First and Second Stage Risk Factors Associated with Perineal Lacerations.

OBJECTIVE: To determine intrapartum factors associated with perineal laceration at delivery. METHODS: This was a planned secondary analysis of a multicenter randomized clinical trial of delayed versus immediate pushing among term nulliparous women in labor with neuraxial analgesia conducted in the United States. Intrapartum characteristics were extracted from the medical charts. The primary outcome was perineal laceration, defined as second degree or above, characterized at delivery in women participating in longer term pelvic floor assessments post-delivery. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, birth weight, and maternal age. RESULTS: Among the 941 women participating in the pelvic floor follow-up, 40.6% experienced a perineal laceration. No first stage labor characteristics were associated with perineal laceration, including type of labor or length of first stage. Receiving an amnioinfusion appeared protective of perineal laceration (adjusted odds ratio, 0.48; 95% confidence interval 0.26-0.91; P = 0.01). Second stage labor characteristics associated with injury were length of stage (2.01 h vs. 1.50 h; adjusted odds ratio, 1.36; 95% confidence interval 1.18-1.57; P < 0.01) and a prolonged second stage (adjusted odds ratio, 1.64; 95% confidence interval 1.06-2.56; P < 0.01). Operative vaginal delivery was strongly associated with perineal laceration (adjusted odds ratio, 3.57; 95% confidence interval 1.85-6.90; P < 0.01). CONCLUSION: Operative vaginal delivery is a modifiable risk factor associated with an increased risk of perineal laceration. Amnioinfusion appeared protective against injury, which could reflect a spurious finding, but may also represent true risk reduction similar to the mechanism of warm perineal compress.

Video Instruction for Pushing in the Second Stage: a randomized controlled trial.

BACKGROUND: The second stage of labor requires active patient engagement. Previous studies suggest that coaching can influence the second stage of labor duration. However, a standardized education tool has not been established, and patients face many barriers to accessing childbirth education before delivery. OBJECTIVE: This study aimed to investigate the effect of an intrapartum video pushing education tool on the second stage of labor duration. STUDY DESIGN: This was a randomized controlled trial of nulliparous patients with singleton pregnancies ≥37 weeks of gestation admitted for induction of labor or spontaneous labor with neuraxial anesthesia. Patients were consented on admission and block randomized in active labor to 1 of 2 arms in a 1:1 ratio. The study arm viewed a 4-minute video before the second stage of labor on what to anticipate in the second stage of labor and pushing techniques. The control arm received the standard of care: bedside coaching at 10 cm dilation from a nurse or physician. The primary outcome was second stage of labor duration. The secondary outcomes were birth satisfaction (using the Modified Mackey Childbirth Satisfaction Rating Scale), mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, and umbilical artery gases. Of note, 156 patients were needed to detect a 20% decrease in the second stage of labor duration with 80% power, 2-sided alpha level of .05, and 10% loss after randomization. Funding was provided by the Lucy Anarcha Betsy award from the division of clinical research at Washington University. RESULTS: Of 161 patients, 81 were randomized to standard of care, and 80 were randomized to intrapartum video education. Among these patients, 149 progressed to the second stage of labor and were included in the intention-to-treat analysis: 69 in the video group and 78 in the control group. Maternal demographics and labor characteristics were similar between groups. The second stage of labor duration was statistically similar between the video arm (61 minutes [interquartile range, 20-140]) and the control arm (49 minutes [interquartile range, 27-131]) (P=.77). There was no difference in mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, or umbilical artery gases between groups. Although the overall birth satisfaction score on the Modified Mackey Childbirth Satisfaction Rating Scale was similar between groups, patients in the video group rated their "level of comfort during birth" and "attitude of the doctors in birth" significantly higher or more positively than patients in the control group (P<.05 for both). CONCLUSION: Intrapartum video education was not associated with a shorter second stage of labor duration. However, patients who received video education reported a higher level of comfort and a more favorable perception of their physician, suggesting that video education may be a helpful tool to improve the birth experience.

Impact of pushing timing on occult injury of levator ani: secondary analysis of a randomized trial.

