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1.
JAMA ; 278(12): 989-95, 1997 Sep 24.
Article in English | MEDLINE | ID: mdl-9307346

ABSTRACT

CONTEXT: Intrauterine infection is thought to be one cause of preterm premature rupture of the membranes (PPROM). Antibiotic therapy has been shown to prolong pregnancy, but the effect on infant morbidity has been inconsistent. OBJECTIVE: To determine if antibiotic treatment during expectant management of PPROM will reduce infant morbidity. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: University hospitals of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. PATIENTS: A total of 614 of 804 eligible gravidas with PPROM between 24 weeks' and 0 days' and 32 weeks' and 0 days' gestation who were considered candidates for pregnancy prolongation and had not received corticosteroids for fetal maturation or antibiotic treatment within 1 week of randomization. INTERVENTIONS: Intravenous ampicillin (2-g dose every 6 hours) and erythromycin (250-mg dose every 6 hours) for 48 hours followed by oral amoxicillin (250-mg dose every 8 hours) and erythromycin base (333-mg dose every 8 hours) for 5 days vs a matching placebo regimen. Group B streptococcus (GBS) carriers were identified and treated. Tocolysis and corticosteroids were prohibited after randomization. MAIN OUTCOME MEASURES: The composite primary outcome included pregnancies complicated by at least one of the following: fetal or infant death, respiratory distress, severe intraventricular hemorrhage, stage 2 or 3 necrotizing enterocolitis, or sepsis within 72 hours of birth. These perinatal morbidities were also evaluated individually and pregnancy prolongation was assessed. RESULTS: In the total study population, the primary outcome (44.1 % vs 52.9%; P=.04), respiratory distress (40.5% vs 48.7%; P=.04), and necrotizing enterocolitis (2.3% vs 5.8%; P=.03) were less frequent with antibiotics. In the GBS-negative cohort, the antibiotic group had less frequent primary outcome (44.5% vs 54.5%; P=.03), respiratory distress (40.8% vs 50.6%; P=.03), overall sepsis (8.4% vs 15.6%; P=.01), pneumonia (2.9% vs 7.0%; P=.04), and other morbidities. Among GBS-negative women, significant pregnancy prolongation was seen with antibiotics (P<.001). CONCLUSIONS: We recommend that women with expectantly managed PPROM remote from term receive antibiotics to reduce infant morbidity.


Subject(s)
Drug Therapy, Combination/therapeutic use , Fetal Membranes, Premature Rupture/drug therapy , Infant, Premature, Diseases/epidemiology , Adult , Amoxicillin/administration & dosage , Amoxicillin/therapeutic use , Ampicillin/administration & dosage , Ampicillin/therapeutic use , Carrier State/drug therapy , Carrier State/physiopathology , Double-Blind Method , Erythromycin/administration & dosage , Erythromycin/therapeutic use , Female , Fetal Membranes, Premature Rupture/microbiology , Humans , Infant, Newborn , Infant, Premature , Pregnancy , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/physiopathology , Pregnancy Outcome , Pregnancy Trimester, Second , Pregnancy Trimester, Third , Proportional Hazards Models , Statistics, Nonparametric , Streptococcal Infections/drug therapy , Streptococcal Infections/physiopathology , Streptococcus agalactiae
2.
Am J Obstet Gynecol ; 174(3): 812-7, 1996 Mar.
Article in English | MEDLINE | ID: mdl-8633648

ABSTRACT

OBJECTIVE: Our goal was to determine the false-negative and false-positive rates of antepartum testing by use of the modified biophysical profile. STUDY DESIGN: From Jan. 1, 1990, through Dec. 31, 1994, antepartum testing results were gathered prospectively and tabulated monthly. For 1 year, 1991, detailed intrapartum and neonatal data were collected from all women admitted and delivered as a result of an abnormal antepartum test result. RESULTS: The false-negative rate of the antepartum testing protocol was 0.8 per 1000 women tested. Sixty percent of those delivered because of an abnormal antepartum test had no evidence of short-term or long-term fetal compromise. False-positive test results led to preterm delivery in 1.5% of those tested before term. CONCLUSION: The false-negative rate of the modified biophysical profile is lower than that of the nonstress test and compares favorably with the false-negative rates of the contraction stress test and the complete biophysical profile. Iatrogenic prematurity resulting from intervention for false positive test results occurred in 1.5% of women tested before 37 weeks.


Subject(s)
Fetal Monitoring , Fetus/physiology , Adult , Biophysical Phenomena , Biophysics , Chi-Square Distribution , False Negative Reactions , False Positive Reactions , Female , Heart Rate, Fetal , Humans , Pregnancy , Pregnancy, High-Risk , Prospective Studies
3.
Obstet Gynecol ; 79(6): 1024-6, 1992 Jun.
Article in English | MEDLINE | ID: mdl-1579300

ABSTRACT

Management of the post-term pregnancy depends on the certainty of dating, likelihood of successful induction, and risks of expectant management. To estimate the risk of fetal death in an expectantly managed post-term population, we reviewed 8038 consecutive post-term gestations followed expectantly with a twice-weekly nonstress test and amniotic fluid index. There were nine antepartum fetal deaths and no intrapartum fetal deaths, a fetal mortality rate of 1.12 per 1000. Timing of delivery of the post-term gestation balances this risk of loss of a viable fetus with the risks of uncertain dating and failure of induction of labor.


Subject(s)
Fetal Death/epidemiology , Fetal Monitoring , Infant, Postmature , Female , Gestational Age , Humans , Infant, Newborn , Pregnancy
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