A randomized, controlled trial of oral and intramuscular dexamethasone in the prevention of neonatal respiratory distress syndrome,☆☆,

Presented at the Eighteenth Annual Meeting of the Society of Perinatal Obstetricians, Miami, Florida, February 2-7, 1998.
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Abstract

Objective: The study’s objective was to compare the efficacies of oral and intramuscular antenatal administration of dexamethasone in reducing neonatal respiratory distress syndrome. Study Design: Subjects at high risk for preterm delivery between 24 and 33 weeks’ gestation were prospectively randomly assigned to receive either 6 mg intramuscular dexamethasone or 8 mg oral dexamethasone every 12 hours for 4 doses. The regimen was repeated weekly until 34 weeks’ gestation if delivery had not yet occurred. A blinded data review was performed. The primary outcome of the trial was respiratory distress syndrome. Data were analyzed in an intent to treat fashion. Comparisons were made with an unpaired t test, χ2 or Fisher exact test, and survival analysis. P < .05 was considered significant. Results: The study was discontinued at 39% enrollment after a blinded review of available outcomes. A total of 170 women with 188 fetuses were randomly assigned. The oral and intramuscular groups had similar mean gestational ages at enrollment (29.9 weeks vs 29.2 weeks) and similar median latencies (9.5 vs 10 days). No difference in the frequency of respiratory distress syndrome was found between the oral and intramuscular groups, (34.3% vs 29.8%). Neonatal sepsis (10.1% vs 1.2%, P = .01) and intraventricular hemorrhage (10.1% vs 2.4%, P = .04) were significantly higher in the oral group. There were no statistical differences in the frequencies of necrotizing enterocolitis or neonatal death. A subgroup analysis of 112 patients who were delivered at <34 weeks’ gestation revealed no statistical difference in respiratory distress syndrome between the groups; however, oral dexamethasone was associated with a significant increase in sepsis (15.9% vs 1.6%, P = .009) and intraventricular hemorrhage (15.9% vs 3.3%, P = .03). Conclusion: Oral administration increases neonatal morbidity without demonstrable benefit and should not at this time be used clinically for induction of fetal pulmonary maturation. (Am J Obstet Gynecol 1998;179:1120-3.)

Section snippets

Material and methods

After institutional review board approval and informed consent were obtained, subjects at high risk for preterm delivery were recruited between 24 and 33 weeks’ gestation. Patients were randomly assigned (by computer-generated numbers placed in sealed envelopes) to receive dexamethasone either as 6 mg intramuscularly or as 8 mg orally every 12 hours for 4 doses. Patient compliance was monitored by nursing personnel. Complete corticosteroid courses were repeated at 7 days after the last

Results

One hundred seventy women were recruited between July 1996 and July 1997. Five patients were unavailable for follow-up, leaving 165 subjects for analysis. Ninety-two women received oral dexamethasone and 78 women received intramuscular dexamethasone. Five women in the intramuscular group and 7 women in the oral group had received 1 dose of betamethasone at their community hospital before transport.

Maternal age, race, gestational age at random assignment, cervical dilation, and prevalence of

Comment

In this study women at risk for preterm delivery were randomly assigned to receive either 8 mg oral or 6 mg intramuscular dexamethasone every 6 hours for 4 doses. The regimen was repeated until 34 weeks’ gestation was reached. Although we found no statistical difference in the primary outcome of respiratory distress syndrome, higher frequencies of intraventricular hemorrhage and neonatal sepsis were seen in the group treated with oral dexamethasone, an unexpected finding. Gestational age at

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From the Department of Obstetrics and Gynecology, University of Tennessee, Memphis.

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Reprint requests: Robert S. Egerman, MD, Department of Obstetrics and Gynecology, University of Tennessee, Memphis, 853 Jefferson, Suite E 102, Memphis, TN 38103.

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