Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial.

Importance: A short cervix as assessed by transvaginal ultrasound is an established risk factor for preterm birth. Study findings for a cervical pessary to prevent preterm delivery in singleton pregnancies with transvaginal ultrasound evidence of a short cervix have been conflicting. Objective: To determine if cervical pessary placement decreases the risk of preterm birth or fetal death prior to 37 weeks among individuals with a short cervix. Design, Setting, and Participants: We performed a multicenter, randomized, unmasked trial comparing a cervical pessary vs usual care from February 2017 through November 5, 2021, at 12 centers in the US. Study participants were nonlaboring individuals with a singleton pregnancy and a transvaginal ultrasound cervical length of 20 mm or less at gestations of 16 weeks 0 days through 23 weeks 6 days. Individuals with a prior spontaneous preterm birth were excluded. Interventions: Participants were randomized 1:1 to receive either a cervical pessary placed by a trained clinician (n = 280) or usual care (n = 264). Use of vaginal progesterone was at the discretion of treating clinicians. Main Outcome and Measures: The primary outcome was delivery or fetal death prior to 37 weeks. Results: A total of 544 participants (64%) of a planned sample size of 850 were enrolled in the study (mean age, 29.5 years [SD, 6 years]). Following the third interim analysis, study recruitment was stopped due to concern for fetal or neonatal/infant death as well as for futility. Baseline characteristics were balanced between participants randomized to pessary and those randomized to usual care; 98.9% received vaginal progesterone. In an as-randomized analysis, the primary outcome occurred in 127 participants (45.5%) randomized to pessary and 127 (45.6%) randomized to usual care (relative risk, 1.00; 95% CI, 0.83-1.20). Fetal or neonatal/infant death occurred in 13.3% of those randomized to receive a pessary and in 6.8% of those randomized to receive usual care (relative risk, 1.94; 95% CI, 1.13-3.32). Conclusions and Relevance: Cervical pessary in nonlaboring individuals with a singleton gestation and with a cervical length of 20 mm or less did not decrease the risk of preterm birth and was associated with a higher rate of fetal or neonatal/infant mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT02901626.

Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor.

OBJECTIVE: To evaluate the association between maternal and delivery characteristics and self-reported perceived control during childbirth. METHODS: A secondary analysis of a multicenter randomized trial was conducted to compare labor induction at 39 weeks of gestation with expectant management in low-risk nulliparous people. Six to 96 hours after delivery, participants who experienced labor completed the Labor Agentry Scale, a validated self-administered questionnaire to ascertain perceived control during childbirth. Scores range from 29 to 203, with higher scores indicating a sense of greater control. Multivariable linear regression was used to determine which maternal and delivery characteristics were associated with the Labor Agentry Scale score. Eligible characteristics included age, self-reported race and ethnicity, marital status, employment status, type of insurance, previous pregnancy loss before 20 weeks of gestation, body mass index (BMI), smoking, alcohol use, mode of delivery, labor pain (0-10 points), and a composite of perinatal death or severe neonatal complications. Significant variables ( P <.05) were retained in the final multivariable model, and adjusted mean differences (95% CIs) between groups were estimated. RESULTS: Of 6,106 people enrolled in the trial, 6,038 experienced labor, of whom 5,750 (95.2%) completed the Labor Agentry Scale and were included in this analysis. Mean [95% CI] adjusted Labor Agentry Scale scores were significantly lower among those who identified as Asian (-6.4 [-10.5 to -2.3]) or Hispanic (-3.7 [-5.7 to -1.7]) compared with White, smoked compared with did not smoke (-2.8 [-5.5 to -0.1]), had BMIs of 35 or higher compared with less than 30 (-2.0 [-3.8 to -0.2]), were unemployed (-3.15 [-4.76 to -1.55]), did not have private health insurance (-2.61 [-4.47 to -0.76]), underwent operative vaginal (-5.1 [-7.7 to -2.6]) or cesarean (-14.4 [-16.1 to -12.6]) delivery compared with spontaneous vaginal delivery, and reported greater labor pain score of 8 or higher compared with less than 8 (-11.9 [-13.4 to -10.4]). Mean [95% CI] adjusted Labor Agentry Scale scores were significantly higher among people who were employed compared with unemployed (3.2 [1.6-4.8]) and had private compared with nonprivate insurance (2.6 [0.76-4.5]). CONCLUSION: In nulliparous people at low risk, unemployment, lack of private health insurance, Asian race, Hispanic ethnicity, smoking, operative delivery, and more labor pain were associated with lower perceived control during labor. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT01990612.

Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery.

BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear. METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed. RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups. CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).

Vaginal progesterone for preterm birth prevention in women with arrested preterm labor.

OBJECTIVE: We tested the hypothesis that administration of vaginal progesterone in women with arrested preterm labor would result in lower rates of preterm birth <37 weeks compared to placebo. STUDY DESIGN: We performed a randomized, placebo-controlled trial comparing vaginal progesterone to placebo in women with arrested preterm labor. Our trial included women with a singleton or twin gestation at 240/7-336/7 weeks' gestation who presented with preterm labor with cervical dilation ≥1 centimeter but remained undelivered. Participants were randomized to receive vaginal progesterone 200 mg daily or an identical placebo. The primary outcome was preterm birth <37 weeks. We performed an updated systematic review and meta-analysis of clinical trials, including our results. We searched MEDLINE, EMBASE, CINHAL, Scopus, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov using the key terms to identify relevant trials. The risk of bias was appraised using the Cochrane risk-of-bias tool. Data were synthesized using random-effects models. Heterogeneity was assessed using Higgins I2. RESULTS: The randomized trial was prematurely terminated due to slow recruitment. There were 18 women randomized to receive vaginal progesterone who had complete follow-up data and 18 women in the placebo group. The risk of preterm birth <37 weeks was not significantly different in the groups (RR 1.10, 95% CI 0.63-1.19). Secondary outcomes were also similar. Thirteen trials with 1658 women (835 in the vaginal progesterone and 823 in the control groups) were included in the meta-analysis. Risk of preterm birth <37 weeks was similar in women who received progesterone and those in the control group (pooled RR 1.06, 95% CI 0.83-1.35). Latency was significantly longer among women with arrested preterm labor who received vaginal progesterone (weighted mean difference: 9.2 d, 95% CI 3.2-15.1), but further analysis showed that prolonged latency was only observed in the subgroup of studies that were not placebo-controlled. CONCLUSIONS: This randomized controlled trial and meta-analysis do not support the use of vaginal progesterone for the prevention of preterm birth in women who present in preterm labor.

Hepatitis C Virus Antibody Screening in a Cohort of Pregnant Women: Identifying Seroprevalence and Risk Factors.

OBJECTIVE: To describe the prevalence of hepatitis C virus (HCV) antibody, evaluate current risk factors associated with HCV antibody positivity, and identify novel composite risk factors for identification of groups most likely to demonstrate HCV antibody seropositivity in an obstetric population from 2012 to 2015. METHODS: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network initiated an observational study of mother-to-child transmission of HCV in 2012 that included offering HCV antibody screening to their entire obstetric population. Women presenting for prenatal care before 23 weeks of gestation without a known multifetal gestation were eligible. For each woman who was HCV antibody-positive, two women at similar gestational age who were HCV antibody-negative were identified and included for comparison. Risk factors were evaluated by patient interview and chart review. Women in the case group were identified to have a signal-to-cutoff value of at least 5 on the Abbott ARCHITECT platform. RNA status was evaluated for women in the case group. RESULTS: Of 106,842 women screened for the HCV antibody, 254 had positive results. The HCV antibody seroprevalence rate was 2.4 cases per 1,000 women (95% CI 2.1-2.7). One hundred thirty-one women in the case group and 251 women in the control group were included in the case-control analysis. Factors associated with HCV antibody positivity included injection drug use (adjusted odds ratio [aOR] 22.9, 95% CI 8.2-64.0), blood transfusion (aOR 3.7, 95% CI 1.3-10.4), having a partner with HCV (aOR 6.3, 95% CI 1.8-22.6), more than three lifetime sexual partners (aOR 5.3, 95% CI 1.4-19.8), and smoking (aOR 2.4, 95% CI 1.2-4.6). A composite of any of these potential risk factors provided the highest sensitivity for detecting HCV antibody (75/82 cases, 91%). CONCLUSION: In this cohort, the seroprevalence of HCV antibody was low, and the current risk factors for HCV screening were not identified. These findings may be useful in defining new strategies for identifying mothers with the HCV antibody and the neonates susceptible to maternal transmission of HCV. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959321.

