Evaluation of Early Screening for Diabetes Mellitus in Pregnancy with Hemoglobin A1c.

Early diabetes screening is recommended for high-risk pregnant women risk via a 1-hour glucose challenge test (1-hour GCT). Hemoglobin A1c (HbA1c) can be obtained with initial obstetric laboratories. We sought to examine the relationship between HbA1c and 1-hour GCT for early diabetes screening in pregnancy. This is a retrospective cohort study of 204 high-risk pregnant women who underwent early HbA1c and 1-hour GCT. Simple logistic regression analysis was performed to predict abnormal 1-hour GCT and diagnosis of diabetes using HbA1c. A total of 158 (77.5%), 44 (21.5%), and 2 (1%) women had HbA1c of less than 5.7, 5.7 to 6.4, and 6.5% or higher, respectively. Seven of 158 (4.4%) women with HbA1c less than 5.7% and 8 of 44 (18.2%) with HbA1c of 5.7 to 6.4% had a diagnosis of diabetes. A positive correlation between early HbA1c and 1-hour GCT was detected. Logistic regression showed HbA1c significantly predicted the risk of diabetes but was not a good predictor of abnormal 1-hour GCT. HbA1c of 5.5% or less had a 97% or higher negative predictive value for early diabetes in pregnancy. There is a positive correlation between HbA1c and 1-hour GCT for the early screening of diabetes in pregnancy. Women with early HbA1c ≤ 5.5% could forego further testing in early pregnancy.

Diabetes Group Prenatal Care: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate the effect of diabetes group prenatal care on rates of preterm birth and large for gestational age (LGA) among patients with diabetes in pregnancy compared with individual diabetes prenatal care. DATA SOURCES: We searched Ovid Medline (1946-), Embase.com (1947-), Scopus (1823-), Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. METHODS OF STUDY SELECTION: We searched electronic databases for randomized controlled trials (RCTs) and observational studies comparing diabetes group prenatal care with individual care among patients with type 2 diabetes mellitus or gestational diabetes mellitus (GDM). The primary outcomes were preterm birth before 37 weeks of gestation and LGA (birth weight at or above the 90th percentile). Secondary outcomes were small for gestational age, cesarean delivery, neonatal hypoglycemia, neonatal intensive care unit admission, breastfeeding at hospital discharge, long-acting reversible contraception (LARC) uptake, and 6-week postpartum visit attendance. Secondary outcomes, limited to the subgroup of patients with GDM, included rates of GDM requiring diabetes medication (A2GDM) and completion of postpartum oral glucose tolerance testing (OGTT). Heterogeneity was assessed with the Cochran Q test and I2 statistic. Random-effects models were used to calculate pooled relative risks (RRs) and weighted mean differences. TABULATION, INTEGRATION, AND RESULTS: Eight studies met study criteria and were included in the final analysis: three RCTs and five observational studies. A total of 1,701 patients were included in the pooled studies: 770 (45.3%) in diabetes group prenatal care and 931 (54.7%) in individual care. Patients in diabetes group prenatal care had similar rates of preterm birth compared with patients in individual care (seven studies: pooled rates 9.5% diabetes group prenatal care vs 11.5% individual care, pooled RR 0.77, 95% CI, 0.59-1.01), which held for RCTs and observational studies. There was no difference between diabetes group prenatal care and individual care in rates of LGA overall (four studies: pooled rate 16.7% diabetes group prenatal care vs 20.2% individual care, pooled RR 0.93, 95% CI, 0.59-1.45) or by study type. Rates of other secondary outcomes were similar between diabetes group prenatal care and individual care, except patients in diabetes group prenatal care were more likely to receive postpartum LARC (three studies: pooled rates 46.1% diabetes group prenatal care vs 34.1% individual care, pooled RR 1.44, 95% CI, 1.09-1.91). When analysis was limited to patients with GDM, there were no differences in rates of A2GDM or postpartum visit attendance, but patients in diabetes group prenatal care were significantly more likely to complete postpartum OGTT (five studies: pooled rate 74.0% diabetes group prenatal care vs 49.4% individual care, pooled RR 1.58, 95% CI, 1.19-2.09). CONCLUSION: Patients with type 2 diabetes and GDM who participate in diabetes group prenatal care have similar rates of preterm birth, LGA, and other pregnancy outcomes compared with those who participate in individual care; however, they are significantly more likely to receive postpartum LARC, and those with GDM are more likely to return for postpartum OGTT. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021279233.

Outcomes after extended azithromycin administration in preterm premature rupture of membranes.

