A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis
Michael A Belfort, George R Saade, Elizabeth Thom, Sean C Blackwell, Uma M Reddy, John M Thorp Jr, Alan T N Tita, Russell S Miller, Alan M Peaceman, David S McKenna, Edward K S Chien, Dwight J Rouse, Ronald S Gibbs, Yasser Y El-Sayed, Yoram Sorokin, Steve N Caritis, J Peter VanDorsten, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network, K Hill, S Timothy, A Sowles, E Clark, M Varner, J Stratford, S Quinn, P Reed, M Gertsch, M Love, A Salazar, J Sikes, B Aguillon, M Wilson-Jimenez, G Hankins, G Olson, M Costantine, T Wen, S Nilsen, H Harirah, L Pacheco, S Jain, S Clark, M Munn, F Ortiz, B Sibai, P Givens, M Phillips, L Garcia, B Rech, K Clark, S Timlin, M Kearney, L Hitchings, S Brody, J Biggio, S Harris, A Todd, G Adams, J Grant, L Merin, M Lee, S Bousleiman, A Mermelstein, C Torres, G Kaur, B Leopanto, C Tocci, J Benson, S Forester, C Boutros, M Lake, G Mallett, N Dekker, A Roy, M Vanecko, E Irwin, M Dinsmoor, K Paychek, F Johnson, K Strafford, R Ozug, K Fennig, T Dible, K Snow, C Milluzzi, B Mercer, W Dalton, B Stetzer, K Kushner, L Polito, D Allard, B Hughes, D Cermik, B Wallin, K Grant, L Beati, J Rousseau, K Hale, N Behrendt, M Donnelly, S Andrews, G Moore, J Hurt, K Kushniruk, M Norton, A Monk, E Kogut, C Willson, K Harney, J Kassis, K Milan, N Hauff, D Driscoll, P Lockhart, H Simhan, M Cotroneo, H Birkland, S Weiner, D Mapp, L Powers-Happ, M Dingman, L S Firrell, B Broderick, A Shaver, V Donohue, C Spong, S Tolivaisa, Michael A Belfort, George R Saade, Elizabeth Thom, Sean C Blackwell, Uma M Reddy, John M Thorp Jr, Alan T N Tita, Russell S Miller, Alan M Peaceman, David S McKenna, Edward K S Chien, Dwight J Rouse, Ronald S Gibbs, Yasser Y El-Sayed, Yoram Sorokin, Steve N Caritis, J Peter VanDorsten, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network, K Hill, S Timothy, A Sowles, E Clark, M Varner, J Stratford, S Quinn, P Reed, M Gertsch, M Love, A Salazar, J Sikes, B Aguillon, M Wilson-Jimenez, G Hankins, G Olson, M Costantine, T Wen, S Nilsen, H Harirah, L Pacheco, S Jain, S Clark, M Munn, F Ortiz, B Sibai, P Givens, M Phillips, L Garcia, B Rech, K Clark, S Timlin, M Kearney, L Hitchings, S Brody, J Biggio, S Harris, A Todd, G Adams, J Grant, L Merin, M Lee, S Bousleiman, A Mermelstein, C Torres, G Kaur, B Leopanto, C Tocci, J Benson, S Forester, C Boutros, M Lake, G Mallett, N Dekker, A Roy, M Vanecko, E Irwin, M Dinsmoor, K Paychek, F Johnson, K Strafford, R Ozug, K Fennig, T Dible, K Snow, C Milluzzi, B Mercer, W Dalton, B Stetzer, K Kushner, L Polito, D Allard, B Hughes, D Cermik, B Wallin, K Grant, L Beati, J Rousseau, K Hale, N Behrendt, M Donnelly, S Andrews, G Moore, J Hurt, K Kushniruk, M Norton, A Monk, E Kogut, C Willson, K Harney, J Kassis, K Milan, N Hauff, D Driscoll, P Lockhart, H Simhan, M Cotroneo, H Birkland, S Weiner, D Mapp, L Powers-Happ, M Dingman, L S Firrell, B Broderick, A Shaver, V Donohue, C Spong, S Tolivaisa
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. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Neoventa Medical; ClinicalTrials.gov number, NCT01131260.).
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Source: PubMed