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.

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

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.

Prevention of pregnancy-induced hypertension by calcium supplementation in angiotensin II-sensitive patients.

OBJECTIVE: To evaluate the efficacy of oral supplemental calcium in reducing the incidence of pregnancy-induced hypertension (gestational hypertension or preeclampsia) in angiotensin-sensitive nulliparas. METHODS: Sensitivity to intravenously infused angiotensin was determined at 24-28 weeks' gestation in 281 nulliparous women who had positive roll-over tests. Angiotensin-sensitive women were given 2 g/day of oral elemental calcium or placebo in a randomized, double-blind clinical trial. The tablets were dispensed by the hospital pharmacy in serially numbered computerized pill bottles so as to assess compliance. Repeat angiotensin sensitivity test was performed at 34-36 weeks' gestation. RESULTS: Sixty-three of 67 angiotensin-sensitive nulliparas were evaluable; 29 received calcium and 34 received placebo tablets. Four of 29 calcium-treated subjects (13.8%, 95% confidence interval [CI] 4-32%) developed preeclampsia, compared to 15 of 34 (44.1%, 95% CI 27-62%) in the placebo group (relative risk [RR] 0.37, 95% CI 0.15-0.92; P = .01). The incidence of any type of hypertension was nine of 29 (31%, 95% CI 15-51%) with calcium treatment, compared to 22 of 34 (64.7%, 95% CI 46-80%) with placebo (RR 0.46, 95% CI 0.25-0.86; P = .01). CONCLUSION: Calcium supplementation given in pregnancy to high-risk nulliparas reduces the incidence of pregnancy-induced hypertension.

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.