A retrospective review of the association between maternal body mass index and the risk of congenital anomalies.

The objective of the study was to examine the association of congenital anomalies with the specific classes of pre-pregnancy BMI. An IRB-approved retrospective cohort study was performed using the data from the Natality Public Use File from the National Center for Health Statistics (2019). We included all singleton live births and excluded pregnancies with suspected or confirmed chromosomal abnormalities and people with pre-existing diabetes mellitus and missing pertinent data. The primary outcome was the incidence of any major congenital anomalies in liveborn infants. The incidence of anomaly was analyzed across all BMI classes, using individuals with BMI between 18.5 and 24.9 kg/m2 as the comparison group. A test of trend was also performed to determine if the risk increased as the BMI class increased. A total of 3 047 382 maternal-neonatal dyads were included in the analysis. A non-significant higher incidence of any major anomaly was noted among people who had underweight and class III BMI. The risk of open neural tube defects, omphalocele, and cleft lip/palate increased and the risk of gastroschisis decreased with an increase in maternal BMI class (p < 0.05). The incidence of congenital anomalies increases as the pre-pregnancy BMI increases. Individuals should be encouraged to optimize their weight prior to conception and if feasible, they should obtain screening for fetal anatomy assessment by a Maternal-Fetal Medicine specialist.

Preeclampsia and Long-term Kidney Outcomes: An Observational Cohort Study.

RATIONALE & OBJECTIVE: Preeclampsia is a pregnancy-related complication characterized by acute hypertension and end-organ dysfunction. We evaluated the long-term association between preeclampsia and the risk of developing chronic hypertension and kidney disease. STUDY DESIGN: Observational cohort study. SETTING & PARTICIPANTS: 27,800 adults with deliveries in the Geisinger Health System between 1996 and 2019. EXPOSURE: Preeclampsia. OUTCOME: Hypertension, reduced estimated glomerular filtration rate (eGFR)<60mL/min/1.73m2), and albuminuria>300mg/g. ANALYTICAL APPROACH: Propensity-score matching and Cox proportional hazards models to evaluate the association between preeclampsia and incident hypertension, reduced eGFR, and albuminuria. RESULTS: Of 27,800 adults with pregnancies during the study period (mean age, 28 years; 3% Black race), 2,977 (10.7%) had at least 1 pregnancy complicated by preeclampsia. After matching for multiple characteristics, individuals with preeclampsia had a higher risk of developing chronic hypertension (HR, 1.77 [95% CI, 1.45-2.16]), eGFR<60mL/min/1.73m2 (HR, 3.23 [95% CI, 1.64-6.36]), albuminuria (HR, 3.60 [95% CI, 2.38-5.44]), and a subsequent episode of preeclampsia (HR, 24.76 [95% CI, 12.47-48.36]), compared with matched controls without preeclampsia. Overall, postpartum follow-up testing was low. In the first 6 months after delivery, 31% versus 14% of individuals with and without preeclampsia had serum creatinine tests, respectively, and testing for urine protein was the same in both groups, with only 26% having follow-up testing. LIMITATIONS: Primarily White study population, observational study, reliance on ICD codes for medical diagnosis. CONCLUSIONS: Individuals with a pregnancy complicated by preeclampsia had a higher risk of hypertension, reduced eGFR, and albuminuria compared with individuals without preeclampsia. PLAIN-LANGUAGE SUMMARY: Preeclampsia is a significant contributor to perinatal and maternal morbidity and is marked by new-onset hypertension and end-organ damage, including acute kidney injury or proteinuria. To gain insight into the long-term kidney effects of the disease, we compared adults with deliveries complicated by preeclampsia with those without preeclampsia in the Geisinger Health System, while also assessing postpartum testing rates. Our results demonstrate that pregnant individuals with preeclampsia are at a heightened risk for future hypertension, reduced eGFR, and albuminuria, with overall low rates of postpartum testing among both individuals with and without preeclampsia. These findings underscore the need to consider preeclampsia as an important risk factor for the development of chronic kidney disease. Further studies are required to determine optimal postpreeclampsia monitoring strategies.

