Treatment for Mild Chronic Hypertension during Pregnancy.

BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).

The effect of digital health interventions on postpartum depression or anxiety: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This study aimed to examine the effect of digital health interventions compared with treatment as usual on preventing and treating postpartum depression and postpartum anxiety. DATA SOURCES: Searches were conducted in Ovid MEDLINE, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. STUDY ELIGIBILITY REQUIREMENTS: The systematic review included full-text randomized controlled trials comparing digital health interventions with treatment as usual for preventing or treating postpartum depression and postpartum anxiety. STUDY APPRAISAL AND SYNTHESIS METHODS: Two authors independently screened all abstracts for eligibility and independently reviewed all potentially eligible full-text articles for inclusion. A third author screened abstracts and full-text articles as needed to determine eligibility in cases of discrepancy. The primary outcome was the score on the first ascertainment of postpartum depression or postpartum anxiety symptoms after the intervention. Secondary outcomes included screening positive for postpartum depression or postpartum anxiety --as defined in the primary study --and loss to follow-up, defined as the proportion of participants who completed the final study assessment compared with the number of initially randomized participants. For continuous outcomes, the Hedges method was used to obtain standardized mean differences when the studies used different psychometric scales, and weighted mean differences were calculated when studies used the same psychometric scales. For categorical outcomes, pooled relative risks were estimated. RESULTS: Of 921 studies originally identified, 31 randomized controlled trials-corresponding to 5532 participants randomized to digital health intervention and 5492 participants randomized to treatment as usual-were included. Compared with treatment as usual, digital health interventions significantly reduced mean scores ascertaining postpartum depression symptoms (29 studies: standardized mean difference, -0.64 [95% confidence interval, -0.88 to -0.40]; I2=94.4%) and postpartum anxiety symptoms (17 studies: standardized mean difference, -0.49 [95% confidence interval, -0.72 to -0.25]; I2=84.6%). In the few studies that assessed screen-positive rates for postpartum depression (n=4) or postpartum anxiety (n=1), there were no significant differences between those randomized to digital health intervention and treatment as usual. Overall, those randomized to digital health intervention had 38% increased risk of not completing the final study assessment compared with those randomized to treatment as usual (pooled relative risk, 1.38 [95% confidence interval, 1.18-1.62]), but those randomized to app-based digital health intervention had similar loss-to-follow-up rates as those randomized to treatment as usual (relative risk, 1.04 [95% confidence interval, 0.91-1.19]). CONCLUSION: Digital health interventions modestly, but significantly, reduced scores assessing postpartum depression and postpartum anxiety symptoms. More research is needed to identify digital health interventions that effectively prevent or treat postpartum depression and postpartum anxiety but encourage ongoing engagement throughout the study period.

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.

Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial.

BACKGROUND: Cesarean delivery is the most performed major surgery among women, and surgical-site infections following a cesarean delivery are a significant source of postoperative morbidity. It is unclear if vaginal cleansing before a cesarean delivery decreases post-cesarean delivery infectious morbidity. OBJECTIVE: This study aimed to evaluate if preoperative vaginal cleansing with povidone-iodine among women undergoing a cesarean delivery after labor decreases postoperative infectious morbidity. STUDY DESIGN: This randomized clinical trial was conducted from August 3, 2015 to January 28, 2021, with 30 days of follow-up and the final follow-up completed on February 27, 2021. Patients met the inclusion criteria if they underwent a cesarean delivery after regular contractions with cervical dilation, rupture of membranes, or any cesarean delivery performed at >4 cm dilation. Participants were randomly assigned in a 1:1 ratio to either abdominal cleansing plus vaginal cleansing with 1% povidone-iodine or abdominal cleansing alone. The primary outcome was composite infectious morbidity including surgical-site infection, fever, endometritis, and wound complications within 30 days after the cesarean delivery. Secondary outcomes included individual components of the composite, length of hospital stay, postoperative hospitalization or outpatient treatment related to infectious morbidity, and empirical treatment for neonatal sepsis. RESULTS: A total of 608 subjects (304 vaginal cleansing group, 304 control group) were included in the intention-to-treat analysis. Patient characteristics were similar between groups. There was no significant difference in the primary composite outcome between the 2 groups (11.8% vs 11.5%; P=.90; relative risk, 1.0; 95% confidence interval, 0.7-1.6). Individual components of the composite and secondary outcomes were also not significantly different between the groups. Similar findings were observed in the as-treated analysis (11.3% vs 11.8%; P=.9; relative risk, 1.0; 95% confidence interval, 0.7-1.6). CONCLUSION: Vaginal cleansing with povidone-iodine before an unscheduled cesarean delivery occurring after labor did not reduce the postoperative infectious morbidity. These findings do not support the routine use of vaginal cleansing for women undergoing a cesarean delivery after labor.