BACKGROUND: Preterm premature rupture of membranes accounts for approximately one-quarter of all preterm deliveries and occurs in 2% to 3% of all pregnancies. With subclinical infection being a suspected cause of preterm premature rupture of membranes, the administration of prophylactic antibiotics is an accepted standard of care to extend the latency period. Historically, erythromycin was used in the antibiotic regimen recommended for women with preterm premature rupture of membranes during expectant management; however, azithromycin has recently been shown to be a suitable alternative. OBJECTIVE: This study aimed to evaluate whether extended azithromycin administration affects the latency time in preterm premature rupture of membranes. STUDY DESIGN: This was a retrospective multi-institutional cohort study in Washington, District of Columbia, of patients admitted from January 2012 to December 2019 with preterm premature rupture of membranes of singleton pregnancies between 23 0/7 and 33 6/7 weeks of gestation. Patients were excluded if they had multiple pregnancies, had an allergy to penicillin or macrolides, were in labor, had suspected placental abruptions, had overt chorioamnionitis, or had nonreassuring fetal status on presentation indicating the need for prompt delivery. Patients that received limited azithromycin administration (<2 days) and patients that received extended azithromycin administration (7 days) were compared. All patients otherwise received the institutional standard of 2 days of intravenous ampicillin followed by 5 days of oral amoxicillin. The primary outcome was length of gestational latency, defined as the time from membrane rupture to delivery. The selective secondary outcomes that were evaluated were rates of chorioamnionitis and adverse neonatal outcomes, including sepsis, respiratory distress, necrotizing enterocolitis, intraventricular hemorrhage, and neonatal death. RESULTS: During the study period, 416 cases of preterm premature rupture of membranes were identified. Of the 287 patients who met the inclusion criteria, 165 (57.5%) received limited azithromycin administration, and 122 (42.5%) received extended azithromycin administration. Adjusted median gestational latency was significantly longer for patients who received extended azithromycin administration, extended by >3 days (2.6 days [interquartile range, 2.2-3.1] for limited azithromycin administration vs 5.8 days [interquartile range, 4.8-6.9] for extended azithromycin administration; P<.001). Neonatal secondary outcome evaluation was performed on 216 cases (76%). There was no difference in chorioamnionitis or adverse neonatal outcomes between the 2 groups. CONCLUSION: Among patients with preterm premature rupture of membranes, extended azithromycin administration was associated with increased latency, without any effect on other maternal or neonatal outcomes.

MicroRNA analysis in maternal blood of pregnancies with preterm premature rupture of membranes reveals a distinct expression profile.

OBJECTIVE: To determine the expression profile of microRNAs in the peripheral blood of pregnant women with preterm premature rupture of membranes (PPROM) compared to that of healthy pregnant women. STUDY DESIGN: This was a pilot study with case-control design in pregnant patients enrolled between January 2017 and June 2019. Patients with healthy pregnancies and those affected by PPROM between 20- and 33+6 weeks of gestation were matched by gestational age and selected for inclusion to the study. Patients were excluded for multiple gestation and presence of a major obstetrical complication such as preeclampsia, diabetes, fetal growth restriction and stillbirth. A total of ten (n = 10) controls and ten (n = 10) patients with PPROM were enrolled in the study. Specimens were obtained before administration of betamethasone or intravenous antibiotics. MicroRNA expression was analyzed for 800 microRNAs in each sample using the NanoString nCounter Expression Assay. Differential expression was calculated after normalization and log2- transformation using the false discovery rate (FDR) method at an alpha level of 5%. RESULTS: Demographic characteristics were similar between the two groups. Of the 800 miRNAs analyzed, 116 were differentially expressed after normalization. However, only four reached FDR-adjusted statistical significance. Pregnancies affected by PPROM were characterized by upregulation of miR-199a-5p, miR-130a-3p and miR-26a-5p and downregulation of miR-513b-5p (FDR adjusted p-values <0.05). The differentially expressed microRNAs participate in pathways associated with altered collagen and matrix metalloprotease expression in the extracellular matrix. CONCLUSION: Patients with PPROM have a distinct peripheral blood microRNA profile compared to healthy pregnancies as measured by the NanoString Expression Assay.

Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether viewing an educational video on pain management reduces opioid use after cesarean delivery. METHODS: We conducted a randomized, controlled trial of women aged 18 years or older who underwent cesarean delivery at a tertiary care center. Eligible women were randomized in a 1:1 ratio to usual discharge pain medication instructions plus an educational video on pain management or to usual discharge pain medication instructions alone. All women received the same opioid prescription at discharge: Twenty 5-mg oxycodone tablets. Participants were contacted at 7 days and at 14 days after delivery to assess the number of oxycodone tablets used, adjunct medication (acetaminophen and ibuprofen) use, pain scores, and overall satisfaction of pain control. The primary outcome was the number of oxycodone tablets used from discharge through postpartum day 14. A sample size of 23 per group (n=46) was planned to detect a 25% difference in mean number of oxycodone tablets used between groups, as from 20 to 15. RESULTS: From July 2019 through December 2019, 61 women were screened and 48 were enrolled-24 in each group. Women who viewed the educational video used significantly fewer opioid tablets from discharge through postpartum day 14 compared with women who received usual pain medication instructions (median 1.5, range 0-20 vs median 10, range 0-24, P<.001). Adjunct medication use, pain scores, and satisfaction with pain control did not differ significantly between groups. CONCLUSION: Among women who underwent cesarean delivery, viewing an educational video on pain management reduced postdischarge opioid use. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03959969.

