 2015

Triggers, bundles, protocols, and checklists--what every maternal care provider needs to know.

Am J Obstet Gynecol 2016 Apr 23;214(4):444-451. Epub 2015 Oct 23.

Department of Obstetrics and Gynecology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH.

The rise in maternal morbidity and mortality has resulted in national and international attention at optimally organizing systems and teams for pregnancy care. Given that maternal morbidity and mortality can occur unpredictably in any obstetric setting, specialists in general obstetrics and gynecology along with other primary maternal care providers should be integrally involved in efforts to improve the safety of obstetric care delivery. Quality improvement initiatives remain vital to meeting this goal. The evidence-based utilization of triggers, bundles, protocols, and checklists can aid in timely diagnosis and treatment to prevent or limit the severity of morbidity as well as facilitate interdisciplinary, patient-centered care. The purpose of this document is to summarize the pertinent elements from this forum to assist primary maternal care providers in their utilization and implementation of these safety tools.
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http://dx.doi.org/10.1016/j.ajog.2015.10.011DOI Listing
April 2016

Outcomes of Term Induction in Trial of Labor After Cesarean Delivery: Analysis of a Modern Obstetric Cohort.

Obstet Gynecol 2015 Jul;126(1):115-23

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, and the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, Ohio.

Objective: To evaluate outcomes of induction of labor, compared with expectant management, in women attempting trial of labor after cesarean delivery (TOLAC) in a large obstetric cohort.

Methods: We performed a secondary analysis of data from the Consortium on Safe Labor that included women with term (37 weeks of gestation or greater) singleton gestations and a history of one prior cesarean delivery who attempted TOLAC. Induction of labor was compared with expectant management by week of gestation from 37 to 40 weeks in both high- and low-risk cohorts. The primary outcome was failed TOLAC. Secondary outcomes included composite maternal morbidity (hysterectomy, transfusion, intensive care unit (ICU) transfer, venous thromboembolism, death), composite neonatal morbidity (5-minute Apgar score less than 5, cord pH less than 7.0, asphyxia, hypoxic ischemic encephalopathy, neonatal death), and neonatal ICU admission. Multivariate logistic regression was performed with adjustment for confounding factors.

Results: We identified 6,033 women attempting TOLAC of whom 1,626 (27.0%) underwent induction of labor and 4,407 (73.0%) did not. Compared with expectant management, induction was associated with an increased risk of failed TOLAC at 37-39 weeks of gestation but not at 40 weeks of gestation (37 weeks of gestation, 48.5% compared with 34.3%, adjusted odds ratio [OR] 1.53, 95% confidence interval [CI] 1.02-2.28]; 38 weeks of gestation, 47.0% compared with 33.0%, adjusted OR 1.74, 95% CI 1.29-2.34; 39 weeks of gestation, 45.6% compared with 29.8%, adjusted OR 2.16, 95% CI 1.76-2.67; 40 weeks of gestation, 37.9% compared with 29.4%, adjusted OR 1.21, 95% CI 0.90-1.66). Induction was associated with an increased risk of composite maternal morbidity at 39 weeks of gestation (adjusted OR 1.87, 95% CI 1.22-2.87) and neonatal ICU admission at 37 weeks of gestation (adjusted OR 2.51, 95% CI 1.62-3.90). Induction was not associated with an increased risk of neonatal morbidity.

Conclusion: Induction of labor in women with one prior cesarean delivery, compared with expectant management, is associated with an increased risk of failed TOLAC. Apart from small increases in maternal morbidity at 39 weeks and neonatal ICU admission at 37 weeks of gestation, induction is not associated with an increased risk of severe maternal or neonatal morbidity.

Level Of Evidence: II.
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http://dx.doi.org/10.1097/AOG.0000000000000922DOI Listing
July 2015

Infant mortality rate as a metric for best gestational age for delivery.

Am J Obstet Gynecol 2015 Jul 3;213(1):111-112. Epub 2015 Mar 3.

Division of Maternal Fetal Medicine, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.

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http://dx.doi.org/10.1016/j.ajog.2015.03.004DOI Listing
July 2015

In reply.