BACKGROUND: Evidence of detachment of the levator ani muscle system is seen more frequently in patients with pelvic floor disorders. It has been suggested that passive descent of the fetus before pushing could be used to decrease operative vaginal delivery and levator ani muscle injury. OBJECTIVE: This planned analysis aimed to determine whether immediate or delayed pushing was associated with an increased proportion of injury to the levator ani muscle system after the first delivery among nulliparous women. STUDY DESIGN: The Optimizing Management of the Second Stage study was a multicenter randomized trial. Nulliparous women with term pregnancies and neuraxial analgesia were randomly assigned at complete cervical dilation to either immediate pushing or delayed pushing for 1 hour. A subset of participants consented to longitudinal objective pelvic floor assessments: (1) during postpartum stay (initial), (2) at 6 weeks (postpartum 1), and (3) at 6 months (postpartum 2) with transperineal 3-dimensional ultrasound. Following the completion of all visits by all subjects, saved 3-dimensional ultrasound volumes were assessed in a masked fashion. The outcome was "occult" levator ani muscle injury on the right or left, defined as a widening of the attachment of the levator ani to its origin utilizing the levator-urethra gap measurement. Measurements and proportions were compared between the 2 groups by study visit using the χ2 test or Fisher exact test for categorical variables and the t test or Mann-Whitney U test for continuous variables as appropriate. RESULTS: Here, 941 of 2414 randomized subjects (39.0%) participated in the pelvic floor assessments: 452 in the immediate pushing group and 489 in the delayed pushing group. We obtained sonograms on 67%, 83%, and 77% of the pelvic floor assessment participants at the initial, postpartum 1, and postpartum-2 visits, respectively. Demographic and labor characteristics were comparable between the 2 groups; 94% of participants were non-Hispanic, and 50% of participants were Black. Levator ani muscle injury was noted in 77 participants (13.6%) at the initial visit, 99 (13.1%) at PP1, and 72 (10.6%) at PP2. There was no difference in injury between women in the immediate pushing group and women in the delayed pushing group. These findings did not change when the threshold (sensitivity) of levator ani muscle injury was adjusted to a less conservative measure. CONCLUSION: Among nulliparous women at term with neuraxial analgesia, the rates of occult levator ani muscle injury were not different between women undergoing immediate pushing and women undergoing delayed pushing in the second stage of labor. Further research efforts are needed to understand the development and potential prevention of subsequent pelvic floor disorders.

Cervical cancer risk and screening among women seeking assistance with basic needs.

BACKGROUND: In the United States, more than half of cervical cancers occur in women who are inadequately screened. Interventions to improve access to cervical cancer preventive care is critical to reduce health inequities. OBJECTIVE: This study aimed to evaluate the need for cervical cancer screening among women seeking assistance with basic needs and to assess best approaches to facilitate Papanicolaou test referral. STUDY DESIGN: This study is a secondary analysis of a randomized controlled trial of low-income female callers to 2-1-1 Missouri, a helpline for local health and social services. The need for cervical cancer screening was assessed. Callers were randomized to 1 of 3 arms, each providing a Papanicolaou test referral: verbal referral only, verbal referral and tailored print reminder, or verbal referral and navigator. The primary outcome was contacting a Papanicolaou test referral 1 month following intervention. Student t tests or Mann-Whitney U tests were used to analyze significant differences in continuous variables, whereas Fisher exact or χ2 tests were used for categorical variables. We stratified by number of unmet basic needs (0-1 vs ≥2) and compared success of contacting a Papanicolaou test referral among study groups (verbal referral vs tailored reminder vs navigator) using the Fisher exact test and χ2 test, respectively. Multivariate logistic regression was used to assess risk factors for nonadherence for Papanicolaou test at baseline and at 1 month follow-up, adjusting for race and ethnicity, age, insurance status, self-rated health, smoking, and study group. RESULTS: Among 932 female callers, 250 (26.8%) needed cervical cancer screening. The frequency of unmet basic needs was high, the most common being lack of money for unexpected expenses (91.2%) and necessities, such as food, shelter, and clothing (73.2%). Among those needing a Papanicolaou test, 211 women received screening referrals. Women in the navigator group (21 of 71, 29.6%) reported higher rates of contacting a Papanicolaou test referral than those exposed to verbal referral only (11/73, 15.1%) or verbal referral and tailored print reminder (9/67, 13.4%) (P=.03). Among 176 women with ≥2 unmet needs who received a Papanicolaou test referral, the provision of a navigator remained associated with contacting the referral (navigator [33.9%] vs verbal referral [17.2%] vs tailored reminder [10.2%]; P=.005). Assignment to the navigator group (adjusted odds ratio, 3.4; 95% confidence interval, 1.4-8.5) and nonwhite race (adjusted odds ratio, 2.0; 95% confidence interval, 1.5-2.8) were independent predictors of contacting a Papanicolaou test referral. CONCLUSION: Low-income women seeking assistance with basic needs often lack cervical cancer screening. Health navigators triple the likelihood that women will make contact with Papanicolaou test services, but most 2-1-1 callers still fail to schedule Papanicolaou testing despite assistance from navigators. Interventions beyond health navigators are needed to reduce cervical cancer disparities.

