C. David Adair

Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis.

OBJECTIVEnThe purpose of this study was to review randomized trials that compared the efficacy of the dinoprostone 10-mg controlled-release vaginal insert with that of vaginally administered misoprostol tablets in cervical ripening and labor induction.nnnSTUDY DESIGNnElectronic databases were used to identify randomized clinical trials that compared dinoprostone with misoprostol. Estimates of the relative risk for individual studies and risk difference from dichotomous outcomes with the use of random and fixed-effects models were calculated.nnnRESULTSnWomen who received misoprostol had a higher incidence of vaginal delivery within 12 and 24 hours of prostaglandin application, compared with dinoprostone. Both modalities had similar incidences of cesarean delivery, uterine hyperstimulation, and fetal tachysystole. There was an increased need for oxytocin augmentation in the dinoprostone group. No significant difference in neonatal outcomes was noted between the 2 groups.nnnCONCLUSIONnVaginally administered misoprostol was more effective than the dinoprostone vaginal insert for cervical ripening and labor induction. The safety profiles of both drugs were similar.

Pyelonephritis in pregnancy: Once-a-day ceftriaxone versus multiple doses of cefazolin: A randomized, double-blind trial

OBJECTIVEnThe purpose of this study was to compare the efficacy of a single daily dose of intravenous ceftriaxone with that of multiple-dose cefazolin in the treatment of acute pyelonephritis in pregnancy.nnnSTUDY DESIGNnThis was a double-blind, randomized, clinical trial. Patients admitted to the hospital with the diagnosis of acute pyelonephritis in pregnancy were enrolled and randomized according to a computer-generated randomization schedule. The study group received a single daily 1 gm dose of ceftriaxone intravenously along with two additional doses of normal saline solution. The comparison group received three daily 2 gm doses of cefazolin intravenously. All infusions were given on an 8-hour schedule. Treatments were continued until the patient became afebrile. Each patient was discharged from the hospital on a regimen of appropriate oral antibiotics as directed by urine culture and sensitivities. At follow-up visits test-of-cure cultures were obtained.nnnRESULTSnDuring the 2-year study period, 178 patients were randomized: 88 received cefazolin and 90 ceftriaxone. Patient demographics and presenting signs and symptoms were similar in both groups. No differences were noted between the groups regarding days of febrile morbidity, length of hospital stay, or treatment failures.nnnCONCLUSIONSnDaily single-dose intravenous ceftriaxone is as effective as multiple-dose cefazolin in the treatment of patients with acute pyelonephritis during pregnancy.

Myocardial infarction during pregnancy: Management with transluminal coronary angioplasty and metallic intracoronary stents

A 29-year-old primiparous woman had an inferior myocardial infarction at 26 weeks gestation. Coronary angiography showed subtotal occlusion of the right coronary artery. Percutaneous transluminal angioplasty and intracoronary urokinase infusion failed to relieve the obstruction. Placement of two Gianturco-Roubin flexible stents created adequate coronary perfusion.

Successful magnesium sulfate tocolysis: is “weaning” the drug necessary

OBJECTIVEnMagnesium sulfate is the most commonly used tocolytic agent for preterm labor. A common clinical practice is to slowly discontinue the drug (wean) after successful tocolysis. Our objective was to determine the necessity of this practice.nnnSTUDY DESIGNnA prospective, randomized clinical trial was performed from June 1993 to July 1996. After successful magnesium sulfate tocolysis, patients with preterm labor were randomized to two groups: stopping the drug abruptly (no weaning) or gradually weaning the drug (approximately 1 gm every 4 hours). Preterm labor was defined as documented cervical change with regular uterine contractions or regular uterine contractions with a cervix of 2 cm and 75% effacement. The primary outcome variable was the necessity to reinstitute magnesium sulfate therapy within 24 hours of discontinuation of successful tocolysis.nnnRESULTSnOne hundred forty-one patients completed the study. No patient in the no-wean group required retocolysis within 24 hours of magnesium discontinuation. However, eight patients in the wean group required retocolysis within 24 hours of magnesium discontinuation (p = 0.01). Significantly more patients in the wean group had retocolysis during pregnancy (3 vs 12, p = 0.03). Patients in the wean group were also in the labor and delivery unit longer and, as would be anticipated, received magnesium sulfate significantly longer. No differences in the neonatal outcomes were noted between the two groups. Seventy-seven percent of the patients in the study were delivered prematurely.nnnCONCLUSIONnThis study demonstrated an increased need for retocolysis in the group weaned from magnesium sulfate. We also found that patients in the wean group had an increased labor and delivery time and a longer administration time of magnesium sulfate. Thus weaning magnesium sulfate increases health care cost. The practice of weaning magnesium sulfate does not appear beneficial.

Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage.

OBJECTIVEnWhen uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony.nnnSTUDY DESIGNnThese data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb).nnnRESULTSnA total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the Instructions for Use. We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding.nnnCONCLUSIONnWe conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.

Digoxin immune fab treatment for severe preeclampsia.

