Objective
The objective of the study was to describe the time from consent to incision (consent time) when informed consent (IC) for cesarean delivery (CD) is obtained during labor and identify risk factors for especially short consent times.
Study Design
The study was a retrospective chart review of 90 cases of CD during labor. Medians and interquartile ranges for times were reported. Multivariable linear and logistic regressions were used to adjust for confounders. A Kaplan-Meier survival analysis was performed to compare consent time among women undergoing CD for fetal heart rate (FHR) indications with other women.
Results
The median consent time was 48 minutes (interquartile range, 25–72); 28.9% of patients delivered less than 30 minutes after consent. When adjusted for potential confounders, the odds of delivering less than 30 minutes after consent were 4.7 times higher (95% confidence interval, 1.4–15.2, P = .01) among women who underwent CD for FHR indications than for women who underwent CD for other indications.
Conclusion
This study demonstrates that when IC for CD is obtained during labor, consent time is brief, particularly among women undergoing CD for FHR indications. Although time is not necessarily a proxy for quality, an especially short consent time is likely to reduce the quality of the conversation and limit a patient’s opportunity to understand and recall information. Additional research regarding the optimal approach to IC for CD in labor is needed; however, this study suggests that the practice of obtaining IC at the time the decision for CD is reached is unlikely to provide optimal time for a complete IC discussion.
For Editors’ Commentary, see Contents
See related editorial, page 166
See Journal Club, page 274
More than 1.2 million cesarean deliveries (CDs) are performed annually in the United States, with approximately half of those occurring after a woman is in labor. Despite the high frequency of CDs in labor and the urgent or emergent nature of CD when it occurs during labor, in many settings, the informed consent (IC) process does not occur until the health care provider reaches the decision to proceed with CD. Chervenak and McCullough described that the expected components of the IC process include providing patients the opportunity to absorb, retain, recall, and understand information and express a value-based preference. Accomplishing this process in the midst of labor is problematic because women are likely to be distracted by pain, fatigue, and/or fear. Additionally, because these decisions are time sensitive, women are often asked to consent in a short period of time, which may have an impact on the quality of the IC process.
Although the practice of obtaining IC for CD during labor is common, the process has not previously been described in the literature.
The data presented are a retrospective chart review of a representative sample of women who underwent CD during labor to describe the amount of time that women had from consent for CD to incision (consent time) and determine whether there were particular patients who were at high risk for especially short consent times. Data on the process of IC in labor may identify potential ways to improve this process and allow for a more authentic consent process.
Materials and Methods
After institutional review board approval, we performed a retrospective analysis of a representative sample of women who underwent CD in labor at an academic medical center with delivery volume of approximately 4000 deliveries annually and a CD rate commensurate with national statistics (approximately 25-30%). At the time of the study, the typical practice in this hospital was to obtain IC for CDs performed during labor when the decision for CD was reached, which is a common practice in many hospitals across the country.
The IC for scheduled CDs was obtained in the outpatient setting during a routine preoperative visit. For antepartum patients, IC for CD was typically obtained at the time of admission. The medical records department was asked to provide a list of patients who underwent CD during the calendar year 2004, which was selected because it was the most recent year that neither author was in practice at this hospital. Women who underwent scheduled CDs (elective repeat CD, placental abnormalities, malpresentation, etc) were excluded. Only women undergoing urgent or emergent CD during labor were included. From the remaining patients, the first 100 patients to deliver during the calendar year were selected for chart review. Given the descriptive nature of this study, no sample-size calculation was indicated. The decision to review 100 charts was based on our estimation that a review of approximately 15% of unscheduled CDs would provide sufficient data to reliably estimate average consent time. Patients with missing or incomplete charts (missing time of CD consent) were excluded.
Each patient’s medical record was reviewed by a single author (K.S.), and data on maternal demographics, labor characteristics (use of oxytocin or fetal scalp electrode [FSE]), indication for CD (active phase arrest, fetal heart rate [FHR], arrest of descent or other), and timing of events were abstracted. Time data were abstracted and confirmed from multiple sources, including nursing and physician labor notes, nursing flow sheets, and operating room paperwork. The time documented on the consent form itself was the preferred source for time data; however, when this was unavailable, a timed nurse or doctor note stating when consent was obtained was also accepted. There were no cases of a significant discrepancy between reported timing of consent. Incision time was recorded on operating room flow sheets by nursing.