Is hormonal therapy after risk-reducing salpingo-oophorectomy associated with an increased risk of malignancy in pathogenic variant carriers?

OBJECTIVES: This study aimed to assess the association between hormone replacement therapy and the incidence of subsequent malignancies in patients who underwent risk-reducing salpingo-oophorectomy and had mutations predisposing them to Müllerian cancers. METHODS: This Institutional Review Board-approved retrospective study was performed at five academic institutions. Women were included if they were age 18-51 years, had one or more confirmed germline highly penetrant pathogenic variants, and underwent risk-reducing salpingo-oophorectomy. Patients with a prior malignancy were excluded. Clinicodemographic data were collected by chart review. Patients with no documented contact for one year prior to study termination were called to confirm duration of hormone use and occurrence of secondary outcomes. Hormone replacement therapy included any combination of estrogen or progesterone. RESULTS: Data were analyzed for 159 women, of which 82 received hormone replacement therapy and 77 did not. In both groups an average of 6 years since risk reduction had passed. The patients treated with hormone replacement therapy did not have a higher risk of subsequent malignancy than those not treated with hormone replacement therapy (6 out of 82 vs. 7 out of 77, P = .68). Patients who received hormone replacement therapy were younger than those who did not receive hormone replacement therapy (39.0 vs. 43.9 years, P < .01) and were more likely to have undergone other risk reductive procedures including mastectomy and/or hysterectomy, though this difference was not statistically significant (69.5% vs. 55.8%, P = .07). CONCLUSIONS: In this multi-institution retrospective study of data from patients with high-risk variant carriers who underwent risk-reducing salpingo-oophorectomy, there was no statistically significant difference in the incidence of malignancy between women who did and did not receive hormone replacement therapy.

A new definition of gestational hypertension? New-onset blood pressures of 130 to 139/80 to 89 mm Hg after 20 weeks of gestation.

BACKGROUND: Diagnostic criteria for hypertensive disorders in pregnancy have historically been based on the American Heart Association and American College of Cardiology's definition of hypertension, previously defined as a blood pressure of ≥140/90 mm Hg. With the recent redefinition of hypertension, blood pressures of 130 to 139/80 to 89 mm Hg are now considered abnormal. OBJECTIVE: In this study, we aimed to test whether the new-onset blood pressure elevations of 130 to 139/80 to 89 mm Hg after 20 weeks of gestation in previously normotensive women are associated with increased risk for adverse pregnancy outcomes, specifically the development of hypertensive disorders in pregnancy. STUDY DESIGN: We performed a retrospective cohort study at a single tertiary care center of all women who delivered singleton gestations after 20 weeks of gestation from January 01, 2014, to June 08, 2016. Normotensive patients were defined as having maximum blood pressure of <130/80 mm Hg before 20 weeks of gestation and no previous diagnosis of chronic hypertension. Patients who remained normotensive for the remainder of pregnancy were then compared with patients who developed new-onset blood pressure elevations of 130 to 139/80 to 89 mm Hg after 20 weeks of gestation before delivery admission. The primary outcome was the development of a hypertensive disorder in pregnancy at hospital admission or during delivery. Clinical outcomes were assessed using χ2 test and multivariable logistic regression. RESULTS: Of the 2090 normotensive women from our cohort who were analyzed, 1318 (63.0%) remained normotensive for their entire antenatal course before delivery admission and 772 (37.0%) had new-onset blood pressure elevations between 130 and 139/80 and 89 mm Hg. Women with new-onset blood pressure elevations between 130 and 139/80 and 89 mm Hg after 20 weeks of gestation have a significantly increased risk for developing a hypertensive disorder in pregnancy at admission or during delivery (adjusted relative risk, 2.41; 95% confidence interval, 2.02-2.85) including an almost 3-fold increased risk for preeclampsia with severe features, even after adjusting for confounders. There were no differences in other secondary obstetrical outcomes. CONCLUSION: Normotensive women with new-onset blood pressures elevations between 130 and 139/80 and 89 mm Hg after 20 weeks of gestation are more likely to experience hypertensive disorders in pregnancy and preeclampsia with severe features at or during their delivery hospitalization. These more modest blood pressure elevations may be an early indicator of disease and call into question our current blood pressure threshold for diagnosis of hypertensive disorders in pregnancy.

