Society for Maternal-Fetal Medicine Special Statement: Emergency checklist, planning worksheet, and system preparedness bundle for placenta accreta spectrum.

Placenta accreta spectrum is a life-threatening complication of pregnancy that is underdiagnosed and can result in massive hemorrhage, disseminated intravascular coagulation, massive transfusion, surgical injury, multisystem organ failure, and even death. Given the rarity and complexity, most obstetrical hospitals and providers do not have comprehensive expertise in the diagnosis and management of placenta accreta spectrum. Emergency management, antenatal interdisciplinary planning, and system preparedness are key pillars of care for this life-threatening disorder. We present an updated sample checklist for emergent and unplanned cases, an antenatal planning worksheet for known or suspected cases, and a bundle of activities to improve system and team preparedness for placenta accreta spectrum.

Risk Profiling In Vitro Fertilization Pregnancies that Develop Placenta Accreta Spectrum.

OBJECTIVE: The objective of this study is to assess whether, among a cohort of placenta accreta spectrum (PAS) patients, antenatal suspicion of PAS was less likely in in vitro fertilization (IVF) compared with non-IVF patients. In addition, we aimed to assess whether IVF patients exhibited similar risk factors for PAS compared with non-IVF patients. STUDY DESIGN: This is an international multicenter retrospective study of patients with pathologically confirmed PAS (accreta, increta, percreta) between 1998 and 2021. PAS patients were identified through a central international PAS database. Antenatal and pathological criteria are specific to each institution. Pregnancies that resulted from IVF were compared with non-IVF pregnancies. Comparisons were made using a chi-square or Fisher's exact test for categorical variables and Wilcoxon rank-sum test for continuous variables. RESULTS: Of the 692 pregnancies included, 44 were in the IVF group and 648 were in the non-IVF group. The IVF group was less likely to have had a prior cesarean delivery (70.5 vs. 91%, p < 0.01) but a similar prevalence of placenta previa (63.6 vs. 68.1%, p = 0.12) compared with the non-IVF group. The IVF group was also less likely to have either a prior cesarean delivery or placenta previa than the non-IVF group (79.5 vs. 95.4%, p < 0.01). Antenatal detection of PAS was less common in the IVF group compared with the non-IVF group (40.9 vs. 60.5%, p < 0.01, respectively), even when adjusted for maternal age, prior cesarean delivery, prior uterine surgery, placenta previa and site (risk ratio: 0.70, 95% confidence interval: 0.62-0.81). The IVF group had less severe pathological disease compared with the non-IVF group (p = 0.02). CONCLUSION: Pregnant people with PAS who underwent IVF are less likely to have an antenatal suspicion compared with non-IVF patients. This finding may be explained by the lower incidence of prior cesarean deliveries and/or placenta previa as well as less severe forms of PAS. KEY POINTS: · IVF group is less likely to have antenatal PAS suspicion.. · IVF group is less likely to have had prior cesarean delivery.. · Risk profile for PAS differs in IVF pregnancies..

Validation of Three Models for Prediction of Blood Transfusion during Cesarean Delivery Admission.

OBJECTIVE: Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. STUDY DESIGN: This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative [CMQCC]) and two regression models (Ahmadzia et al and Albright et al). The primary outcome was intrapartum or postpartum red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS: Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low risk, 5,259 (48.8%) as medium risk, and 3,556 (33.0%) as high risk with corresponding transfusion rates of 2.1% (95% confidence interval [CI]: 1.5-2.9%), 2.2% (95% CI: 1.8-2.6%), and 7.5% (95% CI: 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI: 0.76-0.81) and 0.79 (95% CI: 0.77-0.82), respectively (p = 0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION: Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT: Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed. KEY POINTS: · A total of 3.9% of individuals received a blood transfusion during cesarean delivery admission.. · Three models used in clinical practice are externally valid for blood transfusion prediction.. · Institutional model selection should be based on ease of application until further research identifies the optimal approach..

Delivery outcomes in the subsequent pregnancy following the conservative management of placenta accreta spectrum disorder: a systematic review and meta-analysis.