Comparison of three antepartum risk assessment tools to predict significant postpartum hemorrhage in livebirths.

BACKGROUND: To adequately predict significant postpartum hemorrhage (PPH) at hospital admission, we evaluated and compared the accuracy of three risk assessment tools: 1. California Maternal Quality Care Collaborative (CMQCC), 2. American College of Obstetrics and Gynecology Safe Motherhood Initiative (ACOG SMI) and 3. Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN). STUDY DESIGN AND METHODS: This is a retrospective cohort study of people who delivered liveborn infants from January 2018 to June 2021 at our center. Patients with comorbidities necessitating higher hemoglobin values, those who refused blood transfusions, and missing pertinent data were excluded. Significant PPH was defined as a blood transfusion within 48 hours following delivery. Diagnostic statistics were calculated for each tool. RESULTS: Of the 11,679 included pregnancies, 232 (1.9%) people had significant PPH. Amongst those diagnosed as high-risk by the CMQCC tool, 67/1485 (4.5%) had significant PPH; 62/1672 (3.7%) by the ACOG SMI tool, and 85/1864 (4.6%) by the AWHONN tool had significant PPH. All tools have low sensitivity and high negative predictive values. The area under the receiver operating characteristics curve of the three tools is moderately poor (CMQCC: 0.58, ACOG SMI: 0.55, AWHONN:0.61). DISCUSSION: Upon admission to labor and delivery, all three studied tools are poor predictors of significant PPH. The development and validation of better PPH risk stratification tools are required with the inclusion of additional important variables.

Pregnancy Outcomes in Patients Enrolled in the Healthy Beginnings Plus Program.

OBJECTIVE: To evaluate the effectiveness of enrollment in the Healthy Beginnings Plus Program (HB) on pregnancy outcomes. DESIGN: Retrospective cohort study of 12,299 singleton pregnancies birthed between January 2007 and December 2018. SETTING/LOCAL PROBLEM: Individuals of low socioeconomic status are at increased risk for adverse pregnancy outcomes, such as preterm birth (PTB) and low-birth-weight (LBW) neonates. Pennsylvania offers HB to pregnant individuals with Medical Assistance insurance to provide additional psychosocial and obstetric resources to routine prenatal care to minimize risk. PARTICIPANTS: Individuals with Medical Assistance insurance enrolled in HB (n = 4,645), individuals with Medical Assistance insurance not enrolled in HB (n = 2,874), and individuals with private insurance (n = 4,780). MEASUREMENTS: Primary outcomes were rates of PTB and LBW neonates. Secondary outcomes included rates of gestational diabetes, gestational hypertension, small-for-gestational-age neonates, and admission to the NICU. RESULTS: There were no differences in PTB (adjusted OR [aOR] = 0.93, 95% confidence interval [CI] [0.76, 1.13]) or LBW neonates (aOR = 1.06, 95% CI [0.86, 1.31]) between individuals with Medical Assistance enrolled in HB versus those with Medical Assistance insurance not enrolled in HB. Individuals with Medical Assistance enrolled in HB were less likely to develop gestational hypertension compared to individuals with Medical Assistance insurance not enrolled in HB (aOR = 1.41, 95% CI [1.25, 1.59]) and individuals with private insurance (aOR = 0.85, 95% CI [0.76, 0.96]). They also attended more prenatal visits than individuals with Medical Assistance insurance not enrolled in HB (12.0 vs. 14.0, p < .01). CONCLUSION: Although there was no significant difference between groups for the primary outcomes studied, individuals with Medical Assistance insurance enrolled in HB attended more prenatal visits than those who did not enroll in HB. Similar programs should evaluate outcomes and consider whether changes are needed.

Retrospective application of algorithms to improve identification of pregnancy outcomes from the electronic health record.