Association of abnormal first stage of labor duration and maternal and neonatal morbidity.

BACKGROUND: Contemporary guidelines for labor management do not characterize abnormal labor on the basis of maternal and/or neonatal morbidity. OBJECTIVE: In this study, we aimed to evaluate the association of abnormal duration of the first stage of term labor and the risk of maternal and neonatal morbidity. STUDY DESIGN: We conducted a retrospective analysis of prospectively collected data of all consecutive women admitted for delivery at a single center at ≥37 weeks and 0 to 7 days of gestation with singleton, nonanomalous, vertex infants from 2010 to 2015, who reached 10 cm cervical dilation. Multivariable logistic regression compared odds ratios for maternal and neonatal outcomes among women above and below the 90th, 95th, and 97th percentiles for first stage of labor duration. Receiver operating characteristic curves estimated the association between first stage of labor duration and maternal morbidity. Maternal morbidity was a composite of maternal fever, hemorrhage, transfusion, or endomyometritis; prolonged second stage of labor duration; and third- or fourth-degree perineal laceration. Neonatal morbidity was a composite of hypothermic therapy, need for mechanical ventilation, respiratory distress syndrome, meconium aspiration syndrome, birth injury or trauma, and neonatal seizure or sepsis. RESULTS: Of 6823 women included in this study, 682 were anticipated to have first stage of labor duration above the 90th percentile cutoff point, which was associated with an increased risk of composite maternal morbidity, maternal fever, postpartum transfusion, prolonged second stage of labor duration, third- or fourth-degree perineal laceration, and cesarean or operative vaginal delivery (P≤.02) and an increased risk of composite neonatal morbidity, respiratory distress syndrome, need for mechanical ventilation, and neonatal sepsis (P≤.03). Composite maternal morbidity was 2.2 (95% confidence interval, 1.8-2.7), 1.9 (95% confidence interval, 1.4-2.4), and 1.8 (95% confidence interval, 1.3-2.5) times more likely to occur among women above the 90th, 95th, and 97th percentile, respectively, for first stage of labor duration from 4 to 10 cm. Composite neonatal morbidity was 2.6 (95% confidence interval, 2.1-3.2), 2.2 (95% confidence interval, 1.7-2.9), and 1.9 (95% confidence interval, 1.3-2.8) times more likely to occur among infants delivered by women above the 90th, 95th, and 97th percentiles for first stage of labor duration from 4 to 10 cm. Receiver operating characteristic curves among all women from 4 to 10 cm and 6 to 10 cm, including when stratified by parity and type of labor onset, had an area under the curve of 0.51 to 0.62 and 0.53 to 0.71 for maternal and neonatal morbidity, respectively. Thus, duration of labor has moderate predictive ability, at best, for composite maternal or neonatal morbidity. No curve demonstrated a clear point at which adverse maternal or neonatal outcomes increased that could be used to define abnormal labor. CONCLUSION: The benefit of expectantly managing a prolonged first stage of labor with duration above the 90th percentile in anticipation of vaginal delivery must be weighed against the increased risk of composite maternal and neonatal morbidity. Risks associated with performing cesarean delivery as an alternative management for women with prolonged first stage of labor duration must also be considered.

Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial.