OBJECTIVE: Cesarean hysterectomy is generally presumed to decrease maternal morbidity and mortality secondary to placenta accreta spectrum disorder. Recently, uterine-sparing techniques have been introduced in conservative management of placenta accreta spectrum disorder to preserve fertility and potentially reduce surgical complications. However, despite patients often expressing the intention for future conception, few data are available regarding the subsequent pregnancy outcomes after conservative management of placenta accreta spectrum disorder. Thus, we aimed to perform a systematic review and meta-analysis to assess these outcomes. DATA SOURCES: PubMed, Scopus, and Web of Science databases were searched from inception to September 2022. STUDY ELIGIBILITY CRITERIA: We included all studies, with the exception of case studies, that reported the first subsequent pregnancy outcomes in individuals with a history of placenta accreta spectrum disorder who underwent any type of conservative management. METHODS: The R programming language with the "meta" package was used. The random-effects model and inverse variance method were used to pool the proportion of pregnancy outcomes. RESULTS: We identified 5 studies involving 1458 participants that were eligible for quantitative synthesis. The type of conservative management included placenta left in situ (n=1) and resection surgery (n=1), and was not reported in 3 studies. The rate of placenta accreta spectrum disorder recurrence in the subsequent pregnancy was 11.8% (95% confidence interval, 1.1-60.3; I2=86.4%), and 1.9% (95% confidence interval, 0.0-34.1; I2=82.4%) of participants underwent cesarean hysterectomy. Postpartum hemorrhage occurred in 10.3% (95% confidence interval, 0.3-81.4; I2=96.7%). A composite adverse maternal outcome was reported in 22.7% of participants (95% confidence interval, 0.0-99.4; I2=56.3%). CONCLUSION: Favorable pregnancy outcome is possible following successful conservation of the uterus in a placenta accreta spectrum disorder pregnancy. Approximately 1 out of 4 subsequent pregnancies following conservative management of placenta accreta spectrum disorder had considerable adverse maternal outcomes. Given such high incidence of adverse outcomes and morbidity, patient and provider preparation is vital when managing this population.

The Need for Presurgical Evaluation for Placenta Accreta Spectrum.

Staging or grading of placenta accreta spectrum has historically relied on histopathologic evaluation of placental and uterine specimens. This approach has limited utility, since it is retrospective in nature and does not allow for presurgical planning. Here, we argue for a paradigm shift to use of clinical and imaging characteristics to define the presurgical stage. We summarize past attempts at staging, and define a new data-driven approach to determining the stage prior to delivery. Use of this model may help hospitals direct patients to the most appropriate level of care for workup and management of placenta accreta spectrum. KEY POINTS: · Staging systems that rely on histopathologic grade (accreta, increta, percreta) are unhelpful in antenatal planning for placenta accreta spectrum.. · Past attempts at pre-delivery (pre-surgical) staging have failed to account for key factors that contribute to risk and morbidity.. · We developed a data-driven model that could be easily incorporated as a decision aid into clinical practice to help clinicians decide an individual patient's risk for placenta accreta spectrum..

General Management Considerations for Placenta Accreta Spectrum.

The ideal management of a patient with placenta accreta spectrum (PAS) includes close antepartum management culminating in a planned and coordinated delivery by an experienced multidisciplinary PAS team. Coordinated team management has been shown to optimize outcomes for mother and infant. This section provides a consensus overview from the Pan-American Society for the Placenta Accreta Spectrum regarding general management of PAS.

The Association between Placenta Accreta Spectrum Severity and Incidence of Small for Gestational Age Neonates.