Incidence of Hypertensive Disorders of Pregnancy in Women with COVID-19.

OBJECTIVE: The study aimed to examine the incidence of hypertensive disorders of pregnancy in women diagnosed with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, also known as COVID-19). STUDY DESIGN: This was a retrospective cohort study of all women who delivered at MedStar Washington Hospital Center in Washington, DC from April 8, 2020 to July 31, 2020. Starting April 8, 2020, universal testing for COVID-19 infection was initiated for all women admitted to labor and delivery. Women who declined universal testing were excluded. Hypertensive disorders of pregnancy were diagnosed based on American College of Obstetricians and Gynecologists Task Force definitions.1 Maternal demographics, clinical characteristics, and labor and delivery outcomes were examined. Neonatal outcomes were also collected. Laboratory values from admission were evaluated. Our primary outcome was the incidence of hypertensive disorders of pregnancy among women who tested positive for COVID-19. The incidence of hypertensive disorders of pregnancy was compared between women who tested positive for COVID-19 and women who tested negative. RESULTS: Of the 1,008 women included in the analysis, 73 (7.2%) women tested positive for COVID-19, of which 12 (16.4%) were symptomatic at the time of admission. The incidence of hypertensive disorders of pregnancy was 34.2% among women who tested positive for COVID-19 and 22.9% women who tested negative for COVID-19 (p = 0.03). After adjusting for race, antenatal aspirin use, chronic hypertension, and body mass index >30, the risk of developing any hypertensive disorder of pregnancy was not statistically significant (odds ratio: 1.58 [0.91-2.76]). CONCLUSION: After adjusting for potential confounders, the risk of developing a hypertensive disorder of pregnancy in women who tested positive for COVID-19 compared with women who tested negative for COVID-19 was not significantly different. KEY POINTS: · There is an increased incidence of hypertensive disorders in women who test positive for COVID-19.. · Characteristics of pregnant women with COVID-19 are similar to those with hypertensive disorders.. · Liver function tests were similar between pregnant women with COVID-19 and women without COVID-19..

Refining the clinical definition of active phase arrest of dilation in nulliparous women to consider degree of cervical dilation as well as duration of arrest.

BACKGROUND: Maternal and neonatal outcomes associated with duration of arrest of dilation beyond 4 hours are not well known. In addition, the current definition of arrest does not consider the degree of cervical dilation (6 cm vs 7 cm vs 8 cm vs 9 cm) when arrest occurs. OBJECTIVE: We sought to examine maternal and neonatal outcomes in nulliparous women who achieved the active phase of labor according to the duration they required to achieve a cervical change of at least 1 cm (<4 hours vs 4-5.9 hours vs ≥6 hours) beginning at 6, 7, 8 and 9 cm. STUDY DESIGN: This was a retrospective cohort study of nulliparous women with term singleton cephalic pregnancies in spontaneous or induced active labor (≥6 cm). To evaluate the effect of labor duration on maternal and fetal outcomes at different degrees of cervical dilation, we categorized women based on time intervals they required to achieve a cervical change of at least 1 cm after membrane rupture ("<4 hours," "4-5.9 hours," and "≥6 hours"), and we correlated each time interval with referent cervical dilation status (6 cm, 7 cm, 8 cm, and 9 cm). Maternal and neonatal outcomes were analyzed according to the duration to progress at least 1 cm starting from each degree of cervical dilation. Our primary outcome was a composite of neonatal outcomes, including intensive care unit admission, neonatal death, seizure, ventilator use, birth injury, and neonatal asphyxia. In addition, we examined maternal outcomes. Adjusted odds ratios with 95% confidence intervals were calculated, controlling for predefined covariates. RESULTS: Of 31,505 nulliparous women included in this study, 13,142 (42%), 10,855 (34%), 11,761 (37%), and 17,049 (54%) reached documented cervical dilation of 6, 7, 8, and 9 cm, respectively. At cervical dilation of 6 or 7 cm, the arrest of dilation of <4 hours compared with arrest of dilation of 4 to 5.9 hours was associated with decreased risks of adverse maternal outcomes. When cervical dilation was 8 or 9 cm, arrest of dilation of <4 hours compared with arrest of dilation of 4 to 5.9 hours was associated with decreased risks of adverse maternal and neonatal outcomes. For example, women starting at a cervical dilation of 8 cm who required <4 hours to achieve a cervical change of 1 cm compared with those who required 4 to 5.9 hours had lower rates of cesarean delivery (adjusted odds ratio, 0.40; 95% confidence interval, 0.28-0.55), chorioamnionitis (adjusted odds ratio, 0.42; 95% confidence interval, 0.29-0.60), and the neonatal composite outcome (adjusted odds ratio, 0.51; 95% confidence interval, 0.36-0.72). CONCLUSION: When cervical dilation is 6 or 7 cm, allowing arrest of dilation of ≥4 hours is reasonable because it was not associated with increased risks of adverse neonatal outcomes. When cervical dilation is 8 or 9 cm, the benefit of allowing arrest of dilation of ≥4 hours should be balanced against the risk of adverse maternal and neonatal outcomes.

Evaluation of the Maternal-Fetal Triage Index in a tertiary care labor and delivery unit.

BACKGROUND: The Maternal-Fetal Triage Index is a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit (priority 1 being the highest acuity and priority 5 being the lowest acuity). Although the American College of Obstetricians and Gynecologists recommends implementing labor and delivery triage tools, it remains unclear whether the Maternal-Fetal Triage Index facilitates the timely evaluation of high-acuity pregnant women. OBJECTIVE: We sought to examine the duration of a labor and delivery triage evaluation before and after the implementation of the Maternal-Fetal Triage Index. We also sought to examine the duration of a labor and delivery triage evaluation according to priority levels by the Maternal-Fetal Triage Index. STUDY DESIGN: This was a retrospective quality improvement study of all women presenting to an urban, tertiary labor and delivery triage unit at 16 weeks' gestation or later from December 2017 to February 2018 (historical cohort) and December 2018 to February 2019 (study cohort). As part of a quality improvement initiative, the Maternal-Fetal Triage Index was implemented in the labor and delivery unit in May 2018. All registered nurses who worked in the labor and delivery unit completed a formal education course and assigned the priority levels at the time of triage presentation. The primary outcome was the duration of a labor and delivery triage evaluation, which was defined as the time interval from triage presentation to the completion of history and physical examination in the electronic medical record. Secondary outcomes included the rates of labor and delivery unit admissions. RESULTS: There were 1305 and 1374 women in the historical cohort and study cohort, respectively. The duration of labor and delivery triage evaluation was longer for the study cohort than for the historical cohort (64 minutes vs 61 minutes; P=.02). Of the 1374 women in the study cohort, there were 28 (2%), 290 (21%), 459 (33%), 462 (34%), and 135 (10%) women with priority levels 1, 2, 3, 4, and 5 assigned, respectively. Women with a higher priority according to the Maternal-Fetal Triage Index had a shorter labor and delivery triage evaluation (priority 1, 57 minutes; priority 2, 66 minutes; priority 3, 63 minutes; priority 4, 62 minutes; and priority 5, 83 minutes; P<.001). The rates of admission were higher in the priority 1 and 5 groups (priority 1, 89.3%; priority 2, 41.4%; priority 3, 57.3%; priority 4, 53.3%; and priority 5, 92.6%; P<.001). CONCLUSION: Compared with the historical cohort, the duration of labor and delivery triage evaluation was longer in the study cohort. However, in the study cohort, women classified as higher priority according to the Maternal-Fetal Triage Index had a shorter labor and delivery triage evaluation. Our study supports the American College of Obstetricians and Gynecologists' recommendation on the implementation and utilization of labor and delivery triage tools such as the Maternal-Fetal Triage Index.

Negative pressure wound therapy system in extremely obese women after cesarean delivery compared with standard dressing.

Objective: Data regarding the use of the negative pressure wound therapy (NPWT) system in extremely obese women (body mass index [BMI] ≥ 50 kg/m2) undergoing cesarean delivery are limited. We sought to examine the rate of wound complications in extremely obese women according to postcesarean dressings (NPWT [PICO, Smith & Nephew, St. Peterburg, FL] versus standard dressings).Study design: This was a retrospective cohort study of all extremely obese women (BMI ≥ 50 kg/m2) at 23 weeks' gestation or greater who underwent cesarean delivery at an academic teaching hospital in Washington, DC, between January 2009 and September 2017. During this period, a PICO Single Use NPWT system was used at our institution. Women who missed a postpartum follow-up were excluded. Since 2014, Medstar Washington Hospital Center recommended the use of a PICO Single Use NPWT system for extremely obese women at the time of delivery. However, the ultimate decision to use the NPWT was made by attending physicians, considering the cost of the device and the risk of wound complication. Our primary outcome was a composite of cellulitis, hematoma/seroma, and wound dehiscence. Coarsened exact matching with k-to-k solution was performed using BMI, rupture of membranes, and labor.Results: Of 179 extremely obese women, 73 (40.8%) and 106 (59.2%) received NPWT and standard dressings, respectively; 61 women who received NPWT were matched to 61 women who received standard dressings. The rates of the primary outcome in the unmatched cohort were similar between women who received NPWT and those who received standard dressings (20.6 versus 16.0%; p = .44). The rates of primary outcome remained similar between women who received NPWT and those who received standard dressings after matching (18.0 versus 18.0%; p = 1.00).Conclusion: In extremely obese women undergoing cesarean delivery, prophylactic PICO NPWT was not associated with a decreased risk of the primary outcome compared with standard dressings. A large prospective randomized controlled trial would be useful to answer if NPWT is beneficial for extremely obese women.