Importance: Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women. Objective: To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women. Design, Setting, and Participants: Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019. Interventions: Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808). Main Outcomes and Measures: The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions. Results: Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, -0.53%; 95% CI, -1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, -0.27%; 95% CI, -2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001). Conclusions and Relevance: Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery. Trial Registration: ClinicalTrials.gov Identifier: NCT03009110.

Continuous epidural infusion in gynecologic oncology patients undergoing exploratory laparotomy: The new standard for decreased postoperative pain and opioid use.

OBJECTIVE: To compare the incidence of postoperative complications and opioid pain medication usage in gynecologic oncology patients who did and did not receive an epidural prior to undergoing exploratory laparotomy. METHODS: Retrospective cohort study of all patients undergoing exploratory laparotomy with the gynecologic oncology division at Washington University in St Louis between January 2012 and October 2015. Data on demographics, pathology, postoperative pain and opioid use, and incidence of postoperative complications were collected. RESULTS: Five hundred and sixty-one patients underwent laparotomy, 305 with an epidural and 256 without. Patients with an epidural used significantly less hydromorphone in the post-anesthesia care unit (PACU) (p = 0.003) and on postoperative day (POD)#1 (p = 0.05), less total opioids on POD#0 (p < 0.01), and more non-opioid pain medication on POD#1-3 (p < 0.01). Patients with an epidural had lower pain scores in the PACU (p = 0.01), on POD#0 (p < 0.01), POD#1 (p < 0.01), and POD#3 (p = 0.03). Patients with epidurals had shorter hospital length of stay (p < 0.01), no difference in hospital readmission or incidence of venous thromboembolism up to 90 days postoperatively, longer duration of Foley catheter (20.4 vs 10.3 h, p = 0.02) with no difference in postoperative urinary tract infection, higher incidence of postoperative hypotension (63% vs 36.3%, p < 0.01), and lower incidence of wound complications (5% vs 14.1%, p < 0.01). CONCLUSIONS: Perioperative epidurals used in patients undergoing major abdominal surgery correlate with decreased postoperative opioid use, increased use of non-opioid pain medications, and improved pain relief postoperatively with acceptable postoperative risks and should be standard of care for these patients.

First stage of labor progression in women with large-for-gestational age infants.

BACKGROUND: Women with suspected large-for-gestational age fetuses have higher rates of dysfunctional labor and labor arrest diagnoses and, consequently, higher rates of cesarean deliveries. The identification of the factors that significantly affect labor progression of women with large-for-gestational age infants may better inform expected duration of labor for certain subgroups of this population. OBJECTIVE: Because the standards for the first stage of labor when large-for-gestational age is present have not been defined clearly, the present study aims to evaluate labor progress of women with large-for-gestational age infants who complete the first stage of labor after 3-cm cervical dilation. STUDY DESIGN: We conducted a retrospective cohort study of patients who were admitted for labor from 2004-2014 with a term vertex singleton who achieved 10-cm cervical dilation. Labor curves were constructed with repeated measures regression and were compared between patients who delivered large-for-gestational age infants (actual birthweight, >90th percentile for gestational age) and those who delivered appropriate-for-gestational age infants (actual birthweight, 10-90th percentile for gestational age). Interval-censored regression estimated median duration of labor after 3-cm cervical dilation stratified by actual infant birthweight and further stratified by parity (nulliparity vs multiparity), labor onset (spontaneous [augmented and not augmented] and induced labor), pregestational diabetes mellitus or gestational diabetes mellitus status, and maternal body mass index (obese, ≥30 kg/m2 vs not obese, <30 kg/m2). Multivariate analysis adjusted for confounding factors that were identified by bivariate analysis. RESULTS: Among all 17,097 women who were included, 15,843 women (92.7%) had appropriate-for-gestational age infants; 1254 women (7.3%) had large-for-gestational age infants, of whom 387 (30.9%) were nulliparous; 464 women (37.0%) underwent induction of labor; 863 women (68.8%) were obese, and 158 women (12.6%) had diabetes mellitus or gestational diabetes mellitus. Women with large-for-gestational age infants had a slower progression from 3- to 10-cm cervical dilation compared with those with appropriate-for-gestational age infants (median, 8.57 hours [5th, 95th percentile, 2.95, 24.86] vs 6.46 hours [5th, 95th percentile, 2.23, 18.74]; P<.01). In the large-for-gestational age group, dilation from 6-10 cm progressed slower in nulliparous compared with multiparous women (3.28 hours [5th, 95th percentile, 0.71, 15.16] vs 2.03 hours [5th, 95th percentile, 0.44, 9.39]; P<.01) and in obese compared with not obese women (2.36 hours [5th, 95th percentile, 0.51, 10.91] vs 1.79 hours [5th, 95th percentile, 0.39, 8.31]; P<.01). Labor curves did not differ between large-for-gestational age and appropriate-for-gestational age groups when stratified by labor onset (nonaugmented spontaneous labor vs induced labor) or the presence of diabetes mellitus or gestational diabetes mellitus. CONCLUSION: After 3-cm cervical dilation, the time required to reach the second stage of labor is greater in women with large-for-gestational age infants compared with those with appropriate-for-gestational age infants; these differences are most pronounced in nulliparous and obese women with large-for-gestational age infants in the active phase of labor (6-10 cm). Among women with large-for-gestational age infants, labor onset and presence of diabetes mellitus or gestational diabetes mellitus have no apparent effect on the duration of the first stage of labor after 3-cm cervical dilation.

