Institution-Specific Perinatal Emergency Checklists: Multicenter Report on Development, Implementation, and Sustainability.

OBJECTIVE: The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine endorse checklist use to improve obstetric care. However, there is limited research into development, implementation, and sustained use of perinatal emergency checklists to inform individual institutions. This study aimed to investigate the development and implementation of perinatal emergency checklists in diverse hospital settings in the United States. STUDY DESIGN: A qualitative study was conducted individually with clinicians from three health care systems. The participants developed and implemented institution-tailored perinatal emergency checklists. Interview transcriptions were coded using the Consolidated Framework for Implementation Research. RESULTS: The study sites included two health care systems and one individual hospital. Delivery volumes ranged from 3,500 to 48,000 deliveries a year. Interviews were conducted with all 10 participants approached. Checklists for 19 perinatal emergencies were developed at the three health care systems. Ten of the checklist topics were the same at all three institutions. Participants described the checklists as improving patient care during crises. The tools were viewed as opportunities to promote a shared mental model across clinical roles, to reduce redundancy and coordinate obstetric crisis management. Checklist were developed in small groups. Implementation was facilitated by those who developed the checklists. Participants agreed that simulation was essential for checklist refinement and effective use by response teams. Barriers to implementation included limited clinician availability. There was also an opportunity to strengthen integration of checklists workflow early in perinatal emergencies. Participants articulated that culture change took time, active practice, persistence, reinforcement, and process measurement. CONCLUSION: This study outlines processes to develop, implement, and sustain perinatal emergency checklists at three institutions. Participants agreed that multiple, parallel implementation tactics created the culture shift for integration. The overview and specific Consolidated Framework for Implementation Research components may be used to inform adaptation and sustainability for others considering implementing perinatal emergency checklists. KEY POINTS: · Perinatal emergency checklists reduce redundancy and coordinate obstetric crisis management.. · Perinatal emergency simulation is essential for checklist refinement and effective team use.. · Integrations of perinatal emergency checklists requires culture change and process measurement..

Postpartum Group A strep sepsis after third trimester uterine prolapse: case report and literature review.

INTRODUCTION: Uterine prolapse in pregnancy is an uncommon occurrence that can lead to a wide spectrum of complications. Postpartum Group A Streptococcus (GAS) endometritis is a rare but life-threatening condition. Our aim was to review the literature regarding management of prolapse in pregnancy and maternal infection as a rare complication. METHODS AND RESULTS: We present a case of uterine prolapse with cervical elongation presenting in the third trimester. The patient's prolapse was refractory to pessary management. She was induced at 36 weeks due to an abnormal fetal heart tracing and had an uncomplicated vaginal delivery. Her postpartum course was complicated by GAS endometritis and septic shock. She recovered after antibiotic therapy and her prolapse did not recur postpartum. CONCLUSION: Prolapse during pregnancy carries a risk of several complications but does not preclude a vaginal delivery. Management must be patient-centered and individualized. GAS sepsis is a potential, rare, and life-threatening postpartum complication requiring swift identification and treatment.

Appendicitis and Cholecystitis in Pregnancy.

Up to 2% of pregnant women develop a disease that requires nonobstetrical operative intervention during pregnancy. We discuss the issues unique to pregnant patients as they pertain to the presentation, diagnosis, and management of nonobstetric surgical disease, with an emphasis on 2 of the most common diseases that affect pregnant women: appendicitis and cholecystitis. Surgery has been demonstrated to be safe and effective during pregnancy, provided proper precautions are taken into account. It is the consensus of multiple professional committees and societies that no pregnant women should be delayed or denied a necessary surgery because of pregnancy.

Maternal ornithine transcarbamylase deficiency, a genetic condition associated with high maternal and neonatal mortality every clinician should know: A systematic review.

Ornithine transcarbamylase deficiency (OTCD) is a rare X-linked urea cycle disorder. Maternal OTCD can lead to life-threatening hyperammonemia if untreated. We aimed to compare the outcomes of maternal OTCD when diagnosis is known prior to pregnancy to when diagnosis is made during pregnancy. We performed a systematic literature review on maternal OTCD using the databases Ovid MEDLINE and PubMed from 1982 through 2018. Studies were included if addressed maternal OTCD signs, symptoms, and detailed pregnancy outcomes. We calculated the median or the mean for continuous variables and percentages for categorical variables. Of 36 cases of maternal OTCD, 20 (55%) were diagnosed prior to pregnancy while 16 (45%) were not. In the 20 patients diagnosed prior to pregnancy, 7 (35%) had either a neurologic or psychiatric presentation during pregnancy or postpartum. Two hyperammonemic patients (11%) experienced ICU admission, dialysis, and coma with no maternal deaths. All had a favorable outcome. In the 16 patients not known to have maternal OTCD prior to pregnancy, 13 (81%) had neurologic or psychiatric presentation during pregnancy or postpartum. Four presented with hyperemesis gravidarum. Eleven (69%) hyperammonemic patients had ICU admission and coma and 7 (47%) of them had dialysis. There were 5 (31%) maternal deaths. Three patients (19%) had prolonged hospitalization course. Overall, three male neonatal deaths were reported. Three other male children had liver transplant. Maternal OTCD is associated with high maternal and neonatal morbidity and mortality when diagnosis is made during pregnancy compared to when diagnosis is known prior to pregnancy.

Opioid Utilization by Pregnant Women with Sickle Cell Disease and the Risk of Neonatal Abstinence Syndrome.

BACKGROUND: Pregnant women with sickle cell disease (SCD) are at increased risk of maternal and fetal complications. There are limited data on the outcome of the treatment of VOCs with opioids in relation to neonatal complications during pregnancy. METHODS: This is a retrospective cohort study of women with SCD from January 1999 to December 2008. Women with SCD were identified by ICD-9 codes and matched 2:1 to a control group of women on methadone for opioid dependence. The primary outcome was the rate of neonatal abstinence syndrome (NAS). Secondary outcomes included the mean NAS score prior to treatment and the length of treatment. Statistical analysis was performed using SPSS. RESULTS: Twenty-one women with SCD who delivered a total of 23 neonates were included. The rate of NAS among infants born to women with SCD who were treated with opioids at any time was 22% compared to 54% in the methadone controls (p = .010). The rate of NAS was 27% among infants born to women taking opioids daily compared to 54% in the methadone control group (p = .062). CONCLUSIONS: Neonates born to women with SCD who are treated with daily opioids are at a similar risk for developing NAS as those born to mothers on methadone for opioid dependence. Neonates born to women with SCD treated with episodic opioids are at a significantly lower risk for developing NAS than those born to women on methadone for opioid dependence.

Assessment of a cervicometer compared to transvaginal ultrasound in identifying women with a short cervical length: a multicenter study.

BACKGROUND: Preterm birth remains a major cause of neonatal morbidity and mortality worldwide. Short cervical length (CL) as measured by transvaginal ultrasound (TVU) in the second trimester represents the single most predictive risk factor for spontaneous preterm birth. Previous studies have addressed, in part, the limitations of TVU availability by utilizing a cervicometer to screen patients for short cervix, identifying those patients who may not benefit from TVU CL screening. In view of the prior studies indicating that a cervicometer measurement may have a high negative predictive value (NPV) for a sonographically short cervix, we sought to identify the ideal cervicometer threshold value in a prospective, multicenter study. OBJECTIVE: The primary objective was to determine the cervicometer CL measurement threshold that provides a high NPV for the identification of patients who are highly unlikely to have a TVU CL measurement ≤20 and ≤25 mm and, therefore, may forego TVU. STUDY DESIGN: This prospective study, executed in 5 US centers, included 401 women ≥18 years of age who provided written informed consent to undergo CL measurement in the mid trimester. All women underwent both cervicometer- and TVU-measured CLs by individuals blinded to results of the other measurement. Both measurements were performed at 17-23 weeks' gestation (visit 1) and repeated at 24-29 weeks' gestation (visit 2). All TVU measurement images were reviewed by a central reader. Test characteristics and receiver operating characteristic curves were created to determine and confirm the optimal cervicometer CL threshold, maximizing the NPV. RESULTS: In all, 358 subjects were evaluable at visit 1 and 267 at visit 2. At visit 1, the average TVU CL was 38.7 ± 7.6 mm and the average cervicometer CL was 30.3 ± 8.8 mm. Similar measurements were seen at visit 2. Receiver operating characteristic curves were utilized to graphically identify a cervicometer CL threshold of 30 mm that maximized sensitivity while minimizing the false-positive rate. The 30-mm cervicometer CL threshold provided a 98-100% NPV and 0.0 negative likelihood ratio for identification of women who have a low likelihood to have a sonographic short cervix (ie, transvaginal CL ≤20 mm or ≤25 mm). The 17-23 weeks' gestation 30-mm cervicometer CL threshold has 100% sensitivity, 45-46% specificity, and 1.8 and 0.0 positive and negative likelihood ratios to predict sonographic CL ≤20 and ≤25 mm. CONCLUSION: Cervicometer CL screening successfully identifies women at low risk for short transvaginal CL. Use of a 30-mm threshold by cervicometer CL measurement confers a 98-100% NPV, with high sensitivity and moderate specificity to predict a TVU short CL. Cervicometer measurement of CL may permit almost 50% of women to avoid TVU.

Evaluation of additive effect of quantitative fetal fibronectin to cervical length for prediction of spontaneous preterm birth among asymptomatic low-risk women.

