Induction of labor with misoprostol for premature rupture of membranes beyond thirty-six weeks' gestation.
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Publications and source records attributed to L Sanchez-Ramos.
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OBJECTIVE: Our purpose was to analyze published randomized trials assessing the efficacy of maintenance tocolytic therapy after short-term tocolysis in patients with acute preterm labor. STUDY DESIGN: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized trials assessing the efficacy of maintenance tocolytic therapy after resolution of the acute preterm labor episode. Two masked investigators performed independent trial quality evaluation and data abstraction of each trial. We calculated an estimate of the odds ratio and risk difference for dichotomous outcomes, using both a random- and fixed-effects model. Continuous outcomes were pooled with a variance-weighted average of the within-study difference in means. RESULTS: Of 17 studies identified, 12 met our criteria for meta-analysis. These 12 trials included 1590 patients, including 855 who received maintenance tocolysis and 735 comparison patients who received placebo or no maintenance treatment. Compared with placebo or no treatment, the pooled odds ratio for preventing preterm delivery was 0.95 (95% confidence interval, 0. 77-1.17), and the odds ratio for preventing recurrent preterm labor was 0.81 (95% confidence interval, 0.64-1.03). In addition, use of maintenance tocolytic therapy was not associated with decreased rates of neonatal respiratory distress syndrome, perinatal deaths, or differences in birth weight. Although no difference was noted in mean gestational age at delivery, those receiving tocolytic agents had a longer latency period. CONCLUSION: Maintenance tocolytic therapy after successful treatment of an acute episode of preterm labor does not reduce the incidence of recurrent preterm labor or preterm delivery and does not improve perinatal outcome. Accordingly, the results of this meta-analysis do not support the use of maintenance tocolytic therapy after successful treatment of preterm labor.
OBJECTIVE: To systematically review published randomized trials that compared efficacy of a 10-mg, controlled-release dinoprostone vaginal insert with other prostaglandins for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify randomized clinical trials of dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS OF STUDY SELECTION: We evaluated, abstracted data, and assessed the quality of randomized clinical trials on the efficacy of dinoprostone vaginal inserts as cervical ripening and labor induction agents. Only published randomized trials were included in this meta-analysis. TABULATION, INTEGRATION, AND RESULTS: Seventeen studies were identified, eight of which met our criteria for metaanalysis. Those eight trials included 964 subjects, 490 of whom were allocated to dinoprostone vaginal inserts and 474 to other prostaglandin (PG) preparations. We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. Compared with women who received other PG preparations, those who received dinoprostone vaginal inserts had lower incidence of vaginal delivery within 12 hours of PG application (OR 0.55, 95% confidence interval 0.39, 0.79). Vaginal inserts were associated with longer intervals to vaginal delivery and lower rates of active labor. There were no differences in cesarean delivery rates, incidence of hyperstimulation, or need for oxytocin augmentation between dinoprostone and other PGs. CONCLUSION: Dinoprostone vaginal insert was less effective than other prostaglandins for cervical ripening and labor induction.
OBJECTIVE: To compare the safety, efficacy, and costs of intravaginal misoprostol versus dinoprostone vaginal inserts for cervical ripening and labor induction. METHODS: Two hundred twenty-three labor induction patients were assigned randomly to one of two treatment groups: 1) intravaginal misoprostol or 2) dinoprostone vaginal inserts. Fifty micrograms of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum period of 24 hours. Ten milligrams of dinoprostone was administered in a single application as a vaginal insert for 12 hours. RESULTS: Among 223 patients evaluated, 108 were allocated to the misoprostol group and 115 to the dinoprostone group. The median interval from induction to vaginal delivery was significantly shorter in the misoprostol group: 698 (range 395-1053) versus 1041 (range 792-1531) minutes (P < .001). Vaginal delivery within 12 hours of ripening occurred in 40.7% of patients who received misoprostol compared with 19.1% for those receiving dinoprostone (P < .001); no significant difference between the groups was noted for vaginal delivery within 24 hours. Uterine tachysystole occurred more frequently in patients in the misoprostol group (21.3%) than in the dinoprostone group (7.0%) (P = .004). Nevertheless, no statistically significant differences were noted between the groups with respect to intrapartum complications, including uterine hyperstimulation, mode of delivery, and neonatal or maternal adverse outcomes. The average cost per patient for misoprostol treatment was $85 compared with $606 for treatment with the vaginal insert. CONCLUSION: Intravaginal misoprostol and the dinoprostone vaginal insert appear to be safe agents for cervical ripening and labor induction. However, misoprostol is less expensive and more effective than the dinoprostone vaginal insert.
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.