OBJECTIVE: To improve upon the accuracy of ICD codes for identifying maternal and neonatal outcomes by developing algorithms that incorporate readily available EHR data. STUDY DESIGN: Algorithms were developed for gestational hypertension (GHTN), pre-eclampsia (PreE), gestational diabetes mellitus (GDM) and were compared to ICD codes and chart review. Accuracy and sensitivity analyses were calculated with their respective 95% confidence limits for each of the comparisons between algorithms, ICD codes alone, and chart review. RESULTS: Sensitivity of GHTN ICD codes was 8.1% vs. 83.8% for the algorithm when compared to chart review. In comparison to chart review, sensitivity of ICD codes for PreE was 7.5% vs. 71.4% for the algorithm. GDM had similar sensitivity rates for both ICD codes and the algorithm. CONCLUSION: Application of algorithms, validated by chart review, enhanced capture of several outcomes. Algorithms should be obligatory adjunct tools to the ICD codes for identification of outcomes of interest.

Performance of a Multianalyte 'Rule-Out' Assay in Pregnant Individuals With Suspected Preeclampsia.

BACKGROUND: The ability to diagnose preeclampsia clinically is suboptimal. Our objective was to validate a novel multianalyte assay and characterize its performance, when intended for use as an aid to rule-out preeclampsia. METHODS: Prospective, multicenter cohort study of pregnant individuals presenting between 280/7 and 366/7 weeks' with preeclampsia-associated signs and symptoms. Individuals not diagnosed with preeclampsia after baseline evaluation were enrolled in the study cohort, with those who later developed preeclampsia, classified as cases and compared with a negative control group who did not develop preeclampsia. Individuals with assay values at time of enrollment ≥0.0325, determined using a previously developed algorithm, considered at risk. The primary analysis was the time to develop preeclampsia assessed using a multivariate Cox regression model. RESULTS: One thousand thirty-six pregnant individuals were enrolled in the study cohort with an incidence of preeclampsia of 30.3% (27.6%-33.2%). The time to develop preeclampsia was shorter for those with an at-risk compared with negative assay result (log-rank P<0.0001; adjusted hazard ratio of 4.81 [3.69-6.27, P<0.0001]). The performance metrics for the assay to rule-out preeclampsia within 7 days of enrollment showed a sensitivity 76.4% (67.5%-83.5%), negative predictive value 95.0% (92.8%-96.6%), and negative likelihood ratio 0.46 (0.32-0.65). Assay performance improved if delivery occurred <37 weeks and for individuals enrolled between 28 and 35 weeks. CONCLUSIONS: We confirmed that a novel multianalyte assay was associated with the time to develop preeclampsia and has a moderate sensitivity and negative likelihood ratio but high negative predictive value when assessed as an aid to rule out preeclampsia within 7 days of enrollment. REGISTRATION: The study was registered on Clinicaltrials.gov (Identifier NCT02780414).

Comparison of different methods of patient education on preeclampsia: a randomized controlled trial.

BACKGROUND: Preeclampsia is a life-threatening condition unique to pregnancy that contributes to maternal mortality worldwide. Delays in diagnosis and treatment are contributing factors for most maternal deaths from preeclampsia. Patients who are educated and knowledgeable regarding this disease process may present earlier for care. OBJECTIVE: To assess whether two different visual aids are effective methods to educate patients about preeclampsia, and to evaluate the potential impact of these visual aids on patient anxiety. STUDY DESIGN: Primigravid participants at a tertiary care center were given a survey regarding preeclampsia knowledge 18-25 weeks gestation. Participants were then randomized to preeclampsia education with a graphic card, an educational video, or through routine prenatal care. Participants completed the survey again at 32-37 weeks gestation. We compared the follow-up preeclampsia knowledge score for each type of education as well as the level of anxiety after viewing the video or graphic card. RESULTS: Recruitment began 9 May 2016 and ceased 18 January 2017. A total of 179 patients were randomized and 150 participants completed the study, with 56 shown the graphic card, 45 shown the educational video, and 49 who had only routine prenatal counseling. The remaining 28 patients were lost to follow up and 1 was withdrawn. There was no significant difference in preeclampsia knowledge score at follow-up. There was no significant difference in anxiety score before and after viewing either educational tool for those randomized to either the graphic card (p = .64) or the video (p = .63). CONCLUSIONS: There is no additional improvement of patient knowledge retention when patients receive education with a graphic card versus an educational video over routine prenatal counseling. Patient anxiety does not appear to be impacted by preeclampsia education with a graphic card or an educational video.

