Dataset Information

Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.

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.

SUBMITTER: Kuppermann M

PROVIDER: S-EPMC7267848 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCesarean delivery rates are increasing globally with almost half of them occurring due to a previous Cesarean delivery. A trial of labor after Cesarean (TOLAC) is considered a safe procedure, but most eligible women instead undergo Cesarean before 39 weeks of gestation. Lack of education about TOLAC is often associated with increased repeat Cesarean. To reveal the safety and feasibility of TOLAC, we conducted this observational, prospective study with women's independent decisions. We aimed to clarify the relationship between their chosen mode of delivery and the reason for their previous Cesarean. Additionally, we have tried to identify maternal and obstetric factors associated with failed TOLAC to improve its success rate.MethodsThis was a prospective, observational study of 1086 pregnant women with at least one previous Cesarean delivery. Of these, 735 women met our TOLAC criteria (Table 1), and then, could choose TOLAC or repeat Cesarean after receiving detailed explanations regarding the risks and benefits of both procedures. The primary outcomes were the number of successful TOLAC procedures and 5-min Apgar scores < 7 for the trial of labor after Cesarean group and elective Cesarean group. We collected the maternal and neonatal data including the reasons of previous Cesarean.ResultsIn total, 64.1% of women chose TOLAC. The success rate was 91.3%. The uterine rupture rate was 0.6%. There were no significant differences in the rate of Apgar scores at 5 min < 7 between both groups. Histories of experience of labor in previous Cesarean delivery were observed in 30 and 50% of women who chose TOLAC and repeat Cesarean, respectively (p < 0.05). Factors related to failed TOLAC included ≥40 weeks of gestation (odds: 5.47, 95% CI: 2.55-11.70) and prelabor rupture of membranes (PROM) (odds: 4.47, 95% CI: 2.07-9.63).ConclusionsTOLAC is a favorable delivery option for both mothers and neonates when women meet criteria and choose after receiving detailed explanations. Women who experience PROM or ≥ 40 weeks of gestation, their modes of delivery should be reconsulted.

Project description:ObjectiveTo assess the impact of a web-based decision aid on patient-centered decision making outcomes among women considering a trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery.MethodsThe Birth Decision Aid Study (B-READY) was a quasi-experimental pre-post study of two sequential cohorts. From June 18, 2018 to July 31, 2019, 50 women were enrolled in routine care, followed by 50 women who were enrolled in the decision aid group. Inclusion criteria were singleton pregnancies between 19/0 to 36/6 weeks, ≤2 prior cesareans, and no contraindications to TOLAC. The decision aid group viewed the online Healthwise® "Pregnancy: Birth Options After Cesarean" program. Both groups received the same birth options counseling and completed the same online assessment. Primary patient-centered outcomes were knowledge about birth options and shared decision making at online assessment, and informed, patient-centered decision making about her preferred mode of delivery at delivery admission.ResultsAmong 100 women participated in this study (50 per group), the mean gestational age at enrollment was 31 weeks, and 71% or 63/89 women who consented to delivery data abstraction had a cesarean delivery. Women in the patient decision aid group gained more knowledge (defined as score ≥ 75%) about birth options compared to those in the routine care group (72% vs. 32%; adjusted odds ratio, AOR: 6.15 [95% CI: 2.34 to 16.14]), and were more likely to make an informed, patient-centered decision (60% vs. 26%; AOR: 3.30 [95% CI: 1.20 to 9.04]. Women in both groups reported similar involvement in shared decision making, as well as satisfaction and values. More than 90% of decision aid users reported it was a useful tool and would recommend it to other TOLAC-eligible women.ConclusionsA web-based birth options patient-centered decision aid for TOLAC eligible women can be integrated into prenatal Telehealth and may improve the quality of decision making about mode of delivery.Trial registrationThe study was registered with ClinincalTrials.gov and the ID# was NCT04053413 . Registered 12 August 2019 - Retrospectively registered.

Project description:ObjectiveVaginal birth after cesarean could be considered a reasonable and safe option for most women with a previous cesarean section. However, it is not easy to select pregnant mothers who are a candidate for a trial of labor after cesarean. Therefore, this study is aimed to identify determinants of successful vaginal birth after previous cesarean delivery in public hospitals in East Wollega, Western Ethiopia, 2020.MethodsA facility-based unmatched case-control study was conducted on 115 cases and 115 controls. Cases were those women who successfully delivered vaginally and controls were those women delivered by cesarean section after trial of labor. Data were collected using a pre-tested structured questionnaire and organized using Epidata version 3.1. Descriptive analysis and logistic regressions were performed. The adjusted odds ratio with a 95% confidence interval was used and statistical significance was declared at P-value < 0.05.ResultsThe study revealed that rural residence (adjusted odds ratio = 3, 95% confidence interval = 1.25-7.21), having no history of stillbirth (adjusted odds ratio = 4.2, 95% confidence interval = 1.20-14.62), prior vaginal birth after cesarean (adjusted odds ratio = 2.4, 95% confidence interval = 1.2-6.4), counseling about a trial of labor after cesarean during antenatal follow-up (adjusted odds ratio = 4.7, 95% confidence interval = 1.88-11.74), and birth interval of >2 years (adjusted odds ratio = 8.9, 95% confidence interval = 3.25-24.67) were found to be determinants of successful vaginal birth after cesarean.ConclusionPlace of residence, history of stillbirth, history of vaginal birth after cesarean, counseling about mode of delivery during antenatal care, and birth interval were determinants of successful trial of labor after cesarean. Given these factors, it is recommended that care providers should advocate delaying pregnancy for at least 2 years and counseling women about trial of labor after cesarean during antenatal care follow-up.