OBJECTIVE: To analyze published randomized trials assessing the safety and efficacy of misoprostol for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic data bases with references cited in original studies and review articles to identify randomized trials of misoprostol for cervical ripening and labor induction. METHODS OF STUDY SELECTION: Two blinded investigators performed independent trial quality evaluation and data abstraction of randomized clinical trials assessing the efficacy of misoprostol as a cervical ripening and labor-inducing agent. TABULATION, INTEGRATION, AND RESULTS: We calculated an estimate of the odds ratio (OR) and risk difference for dichotomous outcomes, using both a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of the within-study difference in means. Of 16 studies identified, eight met our criteria for meta-analysis. These eight trials included 966 patients (488 received misoprostol and 478 were controls). Women who received misoprostol for cervical ripening and labor induction had a significantly lower overall cesarean rate (OR 0.67, 95% confidence interval [CI] 0.48, 0.93) and a higher incidence of vaginal delivery within 24 hours of misoprostol application (OR 2.64, 95% CI 1.87, 3.71). Use of misoprostol was associated with a higher incidence of tachysystole (OR 2.70, 95% CI 1.80, 4.04) but not hyperstimulation (OR 1.91, 95% CI 0.98, 3.73). The incidences of abnormal 5-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the misoprostol and control groups. The pooled estimate of the mean interval from start of induction to delivery was 4.6 hours fewer (95% CI -3.5, -5.7) in the misoprostol group. CONCLUSION: Published data confirm the safety and efficacy of intravaginal misoprostol as an agent for cervical ripening and labor induction.
OBJECTIVE: To evaluate the safety and clinical effectiveness of intravaginal misoprostol, a synthetic prostaglandin E1 analogue, for labor induction in gravidas with premature rupture of membranes (PROM) at term. METHODS: One hundred forty-one pregnant women with term PROM were assigned randomly to one of two induction groups: 1) intravaginal misoprostol or 2) intravenous oxytocin by continuous infusion. RESULTS: Seventy subjects were allocated to the misoprostol group and 71 to the oxytocin group. The mean (+/- standard deviation) interval from induction to delivery was significantly shorter in the misoprostol group (416 +/- 276 compared with 539 +/- 372 minutes; P = .04). In 85.7% of patients in the misoprostol group, only one dose was required. Intrapartum complication rates, mode of delivery, and neonatal or maternal adverse event rates were similar in the two treatment groups. Uterine tachysystole occurred more frequently with misoprostol than with oxytocin (28.6% compared with 14.0%; P < .04). CONCLUSION: Intravaginal administration of misoprostol induces labor safely and effectively in patients with PROM at term.
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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.
OBJECTIVE: To evaluate the efficacy of intrapartum prophylactic administration of ampicillin-sulbactam in reducing intraamniotic infection and postpartum endometritis in patients with meconium-stained amniotic fluid (AF). METHODS: Patients with intrapartum meconium-stained AF were randomized to receive either ampicillin-sulbactam or normal saline (placebo) intravenously at the time of diagnosis of meconium and every 6 hours until delivery. The outcomes of the two groups were compared with respect to intra-amniotic infection and postpartum endometritis. RESULTS: During the study period, 332 patients with meconium-stained AF were approached for participation, and 120 patients met inclusion criteria and were enrolled. Patient demographics, labor, and delivery characteristics were similar. Ampicillin-sulbactam reduced the incidence of intra-amniotic infection from 23.3 to 6.7%, (P = .02; relative risk [RR] 0.48, 95% confidence interval [CI] 0.22-0.98). The incidence of postpartum endometritis was also reduced, but the difference was statistically nonsignificant (8.3 versus 16.7%, P = .16; RR 0.64, 95% CI 0.30-1.33). CONCLUSION: Prophylactic intravenous ampicillin-sulbactam significantly reduces intra-amniotic infection in patients with meconium-stained AF.
OBJECTIVE: To compare oxytocin infusion alone and with intravenous (i.v.) propranolol in the management of dysfunctional labor. METHODS: Ninety-six parturients with abnormalities of the active phase of labor were randomly assigned to either propranolol 2 mg IV or an identical placebo, in addition to continuous infusion of oxytocin. Administration of propranolol or placebo was repeated in 1 hour if there was no change in cervical dilation. Patients not responding to this second administration of propranolol or placebo were delivered by cesarean. RESULTS: Among 96 subjects enrolled, 49 were allocated to the propranolol group and 47 to the placebo group; 13 (26.5%) of the former were delivered by cesarean, compared with 24 (51.1%) of the latter (relative risk 0.58, 95% confidence interval 0.35-0.93; P = .02). Between the two groups, no differences were observed in low Apgar scores, cord arterial pH, or incidence of admissions to the neonatal intensive care nursery. Maternal morbidity was similar in both groups. After logistic regression analysis controlling for nulliparity, birth weight, and epidural anesthetic use, the significant reduction in the cesarean rate associated with use of propranolol persisted. Propranolol administration was associated with a markedly reduced cesarean rate among patients with inadequate uterine contractility. CONCLUSION: Low-dose administration of IV propranolol in patients with dysfunctional labor augmented with oxytocin safely reduced the need for cesarean delivery, particularly among patients with inadequate uterine contractility.
