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Feedback device helped shorten second stage of labor

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Key clinical point: A system designed to provide real-time maternal feedback helped shorten the second stage of labor, and reduced composite adverse maternal outcomes and neonatal ICU admissions.

Major finding: The incidence of the composite adverse outcome was 9% in the feedback group, compared with 33% in the control group (P = .011). This corresponded to a 73% reduction in the composite outcome in the feedback group.

Data source: A randomized, controlled study of 69 laboring nulliparous women with singleton pregnancies who were at least 36 weeks’ gestation with epidural anesthesia.

Disclosures: Dr. Fausett disclosed that he is a shareholder in OB Technologies.

The study was halted after the planned interim analysis because the researchers identified a difference in the composite outcome between study and controls that was substantially above the threshold prescribed by the study design (more than 30%), Dr. Fausett said.

He presented findings from 46 women in the feedback group and 23 women in the control group. There were no differences between the groups in birth weights, mean station at the initiation of pushing, or in the maternal body mass indexes. However, the incidence of the composite adverse outcome was 9% in the feedback group, compared with 33% in the control group (P = .011). This corresponded to a 73% reduction in the composite outcome in the feedback group.

With regard to pushing time, the median pushing time was 77 minutes versus 58 minutes for control and study groups, respectively (P = .016).

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The researchers did not identify any statistical differences in the incidence of cesarean delivery or intra-amniotic infections between the study and control groups. However, in the feedback group there were significant reductions in the incidences of operative vaginal deliveries (6.6% vs. 25%; P = .035), third- and fourth-degree lacerations (0% vs. 17%; P = .005), and neonatal ICU admission (0% vs. 13%; P = .015).

Among the 35 subjects that responded to a survey about the device on postpartum day one, “the majority strongly agreed that the device was comfortable, it helped them to push better, and they felt it gave them an increased sense of control during pushing,” he said.

Dr. Fausett acknowledged certain limitations of the study, including the potential for bias since it was not a blinded trial.

“We also did not address the optimal method or methods of feedback in this study,” he said. “Additional studies should evaluate and validate our findings as well as focus on fine-tuning the methods of graphic, auditory, and haptic feedback. If such feedback continues to prove effective, there are significant potential benefits on perinatal outcomes with important medical and economic consequences.”

Dr. Fausett disclosed that he is a shareholder in OB Technologies.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk