Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction.

OBJECTIVE: Our purpose was to compare the safety and effectiveness of intravaginally administered misoprostol at doses of 25 micrograms and 50 micrograms for indicated labor induction in patients with an unfavorable cervix. STUDY DESIGN: Three hundred ninety-nine patients received either 25 micrograms or 50 micrograms of misoprostol, placed intravaginally in the posterior fornix, in this randomized double-blind trial. The dose was repeated every 3 hours until adequate labor was achieved (at least three contractions in 10 minutes). RESULTS: Among 399 patients evaluated, 192 patients were allocated to the 25 micrograms group and 207 patients to the 50 micrograms group. The start-to-delivery interval was shorter in the 50 micrograms group (826 minutes vs 970 minutes, p = 0.02). The incidence of vaginal delivery after one dose was higher in the 50 micrograms group (38.2% vs 25.0%, p = 0.007). Patients receiving 25 micrograms required oxytocin augmentation more frequently than did those receiving 50 micrograms (27.1% vs 16.9%, p = 0.02). No differences were noted in the cesarean or other operative delivery rates among patients in the two treatment groups. The incidence of newborns with a cord pH < 7.16 was greater in the 50 micrograms group (13.0% vs 6.8%, p = 0.04). Although the incidence of hyperstimulation was similar between the groups, the incidence of tachysystole was higher in the 50 micrograms group (32.8% vs 15.6%, p = 0.0001). CONCLUSIONS: Although a dose of 50 micrograms is associated with a shorter start-to-delivery interval and a higher incidence of vaginal delivery after one dose, 25 micrograms of intravaginal misoprostol is effective and associated with a lower incidence of tachysystole and cord pH values < 7.16.

PIP: The safety and effectiveness of 25 and 50 mcg of intravaginally administered misoprostol for cervical ripening and labor induction were evaluated in a randomized double-blind trial involving 395 US women. The most frequent indications for labor induction in both dosage groups were pregnancy-induced hypertension and premature rupture of the membranes. The prostaglandin dosage was repeated every 3 hours until labor was induced. The mean start-to-delivery interval among the 192 women in the 25 mcg group was 970 minutes, compared to only 826 minutes among the 207 women in the 50 mcg group. 82% of women in the 25 mcg group and 84% of those in the 50 mcg group were delivered within 24 hours. The incidence of vaginal delivery after 1 dose was higher in the 50 mcg group (38.2%) than in the 25 mcg group (25.0%) and women in the lower-dose group required oxytocin administration more frequently than those in the 50 mcg group (27.1% and 16.9%, respectively). On the other hand, the incidence of newborns with a cord pH under 7.16 was greater in the 50 mcg group (13.0%) than in the 25 mcg group (6.8%), and the incidence of tachysystole was higher (32.8% and 15.6%, respectively). Thus, despite the greater effectiveness of the 50 mcg dosage, a regimen of 25 mcg of misoprostol administered intravaginally every 3 hours is indicated to minimize neonatal morbidity.

Interpretation of the TDx-FLM fluorescence polarization assay in pregnancies complicated by diabetes mellitus.

The objective of this paper is to determine the applicability of the Abbott TDx-FLM fluorescence polarization assay in pregnancies complicated by diabetes mellitus. Retrospective review of records of women with pregnancies complicated by diabetes who underwent amniocentesis for fetal lung maturity using the Abbott TDx-FLM assay within 3 days of delivery was considered. Maternal diabetic control, neonatal birth weight, Apgar scores, umbilical cord gases, admissions to Neonatal Intensive Care Unit (NICU), development of respiratory distress syndrome (RDS) were evaluated. One hundred twenty-one patients with diabetes mellitus were identified. Thirteen (10.7%) had an FLM < or = 70 mg/g and 108 patients had > or = 70 mg/g. All obstetrical and diabetic variables were similar. RDS was not observed in neonates who had an FLM of > or = 70 mg/g. One neonate had RDS (FLM = 7.2 mg/g). The TDx-FLM > or = 70 mg/g may be interpreted as mature when obtained from transabdominal amniocentesis.

Group B streptococcus colonization in pregnant diabetic women.