Marked variability in intrapartum electronic fetal heart rate patterns: association with neonatal morbidity and abnormal arterial cord gas.

OBJECTIVE: Investigate marked variability in fetal heart rate (FHR) patterns before delivery and its association with neonatal morbidity and abnormal arterial cord gases. STUDY DESIGN: Prospective cohort of laboring patients at term. Composite neonatal morbidity (respiratory distress, mechanical ventilation, suspected sepsis, meconium aspiration syndrome, therapeutic hypothermia, hypoxic-ischemic encephalopathy, seizure, and death) and abnormal arterial cord gases (pH < 7.10, lactate ≥ 4 mmol/L, base deficit < -12 mEq/L) were assessed with multivariable logistic regression. RESULT: Three hundred and ninety (4.5%) neonates had marked variability in FHR patterns before delivery. There was no difference in composite neonatal morbidity (aRR 1.22; 95% CI 0.91-1.63), though neonates with marked variability in FHR patterns were more likely to have a respiratory distress (aRR 1.85; 95% CI 1.25-2.70). There was an increased risk of composite abnormal arterial cord gases (aRR 1.66; 95% CI 1.47-1.88). CONCLUSION: Marked variability in FHR patterns was not associated with composite neonatal morbidity but was associated with abnormal arterial cord gases.

Fetal thrombocytopenia in pregnancies complicated by fetal anemia due to red-cell alloimmunization: cohort study and meta-analysis.

OBJECTIVE: To estimate the prevalence and characteristics of fetal thrombocytopenia at the time of percutaneous umbilical cord sampling (PUBS) in pregnancies complicated by alloimmunization and to conduct a systematic review on fetal thrombocytopenia in these pregnancies. STUDY DESIGN: Retrospective cohort study of all patients undergoing PUBS at our institution from 2000-2017. Clinical data, including fetal platelet counts, were abstracted from the medical record and analyzed with routine statistical procedures. A systematic review and meta-analysis were also conducted according to standard procedures. RESULT: At first procedure, prior to any transfusion, 13/36 fetuses (36%) had thrombocytopenia: 11/36 (31%) had moderate thrombocytopenia and 2/36 (6%) had severe thrombocytopenia (14 patients had no platelet count at first procedure). The systematic review identified six studies, and the prevalence of fetal thrombocytopenia at the time of PUBS for alloimmunization was 18% (95% confidence interval 11%, 26%). CONCLUSION: Thrombocytopenia is common and underappreciated in fetuses undergoing PUBS for alloimmunization.

Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3).

BACKGROUND: This Enhanced Recovery After Surgery Guideline for postoperative care in cesarean delivery will provide best practice, evidenced-based recommendations for postoperative care with primarily a maternal focus. OBJECTIVE: The pathway process for scheduled and unscheduled cesarean delivery for this Enhanced Recovery After Surgery cesarean delivery guideline will consider time from completion of cesarean delivery until maternal hospital discharge. STUDY DESIGN: The literature search (1966-2017) used Embase and PubMed to search medical subject headings that included "Cesarean Section," "Cesarean Delivery," "Cesarean Section Delivery," and all postoperative Enhanced Recovery After Surgery items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses evaluated the quality of evidence, and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system as used and described in previous Enhanced Recovery After Surgery Guidelines. RESULTS: The Enhanced Recovery After Surgery cesarean delivery guideline/pathway has created a pathway for postoperative care. Specifics include sham feeding, nausea and vomiting prevention, postoperative analgesia, nutritional care, glucose control, thromboembolism prophylaxis, early mobilization, urinary drainage, and discharge counseling. A number of elements of postoperative care of women who undergo cesarean delivery are recommended, based on the evidence. CONCLUSION: As the Enhanced Recovery After Surgery cesarean delivery pathway (elements/processes) are studied, implemented, audited, evaluated, and optimized by the maternity care teams, there will be an opportunity for focused and optimized areas of care and recommendations to be further enhanced.

A Prediction Model for Severe Maternal Morbidity in Laboring Patients at Term.