Considering Criteria for Active Phase Labor Management of Nulliparous Women: A Cost-Effectiveness Analysis.

OBJECTIVE: The aim of the study is to evaluate differences in maternal and neonatal outcomes based on updated criteria for defining active labor at 6 cm of cervical dilation and to determine if these recommendations are cost-effective. STUDY DESIGN: A decision-analytic model was built using TreeAge Pro 2020 software. We included maternal outcomes of mode of delivery, endometritis, postpartum hemorrhage requiring transfusion, and death. Neonatal outcomes included rates of shoulder dystocia and permanent brachial plexus injury. Costs and quality-adjusted life years (QALYs) were included from the maternal and infant perspectives. We used a willingness-to-pay threshold of $100,000 per QALY and all model inputs were subjected to sensitivity analysis. RESULTS: In a theoretical cohort of 1.4 million women, a threshold of 6 cm to define active labor resulted in 373,668 fewer cesarean deliveries, 33,181 fewer cases of endometritis, 143 fewer postpartum hemorrhages requiring transfusions, and seven fewer maternal deaths when compared with a threshold of 4 cm. However, there were higher rates of adverse neonatal outcomes, including 484 more cases of shoulder dystocia and 17 more instances of permanent brachial plexus injury. Using 6 cm as the threshold resulted in lower costs and greater effectiveness, making it a dominant strategy. Multivariate sensitivity analysis demonstrated the model was robust over a wide range of assumptions. CONCLUSION: In this model, considering 6 cm of cervical dilation as the threshold for the active phase of labor compared with 4 cm was a cost-effective strategy to prevent primary cesarean deliveries, lower costs, and improve maternal outcomes, despite associated increased adverse neonatal outcomes. KEY POINTSG: · Cervical dilation of 6 cm should be considered the threshold for the active phase of labor. This is a change from the prior definition of 4 cm.. · We built a theoretical model to compare outcomes and costs associated with the new active phase definition of 6 cm.. · Using a 6-cm threshold is a cost-effective strategy for decreasing primary cesarean deliveries..

Obstetric Outcomes in Singleton Pregnancies with Abnormal Placental Cord Insertions.

OBJECTIVE: There is wide variation in the management of pregnancies complicated by abnormal placental cord insertion (PCI), which includes velamentous cord insertion (VCI) and marginal cord insertion (MCI). We tested the hypothesis that abnormal PCI is associated with small for gestational age (SGA) infants. STUDY DESIGN: This is a retrospective cohort study of all pregnant patients undergoing anatomic ultrasound at a single institution from 2010 to 2017. Patients with abnormal PCI were matched in a 1:2 ratio by race, parity, gestational age at the time of ultrasound, and obesity to patients with normal PCIs. The primary outcome was SGA at delivery. Secondary outcomes were cesarean delivery, preterm delivery, cesarean delivery for nonreassuring fetal status, 5-minute Apgar score < 7, umbilical artery pH < 7.1, and neonatal intensive care unit admission. These outcomes were compared using univariate and bivariate analyses. RESULTS: Abnormal PCI was associated with an increased risk of SGA (relative risk [RR]: 2.43; 95% confidence interval [CI]: 1.26-4.69), increased risk of preterm delivery <37 weeks (RR: 3.60; 95% CI: 1.74-7.46), and <34 weeks (RR: 3.50; 95% CI: 1.05-11.63) compared with patients with normal PCI. There was no difference in rates of cesarean delivery, Apgar score of <7 at 5 minutes, acidemia, or neonatal intensive care unit admission between normal and abnormal PCI groups. In a stratified analysis, the association between abnormal PCI and SGA did not differ by the type of abnormal PCI (p for interaction = 0.46). CONCLUSION: Abnormal PCI is associated with an increased risk of SGA and preterm delivery. These results suggest that serial fetal growth assessments in this population may be warranted. KEY POINTS: · Abnormal PCI is associated with SGA infants and preterm birth.. · If an abnormal PCI is identified, the provider should consider serial growth ultrasounds.. · There is no difference in obstetric outcomes between VCI and MCI..