Intraamniotic Infection Rates after Intrauterine Pressure Catheter with and without Amnioinfusion.

OBJECTIVE: This study aimed to examine the rates of intraamniotic infection between intrauterine pressure catheter with amnioinfusion and intrauterine pressure catheter alone. STUDY DESIGN: This was a retrospective cohort study of all women who had an intrauterine pressure catheter placement during labor at a tertiary referral hospital from January 2016 to June 2018. Outcomes were compared between women who had an intrauterine pressure catheter with amnioinfusion and intrauterine pressure catheter placement alone. The primary outcome was the rate of intraamniotic infection. Secondary outcomes included postpartum endometritis, postpartum hemorrhage (blood loss of ≥1,000 mL), quantitative blood loss (mL), and cesarean delivery. Multivariable logistic regression analysis was performed to calculate adjusted odds ratios (aOR) and 95% confidence interval (95% CI), controlling for age, race, body mass index, gestational age, and length of time of rupture of membranes. RESULTS: Of 1,268 women with an intrauterine pressure catheter, 298 (23.5%) also had an amnioinfusion. Women who had amnioinfusion through an intrauterine pressure catheter compared with those who had intrauterine pressure catheter alone had similar rates of intraamniotic infection (5.4 vs. 8.0%, crude p = 0.12, aOR 0.69; 95% CI 0.39-1.21), as well as secondary outcomes such as postpartum endometritis (3.0 vs. 2.5%, crude p = 0.61, aOR 1.12; 95% CI 0.49-2.53), postpartum hemorrhage (16.1 vs. 15.8%, crude p = 0.89, aOR 1.07; 95% CI 0.75-1.54), blood loss (479.5 vs. 500 mL, adjusted p = 0.89), and cesarean delivery (40.6 vs. 43.1%, crude p = 0.45, aOR 0.90; 95% CI 0.68-1.19). CONCLUSION: Amnioinfusion was not associated with increased odds of intraamniotic infection compared with intrauterine pressure catheter placement alone. KEY POINTS: · Amnioinfusion involves instilling fluid into the amniotic cavity to relieve variable decelerations.. · Amnioinfusion is not associated with increased odds of chorioamnionitis compared to IUPC alone.. · Amnioinfusion is not associated with increased odds of PPH compared to IUPC placement alone..

Racial Disparity in Postpartum Readmission due to Hypertension among Women with Pregnancy-Associated Hypertension.

OBJECTIVE: Postpartum hypertension is a leading cause of readmission in the postpartum period. We aimed to examine the prevalence of racial/ethnic differences in postpartum readmission due to hypertension in women with antepartum pregnancy-associated hypertension. STUDY DESIGN: This was a multi-institutional retrospective cohort study of all women with antepartum pregnancy-associated hypertension diagnosed prior to initial discharge from January 2009 to December 2016. Antepartum pregnancy-associated hypertension, such as gestational hypertension, preeclampsia (with or without severe features), hemolysis, elevated liver enzyme, low platelet (HELLP) syndrome, and eclampsia was diagnosed based on American College of Obstetricians and Gynecologists Task Force definitions. Women with chronic hypertension and superimposed preeclampsia were excluded. Our primary outcome was postpartum readmission defined as a readmission due to severe hypertension within 6 weeks of postpartum. Risk factors including maternal age, gestational age at admission, insurance, race/ethnicity (self-reported), type of antepartum pregnancy-associated hypertension, marital status, body mass index (kg/m2), diabetes (gestational or pregestational), use of antihypertensive medications, mode of delivery, and postpartum day 1 systolic blood pressure levels were examined. Multivariable logistic regression models were performed to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs). RESULTS: Of 4,317 women with pregnancy-associated hypertension before initial discharge, 66 (1.5%) had postpartum readmission due to hypertension. Risk factors associated with postpartum readmission due to hypertension included older maternal age (aOR = 1.44; 95% CI: 1.20-1.73 for every 5 year increase) and non-Hispanic black race (aOR = 2.12; 95% CI: 1.16-3.87). CONCLUSION: In women with pregnancy-associated hypertension before initial discharge, non-Hispanic black women were at increased odds of postpartum readmission due to hypertension compared with non-Hispanic white women.

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.

Characterizing placental stiffness using ultrasound shear-wave elastography in healthy and preeclamptic pregnancies.

PURPOSE: To measure the stiffness of the placenta in healthy and preeclamptic patients in the second and third trimesters of pregnancy using ultrasound shear-wave elastography (SWE). We also aimed to evaluate the effect of age, gestational age, gravidity, parity and body mass index (BMI) on placental stiffness and a possible correlation of stiffness with perinatal outcomes. METHODS: In a case-control study, we recruited a total of 47 singleton pregnancies in the second and third trimesters of which 24 were healthy and 23 were diagnosed with preeclampsia. In vivo placental stiffness was measured once at the time of recruitment for each patient. Pregnancies with posterior placentas, multiple gestation, gestational hypertension, chronic hypertension, diabetes, autoimmune disease, fetal growth restriction and congenital anomalies were excluded. RESULTS: The mean placental stiffness was significantly higher in preeclamptic pregnancies compared to controls in the third trimester (difference of means = 16.8; 95% CI (9.0, 24.5); P < 0.001). There were no significant differences in placental stiffness between the two groups in the second trimester or between the severe preeclampsia and preeclampsia without severe features groups (difference of means = 9.86; 95% CI (-5.95, 25.7); P ≥ 0.05). Peripheral regions of the placenta were significantly stiffer than central regions in the preeclamptic group (difference of means = 10.67; 95% CI (0.07, 21.27); P < 0.05), which was not observed in the control group (difference of means = 0.55; 95% CI (- 5.25, 6.35); P > 0.05). We did not identify a correlation of placental stiffness with gestational age, maternal age, gravidity or parity. However, there was a statistically significant correlation with BMI (P < 0.05). In addition, pregnancies with higher placental stiffness during the 2nd and 3rd trimesters had significantly reduced birth weight (2890 ± 176 vs. 2420 ± 219 g) and earlier GA (37.8 ± 0.84 vs. 34.3 ± 0.98 weeks) at delivery (P < 0.05). CONCLUSION: Compared to healthy pregnancies, placentas of preeclamptic pregnancies are stiffer and more heterogeneous. Placental stiffness is not affected by gestational age or the severity of preeclampsia but there is a correlation with higher BMI and poor perinatal outcomes.

Neonatal and maternal outcomes of pregnancies with a fetal diagnosis of congenital heart disease using a standardized delivery room management protocol.

OBJECTIVE: We sought to determine if fetuses with prenatally diagnosed congenital heart disease (CHD) were more likely to undergo cesarean delivery in the setting of a non-reassuring fetal heart rate tracing (NRFHT) and to determine if those fetuses were more likely to have a fetal acidosis. STUDY DESIGN: A retrospective cohort study of neonates prenatally diagnosed with CHD from August 2010 to July 2016. The control group consisted of gestational age matched controls without CHD. RESULTS: Each group consisted of 143 patients. The most common reason for cesarean delivery was a NRFHT (control 31% vs CHD 35%, p = 0.67). Fetal acidosis was a rare outcome occurring in only five controls (3.5%) and 11 cases (7.7%) (p = 0.12). CONCLUSION: These findings demonstrate that with multidisciplinary care coordination, fetuses with a prenatal diagnosis of CHD have similar cesarean rates, labor and delivery management, and delivery room compromise as healthy fetuses.

Umbilical Cord Blood Gas in Newborns with Prenatal Diagnosis of Congenital Heart Disease: Insight into In-Utero and Delivery Hemodynamics.

The primary objective was to determine if newborns with congenital heart disease (CHD) are at a higher risk for acidosis at delivery as determined by cord blood gas analysis. The secondary objective was to determine whether specific fetal cardiac diagnosis, delivery method, or duration of labor is associated with an increased risk for acidosis. This was a retrospective study of newborns with CHD diagnosed prenatally and comparable patients without a CHD diagnosis. Study participants included 134 CHD-affected newborns and 134 controls. Median UA pH in CHD newborns was 7.22 (CI 7.2-7.4) and in controls it was 7.22 (CI 7.21-7.24), p = 0.91. There was no difference in median UA pH comparing newborns with single-ventricle CHD and two-ventricle CHD [7.23 (CI 7.2-7.26) vs. 7.22 (CI 7.22-7.24), p = 0.77], or newborns with CHD with aortic obstruction and those without aortic obstruction [7.23 (CI 7.21-7.26) vs. 7.22 (CI 7.2-7.24), p = 0.29]. After controlling for delivery method and duration of labor, CHD patients who underwent a spontaneous vaginal delivery were found to have a declining median UA pH as labor progressed. Our results show that newborns with CHD have a normal UA pH at delivery suggesting a compensated circulation in utero. Spontaneous vaginal delivery with a progressively longer duration of labor in CHD newborns was associated with lower UA pH. This suggests that fetuses with CHD may be at risk for hemodynamic instability at birth with a longer duration of labor as a potentially modifiable factor to improve outcome.