A retrospective review of pregnancy outcomes in women with uncomplicated mild to moderate chronic hypertension.

OBJECTIVE: To examine pregnancy complications in women with uncomplicated mild-moderate chronic hypertension (CHTN) treated with antihypertensives prior to 20 weeks compared to those not on antihypertensives. STUDY DESIGN: This retrospective cohort study examined singleton pregnancies of women with mild-moderate CHTN who delivered from 01/2014-3/2019. Pregnancies complicated by hypertension at ≥ 20 weeks, end organ damage, preexisting diabetes mellitus, early-onset gestational diabetes, multifetal gestation, and fetal anomalies were excluded. Adjusted logistic regression analyses were performed for each of the outcomes. Adjusted odds ratios (aOR) were reported along with associated 95% confidence intervals (CI) and p-values. MAIN OUTCOME MEASURES: Primary outcome was superimposed preeclampsia with severe features. Additional maternal outcomes were superimposed preeclampsia without severe features, severe hypertension, indicated preterm delivery, placental abruption, and mode of delivery. Neonatal outcomes included composite perinatal outcomes (fetal growth restriction, intrauterine fetal demise, and small for gestational age neonate), low birth weight, very low birth weight, admission to the neonatal intensive care unit, and Apgar score <7 at 5-minutes. RESULTS: 345 women were identified: 232 (67.2%) were not taking antihypertensives and 113 (32.8%) were taking ≥1 antihypertensive. There was no significant difference in the primary outcome (p = 0.65; aOR = 0.88; 95% CI 0.51-1.52) among the group taking antihypertensive therapy as compared to those not taking antihypertensives. No statistically significant differences were seen for any of the other secondary maternal or neonatal outcomes. CONCLUSIONS: Our data supports that the use of antihypertensive therapy in women with mild-moderate CHTN does not reduce the risk of developing superimposed preeclampsia.

Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.

OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.

Maternal risk factors associated with persistent placenta previa.

INTRODUCTION: Maternal risk factors associated with placenta previa are well documented in the literature. However, there are limited studies identifying maternal characteristics associated with the persistence of placenta previa. The objective of the study was to determine maternal characteristics associated with the persistent placenta previa. METHODS: A retrospective cohort study was conducted in which 705 pregnant women diagnosed with low-lying placenta or placenta previa between 17 and 24 weeks gestation were identified from a single institution between 2003 and 2017. The primary outcome included persistent placenta previa (i.e., persistent placental tissue within 2 cm of the internal os) at or after 36 weeks 0 days. Those with abnormal placentation (e.g., vasa previa, placenta accreta) or delivery prior to 36 weeks 0 days were excluded. Multivariable logistic regression modeling was utilized to determine significant maternal characteristics associated with persistent placenta previa among women diagnosed with either placenta previa or low-lying placenta. RESULTS: Women with a prior cesarean delivery were seven times more likely to have persistent placenta previa (odds ratio, 7.0, 95% confidence interval, 3.7-13.1). A history of intrauterine curettage or evacuation in the setting of placenta previa increases the likelihood of persistent placenta previa almost 3-fold (odds ratio, 2.5, 95% confidence interval, 1.3-5.0). DISCUSSION: To date, our study is the largest, retrospective cohort study assessing maternal risk factors associated with persistent placenta previa; and is the first to detect a statistically significant correlation between a history of intrauterine surgeries and persistent placenta previa.

Obstetricians' knowledge and practices regarding the management of preeclampsia.