We evaluated the efficacy, safety, and biological mechanisms of digoxin immune Fab (DIF) treatment of severe preeclampsia. Fifty-one severe preeclamptic patients were randomized in double-blind fashion to DIF ( N = 24) or placebo ( N = 27) for 48 hours. Primary outcomes were change in creatinine clearance (CrCl) at 24 to 48 hours and antihypertensive drug use. Serum sodium pump inhibition, a sequela of endogenous digitalis-like factors (EDLF), was also assessed. CrCl in DIF subjects was essentially unchanged from baseline versus a decrease with placebo (-3 +/- 10 and -34 +/- 10 mL/min, respectively, P = 0.02). Antihypertensive use was similar between treatments (46 and 52%, respectively, P = 0.7). Serum sodium pump inhibition was decreased with DIF compared with placebo at 24 hours after treatment initiation (least squares mean difference, 19 percentage points, P = 0.03). DIF appeared to be well tolerated. These results suggest DIF prevents a decline in renal function in severe preeclampsia by neutralizing EDLF. Sodium pump inhibition was significantly improved. Further research is warranted.

Preinduction cervical ripening with commercially available prostaglandin E2 gel: A randomized, double-blind comparison with a hospital-compound preparation

OBJECTIVEnOur purpose was to compare the efficacy, safety, and cost of commercially available dinoprostone cervical gel 0.5 mg with a hospital-compounded formulation.nnnSTUDY DESIGNnOne hundred thirty-four patients undergoing labor induction were randomly assigned to one of two cervical ripening groups. Commercially available dinoprostone gel 0.5 mg or a compounded formulation of 0.5 mg of prostaglandin E2 gel was administered endocervically. On the basis of cervical scores, gel was reapplied at 6-hour intervals for a maximum of three doses. Physicians managing labor were blinded as to treatment group allocation.nnnRESULTSnAmong 134 patients evaluated, 70 were allocated to the commercially available gel and 64 to the compounded gel. No statistically significant differences were noted between the treatment groups with respect to start-to-delivery interval, number of doses, amount of oxytocin, or neonatal adverse outcomes. However, cesarean delivery was performed less frequently in patients in the group receiving the commercially available gel (12.9%) than in the group receiving the compounded gel (28.1%) (p = 0.03). Because of the higher cesarean delivery rate in the compound group, use of this formulation was not associated with cost savings.nnnCONCLUSIONSnThe two prostaglandin E2 formulations appeared equivalent with respect to efficacy. An unexplained higher cesarean section rate, however, was associated with the use of the compounded preparation.

Expectant management of mild preeclampsia versus superimposed preeclampsia up to 37 weeks

OBJECTIVEnWe sought to compare maternal and neonatal outcomes of expectantly managed pregnancies complicated by chronic hypertension with superimposed preeclampsia vs mild preeclampsia up to 37 weeks of gestation.nnnSTUDY DESIGNnThis was a multicenter retrospective cohort study of all pregnancies complicated by chronic hypertension with superimposed preeclampsia or mild preeclampsia expectantly managed in the hospital from January 2008 through December 2011. The primary outcomes, adverse maternal and neonatal composite morbidities, were compared between these 2 groups. Frequency differences of maternal adverse outcomes were stratified by gestational age at delivery of <34 and 34-36(6/7) weeks of gestation.nnnRESULTSnWe found no significant differences in rates of neonatal composite morbidity or latency periods between women with superimposed preeclampsia and mild preeclampsia. Adverse neonatal outcomes were significantly higher at <34 compared to 34-36(6/7) weeks of gestation (97-98% vs 48-50%) in both cohorts. Maternal adverse composite outcome occurred more frequently in women with superimposed preeclampsia compared to mild preeclampsia (15% vs 5%; Pxa0= .003; relative risk, 3.0; 95% confidence interval, 1.45-6.29).nnnCONCLUSIONnWomen with superimposed preeclampsia have similar neonatal outcomes but more maternal complications than women with preeclampsia without severe features who are expectantly managed <37 weeks.

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

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

Placental concentrations of essential, toxic, and understudied metals and relationships with birth outcomes in Chattanooga, TN

Background: Comprehensive examinations of placental metal concentrations and correlations with infant parameters are under‐investigated. Chattanooga, Tennessees consistently high incidence of low birth weight and potential for metal exposure provides an ideal opportunity to investigate potential correlations. Objectives: To investigate the associations between a wide variety of metals in placental tissue and multiple infant parameters. Methods: A total of 31 elements were screened via ICP‐MS in 374 individual placental samples. Of those, 14 were quantifiable in > 86% of the samples. We examined correlations between metal concentrations and infant parameters (birth weight, gestational age, birth weight centile, placental weight, birth length and head circumference). We fit multivariable regression models to estimate the covariate‐adjusted associations of birth weight with ln‐transformed concentrations of each of the 14 metals and used generalized additive models to examine nonlinear relationships. Results: Some of the strongest relationships with infant parameters came from several lesser‐studied metals. Placental rhodium concentrations were negatively correlated with almost all infant parameters. In the fully adjusted regression model, birth weight was significantly associated with several metals. On an IQR (25th to the 75th percentile) basis, estimated changes in birthweight were: for cobalt (82.5 g, IQR=6.05 &mgr;g/kg, p = 0.006), iron (−51.5 g, IQR = 171800 &mgr;g/kg, p = 0.030), manganese (−27.2 g, IQR=152.1 &mgr;g/kg, p = 0.017), lead (−72.7 g, IQR=16.55 &mgr;g/kg, p = 0.004) and rhodium (−1365.5 g, IQR = 0.33 &mgr;g/kg, p < 0.001). Finally, a generalized additive model showed significant nonlinear relationships between birth weight and concentrations of Co and Rh. Conclusions: Our comprehensive examination of placental metals illustrate many strong associations between lesser‐studied metals and infant parameters. These data, in combination with our correlations of well‐studied metals, illustrate a need to consider in utero exposure to a broad array of metals when considering fetal development.