Reducing Cesarean Delivery Surgical Site Infections: A Resident-Driven Quality Initiative.

OBJECTIVE: To examine the association of a resident-driven quality initiative with cesarean delivery surgical site infections. METHODS: This was a quasi-experimental, preintervention and postintervention study of women undergoing cesarean delivery at 23 weeks of gestation or greater between January 2015 and June 2018 at a single tertiary care center. We implemented a resident-driven, evidence-based surgical bundle, excluding women who underwent emergency cesarean or had chorioamnionitis. The bundle included routine prophylactic antibiotics (both cefazolin and azithromycin), chlorhexidine alcohol skin preparation, use of clippers instead of a razor, vaginal cleansing with povidone iodine, placental removal by umbilical cord traction, subcutaneous tissue closure if wound thickness greater than 2 cm, suture skin closure, dressing removal between 24 and 48 hours, and use of postoperative chlorhexidine soap. Our primary outcome was surgical site infections (superficial incisional, deep incisional, and organ or space surgical site infections) occurring up to 6 weeks postpartum. Outcomes were compared between the preimplementation period (January 2015-August 2016) and postimplementation period (December 2016-June 2018). Coarsened Exact Matching with k-to-k solution was performed using age, race-ethnicity, body mass index, rupture of membranes, and labor. RESULTS: In total, 1,624 underwent cesarean delivery in the preimplementation and 1,523 postimplementation periods, respectively; 1,100 women in the postimplementation period were matched to 1,100 women in the preimplementation period. The rate of surgical site infections in the unmatched cohort was significantly lower in the postimplementation period compared to those in the preimplementation period (2.2% [33/1,523] vs 4.5% [73/1,624]; odds ratio [OR] 0.47 [95% CI 0.31-0.71]; P<.001). This decrease in the rate of surgical site infections remained statistically significant after matching (1.9% [21/1,100] vs 4.1% [45/1,100]; OR 0.46 [0.27-0.77]; P<.001). CONCLUSION: After implementation of a resident-driven quality initiative using a surgical bundle, we observed a significant decrease in cesarean surgical site infections.

Third trimester ultrasound for fetal macrosomia: optimal timing and institutional specific accuracy.

PURPOSE: To determine the performance of third trimester ultrasound in women with suspected fetal macrosomia. MATERIALS AND METHODS: We performed a retrospective cohort study of fetal ultrasounds from January 2004 to December 2014 with estimated fetal weight (EFW) between 4000 and 5000 g. We determined accuracy of birth weight prediction for ultrasound performed at less than and greater than 38 weeks, accounting for diabetic status and time between ultrasound and delivery. RESULTS: There were 405 ultrasounds evaluated. One hundred and twelve (27.7%) were performed at less than 38 weeks, 293 (72.3%) at greater than 38 weeks, and 91 (22.5%) were performed in diabetics. Sonographic identification of EFW over 4000 g at less than 38 weeks was associated with higher correlation between EFW and birth weight than ultrasound performed after 38 weeks (71.5 versus 259.4 g, p < .024). EFW to birth weight correlation was within 1.7% of birth weight for ultrasound performed less than 38 weeks and within 6.5% of birth weight for ultrasound performed at greater than 38 weeks. CONCLUSIONS: Identification of EFW with ultrasound performed less than 38 weeks has greater reliability of predicting fetal macrosomia at birth than measurements performed later in gestation. EFW to birth weight correlation was more accurate than previous reports.

Early preterm preeclampsia outcomes by intended mode of delivery.

