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Published on: November 20, 2015
Indication Creep of Antenatal Late Preterm Steroids
Eliza R McElwee1, Kyla Wilkinson1, Rebecca Crowe1
1Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Medical University of South Carolina, Charleston, South Carolina.
Insights
Over one-third of women received late preterm antenatal corticosteroids (ACS) inappropriately, indicating potential "indication creep." This inappropriate use is linked to higher rates of nonoptimal exposure, highlighting the need for strict adherence to clinical criteria.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Medicine
- Clinical Pharmacology
Background:
- Antenatal corticosteroids (ACS) are crucial for reducing respiratory morbidity in preterm infants.
- The Antenatal Betamethasone for Women at Risk for Late Preterm Delivery (ALPS) trial established strict criteria for ACS use in the late preterm period.
- The widespread adoption of late preterm ACS as standard care raises concerns about potential deviations from original trial criteria.
Purpose of the Study:
- To investigate the phenomenon of "indication creep" in the administration of late preterm antenatal corticosteroids (ACS).
- To assess the rate of inappropriate ACS exposure based on ALPS trial criteria since its widespread adoption.
- To evaluate the association between inappropriate ACS administration and nonoptimal exposure outcomes.
Main Methods:
- Retrospective cohort study analyzing data from 2016-2019.
- Identified pregnant women who received late preterm ACS.
- Defined inappropriate exposure as nonadherence to ALPS trial inclusion/exclusion criteria; analyzed nonoptimal exposure (delivery >7 days from ACS or term delivery).
- Used logistic regression to compare epochs and assess confounders.
Main Results:
- Out of 660 women, 229 (34.6%) received inappropriate late preterm ACS.
- Preterm premature rupture of membranes (PPROM) was the most common reason for inappropriate use (29.0%).
- No significant difference in inappropriate exposure rates was found between 2016-2017 and 2018-2019 epochs (aOR=0.83).
- A reduction in nonoptimal exposure was observed over time (aOR=0.67).
- Inappropriate ACS use was associated with higher rates of term delivery and preterm labor, and longer latency to delivery in cases of preterm labor.
Conclusions:
- A significant proportion of late preterm ACS administrations may represent "indication creep," deviating from evidence-based criteria.
- Inappropriate ACS administration is associated with increased nonoptimal exposure, particularly in specific clinical scenarios like preterm labor.
- Adherence to established clinical criteria is essential to ensure optimal benefit and minimize potential risks associated with late preterm ACS.
Objective:
While antenatal corticosteroids (ACS) administered in the late preterm period have been shown to reduce respiratory morbidity, this finding was demonstrated in a well-designed randomized controlled trial (the Antenatal Betamethasone for Women at Risk for Late Preterm Delivery [ALPS]) with strict inclusion/exclusion criteria that may differ from clinical practice. The aim of this study was to investigate whether there has been indication creep since use of late preterm ACS became standard of care.
Study Design:
Retrospective cohort study of pregnant women who received late preterm ACS between 2016 and 2019 were identified and separated into epochs of 2016 to 2017 and 2018 to 2019 based on year of exposure. The primary outcome was rate of inappropriate ACS exposure, defined as nonadherence to the inclusion/exclusion criteria of the ALPS trial. Secondary outcomes were rates of nonoptimal ACS exposure (delivery >7 days from ACS or term delivery). Logistic regression was used to generate adjusted odds ratios (aORs) between epochs for the primary outcome adjusting for confounders.
Results:
There were 660 women who received late preterm ACS during the study period with 229 (34.6 %) deemed inappropriate exposures. The most common reason for inappropriate treatment was preterm premature rupture of membrane (PPROM; 29.0%) with exclusionary cervical examination or contraction frequency. No difference was observed in inappropriate ACS exposure between epochs (aOR = 0.83, 95% confidence interval [CI]: 0.59-1.2). However, there was a reduction in nonoptimal exposure over time (aOR = 0.67, 95% CI: 0.47-0.97) . Women receiving inappropriate ACS were more likely to deliver at term if indicated for maternal/fetal status (50.0 vs. 19.5%, p < 0.001) and preterm labor (66.0 vs. 41.9%; p = 0.015). Further, inappropriate exposure in preterm labor had higher rates of exposure latency >7 days (62.3 vs. 39.1%, p = 0.006) with a longer latency to delivery (3 vs. 16 days; p < 0.001).
Conclusion:
Over one-third of women received late preterm ACS for an indication that could be classified as indication creep. Depending on indication, inappropriate administration is associated with higher rates of nonoptimal exposure.
Key Points:
· There is potential for indication creep of ACS administration.. · One third of late preterm ACS exposures in our study were inappropriate.. · Utilizing clinical criteria can aid in identifying patients who best benefit from late preterm ACS..
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