OBJECTIVE: To evaluate the influence of maternal diabetes on the risk of group B streptococcus colonization during pregnancy. METHODS: We prospectively analyzed data on 105 pregnant women with diabetes mellitus, both pregestational and gestational, and a control group of 300 pregnant women without carbohydrate intolerance. All had singleton gestations, negative tests for human immunodeficiency virus, and intact membranes at enrollment. Culture specimens for group B streptococcus were obtained from the lower vaginal walls and rectum. Two-tailed unpaired Student t test, Mann-Whitney U test, and chi 2 test were used as appropriate. Multiple logistic regression analyses were performed to evaluate the independent influence of maternal diabetes on the rate of group B streptococcus colonization. RESULTS: Compared to controls, diabetic women had a higher colonization rate (43.8 versus 22.7%, odds ratio [OR] 2.56, 95% confidence interval [CI] 1.6, 4.1). The prevalence of group B streptococcus colonization in pregestational diabetic women was 54.1% and in women with gestational diabetes it was 35.1% (P = .05). Among women with pregestational diabetes, the prevalence of group B streptococcus colonization was 59.1% in class B and 50.0% in class C to R (P = not significant). After we adjusted for maternal age, race, and obesity, diabetic women continued to be at increased risk of group B streptococcus colonization (OR 3.1, 95% CI 1.8, 5.2). CONCLUSION: Carbohydrate intolerance appears to be an independent risk factor for group B streptococcus colonization during pregnancy.

A comparison of the 3 H glucose tolerance test and the 2 H value in identifying risk for excessive fetal growth.

The objective of this study was to determine if the 2 h value of the glucose tolerance test (GTT) is as reliable as the complete GTT in identifying risk for excessive fetal growth. Five hundred eighty-eight patients underwent a 3 h oral GTT at 26-28 weeks' gestation. The 2 h value of the test was compared to the results of the GTT. The incidence of large for gestational age (LGA) infants was compared for patients who had an abnormal GTT or an abnormal 2 h value only. A normal 2 h value was associated with a normal GTT in 98.5% of cases, while an abnormal 2 h value was associated with an abnormal GTT in 70% of cases. An abnormal GTT was associated with a 22% incidence of LGA, while a 2 h value > or = 165 mgm/dl was associated with a 20% incidence of LGA. This difference was not statistically significant. A single 2 h value GTT is more cost-effective and as predictive as a complete 3 h GTT in identifying risk for excessive fetal growth.

Use of misoprostol (prostaglandin E1 methyl analogue) to expedite delivery in severe preeclampsia remote from term.

Intravaginal misoprostol was used for labor induction in 2 patients with severe preeclampsia remote from term. Both patients had an uneventful vaginal delivery within 14 h of the initial application. Misoprostol appears to be effective for labor induction in cases where expeditious vaginal delivery is necessary.

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

OBJECTIVE: Our purpose was to compare the efficacy, safety, and cost of commercially available dinoprostone cervical gel 0.5 mg with a hospital-compounded formulation. STUDY DESIGN: One 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. RESULTS: Among 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. CONCLUSIONS: The 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.

Predicting fetal lung maturity by visual assessment of amniotic fluid turbidity: comparison with fluorescence polarization assay.

We prospectively studied 159 patients having clinically indicated amniocentesis. Amniotic fluid (3 to 5 mL) was placed in a nonheparinized glass tube. This sample was then classified as turbid (indicating maturity) or clear (indicating immaturity) on the basis of a single examiner's ability to read newspaper print through the glass tube. These results were then compared with fluorescence polarization values for the same sample. A value of 70 mg/g was considered positive evidence of fetal lung maturity. By study criteria, 62 samples (39%) indicated immaturity and 97 (61%) indicated maturity. Turbidity correctly identified 89 samples that produced fluorescence polarization values of at least 70 mg/g. Turbidity as a predictor of fetal lung maturity when compared with fluorescence polarization assay has a 91% positive and 87% negative predictive value. Visual inspection of amniotic fluid may be of value in areas where sophisticated methods are unavailable.

Calcium supplementation in mild preeclampsia remote from term: a randomized double-blind clinical trial.

OBJECTIVE: To determine whether calcium supplementation prevents progression to severe disease in preterm nulliparous women with mild preeclampsia. METHODS: Seventy-five women hospitalized at 24-36 weeks' gestation because of mild preeclampsia were randomized to receive either 2 g/day of elemental calcium (36 women) or placebo (39). Both groups had similar demographic characteristics, initial blood pressure measurements, and amount of proteinuria. Diagnostic criteria and clinical management for severe preeclampsia were applied consistently. RESULTS: Eighteen of 36 calcium-treated subjects (50%, 95% confidence interval [CI] 33-67) developed severe preeclampsia, compared with 19 of 39 (48.7%, 95% CI 32-65) in the placebo group (relative risk 1.03, 95% CI 0.64-1.03; P = 1.00). Blood pressure values, gestational age at delivery, newborn weights, incidence of low Apgar scores, and umbilical arterial blood gases were similar for the two groups. CONCLUSION: Calcium supplementation does not prevent severe preeclampsia in preterm patients with mild disease.