BACKGROUND: The optimal route of delivery in early-onset preeclampsia before 34 weeks is debated because many clinicians are reluctant to proceed with induction for perceived high risk of failure. OBJECTIVE: Our objective was to investigate labor induction success rates and compare maternal and neonatal outcomes by intended mode of delivery in women with early preterm preeclampsia. STUDY DESIGN: We identified 914 singleton pregnancies with preeclampsia in the Consortium on Safe Labor study for analysis who delivered between 24 0/7 and 33 6/7 weeks. We excluded fetal anomalies, antepartum stillbirth, or spontaneous preterm labor. Maternal and neonatal outcomes were compared between women undergoing induction of labor (n = 460) and planned cesarean delivery (n = 454) and women with successful induction of labor (n = 214) and unsuccessful induction of labor (n = 246). We calculated relative risks and 95% confidence intervals to determine outcomes by Poisson regression model with propensity score adjustment. The calculation of propensity scores considered covariates such as maternal age, gestational age, parity, body mass index, tobacco use, diabetes mellitus, chronic hypertension, hospital type and site, birthweight, history of cesarean delivery, malpresentation/breech, simplified Bishop score, insurance, marital status, and steroid use. RESULTS: Among the 460 women with induction (50%), 47% of deliveries were vaginal. By gestational age, 24 to 27 6/7, 28 to 31 6/7, and 32 to 33 6/7, the induction of labor success rates were 38% (12 of 32), 39% (70 of 180), and 54% (132 of 248), respectively. Induction of labor compared with planned cesarean delivery was less likely to be associated with placental abruption (adjusted relative risk, 0.33; 95% confidence interval, 0.16-0.67), wound infection or separation (adjusted relative risk, 0.23; 95% confidence interval, 0.06-0.85), and neonatal asphyxia (0.12; 95% confidence interval, 0.02-0.78). Women with vaginal delivery compared with those with failed induction of labor had decreased maternal morbidity (adjusted relative risk, 0.27; 95% confidence interval, 0.09-0.82) and no difference in neonatal outcomes. CONCLUSION: About half of women with preterm preeclampsia who attempted an induction had a successful vaginal delivery. The rate of successful vaginal delivery increases with gestational age. Successful induction has the benefit of preventing maternal and fetal comorbidities associated with previous cesarean deliveries in subsequent pregnancies. While overall rates of a composite of serious maternal and neonatal morbidity/mortality did not differ between induction of labor and planned cesarean delivery groups, women with failed induction of labor had increased maternal morbidity highlighting the complex route of delivery counseling required in this high-risk population of women.

Neonatal outcomes in fetuses with cardiac anomalies and the impact of delivery route.

BACKGROUND: Congenital fetal cardiac anomalies compromise the most common group of fetal structural anomalies. Several previous reports analyzed all types of fetal cardiac anomalies together without individualized neonatal morbidity outcomes based on cardiac defect. Mode of delivery in cases of fetal cardiac anomalies varies greatly as optimal mode of delivery in these complex cases is unknown. OBJECTIVE: We sought to determine rates of neonatal outcomes for fetal cardiac anomalies and examine the role of attempted route of delivery on neonatal morbidity. STUDY DESIGN: Gravidas with fetal cardiac anomalies and delivery >34 weeks, excluding stillbirths and aneuploidies (n = 2166 neonates, n = 2701 cardiac anomalies), were analyzed from the Consortium on Safe Labor, a retrospective cohort study of electronic medical records. Cardiac anomalies were determined using International Classification of Diseases, Ninth Revision codes and organized based on morphology. Neonates were assigned to each cardiac anomaly classification based on the most severe cardiac defect present. Neonatal outcomes were determined for each fetal cardiac anomaly. Composite neonatal morbidity (serious respiratory morbidity, sepsis, birth trauma, hypoxic ischemic encephalopathy, and neonatal death) was compared between attempted vaginal delivery and planned cesarean delivery for prenatal and postnatal diagnosis. We used multivariate logistic regression to calculate adjusted odds ratio for composite neonatal morbidity controlling for race, parity, body mass index, insurance, gestational age, maternal disease, single or multiple anomalies, and maternal drug use. RESULTS: Most cardiac anomalies were diagnosed postnatally except hypoplastic left heart syndrome, which had a higher prenatal than postnatal detection rate. Neonatal death occurred in 8.4% of 107 neonates with conotruncal defects. Serious respiratory morbidity occurred in 54.2% of 83 neonates with left ventricular outflow tract defects. Overall, 76.3% of pregnancies with fetal cardiac anomalies underwent attempted vaginal delivery. Among patients who underwent attempted vaginal delivery, 66.1% had a successful vaginal delivery. Women with a fetal cardiac anomaly diagnosed prenatally were more likely to have a planned cesarean delivery than women with a postnatal diagnosis (31.7 vs 22.8%; P < .001). Planned cesarean delivery compared to attempted vaginal delivery was not associated with decreased composite neonatal morbidity for all prenatally diagnosed (adjusted odds ratio, 1.67; 95% confidence interval, 0.85-3.30) or postnatally diagnosed (adjusted odds ratio, 0.99; 95% confidence interval, 0.77-1.27) cardiac anomalies. CONCLUSION: Most fetal cardiac anomalies were diagnosed postnatally and associated with increased rates of neonatal morbidity. Planned cesarean delivery for prenatally diagnosed cardiac anomalies was not associated with less neonatal morbidity.