OBJECTIVE: To determine the factors associated with severe maternal morbidity in a modern cohort of women laboring at term and to create a prediction model. STUDY DESIGN: This is a retrospective cohort study of all term, laboring patients with live births at a single tertiary care center from 2004 to 2014. The primary outcome was composite maternal morbidity including organ failure, amniotic fluid embolism, anesthesia complications, sepsis, shock, thrombotic events, transfusion, or hysterectomy. Multivariable logistic regression was used to identify independent risk factors. Antepartum, intrapartum, and combined risk scores were created and test characteristics were analyzed. RESULTS: Among 19,249 women delivering during the study period, 323 (1.68%) patients experienced severe morbidity, with blood transfusion the most common complication (286, 1.49%). Factors in the antepartum model included advanced maternal age, race, hypertension, nulliparity, history of cesarean delivery, smoking, and unfavorable Bishop score. Intrapartum factors included mode of delivery, use of cervical ripening agents or oxytocin, prolonged second stage, and macrosomia. The combined model had an area under the curve of 0.76 (95% confidence interval [CI], 0.73, 0.79). CONCLUSION: This three-part risk scoring system can help clinicians counsel patients and guide clinical decision making for anticipating severe maternal morbidity and necessary resources.

Risk Factors and Maternal Morbidity Associated with Unintentional Hysterotomy Extension at the Time of Cesarean Delivery.

OBJECTIVE: Our aim was to estimate the incidence of unintentional hysterotomy extension at the time of cesarean delivery and to identify associated risk factors and maternal morbidity. STUDY DESIGN: We conducted a secondary analysis of a randomized controlled trial evaluating chlorhexidine-alcohol versus iodine-alcohol for skin antisepsis in women undergoing cesarean delivery. We included patients with a low transverse hysterotomy. The primary outcome was the incidence of unintentional hysterotomy extension. Logistic regression was performed to identify independent factors associated with hysterotomy extension. Maternal morbidity was compared between patients with and without extension. RESULTS: Of 1,038 patients meeting the inclusion criteria, 71 (6.8%; 95% confidence interval [CI]: 5.4-8.5%) experienced a hysterotomy extension. Of several potential risk factors assessed, the second stage of labor was the only independent predictor of hysterotomy extension (adjusted odds ratio: 10.2; 95% CI: 2.6-39.8). Hysterotomy extension was associated with increased operative time (73 vs. 55.3 minutes; p< 0.01), need for blood transfusion (relative risk: 5; 95% CI: 1.6-15.2), and rate of additional surgical injury (RR: 17; 95% CI: 6.9-41.8). CONCLUSION: Hysterotomy extensions are not infrequent at the time of cesarean delivery and are associated with increased maternal morbidity. Cesarean delivery during the second stage of labor is the main independent risk factor for hysterotomy extension.

Evaluation of patient- versus provider-collected vaginal swabs for microbiome analysis during pregnancy.

OBJECTIVE: We aimed to evaluate if patient- and provider-collected vaginal swabs in pregnant women reflect similar bacterial community characteristics. Pregnant patients performed a self-collected vaginal swab, then underwent a provider-collected swab via speculum exam. DNA pyrosequencing of the 16S rRNA gene V1V3 and V3V5 variable regions was performed. Relative abundance of taxa, alpha diversity, and beta diversity of patient- and provider-collected swabs were compared. RESULTS: Ninety-four vaginal swabs from 47 women were analyzed. On non-metric multi-dimensional scaling plots, paired patient- and provider-collected swabs clustered closely. The median Pearson correlation coefficient was 0.993 (interquartile range 0.951-0.999) for V1V3 and 0.987 (interquartile range 0.902-0.999) for V3V5. Among paired V1V3 and V3V5 sequences, 83.0% and 73.9% showed strong Pearson correlation (> 0.9), respectively, between patient- and provider-collected swabs; V1V3 and V3V5 sequences with weaker Pearson correlation (< 0.9) had correlation coefficients 0.57-0.89 and 0.49-0.89, respectively. No taxa were preferentially detected by sampling method, with relative abundance of taxa highly conserved. No significant difference in Shannon diversity for V1V3 (p = 0.22) and V3V5 (p = 0.11) sequences among paired samples was seen. We demonstrate that bacterial communities defined from patient- and provider-collected vaginal swabs in pregnant women are similar, validating utilization of patient-collected swabs for vaginal bacterial microbiome sampling during pregnancy.

Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1).