INTRODUCTION: Our objective was to evaluate the possible additive effect of quantitative fetal fibronectin to transvaginal ultrasound cervical length measurement between 18(0/7) and 23(6/7)  weeks for prediction of spontaneous preterm birth at <37(0/7)  weeks among asymptomatic low-risk women. MATERIAL AND METHODS: A prospective observational study was performed of asymptomatic women with singleton gestations between 18(0/7) and 23(6/7)  weeks and no prior spontaneous preterm birth. Women with multiple gestations, rupture of membranes, vaginal bleeding, intercourse or vaginal exam within 48 h of enrollment were excluded. Physicians were blinded to the quantitative fetal fibronectin levels, but the cervical length measurements were made available. The primary outcome was spontaneous preterm birth at <37(0/7)  weeks. RESULTS: Of the 528 asymptomatic low-risk women who were prospectively enrolled, 36 (6.82%) had spontaneous preterm birth at <37(0/7)  weeks. Using the receiver-operating characteristic curve, fetal fibronectin value of ≥5 ng/mL was identified as the optimal cut-off for predicting spontaneous preterm birth at <37(0/7)  weeks. As compared with cervical length ≥20 mm alone, with the use of cervical length ≤20 mm or quantitative fetal fibronectin ≥5 ng/mL as screening criteria for prediction of spontaneous preterm birth at <37(0/7)  weeks; sensitivity improved from 11.11 to 61.11%, specificity decreased from 99.59 to 55.08%, positive predictive value decreased from 66.67 to 9.05%, negative predictive value marginally improved from 93.87 to 95.09% and predictive accuracy decreased from 93.56 to 55.49%. CONCLUSIONS: Although the sensitivity improved, other predictive statistics and predictive accuracy did not improve by the addition of mid-trimester quantitative fetal fibronectin to cervical length measurement. Therefore, addition of mid-trimester quantitative fetal fibronectin to cervical length measurement cannot be recommended at this time for prediction of spontaneous preterm birth at <37(0/7)  weeks in asymptomatic low-risk women.

Second Trimester Cervical Length and Its Association with Vaginal Birth after Cesarean Delivery.

OBJECTIVE: This study aims to evaluate the relationship between cervical length (CL) and trial of labor after cesarean (TOLAC) delivery. STUDY DESIGN: This retrospective cohort study evaluated second trimester CL and likelihood of successful TOLAC. Women undergoing TOLAC from January 2009 to December 2011 who underwent transvaginal ultrasound CL between 18(0/7) to 23(6/7) weeks gestation were included. The threshold for CL was assessed using a receiver operating characteristics curve, with ≥ 45 mm determined to be the optimal threshold. Women with CL < 45 mm were compared with women with CL ≥ 45 mm with respect to TOLAC. Multivariate analysis was used to assess the association of CL with TOLAC. RESULTS: A total of 45 patients met inclusion criteria, 14 (31%) with a long CL (≥ 45 mm) and 31 (69%) with CL < 45 mm. Groups did not differ in demographics or factors predictive of vaginal birth after cesarean (VBAC) delivery. More women with CL < 45 mm had successful VBAC (81%) than women with long CL (43%, relative risk 1.9, p = 0.03). Prior vaginal delivery and CL < 45 mm were both significant predictors of VBAC (odds ratio 1.8 and 2.0, respectively). CONCLUSION: CL < 45 mm is associated with VBAC.

Detection of microbial invasion of the amniotic cavity by analysis of cervicovaginal proteins in women with preterm labor and intact membranes.

OBJECTIVE: Microbial invasion of the amniotic cavity (MIAC) is common in early preterm labor and is associated with maternal and neonatal infectious morbidity. MIAC is usually occult and is reliably detected only with amniocentesis. We sought to develop a noninvasive test to predict MIAC based on protein biomarkers in cervicovaginal fluid (CVF) in a cohort of women with preterm labor (phase 1) and to validate the test in an independent cohort (phase 2). STUDY DESIGN: This was a prospective study of women with preterm labor who had amniocentesis to screen for MIAC. MIAC was defined by positive culture and/or 16S ribosomal DNA results. Nine candidate CVF proteins were analyzed by enzyme-linked immunosorbent assay. Logistic regression was used to identify combinations of up to 3 proteins that could accurately classify the phase 1 cohort (N = 108) into those with or without MIAC. The best models, selected by area under the curve (AUC) of the receiver operating characteristic curve in phase 1, included various combinations of interleukin (IL)-6, chemokine (C-X-C motif) ligand 1 (CXCL1), alpha fetoprotein, and insulin-like growth factor binding protein-1. Model performance was then tested in the phase 2 cohort (N = 306). RESULTS: MIAC was present in 15% of cases in phase 1 and 9% in phase 2. A 3-marker CVF model using IL-6 plus CXCL1 plus insulin-like growth factor binding protein-1 had AUC 0.87 in phase 1 and 0.78 in phase 2. Two-marker models using IL-6 plus CXCL1 or alpha fetoprotein plus CXCL1 performed similarly in phase 2 (AUC 0.78 and 0.75, respectively), but were not superior to CVF IL-6 alone (AUC 0.80). A cutoff value of CVF IL-6 ≥463 pg/mL (which had 81% sensitivity in phase 1) predicted MIAC in phase 2 with sensitivity 79%, specificity 78%, positive predictive value 38%, and negative predictive value 97%. CONCLUSION: High levels of IL-6 in CVF are strongly associated with MIAC. If developed into a bedside test or rapid laboratory assay, cervicovaginal IL-6 might be useful in selecting patients in whom the probability of MIAC is high enough to warrant amniocentesis or transfer to a higher level of care. Such a test might also guide selection of potential subjects for treatment trials.