OBJECTIVE: The aim of the study is to evaluate whether pathologic severity of placenta accreta spectrum (PAS) is correlated with the incidence of small for gestational age (SGA) and neonatal birthweight. STUDY DESIGN: This was a multicenter cohort study of viable, non-anomalous, singleton gestations delivered with histology-proven PAS. Data including maternal history, neonatal birthweight, and placental pathology were collected and deidentified. Pathology was defined as accreta, increta, or percreta. The primary outcome was rate of SGA defined by birth weight less than the 10th percentile. The secondary outcomes included incidence of large for gestational age (LGA) babies as defined by birth weight greater than the 90th percentile as well as incidence of SGA and LGA in preterm and term gestations. Statistical analysis was performed using Chi-square, Kruskal-Wallis, and log-binomial regression. Increta and percreta patients were each compared with accreta patients. RESULTS: Among the cohort of 1,008 women from seven United States centers, 865 subjects were included in the analysis. The relative risk (RR) of SGA for increta and percreta did not differ from accreta after adjusting for confounders (adjusted RR = 0.63, 95% confidence interval [CI]: 0.36-1.10 for increta and aRR = 0.72, 95% CI: 0.45-1.16 for percreta). The results were stratified by placenta previa status, which did not affect results. There was no difference in incidence of LGA (p = 1.0) by PAS pathologic severity. The incidence of SGA for all PAS patients was 9.2% for those delivered preterm and 18.7% for those delivered at term (p = 0.004). The incidence of LGA for all PAS patients was 12.6% for those delivered preterm and 13.2% for those delivered at term (p = 0.8203). CONCLUSION: There was no difference in incidence of SGA or LGA when comparing accreta to increta or percreta patients regardless of previa status. Although we cannot suggest causation, our results suggest that PAS, regardless of pathologic severity, is not associated with pathologic fetal growth in the preterm period. KEY POINTS: · PAS severity is not associated with SGA in the preterm period.. · PAS severity is not associated with LGA.. · Placenta previa does not affect the incidence of SGA in women with PAS..

Surgical Techniques for the Management of Placenta Accreta Spectrum.

The surgical management of placenta accreta spectrum (PAS) is often challenging. There are a variety of techniques and management options described in the literature ranging from uterine sparing to cesarean hysterectomy. Following the inaugural meeting of the Pan-American Society for Placenta Accreta Spectrum a multidisciplinary group collaborated to describe collective recommendations for the surgical management of PAS. In this manuscript, we outline individual components of the procedure and provide suggested direction at key points of a cesarean hysterectomy in the setting of PAS. KEY POINTS: · The surgical management of PAS requires careful planning and expertise.. · Multidisciplinary team care for pregnancies complicated by PAS can decrease morbidity and mortality.. · Careful surgical techniques can minimize risk of significant hemorrhage by avoiding pitfalls..

Imaging the Uterus in Placenta Accreta Spectrum Disorder.

Antenatal diagnosis of placenta accreta spectrum (PAS) improves maternal and neonatal outcomes by allowing for multidisciplinary planning and preparedness. Ultrasound is the primary imaging tool. Simplification and standardization of placental evaluation and reporting terminology allows improved communication and understanding between teams. Prior to 10 weeks of gestation, gestational sac position and least myometrial thickness surrounding the gestational sac help PAS diagnosis very early in pregnancy. Late first-, second-, and third-trimester evaluation includes comprehensive evaluation of the placenta, transabdominal and transvaginal with partially full maternal urinary bladder, and by color Doppler. Subsequently, the sonologist should indicate whether the evaluation was optimal or suboptimal; the level of suspicion as low, moderate, or high; and the extent as focal, global, or extending beyond the uterus. Other complementary imaging modalities such as 3D-power Doppler ultrasound, magnetic resonance imaging (MRI), and vascular topography mapping strive to improve antenatal placental evaluation but remain investigational at present. KEY POINTS: · Antenatal imaging, primarily using ultrasound with partially full maternal urinary bladder, is an essential means of evaluation of those at risk for PAS.. · Simplification and standardization of placental evaluation and reporting will allow improved communication between the multidisciplinary teams.. · Gestational sac location prior to 10 weeks of gestation and four markers after that (placental lacunae and echostructure, myometrial thinning, hypoechoic zone with or without bulging between placenta and myometrium, and increased flow on color Doppler)..

Confirmatory Middle Cerebral Artery Doppler Testing in Alloimmunized Patients with Suspected Fetal Anemia.