The transition from latent to active labor and adverse obstetrical outcomes.

BACKGROUND: Recommendations on preventing primary cesarean delivery removed the previously defined time limits for latent labor (defined as ending at 6 cm) and urged clinicians to avoid cesarean delivery for labor abnormalities in the latent phase. However, relatively little is known about the implications of labor curve abnormalities from 4 to 6 cm and subsequent outcomes. OBJECTIVE: To examine the association between length of time for dilation from 4 to 6 cm, delivery outcomes, and maternal and neonatal morbidity. STUDY DESIGN: This is a secondary analysis of a prospective cohort study of patients at ≥37 weeks presenting in spontaneous or induced labor with a nonanomalous living singleton in vertex presentation. Patients with a history of cesarean delivery or who did not achieve 6-cm dilation were excluded. We used interval censored regression to determine the 90th percentile for dilation time from 4 to 6 cm and used logistic regression to estimate the odds ratios and 95% confidence intervals for adverse outcomes for patients above this cutoff percentile compared with those at or below. Analyses were adjusted for obesity, nulliparity, race, hypertension, diabetes, and type of labor (induced vs spontaneous/augmented). Outcomes included cesarean delivery, maternal morbidity (composite of postpartum fever, wound infection, hemorrhage), and neonatal morbidity (composite of neonatal death, hypothermic therapy, mechanical ventilation, respiratory distress, meconium aspiration syndrome, seizure, or treatment of sepsis). In addition, we created receiver operator characteristic curves to predict cesarean delivery, and maternal and neonatal morbidity based on time to dilate from 4 to 6 cm. The cutoff for time for each outcome was identified using the Youden index to maximize sensitivity and specificity, and test characteristics were computed. RESULTS: There were 7355 patients eligible for analysis, 728 (10%) had dilation times from 4 to 6 cm >10.3 hours, which was the 90th percentile, and 6627 (90%) had dilation times ≤10.3 hours. Having dilation time from 4 to 6 cm above the 90th percentile (10.3 hours) was associated with cesarean delivery (adjusted odds ratio, 2.05; 95% confidence interval, 1.67-2.52), composite maternal morbidity (adjusted odds ratio, 1.48; 95% confidence interval, 1.10-2.00), and composite neonatal morbidity (adjusted odds ratio 1.92; 95% confidence interval 1.52-2.4). The area under the receiver operator characteristic curve for predicting cesarean delivery was 0.73 (95% confidence interval, 0.71-0.75). The test characteristics for the cutoff of 9.75 hours were sensitivity 68.3% (95% confidence interval, 64.8%-71.7%), specificity 66.2% (95% confidence interval, 55.0%-67.3%), positive predictive value 18.5% (95% confidence interval, 17.1%-20.0%), and negative predictive value 94.9% (95% confidence interval, 94.2%-95.5%). For composite maternal morbidity, the cutoff was 6.98 hours and the area under the curve was 0.62 (95% confidence interval, 0.59-0.65), whereas for composite neonatal morbidity it was 5.5 hours (area under the curve 0.69; 95% confidence interval, 0.67-0.71). CONCLUSIONS: Patients whose dilation time from 4 to 6 cm exceeds the 90th percentile have increased odds of cesarean delivery and postpartum complications. Prolonged dilation time has moderate predictive ability for adverse outcomes. Future studies should investigate at what point, if any, intervention is warranted during this period to reduce these risks.

