Web-based comparison of historical vs contemporary methods of fetal heart rate interpretation.

BACKGROUND: Contemporary interpretation of fetal heart rate patterns is based largely on the tenets of Drs Quilligan and Hon. This method differs from an older method that was championed by Dr Caldeyro-Barcia in recording speed and classification of decelerations. The latter uses a paper speed of 1 cm/min and classifies decelerations referent to uterine contractions as type I or II dips, compared with conventional classification as early, late, or variable with paper speed of 3 cm/min. We hypothesized that 3 cm/min speed may lead to over-analysis of fetal heart rate and that 1 cm/min may provide adequate information without compromising accuracy or efficiency. OBJECTIVE: The purpose of this study was to compare the Hon-Quilligan method of fetal heart rate interpretation with the Caldeyro-Barcia method among groups of obstetrics care providers with the use of an online interactive testing tool. STUDY DESIGN: We deidentified 40 fetal heart rate tracings from the terminal 30 minutes before delivery. A website was created to view these tracings with the use of the standard Hon-Quilligan method and adjusted the same tracings to the 1 cm/min monitoring speed for the Caldeyro-Barcia method. We invited 2-4 caregivers to participate: maternal-fetal medicine experts, practicing maternal-fetal medicine specialists, maternal-fetal medicine fellows, obstetrics nurses, and certified nurse midwives. After completing an introductory tutorial and quiz, they were asked to interpret the fetal heart rate tracings (the order was scrambled) to manage and predict maternal and neonatal outcomes using both methods. Their results were compared with those of our expert, Edward Quilligan, and were compared among groups. Analysis was performed with the use of 3 measures: percent classification, Kappa, and adjusted Gwet-Kappa (P < .05 was considered significant). RESULTS: Overall, our results show from moderate to almost perfect agreement with the expert and both between and within examiners (Gwet-Kappa 0.4-0.8). The agreement at each stratum of practitioner was generally highest for ascertainment of baseline and for management; the least agreement was for assessment of variability. CONCLUSION: We examined the agreement of fetal heart rate interpretation with a defined set of rules among a number of different obstetrics practitioners using 3 different statistical methods and found moderate-to-substantial agreement among the clinicians for matching the interpretation of the expert. This implies that the simpler Caldeyro-Barcia method may perform as well as the newer classification system.

A randomized, double-masked trial of prophylactic indomethacin tocolysis versus placebo in women with premature rupture of membranes.

Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and frequently results in preterm birth, often within 48 hours of membrane rupture. Our objective was to determine if subjects with PPROM between 24 and 31 (6)/ (7) weeks' gestation benefit from a 48-hour course of prophylactic indomethacin tocolysis. This was a double-masked randomized controlled trial. Subjects with PPROM between 24 and 31 (6)/ (7) weeks' gestation were randomized to receive indomethacin or placebo for 48 hours in addition to corticosteroids and latency antibiotics. The primary outcome of the study was delivery within 48 hours. Maternal and neonatal outcomes were also compared. This study was concluded prematurely due to slow accrual after a total of 50 subjects were enrolled. A total of 23/25 (92%) subjects in the indomethacin group remained pregnant beyond 48 hours compared with 20/22 (90.9%) in the placebo group (relative risk, 1.01; 95% confidence interval, 0.84 to 1.21). The latency period medians and interquartile ranges were similar between the two groups [indomethacin 193 (92 to 376.5) hours versus placebo 199 (77.5 to 459) hours, P = 0.91], and no differences were noted in any maternal or neonatal secondary outcomes. This limited study demonstrates no benefit with the use of prophylactic indomethacin tocolysis for women with PPROM.

Phase II, Double-Blind, Vehicle-Controlled Study to Determine the Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts.

BACKGROUND: External genital warts are caused by various subtypes of the human papilloma virus and spread through direct skin-to-skin contact. Approximately 1% of the US population have external genital warts. Although cantharidin has been used to treat external genital warts for decades, there are no US Food and Drug Administration-approved cantharidin products and no reliable or controlled sources of cantharidin available. VP-102 is a drug-device combination product containing cantharidin (0.7% w/v) in a single-use shelf-stable applicator. OBJECTIVE: The objective of this randomized, double-blind, vehicle-controlled, phase II clinical trial was to determine the optimal regimen for the treatment, safety, and efficacy of VP-102 in external genital warts. METHODS: The study was conducted in two parts. Part A was dose finding and Part B was performed following the completion of Part A for a safety and efficacy evaluation. Following completion of Part A, 6-h and 24-h VP-102 regimens under occlusion were selected to be evaluated in Part B. RESULTS: Pooled results from Part B and Part A of the 6-h and 24-h VP-102 treatment regimens showed that 36.7% and 33.3% of participants achieved complete clearance of all treatable external genital warts at the end of treatment vs 4.2% (p < 0.0048) and 0% (p < 0.0075) with the vehicle. Adverse events experienced by the VP-102-treated participants were consistent with the pharmacodynamic action of cantharidin as a vesicant and were primarily mild to moderate in severity. The most common adverse events included application-site vesicles, pain, and erythema. No participants discontinued the study because of adverse events and no serious adverse events were deemed treatment related. CONCLUSIONS: The adverse event profile and efficacy of VP-102 under occlusion demonstrated in this study support the conclusion that a 6-h or up to 24-h exposure regimen represents an acceptable risk:benefit profile and justifies the conduct of a larger vehicle-controlled phase III study in external genital warts. CLINICAL TRIAL REGISTRATION: NCT03981822, actual study start date: 25 June, 2019; actual primary completion date: 21 May, 2020; actual study completion date: 8 July, 2020.

Comparison of urinary cytokines after ingestion of cranberry juice cocktail in pregnant subjects: a pilot study.

Our objective was to evaluate urinary cytokine excretion after daily cranberry or placebo exposure in pregnant women. Four-hour urine samples were collected from 27 pregnant women subjects who were randomized to cranberry juice cocktail or placebo in three treatment arms: A: Cranberry (C) two times daily (C, C; n = 10 pregnant); B: cranberry in the AM, then placebo (P) in the PM (C, P; n = 9 pregnant); and C: placebo two times daily (P, P; n = 8 pregnant). Urinary cytokines were measured using commercially available kits. There was a statistically significant difference in interleukin (IL)-6 of the urinary cytokines between the multiple daily cranberry dosing group (group A [C, C]): median, 3.16 (range, 0.01 to 7.34) and the placebo group (group C [P, P]): 9.32 (0.53 to 29.61 pg/mL; p = 0.038, Kruskal-Wallis test). We concluded that a difference in IL-6 was found in the multiple daily cranberry dosing groups compared with placebo. Lack of differences based on treatment allocation in the other cytokines may be due to beta error. Further studies are planned to evaluate these assays for the assessment of clinical effect.

The accuracy of late third-trimester antenatal screening for group B streptococcus in predicting colonization at delivery.

We reevaluated the accuracy of antenatal group B streptococcal (GBS) culture results in predicting colonization at the time of delivery in a general practice setting. Patients who had late third-trimester antenatal GBS cultures were prospectively identified. A repeat GBS culture was performed when admitted in labor using a strict protocol and laboratory analysis. Sensitivity, specificity, and positive and negative predicative values were calculated. In comparing the office culture results to the intrapartum cultures in 1472 patients, the sensitivity was 51%, specificity 94%, positive predictive value 67%, and negative predictive value 88%. The antenatal positive culture rate of 15.4% was significantly lower than the 20.1% intrapartum positive culture rate. There were 144 patients (9.8%) who had false-negative antenatal culture results. Through office survey, several aspects of the recommended antenatal procedures were not followed. The results support the previously reported high specificity and negative predictive values for this test. The near 10% false-negative rate with the significant difference between the antenatal versus intrapartum positive culture rate highly suggests that late third-trimester culture accuracy may be affected if the specified procedures are not completely followed, including the culturing technique, the use of recommended transport medium, and the laboratory culture protocol.

Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts.

OBJECTIVE: To evaluate the maternal and pregnancy characteristics that independently predict successful induction of labor, defined as vaginal delivery. METHODS: The study was a secondary analysis of the data collected during the Misoprostol Vaginal Insert Trial, a multisite, double-blind, randomized trial of women requiring cervical ripening before induction of labor. The primary outcome was to estimate the maternal and pregnancy characteristics that independently predict successful induction of labor. Univariable and multiple regression analyses were performed for maternal and pregnancy-related factors that potentially could predict a successful induction of labor. RESULTS: A total of 1,274 patients had sufficient labor and delivery data for a comparative analysis. Nine hundred sixteen (72%) induced patients subsequently had vaginal deliveries. Multiparity (odds ratio [OR] 4.63, 95% confidence interval [CI] 3.39-6.32, P<.001), maternal body mass index (BMI) less than 30 (OR 1.69, 95% CI 1.32-2.22, P<.001) and height greater than 5'5" (OR 1.47, 95% CI 1.15-1.9, P=.002), baseline modified Bishop score of 4 (OR 2.15, 95% CI 1.12-4.20, P=.047), and birth weight below 4,000 g (OR 2.17, 95% CI 1.51-3.13, P<.001) were significant for predicting successful induction of labor. Logistic regression analysis was performed to evaluate each factor as an independent predictor. In addition to the above-mentioned factors, maternal age younger than 35 years (OR 1.81, 95% CI 1.15-2.86, P=.01) and Hispanic race (OR 1.45, 95% CI 1.02-2.05, P=.036) each proved to significantly favor a successful induction. Conversely, African-American race was correlated with a higher incidence of cesarean delivery (OR 1.47, 95% CI 1.02-2.13, P<.001). CONCLUSION: Maternal characteristics such as BMI, parity, age, and race and neonatal birth weight are important variables to consider when predicting a successful induction of labor. The nearly 30% rate of cesarean delivery in this study underscores the importance of selecting appropriate candidates. LEVEL OF EVIDENCE: II.

A randomized, double-blinded, controlled trial comparing parenteral normal saline with and without dextrose on the course of labor in nulliparas.

OBJECTIVE: The objective of the study was to compare intravenous normal saline with and without dextrose on the course of labor in nulliparae. STUDY DESIGN: In a double-blinded, controlled trial, term, nulliparae with singletons in active labor were randomized into 1 of 3 groups receiving either normal saline (NS), NS with 5% dextrose (D5NS), or NS with 10% dextrose (D10NS) at 125 mL/h. The primary outcome was total length of labor from onset of study fluid in vaginally delivered subjects. Maternal and neonatal outcomes were also analyzed. RESULTS: Of 300 subjects enrolled, 289 met inclusion criteria and completed the study. In vaginally delivered subjects, significant differences were noted in the second stage (P = .01) and total length of labor (P = .02). No significant differences were observed in the cesarean section rates between the groups (P = .21). No differences were noted in maternal or neonatal secondary outcomes. CONCLUSION: Administration of a dextrose solution, regardless of concentration, was associated with a shortened labor course in term vaginally delivered nulliparae subjects in active labor.

Outpatient oral misoprostol for prolonged pregnancies: a pilot investigation.

UNLABELLED: We evaluated the effectiveness of oral misoprostol for outpatient cervical ripening and labor induction in prolonged pregnancies. We performed a randomized, double-blind, placebo-controlled study of women at 40 to 42 weeks' gestation with well-dated pregnancies, singleton gestations, Bishop scores less than 6, vertex presentations, and intact membranes. Subjects received either oral misoprostol 100 microg or placebo daily for 3 days unless the subject developed significant cervical change or began labor spontaneously. Study drug was repeated every 24 hours for a maximum of three doses if subjects did not develop significant cervical change or enter labor. Induction of labor was not allowed while the subject was enrolled in the study. Forty-three subjects were randomized to receive misoprostol and 44 randomized to receive placebo. A significant difference was noted in reduction of time from study entry to both active phase (p < 0.001) and delivery (p < 0.001) in the misoprostol group. Fewer women remained undelivered after the 72-hour study period in the misoprostol group. There were no differences in route of delivery or neonatal outcomes between groups. CONCLUSION: Daily administration of oral misoprostol over 3 days to women with prolonged pregnancies shortened time intervals from dosing to entry into active labor and delivery compared with placebo.

Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study.