Background: Preeclampsia affects over 4% of pregnancies in the United States. Management of preeclampsia is dependent on the severity of the condition and can range from expectant management to early delivery and inpatient observation. After publication of the hypertension in Pregnancy Task Force guidelines in 2013, little is known about their implementation and acceptance by practicing obstetricians and maternal-fetal medicine (MFM) specialists.Objective: To evaluate Obstetricians' knowledge and practices regarding the management of preeclampsia.Methods: A prospective survey was administered to ob-gyns at three different hospital systems in the Northeastern United States to assess practices regarding preeclampsia management and prevention.Results: A total of 87 out of 130 providers completed and returned a questionnaire (66.9% response rate). Providers with a subspecialty in MFM made up 44.3% of the sample. 90.7% of respondents agreed that preeclampsia is a common diagnosis in their practice, while 85% agreed that aspirin is useful for reducing a patient's risk of preeclampsia. 68.8% of providers reported not administering magnesium sulfate in labor to reduce seizure risk in patients with preeclampsia without severe features. Only 5.8% of providers reported using a preeclampsia prediction algorithm, all of whom were MFMs. Providers who specialized in MFM were more likely to prescribe aspirin for preeclampsia prevention in patients with chronic hypertension (26, 74.3% vs. 17, 39.5%, p = .002). MFM specialists were also more likely to counsel patients with abnormal biomarkers on the risk of preeclampsia (23, 69.7% vs. 15, 35.7%, p = .005).Conclusion: Efforts to inform practicing ob-gyns about the best practices for preeclampsia management and prevention have been largely successful, though there are still discrepancies between current recommendations and practice. Differences between general OBGYNs and MFM specialists were also significant with regards to practice. Given the acknowledgement of how common diagnoses of preeclampsia are in respondents' practices, better education and distribution of guidelines on management of preeclampsia is needed.

Maternal and Infant Health Care Costs Related to Preeclampsia.

OBJECTIVE: To provide U.S. case-based preeclampsia health care cost estimates for mothers and infants from a U.S. payer perspective, with comparisons with both uncomplicated and hypertensive pregnancies. METHODS: Electronic health record and billing data from a large regional integrated health care system in Pennsylvania were used to identify mother-singleton infant pairs with deliveries between 2010 and 2015. Data on clinical care and costs using actual payment amounts were compiled from 20 weeks of gestation to 6 weeks postdelivery for mothers and birth to 12 months for infants. Three defined pregnancy study cohorts, uncomplicated, hypertension and preeclampsia, were matched using a 1:1:1 ratio on the basis of maternal age, parity, body mass index, and comorbidities. Costs per pregnancy were calculated in 2015 dollars and preeclampsia incremental costs estimated by subtracting the average cost of the matched cohorts. RESULTS: The final study population included 712 matched mother-infant pairs in each cohort. The mean combined maternal and infant medical care costs in the preeclampsia cohort of $41,790 were significantly higher than those for the uncomplicated cohort of $13,187 (P<.001) and hypertension cohort of $24,182 (P<.001), and were largely driven by differences in the infant costs. The mean infant cost in the preeclampsia cohort were $28,898, in the uncomplicated cohort $3,669 and $12,648 in the hypertension cohort (P<.001). Mothers with preeclampsia delivered 3 weeks earlier (median 36.5 weeks of gestation) than women in the uncomplicated cohort and more than 2 weeks earlier than women in the hypertension cohort. A significantly larger percentage of women with preeclampsia and their infants experienced adverse events (13.9% for mothers and 14.6% for infants) compared with unaffected women (4.1% and 0.7%) and those with hypertension (9.4% and 4.8%), respectively (P<.001). CONCLUSION: The economic burden of preeclampsia health care is significant with the main cost drivers being infant health care costs associated with lower gestational age at birth and greater adverse outcomes. FUNDING SOURCE: This study is funded by Progenity, Inc.

Comparing Diagnosis of Fetal Growth Restriction and the Potential Impact on Management and Outcomes Using Different Growth Curves.