OBJECTIVE: This article aimed to evaluate pregnancy outcomes when a plan to perform fetal blood sampling (FBS) or delivery was based solely on the first abnormal middle cerebral artery peak velocity (MCA-PV) measurement compared with making a plan after a confirmatory test on a subsequent day. STUDY DESIGN: We performed a descriptive study of pregnancy outcomes including all patients in a single healthcare system with maternal red cell alloimmunization undergoing ultrasound between 2005 and 2017 who had at least one MCA-PV>1.5 multiples of the median (MoM). We excluded patients with any sign of hydrops prior to the index visit or abnormal MCA-PV at>35 weeks. The first exam with a MCA-PV>1.5 MoM was deemed the index visit. RESULTS: Fifty patients were identified. Twenty-one patients underwent intervention (FBS or delivery) based on the first abnormal MCA-PV. Of those, 9 had moderate or severe anemia (positive predictive value [PPV]: 43%), while 12 had mild or no anemia. The other 29 patients underwent a confirmatory MCA test between 2 and 8 days later. Of these, 13 patients had an abnormal confirmatory test and 11 of these underwent FBS and 7 had moderate or severe anemia (PPV: 54%). Sixteen patients undergoing confirmatory MCA Doppler had a normal test on repeat and did not undergo FBS. Of those, none developed moderate or severe anemia. CONCLUSION: A substantial number of patients (55%) had normal MCA-PV testing on repeat, allowing avoidance of invasive testing. Deferring FBS until the abnormal MCA-PV was confirmed was not associated with undetected moderate or severe anemia. KEY POINTS: · False-positive results from MCA-PV Doppler prediction of fetal anemia are common.. · Repeat noninvasive testing is normal in many patients with suspected fetal anemia.. · Invasive fetal testing can often be safely avoided by performing a confirmatory Doppler exam ination..

Patient-Reported Health Outcomes and Quality of Life after Peripartum Hysterectomy for Placenta Accreta Spectrum.

OBJECTIVE: Short-term morbidity of placenta accreta spectrum (PAS) is well described, but few data are available regarding long-term outcomes and quality of life. We aimed to evaluate patient-reported outcomes after hysterectomy for PAS. STUDY DESIGN: This is a prospective cohort study of women with risk factors for PAS who were enrolled antenatally. Exposed women were defined as those who underwent cesarean hysterectomy due to PAS. Unexposed women were those with three or more prior cesareans or placenta previa, but no PAS, who underwent cesarean delivery without hysterectomy. Two surveys were sent to patients at 6, 12, 24, and 36 months postpartum: (1) a general health questionnaire and (2) the SF-36, a validated quality of life survey. Aggregate scores for each questionnaire were calculated and responses were analyzed. RESULTS: At 6 months postpartum, women with PAS were more likely to report rehospitalization (odds ratio [OR] 5.83, 95% confidence interval [CI] 1.40-24.3), painful intercourse (OR 2.50, 95% CI 1.04-6.02), and anxiety/worry (OR 3.77, 95% CI 1.43-9.93), but were not statistically more likely to report additional surgeries (OR 3.39, 95% CI 0.99-11.7) or grief and depression (OR 2.45, 95% CI 0.87-6.95). At 12 months, women with PAS were more likely to report painful intercourse, grief/depression, and anxiety/worry. At 36 months, women with PAS were more likely to report grief/depression, anxiety/worry, and additional surgeries. Women with PAS reported significantly lower quality of life in physical functioning, role functioning, social functioning, and pain at 6 months postpartum, but not in other quality of life domains. Decreased quality of life was also reported at 12 and 36 months in the PAS group. CONCLUSION: Women with PAS are more likely to report ongoing long-term health issues and decreased quality of life for up to 3 years following surgery than those undergoing cesarean for other indications. KEY POINTS: · Long-term placenta accreta spectrum data to guide peripartum patient education.. · This study addresses a critical knowledge gap.. · Women affected by PAS report long-term morbidity..

Human Mesenchymal Stem Cell Sheets Improve Uterine Incision Repair in a Rodent Hysterotomy Model.