Obstet Gynecol 2015 Feb;125(2):494

Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, MetroHealth Hospital, Case Western Reserve University School of Medicine, Cleveland, Ohio, the Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Women's Health, University of Louisville, Louisville, Kentucky, and the Department of Obstetrics & Gynecology, Maternal-Fetal Medicine, Columbia University Medical Center, New York, New York.

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http://dx.doi.org/10.1097/AOG.0000000000000661DOI Listing
February 2015

Determinants of the competing outcomes of intrauterine infection, abruption, or spontaneous preterm birth after preterm premature rupture of membranes.

J Matern Fetal Neonatal Med 2016 7;29(2):258-63. Epub 2015 Jan 7.

a Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology , University Hospitals Case Medical Center and Case Western Reserve University , Cleveland , OH , USA and.

Objective: Patients with PPROM are at risk for a variety of outcomes, including chorioamnionitis (CA), placental abruption (PA), or preterm labor (PTL). Competing risk regression can analyze a cohort's risk of individual outcomes while accounting for ongoing deliveries secondary to competing events.

Methods: A secondary analysis of the subjects from MFMU BEAM study of neuroprotection after preterm birth (BEAM) with conservative PPROM management. Deliveries were categorized as: PA, CA, PTL, "elective" or "indicated". The association between outcomes of PA, CA or PTL and clinical predictors of twins, ethnicity, parity, gestational age at rupture, bleeding, contractions, cervical dilation, preterm birth history, weight, and genitourinary infections were evaluated via competing risk regression.

Result: 1970 subjects were included. The significance and directionality of predictors varied according to specific outcomes. Patients with twins had an increased PTL hazard (1.85) though reductions in CA- (0.66) or PA-specific (0.56) hazards. Decreased latency in African-Americans was almost entirely due to an increased CA hazard (1.44) without a significant association with PTL. Increasing gestational age at membrane rupture was associated with a decreasing hazard of CA although increasing hazard of PTL.

Conclusions: For patients with PPROM, the hazards associated with different clinical predictors vary according to exact outcomes.
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http://dx.doi.org/10.3109/14767058.2014.997703DOI Listing
September 2016

Modified obstetric early warning scoring systems (MOEWS): validating the diagnostic performance for severe sepsis in women with chorioamnionitis.

Am J Obstet Gynecol 2015 Apr 8;212(4):536.e1-8. Epub 2014 Nov 8.

School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.

Objective: We sought to compare the predictive power of published modified obstetric early warning scoring systems (MOEWS) for the development of severe sepsis in women with chorioamnionitis.

Study Design: This was a retrospective cohort study using prospectively collected clinical observations at a single tertiary unit (Chicago, IL). Hospital databases and patient records were searched to identify and verify cases with clinically diagnosed chorioamnionitis during the study period (June 2006 through November 2007). Vital sign data (heart rate, respiratory rate, blood pressure, temperature, mental state) for these cases were extracted from an electronic database and the single worst composite recording was identified for analysis. Global literature databases were searched (2014) to identify examples of MOEWS. Scores for each identified MOEWS were derived from each set of vital sign recordings during the presentation with chorioamnionitis. The performance of these MOEWS (the primary outcome) was then analyzed and compared using their sensitivity, specificity, positive and negative predictive values, and receiver-operating characteristic curve for severe sepsis.

Results: Six MOEWS were identified. There was wide variation in design and pathophysiological thresholds used for clinical alerts. In all, 913 women with chorioamnionitis were identified from the clinical database. In all, 364 cases with complete data for all physiological indicators were included in analysis. Five women developed severe sepsis, including 1 woman who died. The sensitivities of the MOEWS in predicting the severe deterioration ranged from 40-100% and the specificities varied even more ranging from 4-97%. The positive predictive values were low for all MOEWS ranging from <2-15%. The MOEWS with simpler designs tended to be more sensitive, whereas the more complex MOEWS were more specific, but failed to identify some of the women who developed severe sepsis.

Conclusion: Currently used MOEWS vary widely in terms of alert thresholds, format, and accuracy. Most MOEWS have not been validated. The MOEWS generally performed poorly in predicting severe sepsis in obstetric patients; in general severe sepsis was overdetected. Simple MOEWS with high sensitivity followed with more specific secondary testing is likely to be the best way forward. Further research is required to develop early warning systems for use in this setting.
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http://dx.doi.org/10.1016/j.ajog.2014.11.007DOI Listing
April 2015

The maternal early warning criteria: a proposal from the national partnership for maternal safety.