PURPOSE: We compared the effects of daily cranberry juice cocktail to those of placebo during pregnancy on asymptomatic bacteriuria and symptomatic urinary tract infections. MATERIALS AND METHODS: A total of 188 women were randomized to cranberry or placebo in 3 treatment arms of A-cranberry 3 times daily (58), B-cranberry at breakfast then placebo at lunch and dinner (67), and C-placebo 3 times daily (63). After 27.7% (52 of 188) of the subjects were enrolled in the study the dosing regimens were changed to twice daily dosing to improve compliance. RESULTS: There were 27 urinary tract infections in 18 subjects in this cohort, with 6 in 4 group A subjects, 10 in 7 group B subjects and 11 in 7 group C subjects (p = 0.71). There was a 57% and 41% reduction in the frequency of asymptomatic bacteriuria and all urinary tract infections, respectively, in the multiple daily dosing group. However, this study was not sufficiently powered at the alpha 0.05 level (CI 0.14-1.39 and 0.22-1.60, respectively, incidence rate ratios). Of 188 subjects 73 (38.8%) withdrew, most for gastrointestinal upset. CONCLUSIONS: These data suggest there may be a protective effect of cranberry ingestion against asymptomatic bacteriuria and symptomatic urinary tract infections in pregnancy. Further studies are planned to evaluate this effect.

A case-control comparison of the effectiveness of betamethasone to prevent neonatal morbidity and mortality in preterm twin and singleton pregnancies.

We compared the effectiveness of antenatal betamethasone for the prevention of neonatal morbidity and mortality in preterm twin and singleton gestations. We conducted a case-control study of women with twin versus singleton gestations who received betamethasone for risk of prematurity in a university-affiliated, community-based, tertiary care center between 1997 and 2005. Cases were identified from clinical care and pharmacy databases, then matched for neonatal gender and gestational age (GA) at delivery. Sixty cases and 60 controls of deliveries occurring between 24 and 34 weeks' gestation were identified. The mean GA was 30.4 +/- 2.7 weeks. There were no differences between the groups in maternal demographics (with the exception of maternal age), birth weight, head circumference, Apgar scores, need for mechanical ventilation, days on ventilator, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis suspected sepsis, total days in neonatal intensive care unit, or neonatal deaths. No differences in major morbidities or mortality were found in singletons versus twins. Concerns that the added maternal plasma volume in multiple gestations could lessen the neonatal benefits of antenatal betamethasone were not substantiated. This study may be affected by beta-error due to small sample size and sampling bias as a result of a retrospective study.

The effect of maternal oxygen administration on fetal pulse oximetry during labor in fetuses with nonreassuring fetal heart rate patterns.

OBJECTIVE: Using fetal pulse oximetry, we sought to quantify the impact of maternal oxygen administration in the management of nonreassuring fetal heart rate patterns. STUDY DESIGN: In fetuses with specified abnormal nonreassuring fetal heart rate patterns, oxygen was administered to the mother, and fetal oxygenation was monitored with fetal pulse oximetry. After the fetal oxygen saturation on room air was recorded as a baseline, oxygen was administered to the mother for 30 minutes at 40% fraction of inspired oxygen and then 30 minutes at 100% of inspired oxygen. The average fetal oxygen saturation during the last 15 minutes of each period was calculated. Paired Student t test was used for comparison to baseline values. RESULTS: Compared with baseline values, a significant increase in fetal oxygen saturation was identified in women who received oxygen at 40% fraction of inspired oxygen (mean increase, 4.9%; P = .001) and at 100% of inspired oxygen (mean increase, 6.5%; P = .003). CONCLUSION: The administration of supplemental oxygen to laboring patients with nonreassuring fetal heart rate patterns increases fetal oxygen saturation substantially and significantly. Fetuses with the lowest initial oxygen saturations appear to increase the most.

Ethnic disparity in the success of vaginal birth after cesarean delivery.