Normal Cervical Effacement in Term Labor.

OBJECTIVE: To estimate the natural history of cervical effacement in labor. STUDY DESIGN: This is a retrospective cohort study of term, vertex, singletons who reached 10 cm of cervical dilation from 2010 to 2014. Interval-censored regression was used to estimate the median number of hours between changes in effacement (measured in centimeters of the residual cervix) and to estimate the median effacement at a given cervical dilation. Analysis was stratified by parity and labor type. RESULTS: In total, 7,319 patients were included. Multiparas had faster effacement from 1 cm to complete effacement than nulliparas, but nulliparas were significantly more effaced at each cervical dilation. Patients in spontaneous labor had faster effacement and were significantly more effaced at each centimeter of cervical dilation than those who were induced or augmented. Once active labor was established (>6 cm of cervical dilation), 95% of patients had an effacement of 1 cm or less. By 8 cm of cervical dilation, 50% of all patients were completely effaced. CONCLUSION: There is a wide range in the normal length of time for the progression of cervical effacement. However, once a patient is in active labor, 95% of patients have effaced to 1 cm or less.

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.

Effect of endometrial mechanical stimulation in an unselected population undergoing in vitro fertilization: futility analysis of a double-blind randomized controlled trial.

PURPOSE: Implantation failure is a major limiting factor of successful in vitro fertilization (IVF). The objective of this study was to determine if endometrial mechanical stimulation (EMS) by endometrial biopsy in the luteal phase of the cycle prior to embryo transfer (ET) improves clinical outcomes in an unselected subfertile population. METHODS: Double-blind, randomized controlled trial of EMS versus sham biopsy and odds of clinical pregnancy after IVF and embryo transfer. Secondary outcomes included spontaneous miscarriage and live birth. RESULTS: One hundred women enrolled and were randomized from 2013 to 2017. Enrollment was terminated after futility analysis showed no difference in clinical pregnancy between EMS versus control, 47.2% vs 61.7% (OR 0.55, 95% CI 0.25-1.23, p = 0.15). There were no significant differences between women who underwent EMS and those who did not in terms of positive pregnancy test 54.7% vs 63.8% (OR 0.69, 95% CI 0.31-1.53, p = 0.36), miscarriage 7.5% vs 2.1% (OR 3.76 95% CI 0.41-34.85, p = 0.22), or live birth 43.4% vs 61.7% (OR 0.48 95% CI 0.21-1.06, p = 0.07). CONCLUSIONS: EMS in the luteal phase of the cycle preceding embryo transfer does not improve clinical outcomes in an unselected subfertile population and may result in a lower live birth rate. We caution the routine use of EMS in an unselected population.

Correction to: Effect of endometrial mechanical stimulation in an unselected population undergoing in vitro fertilization: futility analysis of a double-blind randomized controlled trial.

The original version of this article unfortunately contained mistakes. The complete list of corrections is given below.