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.

Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.

OBJECTIVE: This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. STUDY DESIGN: A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. RESULTS: Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. CONCLUSION: Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. KEY POINTS: · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..

Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial.

OBJECTIVE: Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. STUDY DESIGN: This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. RESULTS: The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. CONCLUSION: IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. KEY POINTS: · IV iron decreases rates of anemia on admission for delivery compared with oral iron.. · In an unblinded randomized trial, a significant proportion of patients preferred alternate therapy.. · Future RCTs should incorporate double-blinded technique to reduce risk of patient crossover.. · Results from feasibility trial support a larger RCT comparing IV to oral iron for IDA in pregnancy..

Anatomical Survey Versus Fetal Echocardiograms for Diagnosis of Cardiac Defects with a Single Umbilical Artery Cases: A Retrospective Cohort Study and Diagnostic Meta-analysis.

OBJECTIVE: To determine the utility of fetal echocardiography in diagnosing cardiac defects in fetuses with a single umbilical artery (SUA). METHODS: A retrospective cohort study of prenatally diagnosed SUA was conducted over a 10-year period at a single institution. Cardiac anatomy on detailed anatomical survey was compared with fetal echocardiogram for fetuses with prenatally diagnosed SUA. A diagnostic meta-analysis of studies comparing fetal anatomical survey to fetal echocardiogram in fetuses with SUA between 2010 to 2019 was also performed. RESULTS: Three hundred and twenty fetuses with SUA were identified, 113 of which had completed both ultrasound and echocardiography. There were 36 cases of cardiac defects on prenatal echocardiogram and all had abnormal anatomical ultrasounds. There were zero cases of abnormal cardiac exams (0%) when the cardiac views on anatomical survey were normal. The sensitivity, specificity, positive predictive value and negative predictive value of ultrasound were 100%, 77%, 73% and 100%, respectively. A summary ROC curve demonstrated a high predictive value of routine anatomic survey for cardiac defects (AUC: 0.99). CONCLUSION: Anatomic survey is highly predictive in the detection of cardiac defects in fetuses with SUA. Fetal echocardiogram is unnecessary in SUA when cardiac views are normal on ultrasound.

Obesity, Second Stage Duration, and Labor Outcomes in Nulliparous Women.

OBJECTIVE: This study aimed to estimate second stage duration and its effects on labor outcomes in obese versus nonobese nulliparous women. STUDY DESIGN: This was a secondary analysis of a cohort of nulliparous women who presented for labor at term and reached complete cervical dilation. Adjusted relative risks (aRR) were used to estimate the association between obesity and second stage characteristics, composite neonatal morbidity, and composite maternal morbidity. Effect modification of prolonged second stage on the association between obesity and morbidity was assessed by including an interaction term in the regression model. RESULTS: Compared with nonobese, obese women were more likely to have a prolonged second stage (aRR: 1.48, 95% CI: 1.18-1.85 for ≥3 hours; aRR: 1.65, 95% CI: 1.18-2.30 for ≥4 hours). Obesity was associated with a higher rate of second stage cesarean (aRR: 1.78, 95% CI: 1.34-2.34) and cesarean delivery for fetal distress (aRR: 2.67, 95% CI: 1.18-3.58). Obesity was also associated with increased rates of neonatal (aRR: 1.38, 95% CI: 1.05-1.80), but not maternal morbidity (aRR: 1.06, 95% CI: 0.90-1.25). Neonatal morbidity risk was not modified by prolonged second stage. CONCLUSION: Obesity is associated with increased risk of neonatal morbidity, which is not modified by prolonged second stage of labor.

The duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content.