Project description:BackgroundTrial of labor after a previous cesarean delivery (TOLAC) has reduced the rate of cesarean sections (CS). Nevertheless, the widespread use of TOLAC has been limited by an increase in adverse outcomes, the most serious one being the risk of symptomatic uterine rupture, which is possibly associated with oxytocin. In this meta-analysis, we explored the risk association between oxytocin use and uterine rupture in TOLAC.MethodsMultiple electronic databases (PubMed, Embase, Web of Science, and Google Scholar) were searched for cross-sectional studies reporting on TOLAC, oxytocin and uterine rupture, which were published between January 1986 and October 2019. The bias-corrected Hedge's g was calculated as the effect size using the random-effects model. A two-sample Z test was used to compare the differences in synthetic rates between groups. The Newcastle-Ottawa Scale (NOS) was used to evaluate the risk of bias. Quality of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) certainty ratings system.ResultsA total of 14 studies, which included 48,457 women who underwent TOLAC, met the inclusion criteria. The pooled rate of vaginal birth after a cesarean section (VBAC) and the rate of uterine rupture in spontaneous labor were 74.3 and 0.7%, respectively. In addition, the pooled rate of VBAC and the rate of uterine rupture in the induction labor group was 60.7 and 2.2%, respectively. The women who had spontaneous labor had a significantly higher rate of VBAC (p?=?0.001) and a lower rate of uterine rupture (p?=?0.0003) compared to induced labor. The pooled rates of uterine rupture in women using oxytocin and women not using oxytocin in TOLAC were 1.4% and 0.5%, respectively, and the difference was significant (p?=?0.0002). Also, the synthetic rate of uterine rupture in oxytocin augmentation among women with spontaneous labor and women who had a successful induction of labor were 1.7% and 2.2%, respectively, without significant difference (p?=?0.443).ConclusionsWomen with induced labor had a higher risk of uterine rupture compared to women with spontaneous labor following TOLAC. Oxytocin use may increase this risk, which could be influenced by the process of induction or individual cervix condition. Consequently, simplified and standardized intrapartum management, precise protocol, and cautious monitoring of oxytocin use in TOLAC are necessary.

Project description:BACKGROUND:The safety of methods of labor induction in women with previous cesarean deliveries is still debated. We investigated perinatal outcomes associated with labor induction among women with a trial of labor after one cesarean delivery. METHODS:This retrospective study included 339 women with a trial of labor after one prior cesarean and a singleton term fetus in cephalic presentation in 2013-2016 in a French maternity unit. Labor induction was performed with oxytocin, artificial rupture of membranes and/or prostaglandin E2, according to the Bishop score. The primary outcome was a composite of uterine rupture, low Apgar score, neonatal resuscitation or admission to a neonatal unit. The secondary outcomes included cesarean delivery after onset of labor, postpartum hemorrhage and maternal hospital stay after delivery. We used logistic regression to estimate odds ratios adjusted (aOR) for potential confounders. RESULTS:In our sample, 67.3% of women had spontaneous labor and 32.7% were induced. More than half of the women received oxytocin during labor regardless of the mode of labor. The proportions of the composite outcome and of cesarean after onset of labor were higher in the induced group compared to the spontaneous group (26.1% vs 15.8%, p = 0.02 and 45.0% vs 27.6%, p<0.01, respectively). There were 9 uterine ruptures (2.6%) and this proportion was higher in the induced group compared to the spontaneous group, although this difference was not statistically significant (3.6% vs 2.2%, p = 0.48). After adjustment, labor induction was associated with higher risks of the composite outcome (aOR = 2.45, 95% CI: 1.29-4.65), cesarean after onset of labor (aOR = 2.06, 95% CI: 1.15-3.68) and maternal hospital stay after delivery ?6 days (aOR = 6.20, 95% CI: 3.25-11.81). No association was found with postpartum hemorrhage. CONCLUSION:Labor induction after one prior cesarean was associated with a higher risk of adverse perinatal outcome. Nevertheless, the higher proportion of uterine rupture did not differ significantly from that in the spontaneous labor group.