This Enhanced Recovery After Surgery (ERAS) Guideline for perioperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for preoperative, intraoperative, and postoperative phases with, primarily, a maternal focus. The focused pathway process for scheduled and unscheduled cesarean delivery for this ERAS Cesarean Delivery Guideline will consider from the time from decision to operate (starting with the 30-60 minutes before skin incision) to hospital discharge. The literature search (1966-2017) used Embase and PubMed to search medical subject headings that included "Cesarean Section," "Cesarean Section," "Cesarean Section Delivery" and all pre- and intraoperative ERAS items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses that evaluated the quality of evidence and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system, as used and described in previous ERAS Guidelines. The ERAS Cesarean Delivery Guideline/Pathway has created a maternal focused pathway (for scheduled and unscheduled surgery starting from 30-60 minutes before skin incision to maternal discharge) with ERAS cesarean delivery consensus recommendations preoperative elements (anesthetic medications, fasting, carbohydrate supplementation, prophylactic antibiotics/skin preparation, ), intraoperative elements (anesthetic management, maternal hypothermia prevention, surgical technique, hysterotomy creation and closure, management of peritoneum, subcutaneous space, and skin closure), perioperative fluid management, and postoperative elements (chewing gum, management of nausea and vomiting, analgesia, timing of food intake, glucose management, antithrombotic prophylaxis, timing of ambulation, urinary management, and timing of maternal and neonate discharge). Limited topics for optimized care and for antenatal education and counselling and the immediate neonatal needs at delivery are discussed. Strong recommendations for element use were given for preoperative (antenatal education and counselling, use of antacids and histamine, H2 receptor antagonists, 2-hour fasting and small meal within 6 hours surgery, antimicrobial prophylaxis and skin preparation/chlorhexidine-alcohol), intraoperative (regional anesthesia, prevention of maternal hypothermia [forced warm air, warmed intravenous fluids, room temperature]), perioperative (fluid management for euvolemia and neonatal immediate care needs that include delayed cord clamping), and postoperative (fluid management to prevent nausea and vomiting, antiemetic use, analgesia with nonsteroidal antiinflammatory drugs/paracetamol, regular diet within 2 hours, tight capillary glucose control, pneumatic compression stocking for venous thromboembolism prophylaxis, immediate removal of urinary catheter). Recommendations against the element use were made for preoperative (maternal sedation, bowel preparation), intraoperative (neonatal oral suctioning or increased inspired oxygen), and postoperative (heparin should not be used routinely venous thromboembolism prophylaxis). Because these ERAS cesarean delivery pathway recommendations (elements/processes) are studied, implemented, audited, evaluated, and optimized by the maternity care teams, this will create an opportunity for the focused and optimized areas of care research with further enhanced care and recommendation.

Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2).

The Enhanced Recovery After Surgery Society guideline for intraoperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for intraoperative care, with primarily a maternal focus. The "focused" pathway process for scheduled and unscheduled cesarean delivery for this Enhanced Recovery After Surgery cesarean delivery guideline will consider procedure from the decision to operate (starting with the 30-60 minutes before skin incision) through the surgery. The literature search (1966-2017) used Embase and PubMed to search medical subject headings including "cesarean section," "cesarean section," "cesarean section delivery," and all pre- and intraoperative Enhanced Recovery After Surgery items. Study selection allowed titles and abstracts to be screened by individual reviewers to identify potentially relevant articles. Metaanalyses, systematic reviews, randomized controlled studies, nonrandomized controlled studies, reviews, and case series were considered for each individual topic. Quality assessment and data analyses evaluated the quality of evidence and recommendations were evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation system as used and described in previous Enhanced Recovery After Surgery Society guidelines. The Enhanced Recovery After Surgery cesarean delivery guideline/pathway has created a maternal focused pathway (for scheduled and unscheduled surgery starting from 30-60 minutes before skin incision to maternal discharge) with Enhanced Recovery After Surgery-directed preoperative elements, intraoperative elements, and postoperative elements. Specifics of the intraoperative care included the use of prophylactic antibiotics before the cesarean delivery, appropriate patient warming intraoperatively, blunt expansion of the transverse uterine hysterotomy, skin closure with subcuticular sutures, and delayed cord clamping. A number of specific elements of intraoperative care of women who undergo cesarean delivery are recommended based on the evidence. The Enhanced Recovery After Surgery Society guideline for intraoperative care in cesarean delivery will provide best practice, evidenced-based, recommendations for intraoperative care with primarily a maternal focus. When the cesarean delivery pathway (elements/processes) is studied, implemented, audited, evaluated, and optimized by maternity care teams, this will create an opportunity for the focused and optimized areas of care and recommendations to be further enhanced.