Preoperative Factors That Predict the Need to Morcellate in Total Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To determine which preoperative factors best predict the need for uterine morcellation at the time of total laparoscopic hysterectomy (TLH) and to identify cut-offs that can help guide clinical decision-making. DESIGN: Retrospective cohort (Canadian Task Force classification II). SETTING: Tertiary care center. PATIENTS: Women (n = 420) who underwent TLH between July 2012 and June 2015: 223 cases without and 197 cases with morcellation. INTERVENTIONS: Laparoscopic hysterectomies with either laparoscopic power, vaginal, or open morcellation via mini-laparotomy were analyzed. MEASUREMENTS AND MAIN RESULTS: Preoperative factors assessed included uterine volume, cross-sectional area, length, size of largest leiomyoma, and bimanual exam. Receiver operator curves (ROC) were used to establish cut-offs that maximized sensitivity and specificity for each factor. Bivariate and multivariate Poisson regression analyses were used to calculate relative risks associated with these objective cut-offs. ROC curves demonstrated maximized sensitivities and specificities with a cross-sectional area of 48.6 cm2, largest leiomyoma dimension of 4.4 cm, bimanual exam of 11.5 weeks, and uterine volume of 262 mL. Multivariate Poisson regression analysis revealed that the strongest predictors of morcellation were cross-sectional area (adjusted relative risk, 2.94; 95% confidence interval, 1.20-7.19), largest leiomyoma diameter (adjusted relative risk, 2.06; 95% confidence interval, 1.24-3.41), and bimanual exam (adjusted relative risk, 1.88; 95% confidence interval, 1.05-3.37). CONCLUSION: Uterine cross-sectional area, largest leiomyoma dimension, and uterine size on bimanual exam can all be used to predict the need to morcellate at the time of TLH.

Epidurals and the Modern Labor Curve: How Epidural Timing Impacts Fetal Station during Active Labor.

OBJECTIVE: The objective of this study was to estimate epidural timing's impact on fetal station during active labor. STUDY DESIGN: This secondary analysis of a single-institution prospective cohort study included all term singleton pregnancies, stratified by parity. Those with early epidurals (placed at <6 cm) were compared with those with late epidurals (placed at ≥6 cm). The primary outcome was median fetal station from 6 to 10 cm. Secondary outcomes included rate of prolonged first or second stage of labor (>95%). Multivariable logistic regression adjusted for labor type. RESULTS: Among 7,647 women, 3,434 were nulliparous (2,983 with early epidurals and 451 with late epidurals) and 4,213 multiparous (3,141 with early epidurals and 1,072 with late epidurals). Interquartile ranges (IQRs) suggested fetal station at 6 cm was likely lower among those with early epidurals (nulliparous: median head station -1 [IQR: -1 to 0] for early epidural vs. -1 [IQR: -2 to 0] for late epidural, p < 0.01; multiparous: -1 (IQR: -2 to 0] for early epidural vs. -1 [IQR: -3 to -1] for late epidural, p < 0.01). Early epidurals were not associated with increased risk of prolonged first stage, but among nulliparous were associated with decreased risk of prolonged second stage (adjusted odds ratio: 0.66 [95% confidence interval: 0.44-0.99]). CONCLUSION: Early epidurals were associated with lower fetal station in active labor but not prolonged first stage.

Spontaneous Labor Onset and Outcomes in Obese Women at Term.

OBJECTIVE: The objective of this study was to compare the rates of spontaneous labor onset and its progression in obese and nonobese women after 37 weeks. STUDY DESIGN: We performed a secondary analysis of a retrospective cohort of all women who were admitted for delivery at ≥ 37 weeks of gestation at a university-based tertiary care center between 2004 and 2010. The cohort was stratified by weeks of gestation at which the patient presented for delivery. The rates of spontaneous labor, vaginal delivery, and augmentation with oxytocin were compared between obese (body mass index [BMI] ≥ 30) and nonobese (BMI < 30) women. RESULTS: Obese women had lower rates of spontaneous labor than nonobese women at every gestational week (37 weeks, 6.1 vs. 9.3%, p < 0.001; 38 weeks, 12.8 vs. 19.2%, p < 0.001; 39 weeks 26.0 vs. 37.0%, p < 0.001; 40 weeks, 39.6 vs. 50.2%, p < 0.001; 41 weeks, 30.8 vs. 38.0%, p < 0.012). Among women who presented in spontaneous labor, obesity was associated with higher rates of augmentation with oxytocin and lower rates of vaginal delivery. CONCLUSION: Obese women at or beyond 37 weeks are less likely to experience spontaneous labor compared with nonobese women. In addition, obese women presenting in spontaneous labor are less likely that nonobese women to have a vaginal delivery at 37 to 40 weeks, even after oxytocin augmentation.

Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial.

Importance: It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities. Objective: To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities. Design, Setting, and Participants: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018. Interventions: Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes. Main Outcomes and Measures: The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes. Results: Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P < .001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P < .001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P = .005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P = .03). Conclusions and Relevance: Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02137200.