BACKGROUND: Maternal oxygen (O2) administration is a commonly performed intrauterine resuscitation technique though to improve fetal oxygenation. However, hyperoxygenation is known to be harmful in both neonates and adults. Currently, there are no formal recommendations on whether a certain dose or duration of O2 may be most helpful in improving umbilical cord gases or neonatal outcomes. OBJECTIVE: We tested the hypothesis that prolonged supplemental O2 exposure during labor is associated with increased umbilical cord O2 concentrations. STUDY DESIGN: This was a planned secondary analysis of a randomized noninferiority trial comparing O2 with room air in laboring patients. Patients were randomized to receive either 10 L/min O2 or room air at any point during active labor when they developed a category II fetal heart tracing that would otherwise require resuscitation. The primary outcome variable for this analysis was partial pressure of O2 in the umbilical vein. The secondary outcome variable was partial pressure of O2 in the umbilical artery. These outcome variables were compared between patients with short durations of O2 exposure and those with long durations of O2 exposure, defined as <75th percentile and ≥75th percentile of duration, respectively. The outcomes were also compared among the groups that received room air, O2 for short durations, and O2 for long durations. RESULTS: Among the 99 patients with paired and validated cord gases who were included in this analysis, the partial pressure of O2 in the umbilical vein was significantly lower in patients who received O2 supplementation for longer durations than in those who received O2 for shorter durations (median interquartile range 25.5 [21.5-33] vs 32.5 [26.5-37.5] mm Hg; P<.03). There was no difference in the partial pressure of O2 in the umbilical artery or other cord gases between the short and long duration O2 supplementation groups. Other methods of intrauterine resuscitation were similar between the short and long duration O2 supplementation groups. There was no difference in the partial pressure of O2 in the umbilical artery or in the umbilical vein when the room air, short duration O2 supplementation, and long duration O2 supplementation groups were compared. CONCLUSION: Longer durations of O2 exposure are not associated with a higher partial pressure of O2 in the umbilical cord. In fact, patients with longer durations of O2 exposure had lower partial pressure of O2 in the umbilical vein, suggesting impaired placental O2 transfer with prolonged O2 exposure.

The effect of intrapartum oxygen supplementation on category II fetal monitoring.

BACKGROUND: Maternal oxygen administration is a widely used intrauterine resuscitation technique for fetuses with category II electronic fetal monitoring patterns, despite a paucity of evidence on its ability to improve electronic fetal monitoring patterns. OBJECTIVE: This study investigated the effect of intrapartum oxygen administration on Category II electronic fetal monitoring patterns. STUDY DESIGN: This is a secondary analysis of a randomized trial conducted in 2016-2017, in which patients with fetuses at ≥37 weeks' gestation in active labor with category II electronic fetal monitoring patterns were assigned to 10 L/min of oxygen by face mask or room air until delivery. Trained obstetrical research nurses blinded to allocation extracted electronic fetal monitoring data. The primary outcome was a composite of high-risk category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia, or minimal variability 60 minutes after randomization to room air or oxygen. Secondary outcomes included individual components of the composite high-risk category II features, resolution of recurrent decelerations within 60 minutes of randomization, and total deceleration area. The outcomes between the room air and oxygen groups were compared using univariable statistics. Time-to-event analysis was used to compare time to resolution of recurrent decelerations between the groups. Paired analysis was used to compare the pre- and postrandomization outcomes within each group. RESULTS: All 114 randomized patients (57 room air and 57 oxygen) were included in this analysis. There was no difference in resolution of recurrent decelerations within 60 minutes between the oxygen and room air groups (75.4% vs 86.0%; P=.15). The room air and oxygen groups had similar rates of composite high-risk category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia, and minimal variability 60 minutes after randomization. Time to resolution of recurrent decelerations and total deceleration area were similar between the room air and oxygen groups. Among patients who received oxygen, there was no difference in the electronic fetal monitoring patterns pre- and postrandomization. Similar findings were observed in the electronic fetal monitoring patterns pre- and postrandomization in room air patients. CONCLUSION: Intrapartum maternal oxygen administration for category II electronic fetal monitoring patterns did not resolve high-risk category II features or hasten the resolution of recurrent decelerations. These results suggest that oxygen administration has no impact on improving category II electronic fetal monitoring patterns.