Effect of a Home-Based Lifestyle Intervention on Breastfeeding Initiation Among Socioeconomically Disadvantaged African American Women with Overweight or Obesity.

BACKGROUND: Socioeconomically disadvantaged (SED) African American women with overweight or obesity are less likely to breastfeed. OBJECTIVE: To test whether a home-based lifestyle intervention impacts breastfeeding initiation rates in SED African American women with overweight or obesity. STUDY DESIGN: This was a secondary analysis of a randomized controlled trial from October 2012 to March 2016 at a university-based hospital within the LIFE-Moms consortium. SED African American women with overweight or obesity and singleton gestations were randomized by 16 weeks to Parents as Teachers (PAT)-a home-based parenting support and child development educational intervention-or PAT+, PAT with additional content on breastfeeding. Participants completed a breastfeeding survey. Outcomes included breastfeeding initiation and reasons for not initiating or not continuing breastfeeding. RESULTS: One hundred eighteen women were included: 59 in PAT+; 59 in PAT. Breastfeeding initiation rates were similar in each group (78.00% in PAT+; 74.58% in PAT). On a one to four scale, with four denoting "very important," women in PAT+ and PAT were equally likely to rate their beliefs that formula was better than breast milk or breastfeeding would be too inconvenient as the most important reasons to not initiate breastfeeding. On the same scale, women similarly rated their difficulty latching or concern for low milk supply as the most important reasons for breastfeeding cessation. CONCLUSION: SED African American women with overweight or obesity who received a home-based educational intervention had higher breastfeeding rates than is reported nationally for black women (59%). However, the intervention with more breastfeeding content did not further increase breastfeeding rates or impact reasons for breastfeeding cessation. TRIAL REGISTRATION: ClinicalTrials.gov : NCT01768793.

The vaginal eukaryotic DNA virome and preterm birth.

BACKGROUND: Despite decades of attempts to link infectious agents to preterm birth, an exact causative microbe or community of microbes remains elusive. Culture-independent sequencing of vaginal bacterial communities demonstrates community characteristics are associated with preterm birth, although none are specific enough to apply clinically. Viruses are important components of the vaginal microbiome and have dynamic relationships with vaginal bacterial communities. We hypothesized that vaginal eukaryotic DNA viral communities (the "vaginal virome") either alone or in the context of bacterial communities are associated with preterm birth. OBJECTIVE: The objective of this study was to use high-throughput sequencing to examine the vaginal eukaryotic DNA virome in a cohort of pregnant women and examine associations between vaginal community characteristics and preterm birth. STUDY DESIGN: This is a nested case-control study within a prospective cohort study of women with singleton pregnancies, not on supplemental progesterone, and without cervical cerclage in situ. Serial midvaginal swabs were obtained at routine prenatal visits. DNA was extracted, bacterial communities were characterized by 16S ribosomal RNA gene sequencing, and eukaryotic viral communities were characterized by enrichment of viral nucleic acid with the ViroCap targeted sequence capture panel followed by nucleic acid sequencing. Viral communities were analyzed according to presence/absence of viruses, diversity, dynamics over time, and association with bacterial community data obtained from the same specimens. RESULTS: Sixty subjects contributed 128 vaginal swabs longitudinally across pregnancy. In all, 24 patients delivered preterm. Participants were predominantly African American (65%). Six families of eukaryotic DNA viruses were detected in the vaginal samples. At least 1 virus was detected in 80% of women. No specific virus or group of viruses was associated with preterm delivery. Higher viral richness was significantly associated with preterm delivery in the full group and in the African American subgroup (P = .0005 and P = .0003, respectively). Having both high bacterial diversity and high viral diversity in the first trimester was associated with the highest risk for preterm birth. CONCLUSION: Higher vaginal viral diversity is associated with preterm birth. Changes in vaginal virome diversity appear similar to changes in the vaginal bacterial microbiome over pregnancy, suggesting that underlying physiology of pregnancy may regulate both bacterial and viral communities.

