CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Management of the symptomatic placenta previa: a randomized, controlled trial of inpatient versus outpatient expectant management.

OBJECTIVE: Our purpose was to determine the safety, efficacy, and costs of inpatient and outpatient management of symptomatic placenta previa.

STUDY DESIGN: Fifty-three women with the initial diagnosis of placenta previa at 24 to 36 weeks' gestation who required hospitalization for vaginal bleeding were stabilized and then randomized to receive either inpatient or outpatient expectant management. Twenty-seven inpatients were placed at bed rest with minimal ambulation, received weekly corticosteroids until 32 weeks of gestation, and underwent ultrasonographic examination at 2-week intervals to assess fetal growth and placental location. Twenty-six outpatients were discharged home after > or = 72 hours of hospitalization. Each week they also received corticosteroids, until 32 weeks' gestation, and ultrasonographic evaluations. Outpatients with recurrent bleeding were readmitted for evaluation. All subjects who reached 36 weeks' gestation with persistent placenta previa underwent amniocentesis. When fetal lung maturity was present, cesarean delivery was electively performed.

RESULTS: There were insignificant differences between inpatients and outpatients for mean age, parity, race, type of previa (complete or partial), number of prior vaginal bleeding episodes, and initial hemoglobin value. The mean estimated gestational age at enrollment was 29.1 +/- 3.1 (SD) weeks for inpatients and 29.9 +/- 3.1 weeks for outpatients. In eight patients the placenta was found to no longer cover the internal os by 36 weeks' gestation. There were seven patients in each group who did not complete the protocol for initial treatment assignment. The average estimated gestational age at delivery for the inpatients was 34.5 +/- 2.4 weeks and 34.6 +/- 2.3 weeks for the outpatients (p = 0.90), whereas the mean birth weights were 2413.7 +/- 642.7 gm and 2607.8 +/- 587.1 gm, respectively (p = 0.28). Thirty-three patients (62.3%) had recurrent episodes of bleeding, with 26 requiring expeditious cesarean delivery. Four (14.8%) inpatients and one (3.7%) outpatient required blood transfusion (p = 0.67). There was no difference in neonatal morbidity (defined as the presence of respiratory distress syndrome, intracranial hemorrhage, or culture-proved sepsis) between the two groups (relative risk 1.16, 95% confidence interval 0.66 to 2.02). There were no neonatal deaths. The mean number of maternal hospital days differed significantly between the two groups: inpatients required an average of 28.6 +/- 20.3 days and outpatients remained hospitalized for an average of 10.1 +/- 8.5 days (p < 0.0001). Cost analysis based on maternal hospital days reveals a net savings of +15,080 per patient if women with symptomatic placenta previa initially diagnosed before 37 weeks' gestation are treated as outpatients.

CONCLUSIONS: For selected patients, outpatient management of symptomatic placenta previa appears to be an acceptable alternative to traditional conservative expectant inpatient management.

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