OBJECTIVES: The diagnosis of fetal growth restriction (FGR) is managed with close fetal surveillance and often requires iatrogenic delivery, as there is an associated increased risk of fetal demise. However, there is no standard reference for fetal growth. We sought to compare the intrauterine growth curve of Hadlock et al (Radiology 1991; 181:129-133) to other known growth curves to determine which one best identifies fetuses at risk without overburdening the patient and health care system with unnecessary intervention. METHODS: We retrospectively reviewed charts of singleton euploid pregnancies with a diagnosis of FGR (per Hadlock) at a tertiary care center from June 2014 to May 2015. We applied the estimated fetal weights from ultrasound at diagnosis of FGR to 4 population-based growth curves by Brenner et al (Am J Obstet Gynecol 1976; 126:555-564), Williams et al (Obstet Gynecol 1982; 59:624-632), Alexander et al (Obstet Gynecol 1996; 87:163-168), and Duryea et al (Obstet Gynecol 2014; 124:16-22) and reassessed the incidence of FGR using each curve. We reviewed pregnancy demographics, risk factors, pregnancy management, and outcomes of FGR cohorts on each curve to evaluate whether poor outcomes may be missed or interventions may be avoided using the population-based curves. A sensitivity analysis was also done to see how well each curve predicted small-for-gestational-age birth weights. RESULTS: Applying any of the population-based growth curves decreased the number of FGR diagnoses, iatrogenic deliveries, and primary cesarean deliveries. Brenner's growth curve identified the least number of FGR diagnoses at 22 of the 107 identified by Hadlock. Williams' growth curve performed best in the sensitivity analysis with sensitivity of 99% and specificity of 97%. A small number of patients with absent/reversed end-diastolic flow would have been missed by applying the population curves. CONCLUSIONS: Applying the population-based growth curves instead of Hadlock's for diagnosis of FGR decreases its incidence, therefore decreasing the number of visits for ultrasound and fetal surveillance and the number of iatrogenic deliveries. However, using these curves could miss a few fetuses with increased risk of fetal demise.

Patient attitudes toward influenza and tetanus, diphtheria and acellular pertussis vaccination in pregnancy.

BACKGROUND: Routine influenza and tetanus, diphtheria and acellular pertussis (Tdap) vaccination of pregnant women to prevent poor maternal, fetal and neonatal outcomes is recommended practice; however, actual rates of influenza vaccine acceptance are typically well below the (Healthy People 2020, 2015) goal of 80%. OBJECTIVE: We sought to identify barriers to accepting either vaccination. MATERIALS AND METHODS: From December 2014 to April 2015 women were given a questionnaire eliciting their experiences, attitudes and history of influenza and Tdap vaccination in pregnancy during their routine prenatal care appointments at a tertiary care center. Patient demographics were included in the questionnaire. A similar questionnaire was administered to prenatal care providers. Patient influenza and Tdap vaccination acceptance rates were compared and predictors of vaccine acceptance were analyzed with bivariate logistic regression. RESULTS: Out of the 400 patient questionnaires distributed, 338 (84.5%) were completed and returned; 24 of 45 (53.3%) provider questionnaires were returned. Vaccination acceptance rates were 70.7% for the influenza vaccine and 76.3% for the Tdap vaccine. The logistic regression model indicated that predictors of acceptance for either vaccine in pregnancy are patient attitude and previous vaccination history. Patient attitudes were more favorable towards Tdap than influenza vaccination. The combination of healthcare provider recommendation and educational materials was significantly predictive of both Tdap and influenza vaccine acceptance. The most common reasons given for declining the influenza vaccine were safety concerns; the most common reasons given for declining the Tdap vaccine were that patients did not think it was required again when they received the vaccine before pregnancy. CONCLUSIONS: Our study suggests that providers can improve Tdap and influenza vaccination acceptance in pregnancy by recommending the vaccination in combination with provision of educational materials on the vaccines.

Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. METHODS: This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than or equal to 2 cm dilated and less than or equal to 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat. RESULTS: We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied. CONCLUSION: In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01973036.

Gestational Diabetes Mellitus and Frequency of Blood Glucose Monitoring: A Randomized Controlled Trial.