Data were analyzed using Stata 12 (StataCorp, College Station, TX). Outliers in the greater than 97% percentile and less than 3% percentile of consent time were Wisorized to the 97th and third percentiles, respectively. Consent time and time from admission to incision were nonnormally distributed; therefore, log transformations of these variables (which were normally distributed) or nonparametric methods were used where appropriate. For portions of the analysis, consent time was divided into dichotomous categories (less than 15 minutes vs 15 minutes or longer or less than 30 minutes vs 30 minutes or longer).
For bivariate analysis, the χ 2 test was used to compare categorical predictors and dichotomous outcomes, and the Mann-Whitney rank-sum test was used to compare categorical predictors and continuous nonnormally distributed outcomes. Multivariable linear and logistic regression models were used to evaluate associations between key predictors and linear and dichotomous outcomes, respectively. Several variables (maternal age, race, parity, and obesity) were included in these models for face validity, although they were not significantly associated with consent time in bivariate analyses. Finally, a Kaplan-Meier survival analysis was performed to compare consent time among women undergoing CD for fetal indications vs other indications for CD.
Results
Of the 100 cases obtained from medical records, 9 charts were missing or incomplete. One patient was consented for cesarean section as a matter of routine for an antepartum admission prior to labor and was therefore excluded from analysis. The remaining 90 patients were included in the analysis ( Figure 1 ). The most common indication for admission was labor induction (44%), and the most common indication for cesarean section was active-phase arrest (40%) ( Table 1 ). Four women had a history of prior CD and 3 women had a twin pregnancy. Data for 4 women whose consent times were equal to or after incision time were analyzed as being consented 1 minute before delivery and 3 women who had more than 240 minute consent times were analyzed as having a 240 minute consent time.
| Demographics | Value |
|---|---|
| Mean age, y (range) | 29 (18–45) |
| Mean BMI, kg/m 2 (range) | 32.6 (20.4–56.6) |
| Normal weight (BMI <25), n (%) | 7 (7.8) |
| Overweight (BMI 25.0-29.9), n (%) | 31 (34.4) |
| Obese (BMI ≥30), n (%) | 52 (57.8) |
| Mean gestational age, wks (range) | 39.7 (32–42.1) |
| White race, n (%) | 63 (70) |
| Nulliparous, n (%) | 70 (77.8) |
| Indication for admission, n (%) | |
| Induction of labor | 40 (44) |
| Spontaneous labor | 27 (30) |
| Spontaneous rupture of membranes | 22 (24.4) |
| Other | 1 (1.1) |
| Indication for cesarean section, n (%) | |
| Active-phase arrest | 36 (40) |
| Fetal heart rate | 32 (35.6) |
| Arrest of descent | 20 (22.2) |
| Other | 2 (2.2) |
| Labor characteristics, n (%) | |
| Oxytocin used | 67 (74.4) |
| Fetal scalp electrode used | 55 (61.1) |
Overall, the median consent time was 48 minutes, with an interquartile range of 25–72 minutes ( Table 2 ). In a bivariate analysis, when assessed as a continuous outcome, consent time increased linearly with time from admission to incision ( P = .002). Additionally, the use of oxytocin was significantly associated with increased consent time, with a median consent time of 53 minutes when oxytocin was used vs 28 minutes when no oxytocin was used ( P = .01).
| Variable | Value | |
|---|---|---|
| Median time from consent to incision (min), median time (IQR), P value | ||
| Overall | 48 (25–72) | |
| FHR indication | 26 (12–51) | .001 |
| Non-FHR indication | 54 (40–79) | |
| Oxytocin used | 53 (36–79) | .01 |
| No oxytocin used | 28 (14–54) | |
| FSE used | 40 (22–64) | .03 |
| No FSE used | 54 (40–79) | |
| Adjusted change in consent time, % (95% CI) a | ||
| FHR indication for CD | 56.1 ↓ | (8.3 ↓–104 ↓) |
| Oxytocin used | 10.7 ↑ | (44.3.0 ↓–65.8 ↑) |
| FSE used | 2.1 ↓ | (65.9 ↓–24.1 ↑) |
| Consent time <30 minutes, %, P value | ||
| Overall | 28.9 | |
| FHR indication | 56.3 | .001 |
| Non-FHR indication | 13.8 | |
| Oxytocin used | 20.9 | .004 |
| No oxytocin used | 52.2 | |
| FSE used | 40.0 | .004 |
| No FSE used | 11.4 | |
| Adjusted OR for <30 min consent time (95% CI) a | ||
| FHR indication for CD | 4.7 | (1.4–15.2) |
| Oxytocin used | 0.75 | (0.15–3.7) |
| FSE used | 8.01 | (1.8–36.3) |
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