OBJECTIVE: The study aimed to assess the feasibility of creating and transplanting human umbilical cord mesenchymal stem cell sheets applied to a rat model of hysterotomy, and additionally to determine benefits of human umbilical cord mesenchymal stem cell sheet transplantation in reducing uterine fibrosis and scarring. STUDY DESIGN: Human umbilical cord mesenchymal stem cell sheets are generated by culturing human umbilical cord mesenchymal stem cells on thermo-responsive cell culture plates. The temperature-sensitive property of these culture dishes facilitates normal cell culture in a thin contiguous layer and allows for reliable recovery of intact stem cell sheets without use of destructive proteolytic enzymes.We developed a rat hysterotomy model using nude rats. The rat uterus has two distinct horns: one horn provided a control/untreated scarring site, while the second horn was the cell sheet transplantation site.On day 14 following surgery, complete uteri were harvested and subjected to histologic evaluations of all hysterotomy sites. RESULTS: The stem cell sheet culture process yielded human umbilical cord mesenchymal stem cell sheets with surface area of approximately 1 cm2.Mean myometrial thickness in the cell sheet-transplanted group was 274 µm compared with 191 µm in the control group (p = 0.02). Mean fibrotic surface area in the human umbilical cord mesenchymal stem cell sheet-transplanted group was 95,861 µm2 compared with 129,185 µm2 in the control group. Compared with control horn sites, cell sheet-transplanted horns exhibited significantly smaller fibrotic-to-normal myometrium ratios (0.18 vs. 0.27, respectively, p = 0.029). Mean number of fibroblasts in cell sheet-transplanted horns was significantly smaller than the control horns (483 vs. 716/mm2, respectively, p = 0.001). CONCLUSION: Human umbilical cord mesenchymal stem cell sheet transplantation is feasible in a rat model of hysterotomy. Furthermore, use of stem cell sheets reduces fibroblast infiltration and uterine scar fibrotic tissue formation during hysterotomy healing, potentially mitigating risks of uterine scar formation. KEY POINTS: · Stem cell sheet transplanted to hysterotomy promotes myometrial regeneration and reduced fibrotic tissue formation.. · This study demonstrates the feasibility of using human umbilical cord mesenchymal stem cell sheets..

Directly Measured Costs of Severe Maternal Morbidity Events during Delivery Admission Compared with Uncomplicated Deliveries.

OBJECTIVE: To estimate the actual excess costs of care for delivery admissions complicated by severe maternal morbidity (SMM) compared with uncomplicated deliveries. STUDY DESIGN: This is a retrospective cohort study of all deliveries between October 2015 and September 2018 at a single tertiary academic center. Pregnant individuals ≥ 20 weeks' gestation who delivered during a hospital admission (i.e., a "delivery admission") were included. The primary exposure was SMM, as defined by Centers for Disease Control and Prevention (CDC) criteria, CDC criteria excluding blood transfusion, or by validated hospital-defined criteria (intensive care unit admission or ≥ 4 units of blood products). Potential SMM events identified via administrative and blood bank data were reviewed to confirm SMM events had occurred. Primary outcome was total actual costs of delivery admission derived from time-based accounting and acquisition costs in the institutional Value Driven Outcomes database. Cost of delivery admissions with SMM events was compared with the cost of uncomplicated delivery using adjusted generalized linear models, with separate models for each of the SMM definitions. Relative cost differences are reported due to data restrictions. RESULTS: Of 12,367 eligible individuals, 12,361 had complete cost data. Two hundred and eighty individuals (2.3%) had confirmed SMM events meeting CDC criteria. CDC criteria excluding transfusion alone occurred in 1.0% (n = 121) and hospital-defined SMM in 0.6% (n = 76). In adjusted models, SMM events by CDC criteria were associated with a relative cost increase of 2.45 times (95% confidence interval [CI]: 2.29-2.61) the cost of an uncomplicated delivery. SMM by CDC criteria excluding transfusion alone was associated with a relative increase of 3.26 (95% CI: 2.95-3.60) and hospital-defined SMM with a 4.19-fold (95% CI: 3.64-4.83) increase. Each additional CDC subcategory of SMM diagnoses conferred a relative cost increase of 1.60 (95% CI: 1.43-1.79). CONCLUSION: SMM is associated with between 2.5- and 4-fold higher cost than uncomplicated deliveries. KEY POINTS: · Severe maternal morbidity as defined by CDC criteria confers a 2.5-fold increase in delivery hospitalization costs.. · Intensive care unit admission or ≥ 4 units of blood products confer a fourfold increase in cost.. · Costs of maternal morbidity may motivate SMM review..