OBJECTIVE: To estimate whether maternal race/ethnicity is independently associated with successful vaginal birth after cesarean delivery (VBAC). STUDY DESIGN: A retrospective cohort study from January 1, 1997 to July 30, 2002 of women with singleton pregnancies and a previous cesarean delivery. The odds ratio (OR) for successful VBAC as a function of ethnicity was corrected for age >35 years, parity, weight gain, diabetes mellitus, hospital site, prenatal care provider, gestational age, induction, labor augmentation, epidural analgesia, and birth weight >4000 g. RESULTS: Among 54 146 births, 8030 (14.8%) occurred in women with previous cesarean deliveries. The trials of labor rates were similar among Caucasian (46.6%), Hispanic (45.4%), and African American (46.0%) women. However, there was a significant difference among ethnic groups for VBAC success rates (79.3% vs. 79.3% vs. 70.0%, respectively). When compared to Caucasian women, the adjusted OR for VBAC success was 0.37 (95% confidence interval (CI) 0.27-0.50) for African American women and 0.63 (95% CI 0.51-0.79) for Hispanic women. CONCLUSION: African American and Hispanic women are significantly less likely than Caucasian women to achieve successful VBAC.

Ultrasound Measurement of the Fetal Adrenal Gland as a Predictor of Spontaneous Preterm Birth.

OBJECTIVE: To estimate whether ultrasound measurement of the fetal adrenal gland remote from delivery in asymptomatic women can accurately predict spontaneous preterm birth. METHODS: We conducted a prospective multicenter observational nested cohort study of asymptomatic nulliparous women with a singleton pregnancy to study adverse pregnancy outcomes. Between 22 0/7 and 30 6/7 weeks of gestation, credentialed ultrasonographers measured the width (width), length (length), and, when able, depth (depth) of the "fetal zone" of the fetal adrenal gland as well as the width (Width), length (Length), and depth (Depth) of the total gland. We used the ratios of each measurement (width/Width, length/Length, and depth/Depth) to control for variation in adrenal size by gestational age. The accuracy of each ratio measurement in predicting spontaneous preterm birth at less than 37 0/7 weeks of gestation and spontaneous preterm birth at less than 34 0/7 weeks of gestation was assessed by receiver operating characteristic curves using area under the curve. RESULTS: Pregnancy outcomes were available for 1,697 women with one or more fetal adrenal gland measurements. Spontaneous preterm birth at less than 37 0/7 weeks of gestation and spontaneous preterm birth at less than 34 0/7 weeks of gestation occurred in 82 (4.8%) and six women (0.4%), respectively. None of the fetal adrenal gland measurements distinguished spontaneous preterm birth from term birth. The areas under the curve (95% confidence intervals) for spontaneous preterm birth at less than 37 0/7 weeks of gestation were 0.51 (0.45-0.58), 0.50 (0.44-0.56), and 0.52 (0.41-0.63) for width/Width, length/Length, and depth/Depth ratios, respectively. The areas under the curve for spontaneous preterm birth at less than 34 0/7 weeks of gestation were 0.52 (0.25-0.79) and 0.55 (0.31-0.79) for width/Width and length/Length ratios, respectively. Additionally, none of the means of the gland measurements were statistically different between those delivering at term and spontaneous at preterm (P>.05). CONCLUSION: Fetal adrenal size, as measured by ultrasonography between 22 0/7 and 30 6/7 weeks of gestation, is not predictive of spontaneous preterm birth in asymptomatic nulliparous women.

Pilot Study to Evaluate Compliance and Tolerability of Cranberry Capsules in Pregnancy for the Prevention of Asymptomatic Bacteriuria.

OBJECTIVES: To evaluate the compliance with and tolerability of daily cranberry capsule ingestion for asymptomatic bacteriuria (ASB) prevention in pregnancy. DESIGN: A total of 49 pregnant women from two sites were randomly assigned to cranberry or matching placebo, two doses daily, at gestational ages less than 16 weeks. Patients were followed monthly for urinary tract infection until delivery. Up to seven monthly visits were scheduled for each patient. Delivery data were evaluated. RESULTS: Of 38 evaluable patients, the mean compliance rate over the study period was 82% (range, 20%-100%). This compliance rate and the 74% of patients achieving good (≥75%) compliance were similar between those who received cranberry capsules and placebo. Compliance evaluation revealed that most patients stopped capsule consumption after 34-38 weeks of participation. Multivariate logistic regression and longitudinal analysis showed a significant interaction time effect with cranberry treatment. However, cranberry consumption was not a significant predictor of gastrointestinal intolerance or study withdrawal. Although 30% of patients withdrew for various reasons, only 1 withdrew because of intolerance to the cranberry capsules. Loss to follow-up was mostly due to provider change (9 of 49 [18%]) and therapy disinterest (4 of 49 [8%]). Seven cases of ASB occurred in 5 patients: 2 of 24 (8%) in the cranberry group and 3 of 25 (12%) in the placebo group. No cases of cystitis or pyelonephritis were observed. CONCLUSION: One third of pregnant women could not complete the study protocol for various reasons. Compliance with and tolerability of cranberry capsule ingestion appear good; these capsules provide a potentially effective means to prevent ASB in pregnancy. Further studies with large samples are necessary to confirm the findings.

