A Randomized Trial of Electronic Fetal Monitoring in Preterm Labor

Evaluating a New Technology: The Effectiveness of Electronic Fetal Heart Rate Monitoring

“…Six RCTs (20,21,27,35,54,64) found a greater likelihood of Cesarean section with EFM. In two trials (37,38), there was no significant difference. Several schemata (8,40,60) have been advanced for the evaluation of RCTs.…”

“…Indeed, this is the case for eight randomized trials of EFM: Two RCTs (38, 54) found less neonatal seizures with EFM than with periodic auscultation. Six other trials (20,21,27,35,37,64) found no significant difference. Six RCTs (20,21,27,35,54,64) found a greater likelihood of Cesarean section with EFM.…”

“…Six of the trials (20,21,35,37,38,54) had explicit prior hypotheses. In two trials (27,64), hypotheses were nonspecific, seeking to "evaluate the usefulness of continuous fetal heart rate monitoring" or "to determine the effects, beneficial or otherwise, of fetal heart rate monitoring."…”

“…In association with eligibility criteria, exclusionary rules should also be detailed. In two trials (27,64), only low risk pregnancies were entered; four other studies· (20,21,37,54) were restricted to high risk pregnancies, the group for which EFM is believed to be most beneficial (2,II,27).…”

“…Nonetheless, widespread introduction of this technology prompted national controversy (44), which was heightened after four random ized clinical trials (RCTs) indicated no benefit with EFM (20,21,27,54) . Four additional RCTs have been published (35,37,38,64)-all with negative results-but established policies for intrapartum surveillance with EFM have not been altered as a result of these trials. Although the controversy surrounding EFM has diminished substantially during the 1980s, the proper role of EFM in intrapartum care is unsettled.…”