Amniotic fluid infection, inflammation, and colonization in preterm labor with intact membranes.

OBJECTIVE: The purpose of this study was to compare intraamniotic inflammation vs microbial invasion of the amniotic cavity (MIAC) as predictors of adverse outcome in preterm labor with intact membranes. STUDY DESIGN: Interleukin-6 (IL-6) was measured in prospectively collected amniotic fluid from 305 women with preterm labor. MIAC was defined by amniotic fluid culture and/or detection of microbial 16S ribosomal DNA. Cases were categorized into 5 groups: infection (MIAC; IL-6, ≥11.3 ng/mL); severe inflammation (no MIAC; IL-6, ≥11.3 ng/mL); mild inflammation (no MIAC; IL-6, 2.6-11.2 ng/mL); colonization (MIAC; IL-6, <2.6 ng/mL); negative (no MIAC; IL-6, <2.6 ng/mL). RESULTS: The infection (n = 27) and severe inflammation (n = 36) groups had similar latency (median, <1 day and 2 days, respectively) and similar rates of composite perinatal morbidity and mortality (81% and 72%, respectively). The colonization (n = 4) and negative (n = 195) groups had similar outcomes (median latency, 23.5 and 25 days; composite morbidity and mortality rates, 21% and 25%, respectively). The mild inflammation (n = 47) groups had outcomes that were intermediate to the severe inflammation and negative groups (median latency, 7 days; composite morbidity and mortality rates, 53%). In logistic regression adjusting for gestational age at enrollment, IL-6 ≥11.3 and 2.6-11.2 ng/mL, but not MIAC, were associated significantly with composite morbidity and mortality rates (odds ratio [OR], 4.9; 95% confidence interval [CI], 2.2-11.2, OR, 3.1; 95% CI, 1.5-6.4, and OR, 1.8; 95% CI, 0.6-5.5, respectively). CONCLUSION: We confirmed previous reports that intraamniotic inflammation is associated with adverse perinatal outcomes whether or not intraamniotic microbes are detected. Colonization without inflammation appears relatively benign. Intraamniotic inflammation is not simply present or absent but also has degrees of severity that correlate with adverse outcomes. We propose the designation amniotic inflammatory response syndrome to denote the adverse outcomes that are associated with intraamniotic inflammation.

Tocolytics for preterm premature rupture of membranes.

BACKGROUND: In women with preterm labor, tocolysis has not been shown to improve perinatal mortality; however, it is often given for 48 hours to allow for the corticosteroid effect for fetal maturation. In women with preterm premature rupture of membranes (PPROM), the use of tocolysis is still controversial. In theory, tocolysis may prolong pregnancy in women with PPROM, thereby allowing for the corticosteroid benefit and reducing the morbidity and mortality associated with prematurity. OBJECTIVES: To assess the potential benefits and harms of tocolysis in women with preterm premature rupture of membranes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 January 2014). SELECTION CRITERIA: We included pregnant women with singleton pregnancies and PPROM (23 weeks to 36 weeks and six days). We included any tocolytic therapy compared to no tocolytic, placebo, or another tocolytic. DATA COLLECTION AND ANALYSIS: All review authors assessed the studies for inclusion. We extracted and quality assessed data. MAIN RESULTS: We included eight studies with a total of 408 women. Seven of the studies compared tocolysis to no tocolysis. One study compared nifedipine to terbutaline. Compared to no tocolysis, tocolysis was not associated with a significant effect on perinatal mortality in women with PPROM (risk ratio (RR) 1.67; 95% confidence interval (CI) 0.85 to 3.29). Tocolysis was associated with longer latency (mean difference (MD) 73.12 hours; 95% CI 20.21 to 126.03; three trials of 198 women) and fewer births within 48 hours (average RR 0.55; 95% CI 0.32 to 0.95; six trials of 354 women; random-effects, Tau² = 0.18, I² = 43%) compared to no tocolysis. However, tocolysis was associated with increased five-minute Apgar of less than seven (RR 6.05; 95% CI 1.65 to 22.23; two trials of 160 women) and increased need for ventilation of the neonate (RR 2.46; 95% CI 1.14 to 5.34; one trial of 81 women). In the subgroup analysis comparing betamimetic to no betamimetics, tocolysis was associated with increased latency and borderline significance for chorioamnionitis. Prophylactic tocolysis with PPROM was associated with increased overall latency, without additional benefits for maternal/neonatal outcomes. For women with PPROM before 34 weeks, there was a significantly increased risk of chorioamnionitis in women who received tocolysis. However, neonatal outcomes were not significantly different. There were no significant differences in maternal/neonatal outcomes in subgroup analyses comparing cox inhibitor versus no tocolysis, calcium channel blocker versus betamimetic, antibiotic, corticosteroid or combined antibiotic/corticosteroid. AUTHORS' CONCLUSIONS: Our review suggests there is insufficient evidence to support tocolytic therapy for women with PPROM, as there was an increase in maternal chorioamnionitis without significant benefits to the infant. However, studies did not consistently administer latency antibiotics and corticosteroids, both of which are now considered standard of care.

Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery.

BACKGROUND: Given the continued rise in cesarean birth rate and the increased risk of surgical site infections after cesarean birth compared with vaginal birth, effective interventions must be established for prevention of surgical site infections. Prophylactic intravenous (IV) antibiotic administration 60 minutes prior to skin incision is recommended for abdominal gynecologic surgery; however, administration of prophylactic antibiotics has traditionally been withheld until after neonatal umbilical cord clamping during cesarean delivery due to the concern for potential transfer of antibiotics to the neonate. OBJECTIVES: To compare the effects of cesarean antibiotic prophylaxis administered preoperatively versus after neonatal cord clamp on postoperative infectious complications for both the mother and the neonate. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2014) and reference lists of retrieved papers. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing maternal and neonatal outcomes following prophylactic antibiotics administered prior to skin incision versus after neonatal cord clamping during cesarean delivery. Cluster-RCTs were eligible for inclusion but none were identified. Quasi-RCT and trials using a cross-over design were not eligible for inclusion in this review. Studies published in abstract form only were eligible for inclusion if sufficient information was available in the report. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed the studies for inclusion, assessed risk of bias, abstracted data and checked entries for accuracy. We assessed the quality of evidence using the GRADE approach. MAIN RESULTS: We included 10 studies (12 trial reports) from which 5041 women contributed data for the primary outcome. The overall risk of bias was low.When comparing prophylactic intravenous (IV) antibiotic administration in women undergoing cesarean delivery, there was a reduction in composite maternal infectious morbidity (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.45 to 0.72, high quality evidence), which was specifically due to the reduction in endometritis (RR 0.54, 95% CI 0.36 to 0.79, high quality evidence) and wound infection (RR 0.59, 95% CI 0.44 to 0.81, high quality evidence) in those that received antibiotics preoperatively as compared to those who received antibiotics after neonatal cord clamping. There were no clear differences in neonatal sepsis (RR 0.76, 95% CI 0.51 to 1.13, moderate quality evidence).There were no clear differences for other maternal outcomes such as urinary tract infection (UTI), cystitis and pyelonephritis (moderate quality evidence), respiratory infection (low quality evidence), or any neonatal outcomes. Maternal side effects were not reported in the included studies.The quality of the evidence using GRADE was high for composite morbidity, endomyometritis, wound infection and neonatal intensive care unit admission, moderate for UTI/cystitis/pyelonephritis and neonatal sepsis, and low for maternal respiratory infection. AUTHORS' CONCLUSIONS: Based on high quality evidence from studies whose overall risk of bias is low, intravenous prophylactic antibiotics for cesarean administered preoperatively significantly decreases the incidence of composite maternal postpartum infectious morbidity as compared with administration after cord clamp. There were no clear differences in adverse neonatal outcomes reported. Women undergoing cesarean delivery should receive antibiotic prophylaxis preoperatively to reduce maternal infectious morbidities. Further research may be needed to elucidate short- and long-term adverse effects for neonates.

Implementation of a universal cervical length screening program for the prevention of preterm birth.

OBJECTIVE: The objective of this article is to evaluate the implementation and acceptability of a universal cervical length (CL) screening program for prediction and prevention of preterm birth (PTB). STUDY DESIGN: We performed a prospective observational study to evaluate the implementation and acceptability of a universal CL screening program. Between January 1, 2012, and December 31, 2012, women with singleton gestations, without a cerclage or prior spontaneous PTB, were offered transvaginal ultrasound (TVU) for CL between 18(0/7) and 23(6/7) weeks' gestation. Sonographers and medical staff received education before implementation. Intervention for a short CL was interpreted according to a standard protocol. On June 1, 2012, our program was modified from "opt-in" to "opt-out." SPSS 20.0 (released 2011, IBM statistics for Windows version 20, IBM Corp., Armonk, NY) was used for analysis. RESULTS: Over 12 months, 1,484 (87%) of 1,706 eligible women were offered CL screening, and 1,119 (75%) were actually screened. Women were more likely to accept CL screening if they were nulliparous versus multiparous (83 vs. 68%, p < 0.001) and if the sonographer was female versus male (83 vs. 42%, p < 0.001). Implementation of an "opt-out" protocol did not increase the overall number of women accepting CL screening compared with an "opt-in" approach (76 vs. 75%, p = 0.81) CONCLUSION: Universal CL screening can be feasibly implemented and is acceptable to most women.