Interdelivery interval and the success of vaginal birth after cesarean delivery.

OBJECTIVE: To determine whether a short interdelivery interval is associated with decreased rate of successful vaginal birth after cesarean (VBAC). METHODS: A retrospective cohort study from January 1, 1997, to December 31, 2000, was conducted. Patients with previous cesarean delivery who attempted VBAC were identified. The analysis was limited to patients at term with one prior cesarean. The interdelivery interval was calculated in months between the index pregnancy and prior cesarean delivery. RESULTS: A total of 1516 subjects who attempted VBAC were identified among 24,162 deliveries, with complete data available in 1185 cases. The VBAC success rate was 79.0% for patients with an interdelivery interval less than 19 months compared with 85.5% for patients with an interval delivery greater than or equal to 19 months (P =.12). For patients whose labors were induced, interdelivery intervals of less than 19 months were associated with a decreased rate of VBAC success when compared with longer intervals (P <.01). Sufficient power (beta =.95) existed to detect a 64% difference between the groups (alpha =.05). No significant difference was detected in women who underwent spontaneous labor (P =.98). There was no difference in the rate of symptomatic uterine rupture (P = 1.00). CONCLUSION: Interdelivery intervals of less than 19 months were associated with a decreased rate of VBAC success in patients who underwent induction, a difference not found in those with spontaneous labor.

Longitudinal study of CD4+ cell counts in HIV-negative pregnant patients.

OBJECTIVE: To evaluate the absolute CD4+, CD8+, and lymphocyte cell counts and percentages from the first trimester through 6-12 weeks post-delivery in normal human immunodeficiency virus (HIV)-negative pregnant patients. METHODS: A longitudinal laboratory analysis was performed during pregnancy that involved 51 HIV-negative subjects with blood analysis obtained in all trimesters, at delivery, and 6-12 weeks post-delivery. Twenty-five HIV-negative non-pregnant controls were also evaluated. Blood was analysed for absolute CD4+, CD8+, and lymphocyte cell counts and percentages. Means, standard deviations, trends, and differences were examined. RESULTS: The mean white blood cell (WBC) count is elevated above the non-pregnant state and this parameter increases through the pregnancy up to and including parturition. The mean absolute lymphocyte cell count, lymphocyte percentage, and absolute CD4+ cell count are significantly lower during pregnancy and the progression through pregnancy appears U-shaped. The mean absolute CD8+ cell count is not significantly different. The CD4+ and CD8+ percentages are higher during pregnancy and this elevation persists into the 6-12 week post-delivery time period. A 3-digit drop in CD4+ percentage is common during pregnancy between blood draws; whereas, a 30% decrease or more in absolute CD4+ cell count is rare. CONCLUSIONS: By longitudinal analysis, pregnancy appears to significantly elevate the mean values of the WBC count, CD4+ percentage, and CD8+ percentage, but significantly decreases the absolute lymphocyte count, lymphocyte percentage, and absolute CD4+ cell count when compared to non-pregnant controls. The mean absolute CD8+ cell count appears to be unaffected.

Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction.