Comparison of three types of ultrasound transducers in evaluating the amniotic fluid index.

The purpose of this study was to determine whether there was good correlation between amniotic fluid index measurements obtained with different types of ultrasound transducer. Women undergoing obstetric ultrasonography for multiple indications between 26 and 40 weeks' gestation had the four-quadrant amniotic fluid index measured with three ultrasound transducers: 3.5-MHz linear, 3.5-MHz sector and 3.5-MHz convex. Pearson product-moment correlation and linear regression analysis were utilized to compare the amniotic fluid index values. Sixty-five women participated in the study. A statistically significant correlation was noted between the three ultrasound transducers evaluated (P < .001). Placental location did not appear to affect the results. Amniotic fluid index values obtained with the sector or convex transducers were as reliable as those obtained with the "gold standard" linear transducer and may be interpreted in the same manner.

Cervical ripening in women with previous cesarean deliveries.

OBJECTIVE: To evaluate the safety and efficacy of preinduction cervical ripening in women with previous cesarean deliveries undergoing induction of labor. METHODS: Retrospective study of women with previous low transverse cesarean deliveries who underwent ripening of an unfavorable cervix prior to induction of labor (n = 89). Multiparas without previous cesarean deliveries undergoing ripening and induction of labor during the same time period were used for comparison (n = 61). Ripening was performed with prostaglandin E2 (PGE2) gel, or an osmotic dilator, or both. Induction of labor with oxytocin followed the American College of Obstetricians and Gynecologists' guidelines. Outcome data were analyzed using the unpaired Student's t-test or chi 2-test as appropriate. Significance was established at P < 0.05. RESULTS: The mean gestational age was 39.6 +/- 2.6 and 38.2 +/- 2.9 weeks for the study and comparison groups, respectively. There were no differences between the groups in Bishop score, duration of the first stage of labor, maximum dose of oxytocin, indications for cesarean delivery, puerperal morbidity, birthweight, Apgar scores or NICU admissions. Sixty-four percent (57 of 89) of study women delivered vaginally compared with 82% (50 of 61) of women in the comparison group (P < 0.03). The data were analyzed separately for those women undergoing cervical ripening with PGE2 gel only. No differences were observed between the groups in any of the categories mentioned above. CONCLUSION: Cervical ripening appears to be safe and effective in women with previous low transverse cesarean deliveries undergoing induction of labor with an unfavorable cervix.

Serum immunoreactive erythropoietin and red blood cell mass during pregnancy in conscious rats.

Serum erythropoietin concentration increases during human pregnancy and presumably accounts for expansion of red blood cell mass. The mechanism(s) underlying gestational changes of serum erythropoietin are unknown. Moreover, if erythropoietin synthesis increases, then the organ(s) questions about erythropoietin in pregnancy, we first set out to establish an animal model. Chronically instrumented, conscious unrestrained rats were studied. 51Cr-labeled red blood cells and radioimmunoassay were used to assess red blood cell mass and serum erythropoietin, respectively. Except for a lower hematocrit (P < 0.05 vs. virgin rats) and a slightly higher plasma volume (P value not significant) for gravid rats on gestational day 6, all other variables measured in early pregnancy rats were comparable to those measured in virgin control animals. Significant increases in total blood volume, plasma volume, and red blood cell mass were observed by gestational day 13 (midpregnancy) when compared with virgin control rats. These changes were even more pronounced on gestational day 20. Serum immunoreactive erythropoietin was also significantly increased at both of these stages of pregnancy. We conclude that the gravid rat is a reliable animal model of human gestation in which to further investigate erythropoietin in pregnancy.

Labor induction with the prostaglandin E1 methyl analogue misoprostol versus oxytocin: a randomized trial.

