Miriam Kuppermann1,2, Anjali J Kaimal3, Cinthia Blat1, Juan Gonzalez1, Mari-Paule Thiet1, Yamilee Bermingham4, Anna L Altshuler5, Allison S Bryant3, Peter Bacchetti2, William A Grobman6. 1. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco. 2. Department of Epidemiology and Biostatistics, University of California, San Francisco. 3. Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston. 4. Marin Community Clinic, San Rafael, California. 5. California Pacific Medical Center, San Francisco. 6. Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.
Abstract
Importance: Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective: To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants: Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions: Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures: The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results: Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance: Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.
RCT Entities:
Importance: Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective: To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants: Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions: Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures: The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results: Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance: Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.
Authors: Mirjam M Garvelink; Laura Boland; Krystal Klein; Don Vu Nguyen; Matthew Menear; Hilary L Bekker; Karen B Eden; Annie LeBlanc; Annette M O'Connor; Dawn Stacey; France Légaré Journal: Med Decis Making Date: 2019-05-29 Impact factor: 2.583
Authors: Michelle R Wise; Lynn Sadler; Brett Shorten; Kelly van der Westhuizen; Allison Shorten Journal: Aust N Z J Obstet Gynaecol Date: 2019-02-18 Impact factor: 2.100
Authors: Andreea A Creanga; Brian T Bateman; Alexander J Butwick; Lindsay Raleigh; Ayumi Maeda; Elena Kuklina; William M Callaghan Journal: Am J Obstet Gynecol Date: 2015-05-05 Impact factor: 8.661
Authors: Karen R Sepucha; Cornelia M Borkhoff; Joanne Lally; Carrie A Levin; Daniel D Matlock; Chirk Jenn Ng; Mary E Ropka; Dawn Stacey; Natalie Joseph-Williams; Celia E Wills; Richard Thomson Journal: BMC Med Inform Decis Mak Date: 2013-11-29 Impact factor: 2.796
Authors: Rebecca Whybrow; Louise M Webster; Paul T Seed; Jane Sandall; Lucy C Chappell Journal: BMC Pregnancy Childbirth Date: 2022-01-29 Impact factor: 3.007
Authors: Kartik K Venkatesh; Suzanne Brodney; Michael J Barry; Jamie Jackson; Kiira M Lyons; Asha N Talati; Thomas S Ivester; Maria C Munoz; John M Thorp; Wanda K Nicholson Journal: BMC Pregnancy Childbirth Date: 2021-09-23 Impact factor: 3.007