A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis.
BACKGROUND
It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes.


METHODS
We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor. The open system displayed additional information for use when uncertain fetal heart-rate patterns were detected. The primary outcome was a composite of intrapartum fetal death, neonatal death, an Apgar score of 3 or less at 5 minutes, neonatal seizure, an umbilical-artery blood pH of 7.05 or less with a base deficit of 12 mmol per liter or more, intubation for ventilation at delivery, or neonatal encephalopathy.


RESULTS
A total of 11,108 patients underwent randomization; 5532 were assigned to the open group, and 5576 to the masked group. The primary outcome occurred in 52 fetuses or neonates of women in the open group (0.9%) and 40 fetuses or neonates of women in the masked group (0.7%) (relative risk, 1.31; 95% confidence interval, 0.87 to 1.98; P=0.20). Among the individual components of the primary outcome, only the frequency of a 5-minute Apgar score of 3 or less differed significantly between neonates of women in the open group and those in the masked group (0.3% vs. 0.1%, P=0.02). There were no significant between-group differences in the rate of cesarean delivery (16.9% and 16.2%, respectively; P=0.30) or any operative delivery (22.8% and 22.0%, respectively; P=0.31). Adverse events were rare and occurred with similar frequency in the two groups.


CONCLUSIONS
Fetal ECG ST-segment analysis used as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring did not improve perinatal outcomes or decrease operative-delivery rates. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).
From the University of Utah Health Sciences Center, Salt Lake City (M.A.B.); University of Texas Medical Branch, Galveston (G.R.S.); the George Washington University Biostatistics Center, Washington, DC (E.T.); the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston (S.C.B.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); University of North Carolina at Chapel Hill, Chapel Hill (J.M.T.); University of Alabama at Birmingham, Birmingham (A.T.N.T.); Columbia University, New York (R.S.M.); Northwestern University, Chicago (A.M.P.); Ohio State University, Columbus (D.S.M.); MetroHealth Medical Center-Case Western Reserve University, Cleveland (E.K.S.C.); Brown University, Providence, RI (D.J.R.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Stanford University, Stanford, CA (Y.Y.E.-S.); Wayne State University, Detroit (Y.S.); University of Pittsburgh, Pittsburgh (S.N.C.); and Medical University of South Carolina, Charleston (J.P.V.D.).
Michael A
MA
Belfort
George R
GR
Saade
Elizabeth
E
Thom
Sean C
SC
Blackwell
Uma M
UM
Reddy
John M
JM
Thorp
Alan T N
AT
Tita
Russell S
RS
Miller
Alan M
AM
Peaceman
David S
DS
McKenna
Edward K S
EK
Chien
Dwight J
DJ
Rouse
Ronald S
RS
Gibbs
Yasser Y
YY
El-Sayed
Yoram
Y
Sorokin
Steve N
SN
Caritis
J Peter
JP
VanDorsten
D000328:Adult; D001034:Apgar Score; D015148:Cardiotocography / Q000379:methods*; D002585:Cesarean Section / Q000706:statistics & numerical data; D004562:Electrocardiography; D005260:Female; D005313:Fetal Death / Q000517:prevention & control; D006340:Heart Rate, Fetal; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007743:Labor, Obstetric; D011247:Pregnancy