Evidence-based surgery for cesarean delivery: an updated systematic review.

The objective of our systematic review was to provide updated evidence-based guidance for surgical decisions during cesarean delivery (CD). We performed an English-language MEDLINE, PubMed, and COCHRANE search with the terms, cesarean section, cesarean delivery, cesarean, pregnancy, and randomized trials, plus each technical aspect of CD. Randomized control trials (RCTs) involving any aspect of CD technique from Jan. 1, 2005, to Sept. 1, 2012, were evaluated to update a previous systematic review. We also summarized Cochrane reviews, systematic reviews, and metaanalyses if they included additional RCTs since this review. We identified 73 RCTs, 10 metaanalyses and/or systematic reviews, and 12 Cochrane reviews during this time frame. Recommendations with high levels of certainty as defined by the US Preventive Services Task Force favor pre-skin incision prophylactic antibiotics, cephalad-caudad blunt uterine extension, spontaneous placental removal, surgeon preference on uterine exteriorization, single-layer uterine closure when future fertility is undesired, and suture closure of the subcutaneous tissue when thickness is 2 cm or greater and do not favor manual cervical dilation, subcutaneous drains, or supplemental oxygen for the reduction of morbidity from infection. The technical aspect of CD with high-quality, evidence-based recommendations should be adopted. Although 73 RCTs over the past 8 years is encouraging, additional well-designed, adequately powered trials on the specific technical aspects of CD are warranted.

Cervical assessment by ultrasound for preventing preterm delivery.

BACKGROUND: Measurement of cervical length (CL) by transvaginal ultrasound (TVU) is predictive of preterm birth (PTB). It is unclear if this screening test is effective for prevention of PTB. OBJECTIVES: To assess the effectiveness of antenatal management based on transvaginal ultrasound of cervical length (TVU CL) screening for preventing PTB. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2012), reviewed the reference lists of all articles and contacted experts in the field for additional and ongoing trials. SELECTION CRITERIA: Published and unpublished randomized controlled trials including pregnant women between the gestational ages of 14 to 32 weeks screened with TVU CL for risk of PTB. This review focuses exclusively on studies based on knowledge versus no knowledge of TVU CL results. DATA COLLECTION AND ANALYSIS: All potential studies identified from the search were independently assessed for inclusion by three review authors. We also analyzed studies for quality measures and extracted data. MAIN RESULTS: Of the 13 trials identified, five were eligible for inclusion (n = 507). Three included singleton gestations with preterm labor (PTL); one included singleton gestations with preterm premature rupture of membranes (PPROM); and one included twin gestations with or without PTL.In the three trials of singleton gestations with PTL, 290 women were randomized; 147 to knowledge and 143 to no knowledge of TVU CL. Knowledge of TVU CL results was associated with a non-significant decrease in PTB at less than 37 weeks (22.3% versus 34.7%, respectively; average risk ratio 0.59, 95% confidence interval (CI) 0.26 to 1.32; two trials, 242 women) and at less than 34 weeks (6.9% verus 12.6%; RR 0.55, 95% CI 0.25 to 1.20; three trials, 256 women). Delivery occurred at a later gestational age in the knowledge versus no knowledge groups (mean difference (MD) 0.64 weeks, 95% CI 0.03 to 1.25; three trials, 290 women). For all other outcomes for which there were available data (PTB at less than 34 or 28 weeks; birthweight less than 2500 grams; perinatal death; maternal hospitalization; tocolysis; and steroids for fetal lung maturity), there was no evidence of a difference between groups.The trial of singleton gestations with PPROM (n = 92) evaluated as its primary outcome safety of TVU CL in this population, and not its effect on management. There was no evidence of a difference in incidence of maternal and neonatal infections between the TVU CL and no TVU CL groups.In the trial of twin gestations with or without PTL (n = 125), there was no evidence of a difference in PTB at less than 36, 34, or 30 weeks, gestational age at delivery, and other perinatal and maternal outcomes between the TVU CL and the no TVU CL groups. Life-table analysis revealed significantly less PTB at less than 35 weeks in the TVU CL group compared with the no TVU CL group (P = 0.02). AUTHORS' CONCLUSIONS: Currently, there is insufficient evidence to recommend routine screening of asymptomatic or symptomatic pregnant women with TVU CL. Since there is a non-significant association between knowledge of TVU CL results and a lower incidence of PTB at less than 37 weeks in symptomatic women, we encourage further research. Future studies should look at specific populations separately (e.g., singleton versus twins; symptoms of PTL or no such symptoms), report on all pertinent maternal and perinatal outcomes, and include cost-effectiveness analyses. Most importantly, future studies should include a clear protocol for management of women based on TVU CL results, so that it can be easily evaluated and replicated.

Pneumococcal vaccination during pregnancy for preventing infant infection.