Association of Prostaglandin Use for Cervical Ripening with Mode of Delivery in Small for Gestational Age versus Non-Small for Gestational Age Neonates.

OBJECTIVE: Prostaglandins (PGs) use for cervical ripening with small for gestational age (SGA) fetuses is controversial since it remains uncertain if use increases the chance of cesarean delivery (CD). We aimed to assess the association between PG use for cervical ripening and mode of delivery between SGA and appropriate for gestational age (AGA) neonates. STUDY DESIGN: Secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), a prospective observational cohort study of 10,038 nulliparas. We included women undergoing induction with nonanomalous fetuses in the cephalic presentation. Women with >2 cm cervical dilation or prior uterine scar were excluded. We assessed the association of PG use with CD among women with SGA and AGA neonates. SGA was defined as birth weight <10th percentile for gestational age and sex. Multivariable logistic regression was used to adjust for potential confounders and test for interaction. Secondary outcomes included adverse neonatal outcomes, indication for CD, maternal hemorrhage, and chorioamnionitis. RESULTS: Among 2,353 women eligible, PGs were used in 54.8%, SGA occurred in 15.1%, and 35.0% had CD. The association between PG use and CD differed significantly (interaction p = 0.018) for SGA versus AGA neonates; CD occurred more often in SGA neonates exposed to PGs than not (35 vs. 22%, p = 0.009). PG use was not associated with CD among AGA neonates (36 vs. 36%, p = 0.8). This effect remained significant when adjusting for body mass index, race/ethnicity, and cervical dilation. Among SGA neonates, CD for "nonreassuring fetal status" was similar between PG groups. Among SGA neonates, PG use was not associated with adverse neonatal outcomes or postpartum hemorrhage but had a higher rate of chorioamnionitis (7.0 vs. 2.1%, p = 0.048). CONCLUSION: PG use was associated with a higher rate of CD in SGA but not AGA neonates; however, further studies are needed before PG use is discouraged with SGA neonates. KEY POINTS: · PGs are commonly used for cervical ripening.. · PG use was associated with increased risk of cesarean delivery in SGA neonates.. · PG use was not associated with adverse neonatal outcomes..

Society for Maternal-Fetal Medicine Special Statement: Surgical safety checklists for cesarean delivery.

The routine use of surgical safety checklists can reduce perioperative complications. Generic surgical safety checklists are insufficient for cesarean delivery because each cesarean delivery involves 2 patients (the mother and the fetus or newborn), each with separate care teams and health and safety considerations. To address the added complexity of care coordination and communication inherent in cesarean delivery, the Society for Maternal-Fetal Medicine presents sample standard surgical safety checklists for cesarean delivery that include elements of care for both the mother and newborn. In addition, we present an alternative checklist for time-critical emergency cesarean deliveries in which there is no time to safely perform the standard checklist and a sample preoperative checklist for use before moving the patient to the operating room. We also recommend steps for implementation of the checklists at individual facilities.

The Effect of "Off Hours" on Maternal and Perinatal Outcomes in a Diverse U.S. Cohort.