OBJECTIVE: To estimate the effect of maternal body mass index (BMI) on progress and outcomes of prostaglandin labor induction. METHODS: This study was a secondary analysis of data collected during the Misoprostol Vaginal Insert Trial, a multisite, double-blind, randomized trial of women requiring cervical ripening before induction of labor. The duration, characteristics, and outcomes of labor were analyzed after stratification by BMI categories. Multivariable regression analysis was performed on all outcomes of interest, adjusting for race, parity, and treatment group allocation. RESULTS: One thousand two hundred seventy-three patients were stratified according to BMI categories, with 418 study participants classified as lean (BMI less than 30), 644 as obese (BMI 30-39.9), and 211 as extremely obese (BMI 40 or higher). The incidence of cesarean delivery increased from 21.3% in the BMI less than 30 group to 29.8% in the BMI 30-39.9 group (odds ratio [OR] 1.57, 95% confidence interval [CI] 1.18-2.1, P=.002) and 36.5% in the BMI 40 or higher group (OR 2.12, 95% CI 1.47-3.06, P<.001). Median dose and duration of predelivery oxytocin in the lean group (2.6 units and 6.5 hours) was significantly lower than for women in either the obese (3.5 units and 7.7 hours) or the extremely obese (5.0 units and 8.5 hours) group. Median time to delivery was significantly longer in the BMI 40 or higher (27.0 hours) and BMI 30-39.9 (24.9 hours) groups compared with the BMI less than 30 (22.7 hours) group (P<.001). The relationship between maternal obesity and adverse labor and delivery outcomes persisted in a multivariable analysis that adjusted for race, parity, and treatment group allocation. CONCLUSION: Duration of labor, oxytocin requirements, and cesarean delivery rates are significantly higher with increasing maternal obesity in prostaglandin-induced women. LEVEL OF EVIDENCE: II.

Fetal pulse oximetry: correlation between oxygen desaturation, duration, and frequency and neonatal outcomes.

OBJECTIVE: The purpose of this study was to identify the threshold of fetal arterial oxyhemoglobin saturation that predicts neonatal acidosis and adverse outcomes. STUDY DESIGN: Fetal oxygen saturation data from a published randomized controlled trial of fetal pulse oximetry were evaluated in relation to the number and duration of low fetal oxygen saturation episodes and neonatal outcomes. Fetal oxygen saturation episodes (epochs) of at least 10-second duration were categorized into the following groups: (1). <30% and >or=25%, (2). <25% and >or=20%, (3). <20%, and (control) randomly selected control subjects >30%. RESULTS: One hundred seventy-four fetal heart rate tracings were identified. An analysis of mean umbilical artery pH revealed a significant difference between groups 1 and 3 compared with the control subjects. The incidence of adverse neonatal outcome was significantly greater when the number of epochs exceeded 10. An analysis of the duration of fetal oxygen saturation of <30%, as correlated with neonatal compromise, was not significant. CONCLUSION: This study confirms previous findings that fetal oxygen saturation of <30% is associated with declining fetal arterial pH. There appears to be an association between adverse neonatal outcomes and >10 epochs of <30%.

Is the incidence of fetal-to-maternal hemorrhage increased in patients with third-trimester bleeding?

OBJECTIVE: If a pregnancy is complicated by third-trimester bleeding, is there a higher risk of fetal-to-maternal hemorrhage that might necessitate the administration of additional anti-D immune globulin to prevent alloimmunization in the patient who is Rh D-negative? The study objective was to analyze prospectively the incidence of fetal-to-maternal hemorrhage in pregnancies that were complicated by third trimester bleeding compared with three control groups. STUDY DESIGN: Pregnancies that were complicated by third-trimester bleeding, preterm premature rupture of the membranes, and preterm labor were identified prospectively on admission. A group of preterm patients with no complications was also collected prospectively. Patients with any history and/or clinical evidence of trauma were excluded. Kleihauer-Betke tests were performed with all patients, and the results were blinded until study completion. Sample size calculations were performed to determine the minimum number of cases needed in each group. RESULTS: A total of 403 patients were collected during the study period: 91 patients had third-trimester bleeding, 101 patients had preterm premature rupture of the membranes, 116 patients had preterm labor, and 95 patients were in the no complication group. There was no statistical difference identified in the Kleihauer-Betke test results between any of the study groups. CONCLUSION: The incidence of fetal-to-maternal hemorrhage does not appear to be increased in pregnancies that are complicated by third-trimester bleeding when compared to noncomplicated control subjects or to other obstetrically complicated pregnancies. This information would suggest that the routine administration of additional anti-D immune globulin (beyond the current recommended protocol) to women who are Rh D-negative whose pregnancies are complicated by third-trimester bleeding is not indicated.

A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction.

OBJECTIVE: The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. STUDY DESIGN: A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score