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Background Knowledge of fetal oxygen saturation, as an adjunct to electronic fetal monitoring, may be associated with a significant change in the rate of cesarean deliveries or the infant's condition at birth.
Methods We randomly assigned 5341 nulliparous women who were at term and in early labor to either "open" or "masked" fetal pulse oximetry. In the open group, fetal oxygen saturation values were displayed to the clinician. In the masked group, the fetal oxygen sensor was inserted and the values were recorded by computer, but the data were hidden. Labor complicated by a nonreassuring fetal heart rate before randomization was documented for subsequent analysis.
Results There was no significant difference in the overall rates of cesarean delivery between the open and masked groups (26.3% and 27.5%, respectively; P=0.31). The rates of cesarean delivery associated with the separate indications of a nonreassuring fetal heart rate (7.1% and 7.9%, respectively; P=0.30) and dystocia (18.6% and 19.2%, respectively; P=0.59) were similar between the two groups. Similar findings were observed in the subgroup of 2168 women in whom a nonreassuring fetal heart rate was detected before randomization. The condition of the infants at birth did not differ significantly between the two groups.
Conclusions Knowledge of the fetal oxygen saturation is not associated with a reduction in the rate of cesarean delivery or with improvement in the condition of the newborn. (ClinicalTrials.gov number, NCT00098709
[ClinicalTrials.gov]
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Source Information
From the University of Texas Southwestern Medical Center, Dallas (S.L.B.); the National Institute of Child Health and Human Development, Bethesda, MD (C.Y.S.); George Washington University Biostatistics Center, Washington, DC (E.T.); University of Utah, Salt Lake City (M.W.V.); University of Alabama at Birmingham, Birmingham (D.J.R.); the Food and Drug Administration, Rockville, MD (S.W.); University of Texas Health Science Center, Houston (S.M.R.); University of Pittsburgh, Pittsburgh (S.N.C.); Northwestern University, Chicago (A.P.); Wayne State University, Detroit (Y.S.); Drexel University, Philadelphia (A.S.); Brown University, Providence, RI (M.C.); Case Western Reserve University, Cleveland (B.M.); University of North Carolina, Chapel Hill (J.T.); Columbia University, New York (F.M.); Wake Forest University, Winston-Salem, NC (M.H.); Ohio State University, Columbus (J.I.); and University of Texas Medical Branch, Galveston (G.A.).
Address reprint requests to Dr. Bloom at the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390, or at steven.bloom{at}utsouthwestern.edu.
Related Letters:
Fetal Pulse Oximetry and Cesarean Delivery
Peek M. J., Condous G. S., Nanan R. K.H., Bloom S. L., Spong C. Y., Thom E. A., the National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network
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N Engl J Med 2007;
356:1377-1378, Mar 29, 2007.
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