Early Second-Trimester Fetal Growth Restriction and Adverse Perinatal Outcomes.

OBJECTIVE: To estimate the risk of adverse perinatal outcomes among women with isolated fetal growth restriction from 17 to 22 weeks of gestation. METHODS: This was a retrospective cohort study of all singleton, nonanomalous pregnancies undergoing ultrasonography to assess fetal anatomy between 17 and 22 weeks of gestation at a single center from 2010 to 2014. After excluding patients with fetal structural malformations, chromosomal abnormalities, or identified infectious etiologies, we compared perinatal outcomes between pregnancies with and without fetal growth restriction, defined as estimated fetal weight less than the 10th percentile for gestational age. Our primary outcome was small for gestational age (SGA) at birth, defined as birth weight less than the 10th percentile. Secondary outcomes included preterm delivery at less than 37 and less than 28 weeks of gestation, preeclampsia, abruption, stillbirth, neonatal death, neonatal intensive care unit admission, intraventricular hemorrhage, need for respiratory support, and necrotizing enterocolitis. RESULTS: Of 12,783 eligible patients, 355 (2.8%) had early second-trimester fetal growth restriction. Risk factors for growth restriction were African American race and tobacco use. Early second-trimester growth restriction was associated with a more than fivefold increase in risk of SGA at birth (36.9% compared with 9.1%, adjusted odds ratio [OR] 5.5, 95% CI 4.3-7.0), stillbirth (2.5% compared with 0.4%, OR 6.2, 95% CI 2.7-12.8), and neonatal death (1.4% compared with 0.3%, OR 5.2, 95% CI 1.6-13.5). Rates of indicated preterm birth at less than 37 weeks of gestation (7.3% compared with 3.3%, OR 2.3, 95% CI 1.5-3.5) and less than 28 weeks of gestation (2.5% compared with 0.2%, OR 10.8, 95% CI 4.5-23.4), neonatal need for respiratory support (16.9% compared with 7.8%, adjusted OR 1.6, 95% CI 1.1-2.2), and necrotizing enterocolitis (1.4% compared with 0.2%, OR 7.7, 95% CI 2.3-20.9) were also significantly higher for those with growth restriction. Rates of preeclampsia, abruption, and other neonatal outcomes were not significantly different. CONCLUSION: Although fetal growth restriction in the early second trimester occurred in less than 3% of our cohort and most of those with isolated growth restriction did not have adverse outcomes, it is a strong risk factor for SGA, stillbirth, neonatal death, and indicated preterm birth.

Short-term costs of preeclampsia to the United States health care system.

BACKGROUND: Preeclampsia is a leading cause of maternal morbidity and mortality and adverse neonatal outcomes. Little is known about the extent of the health and cost burden of preeclampsia in the United States. OBJECTIVE: This study sought to quantify the annual epidemiological and health care cost burden of preeclampsia to both mothers and infants in the United States in 2012. STUDY DESIGN: We used epidemiological and econometric methods to assess the annual cost of preeclampsia in the United States using a combination of population-based and administrative data sets: the National Center for Health Statistics Vital Statistics on Births, the California Perinatal Quality Care Collaborative Databases, the US Health Care Cost and Utilization Project database, and a commercial claims data set. RESULTS: Preeclampsia increased the probability of an adverse event from 4.6% to 10.1% for mothers and from 7.8% to 15.4% for infants while lowering gestational age by 1.7 weeks (P < .001). Overall, the total cost burden of preeclampsia during the first 12 months after birth was $1.03 billion for mothers and $1.15 billion for infants. The cost burden per infant is dependent on gestational age, ranging from $150,000 at 26 weeks gestational age to $1311 at 36 weeks gestational age. CONCLUSION: In 2012, the cost of preeclampsia within the first 12 months of delivery was $2.18 billion in the United States ($1.03 billion for mothers and $1.15 billion for infants), and was disproportionately borne by births of low gestational age.

Impact of evidence-based interventions on wound complications after cesarean delivery.