OBJECTIVE: This study aimed to evaluate the "off-hour effect" on maternal and neonatal adverse events in a large cohort representing U.S. STUDY DESIGN: A secondary analysis of the Consortium on Safe Labor (CSL) dataset with 208,695 women and 229,385 deliveries was performed. The study included the deliveries of ≥23 gestational weeks from 19 hospitals in the United States from 2002 to 2008. Babies with congenital anomalies were excluded from neonatal outcomes. We compared maternal and neonatal outcomes of patients delivered during weekdays versus off hours (nights and weekends). The primary outcomes of the study were composite maternal and composite neonatal adverse events. The secondary outcomes were delivery type and individual maternal and neonatal adverse events including maternal death and perinatal mortality rate. Associations between off hours and all the outcomes were analyzed in bivariable and multivariable analyses. The same analyses were performed in strata by indication for admission (spontaneous labor or induction of labor). RESULTS: Composite maternal adverse events (6.19 vs. 6.06%, p = 0.41) and maternal death (0.01 vs. 0.01%, p = 0.19) were not significantly different between off hours and weekday groups. In contrast, composite neonatal adverse events (6.91 vs. 5.84%, p < 0.001) and perinatal mortality rate (1.03 vs. 0.77%, p < 0.001) were higher in the off-hour group. After adjusting for confounding variables, only the composite neonatal outcome continued to be associated with off hours (adjusted odds ratio [aOR] = 1.10, 95% confidence interval [CI]: 1.04-1.16). Stratified analyses showed that the off-hour effect for the neonatal composite outcome was not present in those presenting in spontaneous labor (6.1 vs. 5.9%, p = 0.40). CONCLUSION: Off-hour delivery was not associated with severe maternal morbidity and was only modestly associated with severe neonatal morbidity. This association was observed in women undergoing induction, not in those presenting in spontaneous labor. These data draw into question the existence of a clinically meaningful and correctable "off-hour effect" in obstetrics. KEY POINTS: · The presence of a significant off-hour effect in obstetrics is still questionable.. · If the off-hour effect exists, it seems that not to be related with staffing issues.. · There is not a big difference for adverse events at off hours in spontaneously laboring patients..

Accuracy and Interobserver Reliability of Magnetic Resonance Imaging for Placenta Accreta Spectrum Disorders.

OBJECTIVE: This study aims to define the accuracy, predictive value, and interobserver reliability of magnetic resonance imaging (MRI) in the diagnosis of placenta accreta spectrum (PAS) disorders. STUDY DESIGN: Two experienced radiologists independently interpreted the MRI studies of patients with possible PAS from two referral centers. Radiologists were blinded to sonographic and clinical information. We calculated diagnostic testing characteristics and kappa statistics of interobserver reliability for MRI findings of PAS. RESULTS: Sixty-eight MRI cases were evaluated. Confirmed PAS and severe PAS were present in 44 (65%) and 20 (29%) cases. For the diagnosis of any PAS, MRI had a sensitivity 66%, specificity 71%, positive predictive value (PPV) 81%, negative predictive value (NPV) 53%, and accuracy 68%. For the diagnosis of severe PAS (percreta), MRI had a sensitivity 85%, specificity 79%, PPV 63%, NPV 93%, and accuracy 81%. The accuracy of individual signs of PAS was lower (44-65%). Interobserver agreement was almost perfect for previa; substantial for myometrial interruptions, PAS, severe PAS, and placental bulging/balling; and moderate to slight for other signs of PAS. CONCLUSION: Although the interobserver reliability of MRI for a diagnosis of PAS is substantial, the accuracy and predictive value are modest and lower than previously reported.

Impact of the p-Value Threshold on Interpretation of Trial Outcomes in Obstetrics and Gynecology.

OBJECTIVE: Randomized controlled trials (RCTs) are considered the highest level of evidence to inform clinical practice. However, the reproducibility crisis has raised concerns about the scientific rigor of published RCT findings. Some advocate for a lower p-value threshold. We aimed to review published OB/Gyn topical RCTs in three representative OB/Gyn journals and three high impact non-OB/Gyn journals to determine if their interpretations would change with adoption of a p-value threshold for significance of 0.005. Secondarily, we evaluated if there were differences in methodologic characteristics between those that did and did not lose significance. STUDY DESIGN: A manual search was performed to identify all OB/Gyn RCTs published in the selected journals between July 2017 and June 2019. Data were collected on primary outcome(s), methodology, and p-values. We determined the proportion of primary outcomes that would remain statistically significant with adoption of a p-value significance threshold of 0.005 versus be reinterpreted as "suggestive" (defined as p-value between 0.005 and 0.05). Chi-square or Fisher's exact test were used to compare study characteristics. RESULTS: Overall, 202 RCTs met inclusion criteria; 52% in obstetrics and 48% in gynecology. Of 90 studies considered significant with p <0.05 at the time of publication, 54.4% (n = 49) would maintain significant (p < 0.005), while 45.6% (n = 41) would become suggestive using the lower threshold. Most RCTs utilized a single (90.1%) versus composite (8.9%) primary outcome type, used an intent-to-treat analysis (73.3%), and studied a drug intervention (46.5%). Methodologically, 23.7% did not prespecify analysis type, 28.2% did not meet the pre-determined sample size, and 9.4% did not report an a priori sample size calculation. Studies maintaining significance were more likely to be international and report a funding source. CONCLUSION: Adopting a p-value significance threshold of 0.005 would require reinterpretation of almost half of RCT results in the OB/Gyn literature. Highly variable methodological quality was identified. KEY POINTS: · New p-value threshold results in reinterpretation of nearly half of RCT results in OB/Gyn literature.. · Highly variable methodological quality was identified.. · Reduced use of binary interpretations of significance is necessary..