J Obstet Gynecol Neonatal Nurs 2014 Nov-Dec;43(6):771-9. Epub 2014 Sep 9.

Case reviews of maternal death have revealed a concerning pattern of delay in recognition of hemorrhage, hypertensive crisis, sepsis, venous thromboembolism, and heart failure. Early-warning systems have been proposed to facilitate timely recognition, diagnosis, and treatment for women developing critical illness. A multidisciplinary working group convened by the National Partnership for Maternal Safety used a consensus-based approach to define The Maternal Early Warning Criteria, a list of abnormal parameters that indicate the need for urgent bedside evaluation by a clinician with the capacity to escalate care as necessary in order to pursue diagnostic and therapeutic interventions. This commentary reviews the evidence supporting the use of early-warning systems, describes The Maternal Early Warning Criteria, and provides considerations for local implementation.
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http://dx.doi.org/10.1111/1552-6909.12504DOI Listing
December 2015

The maternal early warning criteria: a proposal from the national partnership for maternal safety.

Obstet Gynecol 2014 Oct;124(4):782-786

Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas; the Central Jersey Family Health Consortium, Inc., North Brunswick, New Jersey; the Departments of Cardiology and Maternal-Fetal Medicine, University of California, Irvine, Irvine, California; the Department of Reproductive Biology, Case Western Reserve University School of Medicine and the Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, Ohio; the School of Nursing, Vanderbilt University, Nashville, Tennessee; the Department of Obstetrics and Gynecology, Maternal-Fetal Medicine, University of Iowa Hospitals and Clinics, Iowa City, Iowa; the Department of Obstetrics and Gynecology, Rush University Medical Center, Chicago, Illinois; the Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Women's Health, University of Louisville, Louisville, Kentucky; and the Department of Obstetrics & Gynecology, Maternal-Fetal Medicine, Columbia University Medical Center, New York, New York.

Case reviews of maternal death have revealed a concerning pattern of delay in recognition of hemorrhage, hypertensive crisis, sepsis, venous thromboembolism, and heart failure. Early-warning systems have been proposed to facilitate timely recognition, diagnosis, and treatment for women developing critical illness. A multidisciplinary working group convened by the National Partnership for Maternal Safety used a consensus-based approach to define The Maternal Early Warning Criteria, a list of abnormal parameters that indicate the need for urgent bedside evaluation by a clinician with the capacity to escalate care as necessary in order to pursue diagnostic and therapeutic interventions. This commentary reviews the evidence supporting the use of early-warning systems and describes The Maternal Early Warning Criteria, along with considerations for local implementation.
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http://dx.doi.org/10.1097/AOG.0000000000000480DOI Listing
October 2014

Resident orientation: a time to foster cultural competency.

Obstet Gynecol 2014 Mar;123(3):653-655

Department of Reproductive Biology, Case Western Reserve University School of Medicine, and the Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, Ohio.

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http://dx.doi.org/10.1097/AOG.0000000000000135DOI Listing
March 2014

Changes in care associated with the introduction of a postpartum hemorrhage patient safety program.

Am J Perinatol 2013 Nov 28;30(10):833-8. Epub 2013 Jan 28.

Department of Obstetrics and Gynecology, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio.

Objective: To determine whether the introduction of a postpartum hemorrhage (PPH) patient safety program was associated with changes in patient care or outcomes.

Study Design: A multipronged patient safety program regarding PPH was instituted at a tertiary care maternity hospital. Patient care and outcomes were assessed for 6 months prior to (period A) and 6 months after (period B) program institution.

Results: In all, 278 and 341 women were diagnosed with PPH during periods A and B, respectively. Women who had a PPH after the program were more likely to receive more than one dose of prostaglandin F2 α (24% versus 9%, p = 0.01) and more than one type of uterotonic (34% versus 25%, p = 0.02) and to have a B-lynch suture placed (9.4% versus 4.7%, p = 0.03). The frequency of blood transfusion, hysterectomy, and intensive care unit admission were similar between periods.

Conclusion: Introduction of a PPH safety program resulted in several indications of a more quickly escalated response.
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http://dx.doi.org/10.1055/s-0033-1333674DOI Listing
November 2013