BACKGROUND: Each year at least one million children worldwide die of pneumococcal infections. The development of bacterial resistance to antimicrobials adds to the difficulty of treatment of diseases and emphasizes the need for a preventive approach. Newborn vaccination schedules could substantially reduce the impact of pneumococcal disease in immunized children, but does not have an effect on the morbidity and mortality of infants less than three months of age. Pneumococcal vaccination during pregnancy may be a way of preventing pneumococcal disease during the first months of life before the pneumococcal vaccine administered to the infant starts to produce protection. OBJECTIVES: To assess the effect of pneumococcal vaccination during pregnancy for preventing infant infection. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2011) and reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials in pregnant women comparing pneumococcal vaccine with placebo or doing nothing or with another vaccine to prevent infant infections. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, methodological quality and extracted data using a data collection form. Data were checked for accuracy. We contacted study authors for additional information. MAIN RESULTS: Seven trials were included, but only five trials (579 participants) contributed data. There was no evidence that pneumococcal vaccination during pregnancy reduces the risk of neonatal infection (risk ratio (RR) 0.66; 95% confidence interval (CI) 0.30 to 1.46; two trials, 241 pregnancies). Although the data suggest an effect in reducing pneumococcal colonization in infants by 16 months of age (RR 0.33; 95% CI 0.11 to 0.98; one trial, 56 pregnancies), there was no evidence of this effect in infants at two to three months of age (RR 1.13; 95% CI 0.46 to 2.78; two trials, 146 pregnancies) or by six to seven months of age (RR 0.66; 95% CI 0.20 to 2.17; two trials, 144 pregnancies). No significant difference for tenderness at the injection site between women who received pneumococcal vaccine and those who received control vaccine (RR 3.20; 95% CI 0.32 to 31.54; two trials, 130 women). AUTHORS' CONCLUSIONS: There is insufficient evidence to assess whether pneumococcal vaccination during pregnancy could reduce infant infections.

Incarcerated Gravid Uterus Liberated by Placement of a Vaginal Balloon.

BACKGROUND: Incarceration of the gravid uterus is an infrequent obstetric complication that can cause severe complications. CASE: A 37-year-old woman, G3P2002, at 14 weeks of gestation presented with vomiting, back pain, and urinary retention. She was noted to be in acute renal failure, with a creatinine level of 9.24 mg/dL, and results of her physical examination were concerning for uterine incarceration. Passive maneuvers and manual pressure failed to resolve the incarceration. Under spinal anesthesia, a Bakri balloon was inflated in the posterior vagina, elevating the fundus and relieving the incarcerated uterus. CONCLUSION: An intravaginal balloon may aid in the alleviation of uterine incarceration.

Influence of weight gain on risk for cesarean delivery in obese pregnant women by class of obesity: pregnancy risk assessment monitoring system (PRAMS).

BACKGROUND: Currently, all obese women in the United States (US) are recommend to gain the same amount of weight during pregnancy, regardless of class of obesity. Limited literature has looked at the risk of cesarean, and possible mitigation of this risk, by specific class of obesity. OBJECTIVE: To determine the influence of weight gain on the odds of cesarean delivery for obese women (as determined by pre-pregnancy body mass index [BMI]), by class of obesity. STUDY DESIGN: Retrospective cohort, from the Pregnancy Risk Assessment Monitoring System (PRAMS) in the US. Specifically, the unadjusted odds of cesarean delivery were determined for each class of BMI (underweight, normal weight, overweight, class I obesity, class II obesity, and class III obesity). These odds were then adjusted by demographic and prenatal care factors influencing either weight gain during pregnancy or risk of cesarean delivery. Finally, the association of weight gain (insufficient <11 lbs, adequate 11-20 lbs, and excessive >20 lbs) on the odds of cesarean delivery in obese women was noted via multivariate logistic regression analysis. RESULTS: 60,431 women (including 21,208 with a cesarean delivery) were included in this study, with an adjusted odds ratios (OR) of cesarean delivery by BMI: underweight 0.92 (95% CI 0.83, 1.01), normal weight (referent group), overweight 1.38 (95% CI 1.32, 1.45), class I obesity 1.77 (95% CI 1.68, 1.88), class II obesity 2.17 (95% CI 2.02, 2.34), and class III obesity 3.07 (95% CI 2.82, 3.34). Class I and II obese women are more likely to have a cesarean with excessive weight gain, with class I OR 1.20 (95% CI 1.06, 1.36) and class II OR 1.24 (1.04, 1.48) when compared to women in their same class of obesity with adequate weight gain. There was no difference in risk for cesarean for class III obese women by weight gain. CONCLUSION: Although obesity is a known risk factor for cesarean delivery, this risk is thought to be mitigatable by appropriate weight gain during the pregnancy. Weight gain of 11-20 pounds was associated with the least risk of cesarean delivery among obese (specifically class I and II) individuals.

Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort.