Predictive Value of Midtrimester Universal Cervical Length Screening Based on Parity.

OBJECTIVES: To evaluate the effect of parity on performance characteristics of midtrimester cervical length (CL) in predicting spontaneous preterm birth (sPTB) before 37 weeks. METHODS: This was a retrospective cohort study of 13,508 women with no history of sPTB undergoing universal transvaginal CL screening at 17 to 23 weeks' gestation from 2011 to 2016. Patients who declined screening or with unknown delivery outcomes were excluded. Areas under the receiver operator characteristic curves were used to assess and compare the predictive ability of CL screening for sPTB. The sensitivity, specificity, and positive and negative predictive values were estimated for specific CL cutoffs for prediction of sPTB. RESULTS: There were 20,100 patients, of whom 2087 (10%) declined screening and 4505 (22%) did not meet inclusion criteria. Of the remaining 13,508 patients, 43% were nulliparous. The incidence rates of sPTB were 6.5% in nulliparas and 4.9% in multiparas (P < .001). The mean CLs were 39.9 mm in nulliparas and 41.8 mm in multiparas (P < .001), and those of the first percentiles were 19.0 mm in nulliparas and 24.0 mm in multiparas. Cervical length was significantly more predictive of sPTB in nulliparas (area under the curve, 0.67; 95% confidence interval, 0.63-0.70; versus 0.61, 95% confidence interval, 0.57-0.63; P = .008). At CL cutoffs of 10, 15, 20, and 25 mm or less, the sensitivity was lower in multiparas, and the specificity was comparable between the groups. CONCLUSIONS: Midtrimester CL is less predictive of sPTB in multiparas compared to nulliparas. The poor predictive ability, especially in multiparas, calls into question the value of universal CL screening in this population.

Electronic Fetal Monitoring and Neonatal Outcomes when a Nuchal Cord Is Present at Delivery.

OBJECTIVE: This study aimed to determine the association between nuchal cord, electronic fetal monitoring parameters, and adverse neonatal outcomes. STUDY DESIGN: This was a prospective cohort study of 8,580 singleton pregnancies. Electronic fetal monitoring was interpreted, and patients with a nuchal cord at delivery were compared with those without. The primary outcome was a composite neonatal morbidity index. Logistic regression was used to adjust for confounders. RESULT: Of 8,580 patients, 2,071 (24.14%) had a nuchal cord. There was no difference in the risk of neonatal composite morbidity in patients with or without a nuchal cord (8.69 vs. 8.86%; p = 0.81). Nuchal cord was associated with category II fetal heart tracing and operative vaginal delivery (OVD) (6.4 vs. 4.3%; p < 0.01). CONCLUSION: Nuchal cord is associated with category II electronic fetal monitoring parameters, which may drive increased rates of OVD. However, there is no significant association with neonatal morbidity.

Acidemia Can Occur Despite Category I Tracing.

OBJECTIVE: Electronic fetal monitoring (EFM) is intended to assess fetal well-being during labor. Our objective was to test the hypothesis that findings of a category I tracing at any time in the 60 minutes prior to delivery would rule out neonatal acidemia. STUDY DESIGN: This was a planned secondary analysis of a single-center prospective cohort study of 8,580 singleton pregnancies undergoing labor with nonanomalous infants at term. Monitoring was reviewed by obstetric research nurses at 10-minute intervals in the 60 minutes prior to delivery. The primary outcome was acidemia, defined as an umbilical cord arterial pH of 7.10 or less. RESULTS: Of the 4,274 patients included, 42 (0.98%) infants had acidemia at birth. Of the 42 infants with acidemia, 13 (31%) had category I tracings in the 30 minutes prior to delivery. Three (7%) infants had neonatal acidemia despite category I tracing for >40 minutes in the 60 minutes prior to delivery. CONCLUSION: Even in the presence of category I tracing in the 60 minutes prior to delivery, neonatal acidemia can still occur. Periods of category I should be interpreted within the clinical context of a priori risk for acidemia, knowing that it does not completely rule out acidemia.

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.

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

BACKGROUND: Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States. METHODS: In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention. RESULTS: From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups. CONCLUSIONS: The use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

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.