BACKGROUND: A number of evidence-based interventions have been proposed to reduce post-cesarean delivery wound complications. Examples of such interventions include appropriate timing of preoperative antibiotics, appropriate choice of skin antisepsis, closure of the subcutaneous layer if subcutaneous depth is ≥2 cm, and subcuticular skin closure with suture rather than staples. However, the collective impact of these measures is unclear. OBJECTIVE: We sought to estimate the impact of a group of evidence-based surgical measures (prophylactic antibiotics administered before skin incision, chlorhexidine-alcohol for skin antisepsis, closure of subcutaneous layer, and subcuticular skin closure with suture) on wound complications after cesarean delivery and to estimate residual risk factors for wound complications. STUDY DESIGN: We conducted a secondary analysis of data from a randomized controlled trial of chlorhexidine-alcohol vs iodine-alcohol for skin antisepsis at cesarean delivery from 2011-2015. The primary outcome for this analysis was a composite of wound complications that included surgical site infection, cellulitis, seroma, hematoma, and separation within 30 days. Risk of wound complications in women who received all 4 evidence-based measures (prophylactic antibiotics within 60 minutes of cesarean delivery and before skin incision, chlorhexidine-alcohol for skin antisepsis with 3 minutes of drying time before incision, closure of subcutaneous layer if ≥2 cm of depth, and subcuticular skin closure with suture) were compared with those women who did not. We performed logistic regression analysis limited to patients who received all the evidence-based measures to estimate residual risk factors for wound complications and surgical site infection. RESULTS: Of 1082 patients with follow-up data, 349 (32.3%) received all the evidence-based measures, and 733 (67.7%) did not. The risk of wound complications was significantly lower in patients who received all the evidence-based measures compared with those who did not (20.3% vs 28.1%; adjusted relative risk, 0.75; 95% confidence interval, 0.58-0.95). The impact appeared to be driven largely by a reduction in surgical site infections. Among patients who received all the evidence-based measures, unscheduled cesarean delivery was the only significant risk factor for wound complications (27.5% vs 16.1%; adjusted relative risk, 1.71; 95% confidence interval, 1.12-2.47) and surgical site infection (6.9% vs 1.6%; relative risk, 3.74; 95% confidence interval, 1.18-11.92). Other risk factors, which include obesity, smoking, diabetes mellitus, chorioamnionitis, surgical experience, and skin incision type, were not significant among patients who received all of the 4 evidence-based measures. CONCLUSION: Implementation of evidence-based measures significantly reduces wound complications, but the residual risk remains high, which suggests the need for additional interventions, especially in patients who undergo unscheduled cesarean deliveries, who are at risk for wound complications even after receiving current evidence-based measures.

A stillbirth calculator: Development and internal validation of a clinical prediction model to quantify stillbirth risk.

OBJECTIVE: To generate a clinical prediction tool for stillbirth that combines maternal risk factors to provide an evidence based approach for the identification of women who will benefit most from antenatal testing for stillbirth prevention. DESIGN: Retrospective cohort study. SETTING: Midwestern United States quaternary referral center. POPULATION: Singleton pregnancies undergoing second trimester anatomic survey from 1999-2009. Pregnancies with incomplete follow-up were excluded. METHODS: Candidate predictors were identified from the literature and univariate analysis. Backward stepwise logistic regression with statistical comparison of model discrimination, calibration and clinical performance was used to generate final models for the prediction of stillbirth. Internal validation was performed using bootstrapping with 1,000 repetitions. A stillbirth risk calculator and stillbirth risk score were developed for the prediction of stillbirth at or beyond 32 weeks excluding fetal anomalies and aneuploidy. Statistical and clinical cut-points were identified and the tools compared using the Integrated Discrimination Improvement. MAIN OUTCOME MEASURES: Antepartum stillbirth. RESULTS: 64,173 women met inclusion criteria. The final stillbirth risk calculator and score included maternal age, black race, nulliparity, body mass index, smoking, chronic hypertension and pre-gestational diabetes. The stillbirth calculator and simple risk score demonstrated modest discrimination but clinically significant performance with no difference in overall performance between the tools [(AUC 0.66 95% CI 0.60-0.72) and (AUC 0.64 95% CI 0.58-0.70), (p = 0.25)]. CONCLUSION: A stillbirth risk score was developed incorporating maternal risk factors easily ascertained during prenatal care to determine an individual woman's risk for stillbirth and provide an evidenced based approach to the initiation of antenatal testing for the prediction and prevention of stillbirth.