OBJECTIVE: To assess whether testing blood glucose four times daily compared with four times every other day would lead to similar birth weights among patients with gestational diabetes mellitus (GDM). METHODS: This noninferiority randomized controlled trial was conducted at five centers. After receiving a diagnosis of GDM, women tested their blood glucose every day for 7 days. After that period, compliant women without hyperglycemia requiring treatment were randomized to either blood glucose testing four times a day or every other day. Noninferiority would be declared if the mean birth weight in the every-other-day group was no higher than 165 g (5% difference assuming an average birth weight of 3,296 g) compared with the four times a day group. A total sample size of 286 women allowed noninferiority to be tested (one-sided .05 level of significance). RESULTS: From May 2013 to May 2016, of the 293 women with GDM who were randomized, 149 (51%) were tested four times a day and 144 (49%) were tested every other day. Between the two groups, there were no significant differences with regard to need for medical treatment, induction, gestational age at delivery, mode of delivery, rate of preeclampsia, or shoulder dystocia. Birth weight was similar between both groups and the upper bound of the 90% confidence interval (CI) was less than 165 g, establishing noninferiority with a mean difference of -41 g (90% CI -137 to 54 g). Rate of compliance with blood glucose testing was higher in the every-other-day group (89% compared with 92%, P<.01). The differences in rates of macrosomia and birth weight greater than the 95th percentile were not clinically significant. Neonatal outcomes including neonatal hypoglycemia were similar. CONCLUSION: Among patients with well-controlled GDM, testing blood glucose values every other day did not increase birth weight, although it did increase compliance with testing when compared with women who tested every day. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01818557.

Influenza Vaccination among Pregnant Women: Patient Beliefs and Medical Provider Practices.

ACOG's research department recruited four medical centers to participate in a study on the attitudes and practices of medical providers and pregnant patients regarding influenza vaccination. Medical providers and patients were given voluntary surveys and medical record data was collected over two flu seasons, from 2013 to 2015. Discrepancies between self-reports of medical providers and patients and medical records were observed. Nearly 80% of patients self-reported accepting the influenza vaccine, but medical record data only reported 36% of patients accepting the vaccine. Similarly, all medical providers reported giving recommendations for the vaccine, but only 85% of patients reported receiving a recommendation. Age, education, a medical provider's recommendation, and educational materials were found to positively influence patient beliefs about the influenza vaccine. Accepting the vaccine was influenced by a patient's previous actions, beliefs, and a medical provider's recommendation. Patients who reported previously not accepting the vaccine and had negative feelings towards the vaccine but accepted it while pregnant reported concern for the health and safety of their baby. Future research should focus on groups that may be less likely to accept the vaccine and ways to dispel negative myths. Medical provider should continue to strongly recommend the vaccine and provide educational materials.

The effect of the MFM obesity protocol on cesarean delivery rates.

BACKGROUND: Obesity in pregnancy has an impact on both the mother and the fetus. To date, no universal protocol has been established to guide the management of pregnancy in obese woman. In April 2011, the Geisinger Maternal-Fetal Medicine Department implemented an obesity protocol in which women meeting the following criteria were delivered by their estimated due dates: (1) class III obese or (2) class II obese with additional diagnoses of a large-for-gestational-age fetus or pregnancy complicated by gestational diabetes or (3) class I obese with large-for-gestational-age and gestational diabetes. OBJECTIVE: We sought to assess the impact of this protocol on the rate of cesarean deliveries in obese women. STUDY DESIGN: We performed a retrospective cohort study of 5000 randomly selected women who delivered at Geisinger between January 2009 and September 2013, excluding those who delivered in 2011. The data were stratified into obese and nonobese and divided into before protocol and after protocol. Comparison across all groups was accomplished using Wilcoxon rank sum and Pearson's χ(2) tests. Potential confounders were controlled for using logistic regression. RESULTS: The cesarean delivery rate in the obese/after protocol group was 10.8% lower than in the obese/before protocol group (42.4% vs 31.6%, respectively; P < .0001). In addition, when controlling for age, race, smoking status, preeclampsia, gestational diabetes, and intrauterine growth restriction, obese women were 37% less likely to have a cesarean delivery after the protocol than they were before (odds ratio, 0.63; 95% confidence interval, 0.52, 0.76, P < .0001). CONCLUSION: Implementation of a maternal-fetal medicine obesity protocol did not increase the rate of cesarean deliveries in obese women. On the contrary, obese women were less likely to have a cesarean delivery after implementation of the protocol.