OBJECTIVES: Preterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment. METHODS: The ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p < .05). RESULTS: The model predicted improvements for all outcomes. RP-CM decreased neonatal and maternal hospital stay by 19% (p = .029) and 8.5% (p = .001), respectively; neonatal costs' point estimate by 16% (p = .098); and moderate-to-severe neonatal morbidity/mortality by 29% (p = .025). RP-MM strengthened observed reductions and significance. Point estimates of benefit did not differ by race/ethnicity. CONCLUSIONS: Modeled evaluation of a biomarker-based test-and-treat strategy in a diverse population predicts clinically and economically meaningful improvements in neonatal and maternal outcomes.

Preterm birth, defined as delivery before 37 weeks' gestation, is the leading cause of illness and death in newborns. In the United States, more than 10% of infants are born prematurely, and this rate is substantially higher in lower-income, inner-city and Black populations. Prematurity associates with greatly increased risk of short- and long-term medical complications and can generate significant costs throughout the lives of affected children. Annual U.S. health care costs to manage short- and long-term prematurity complications are estimated to exceed $25 billion.Clinical interventions, including case management (increased patient outreach, education and specialist care), pharmacological treatment and their combination can provide benefit to pregnancies at higher risk for preterm birth. Early and sensitive risk detection, however, remains a challenge.We have developed and validated a proteomic biomarker risk predictor for early identification of pregnancies at increased risk of preterm birth. The ACCORDANT study modeled treatments with real-world patient data from a racially and ethnically diverse U.S. population to compare the benefits of risk predictor testing plus clinical intervention for higher-risk pregnancies versus no testing and standard care. Measured outcomes included neonatal and maternal length of hospital stay, associated costs and neonatal morbidity and mortality. The model projected improved outcomes and reduced costs across all subjects, including ethnic and racial minority populations, when predicted higher-risk pregnancies were treated using case management with or without pharmacological treatment. The biomarker risk predictor shows high potential to be a clinically important component of risk stratification for pregnant women, leading to tangible gains in reducing the impact of preterm birth.

Tocolytics for preterm premature rupture of membranes.

BACKGROUND: In women with preterm labor, tocolysis has not been shown to improve perinatal mortality; however, it is often given for 48 hours to allow for the corticosteroid effect for fetal maturation. In women with preterm premature rupture of membranes (PPROM), the use of tocolysis is still controversial. In theory, tocolysis may prolong pregnancy in women with PPROM, thereby allowing for the corticosteroid benefit and reducing the morbidity and mortality associated with prematurity. OBJECTIVES: To assess the potential benefits and harms of tocolysis in women with preterm premature rupture of membranes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 April 2011), CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE (1966 to 6 April 2011) and EMBASE (1974 to 6 April 2011). SELECTION CRITERIA: We included pregnant women with singleton pregnancies and PPROM (23 weeks to 36 weeks and six days). We included any tocolytic therapy compared to no tocolytic, placebo, or another tocolytic. DATA COLLECTION AND ANALYSIS: All review authors assessed the studies for inclusion. We extracted and quality assessed data. MAIN RESULTS: We included eight studies with a total of 408 women. Seven of the studies compared tocolysis to no tocolysis. One study compared nifedipine to terbutaline. Compared to no tocolysis, tocolysis was not associated with a significant effect on perinatal mortality in women with PPROM (risk ratio (RR) 1.67; 95% confidence interval (CI) 0.85 to 3.29). Tocolysis was associated with longer latency (mean difference (MD) 73.12 hours; 95% CI 20.21 to 126.03; three trials of 198 women) and fewer births within 48 hours (average RR 0.55; 95% CI 0.32 to 0.95; six trials of 354 women; random-effects, T(2) = 0.18, I(2) = 43%) compared to no tocolysis. However, tocolysis was associated with increased five-minute Apgar of less than seven (RR 6.05; 95% CI 1.65 to 22.23; two trials of 160 women) and increased need for ventilation of the neonate (RR 2.46; 95% CI 1.14 to 5.34; one trial of 81 women). In the subgroup analysis comparing betamimetic to no betamimetics, tocolysis was associated with increased latency and borderline significance for chorioamnionitis. Prophylactic tocolysis with PPROM was associated with increased overall latency, without additional benefits for maternal/neonatal outcomes. For patients with PPROM before 34 weeks, there was a significantly increased risk of chorioamnionitis in women who received tocolysis. However, neonatal outcomes were not significantly different. There were no significant differences in maternal/neonatal outcomes in subgroup analyses comparing cox inhibitor versus no tocolysis, calcium channel blocker versus betamimetic, antibiotic, corticosteroid or combined antibiotic/corticosteroid. AUTHORS' CONCLUSIONS: Our review suggests there is insufficient evidence to support tocolytic therapy for women with PPROM, as there was an increase in maternal chorioamnionitis without significant benefits to the infant. However, studies did not consistently administer latency antibiotics and corticosteroids, both of which are now considered standard of care.