A randomized trial of intrapartum fetal ECG ST-segment analysis

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network

Research output: Contribution to journalArticle

67 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)632-641
Number of pages10
JournalNew England Journal of Medicine
Volume373
Issue number7
DOIs
StatePublished - Aug 13 2015
Externally publishedYes

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Fetal Heart Rate
Fetus
Apgar Score
Newborn Infant
Fetal Monitoring
Umbilical Arteries
Fetal Death
Brain Diseases
Random Allocation
Intubation
Multicenter Studies
Ventilation
Dilatation
Seizures
Confidence Intervals
Pregnancy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network (2015). A randomized trial of intrapartum fetal ECG ST-segment analysis. New England Journal of Medicine, 373(7), 632-641. https://doi.org/10.1056/NEJMoa1500600

A randomized trial of intrapartum fetal ECG ST-segment analysis. / Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

In: New England Journal of Medicine, Vol. 373, No. 7, 13.08.2015, p. 632-641.

Research output: Contribution to journalArticle

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network 2015, 'A randomized trial of intrapartum fetal ECG ST-segment analysis', New England Journal of Medicine, vol. 373, no. 7, pp. 632-641. https://doi.org/10.1056/NEJMoa1500600
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A randomized trial of intrapartum fetal ECG ST-segment analysis. New England Journal of Medicine. 2015 Aug 13;373(7):632-641. https://doi.org/10.1056/NEJMoa1500600
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. / A randomized trial of intrapartum fetal ECG ST-segment analysis. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 7. pp. 632-641.
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abstract = "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.",
author = "{Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network} and Belfort, {Michael A.} and George Saade and Elizabeth Thom and Blackwell, {Sean C.} and Reddy, {Uma M.} and Thorp, {John M.} and Tita, {Alan T N} and Miller, {Russell S.} and Peaceman, {Alan M.} and McKenna, {David S.} and Chien, {Edward K S} and Rouse, {Dwight J.} and Gibbs, {Ronald S.} and El-Sayed, {Yasser Y.} and Yoram Sorokin and Caritis, {Steve N.} and VanDorsten, {J. Peter}",
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T1 - A randomized trial of intrapartum fetal ECG ST-segment analysis

AU - Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network

AU - Belfort, Michael A.

AU - Saade, George

AU - Thom, Elizabeth

AU - Blackwell, Sean C.

AU - Reddy, Uma M.

AU - Thorp, John M.

AU - Tita, Alan T N

AU - Miller, Russell S.

AU - Peaceman, Alan M.

AU - McKenna, David S.

AU - Chien, Edward K S

AU - Rouse, Dwight J.

AU - Gibbs, Ronald S.

AU - El-Sayed, Yasser Y.

AU - Sorokin, Yoram

AU - Caritis, Steve N.

AU - VanDorsten, J. Peter

PY - 2015/8/13

Y1 - 2015/8/13

N2 - 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.

AB - 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.

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