OBJECTIVE: Our purpose was to determine the efficacy and safety of a trial of labor in patients previously delivered at least once by a lower uterine vertical cesarean section. STUDY DESIGN: A retrospective review was performed at a single tertiary perinatal center, The University of Florida Health Science Center, Jacksonville. The medical records of all patients with a previous low vertical cesarean section who underwent a trial of labor during a 72-month period from January 1988 until December 1993 were reviewed. The medical records of the next two patients who did not have a prior uterine incision admitted to labor and delivery after the index case served as the controls. The duration and outcome of labor, including mode of delivery, maternal and perinatal morbidity, and birth trauma were evaluated. RESULTS: Of 77 patients with a previous low vertical cesarean incision, 11 (14.3%) had a repeat operation compared with 14 of 154 patients (9.0%) in the no previous cesarean section group (not significant). No differences were noted in the incidences of operative vaginal deliveries or prolonged duration of the first or second stages of labor, or in the rate or maximum dose of oxytocin infusion between the two groups. One patient in the previous cesarean section group had uterine rupture. The incidence of umbilical artery pH < or = 7.20 was similar. No difference in the number of infants with 1- or 5-minute Apgar scores < or = 7 was noted. CONCLUSION: A trial of labor in women with previous low vertical cesarean sections results in an acceptable rate of vaginal delivery and appears safe for both mother and fetus.
OBJECTIVE: Our purpose was to evaluate the effects of n-3 fatty acid supplementation on vascular reactivity as measured by the angiotensin II sensitivity test. STUDY DESIGN: Ten subjects with uneventful pregnancies, who were free of any chronic medical illnesses, between 24 and 34 weeks' gestation participated. Each subject was provided with OMEGA-3 700 softgel capsules and instructed to take three tablets three times daily (approximately 3.6 gm of eicosapentaenoic acid). The angiotensin II sensitivity test was performed before and 28 days after supplementation. Compliance was assessed by analysis of computerized pill bottles. Statistical analyses of the data were performed with a paired t test for evenly distributed continuous data. A sample size of eight patients was required to detect a difference in effective pressor dose of > or = 10 ng/kg/min between the presupplement and postsupplement results, assuming an alpha of 0.05 and a beta of 0.20 (80% power). RESULTS: The effective pressor dose before treatment (13.6 +/- 6.3 ng/kg/min) (mean +/- SD) was significantly less (p = 0.001) than after supplementation (35.8 +/- 15.9 ng/kg/min). CONCLUSIONS: High-dose n-3 fatty acid supplementation resulted in an enhancement of the pregnancy-acquired refractoriness to angiotensin II.
OBJECTIVE: The 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. STUDY DESIGN: This 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. RESULTS: During 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. CONCLUSIONS: Daily single-dose intravenous ceftriaxone is as effective as multiple-dose cefazolin in the treatment of patients with acute pyelonephritis during pregnancy.
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.
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.
To determine the efficacy and safety of labor induction in patients previously delivered by at least one low transverse cesarean section, a retrospective review was done at a single tertiary perinatal center, the University of Florida Health Science Center, Jacksonville. All patients with a previous cesarean section who required labor induction from 1988 until the end of 1992 were identified. Duration and outcome of labor induction, including mode of delivery, maternal and perinatal morbidity, and birth trauma, were evaluated. Of 160 patients with a previous cesarean, 50 (31.3%) had a repeat operation compared to 18 (11.2%) in the no previous cesarean group (p = 0.001, odds ratio = 3.59; 95% confidence interval, 1.98, 6.49). Women in the cesarean group had a higher incidence of operative vaginal deliveries, prolonged duration of the first and second stages of labor, rate and maximum dose of oxytocin infusion. One patient in the previous cesarean group experienced uterine rupture. There was no difference in the rate of infants with low 5-minute Apgar scores or with cord pH values less than 7.20. Labor induction in women with previous low transverse cesarean sections results in an acceptable rate of vaginal delivery and appears safe for both mother and fetus.
Amnioinfusion has become accepted in the management of intrapartum cord compression, meconium-stained fluid, and oligohydramnios. Limited experience exists regarding amnioinfusion in patients undergoing a trial of labor after cesarean section and its potential complications. We report a case of trial of labor in which uterine rupture occurred following intrapartum amnioinfusion. This case demonstrates the need for careful attention to amnioinfusion volumes and administration in patients with a previous cesarean section.