Association of multifetal gestation with obstetric and neonatal outcomes in gestational carrier pregnancies.

OBJECTIVE: Multifetal gestation is more frequent among gestational carrier pregnancies than non-surrogacy IVF pregnancies. We aimed to evaluate the association between multifetal gestation and obstetric and neonatal morbidity among gestational carrier pregnancies. METHODS: Pooled cross-sectional study of birth certificate data from gestational carrier pregnancies in Utah from 2009 to 2018. Our primary outcome was a composite of severe obstetric morbidity; secondary outcomes included cesarean delivery (CD), hypertensive disorders of pregnancy, preterm birth (PTB), and a neonatal morbidity composite. Logistic regression was utilized to compare odds of these outcomes between gestational carrier pregnancies with and without multifetal gestation. RESULTS: A total of 361 gestational carrier pregnancies resulted in the delivery of 435 neonates during the study period. Of these, 284 were singleton pregnancies, and 77 were multifetal, a multifetal gestation rate of 21.3%. Baseline demographic characteristics did not differ between singleton and multifetal gestations. Multifetal gestation was not associated with higher rates of severe obstetric morbidity (odds ratio [OR] 1.87, 95% confidence interval [CI] 0.34-10.39). Multifetal gestation was associated with increased odds of neonatal morbidity (OR 9.49, 95% CI 5.35-15.83); PTB < 37, 34, and 32 weeks (OR 21.88, 95% CI 11.64-41.12; OR 11.67, 95% CI 5.25-25.91; OR 8.79, 95% CI 3.41-22.68); and CD (OR 4.82, 95% CI 2.81-8.27). CONCLUSION: Severe obstetric morbidity did not differ between singleton and multifetal gestations among gestational carrier pregnancies. However, multifetal gestation was associated with increased odds of neonatal morbidity, CD, and PTB. This information may be useful when counseling prospective gestational carriers and intended parents.

Obstetric morbidity in gestational carrier pregnancies: a population-based study.

PURPOSE: We sought to characterize severe obstetric morbidity among women who are gestational carriers compared to other patients. METHODS: This was a population-based study comparing gestational carrier pregnancies to non-surrogate pregnancies (non-surrogate IVF pregnancies, all non-gestational carrier pregnancies, and a cohort of matched controls) delivering in Utah between 2009 and 2018, using birth certificate data. Our primary outcome was a composite of severe morbidity, including death, ICU admission, eclampsia, HELLP syndrome, transfusion, and unplanned hysterectomy. Our secondary outcomes were cesarean delivery (CD) and hypertensive disorders of pregnancy. RESULTS: During the study period, 361 gestational carrier pregnancies and 509,015 other pregnancies resulted in live births. Severe morbidity was less common among gestational carrier pregnancies than IVF pregnancies (1.7% versus 5.5%, odds ratio [OR] 0.29, 95% confidence interval [CI] 0.12-0.70), but was not different when compared to all other pregnancies (1.0%, OR 1.61, 95% CI 0.72-3.60), or a cohort of matched controls (1.0%, OR 1.37, 95% CI 0.55-3.40). CD was less common among gestational carrier pregnancies than IVF pregnancies, but not different than all other pregnancies or matched controls. While frequency of hypertensive disorders of pregnancy was lower among gestational carrier pregnancies than IVF pregnancies, it was higher than all other women who delivered and comparable to matched controls. CONCLUSION: Severe obstetric morbidity is uncommon among gestational carrier pregnancies. Women who are gestational carriers are at lower risk of morbidity and CD than others who conceive through IVF and do not appear to be at increased risk compared to matched controls.