OBJECTIVE: To compare the safety and efficacy of intravaginal misoprostol versus intravenous (IV) oxytocin infusion for labor induction. METHODS: One hundred thirty patients were randomly assigned to one of two induction groups: 1) intravaginal misoprostol or 2) IV oxytocin by continuous infusion, with prior cervical ripening using prostaglandin (PG) E2 gel if necessary. RESULTS: Among 129 patients evaluated, 64 were allocated to the misoprostol group and 65 to the oxytocin group. Prostaglandin E2 gel was administered to 29 patients (45%) in the oxytocin group with unripe cervices. Uterine tachysystole occurred more frequently in patients in the misoprostol group (34.4%) than in the oxytocin group (13.8%) (P < .05). Nevertheless, no statistically significant differences were noted between the groups in intrapartum complications including uterine hyperstimulation syndrome, mode of delivery, and neonatal or maternal adverse outcomes. The interval from induction to vaginal delivery was significantly shorter in the misoprostol group (11 versus 18 hours; P = .004). In 74% of patients in the misoprostol group, only one intravaginal dose was required for successful labor induction. CONCLUSIONS: Intravaginal administration of misoprostol safely and effectively induces labor while minimizing the expense associated with IV oxytocin infusion. The higher frequency of uterine tachysystole associated with the use of misoprostol did not increase the risk of adverse intrapartum or perinatal outcomes. The use of PGE2 gel for cervical ripening contributed to the longer induction-to-vaginal delivery interval noted in the oxytocin group. Clinical trials appear warranted to detail misoprostol's optimal route, dose, and schedule for labor induction and its safety.

Does closure of Camper fascia reduce the incidence of post-cesarean superficial wound disruption?

OBJECTIVE: To determine whether closure of Camper fascia prevents the development of superficial wound disruption after cesarean delivery. METHODS: During a 1-year period, 438 women undergoing cesarean delivery were randomized into groups with and without approximation of Camper fascia with absorbable suture during closure of the abdominal incision. All women received routine postoperative care following our departmental guidelines. We reviewed charts after the puerperium to identify women with postoperative superficial wound disruption and to obtain demographic and delivery information for analysis. RESULTS: We found a significantly higher incidence of wound disruption in the group without the suture than in those in whom the tissue was approximated (P = .03). Four or more vaginal examinations and higher body mass index were also associated with a higher incidence of wound disruption (P = .05 and P = .04, respectively). Logistic regression correction for covariables that might influence the results of our main analysis revealed no effect of maternal age, parity, indications for cesarean delivery, duration of labor, duration of ruptured membranes, duration of surgery, use of internal monitoring, type of incision, use of antibiotic prophylaxis, surgeon's level of training, or maternal diabetes mellitus and/or hypertension. CONCLUSION: Approximation of Camper fascia with absorbable suture at closure of the abdominal incision during cesarean delivery appears to protect against postoperative superficial wound disruption and is therefore recommended.

The biophysical profile and the nonstress test: poor predictors of chorioamnionitis and fetal infection in prolonged preterm premature rupture of membranes.

Sixty-eight women admitted with the diagnosis of preterm premature rupture of membranes (PROM) and a latency period of at least 48 hours were followed expectantly. Fetal surveillance consisted of daily kick counts, daily nonstress test (NST), and fetal biophysical profile every 48-72 hours. Patients were delivered as a result of spontaneous labor, clinical chorioamnionitis, fetal distress, or attainment of 37 weeks' gestation. No corticosteroids, tocolytics, or prophylactic antibiotics were used. The last biophysical profile and the last NST before delivery were evaluated for each patient. There was no statistically significant association between chorioamnionitis or fetal infection and the following: 1) a low biophysical profile (score of 6 or lower), 2) a low biophysical profile that included a nonreactive NST and absent fetal breathing movements, or 3) a nonreactive NST. We conclude that the biophysical profile and the NST are poor predictors of perinatal infectious complications.

Prenatal diagnosis of triploidy. A case report.

Fetal triploidy can be suspected but not diagnosed based on ultrasonographic findings. A patient was diagnosed with fetal triploidy in the second trimester.

Diagnosis of cervical change in pregnancy by means of transvaginal ultrasonography.

There are no absolute objective diagnostic criteria for cervical incompetence. Abdominal and endovaginal ultrasonographic assessment of endocervical length, both of which have been associated with technical problems, have been used to establish the diagnosis. Cervical cerclage may be useful in preventing silent cervical dilatation; however, no prospective trials with and without cerclage have been performed when endocervical shortening has been demonstrated by ultrasonography.

Acute posttraumatic fetal anemia treated with fetal intravascular transfusion.

Fetal trauma resulting in acute anemia after maternal blunt abdominal trauma is a rare but potentially lethal condition. We recently managed such a case with the use of fetal intravascular transfusion.