Research Letter | Obstetrics and Gynecology
Rates of Induction of Labor at 39 Weeks and Cesarean Delivery
Following Publication of the ARRIVE Trial
Rachel Wood, MD; Taylor S. Freret, MD; Mark Clapp, MD, MPH; Sarah Little, MD, MPH
Introduction + Supplemental content
In August 2018, A Randomized Trial of Induction vs Expectant Management (ARRIVE) trial was Author affiliations and article information are
1 listed at the end of this article.
published in the New England Journal of Medicine. This trial found that low-risk, nulliparous patients
who were induced at 39 weeks’ gestation had a 16% relative risk reduction in cesarean delivery (CD)
as compared with expectant management. Our objective was to evaluate if the publication of this
trial was associated with observable obstetric practice changes in the US. We hypothesized the rate
of 39-week induction would increase and CD would decrease for low-risk nulliparous patients after
publication and dissemination of the ARRIVE trial.
Methods
This cross-sectional study followed the Strengthening the Reporting of Observational Studies in
Epidemiology (STROBE) reporting guideline. The Mass General Brigham institutional review board
deemed the study exempt and informed consent was waived because the data were collected at the
population level and publicly available.
We conducted a population-level interrupted time series (ITS) analysis2 of low-risk nulliparous
patients who delivered at 39 weeks of gestation or longer between January 2016 and March 2020
using publicly available US natality data.3 Patients who were considered to be low risk were defined
as having a singleton, vertex-presenting, nonanomalous live birth without chronic hypertension or
diabetes. Demographic data were also collected, including race and ethnicity by self-report because
the racial and ethnic proportions of the US population have changed over time and minoritized racial
and ethnic groups experience disparities in CD rates. Self-reported race categories of Asian, Black,
Native American, Native Hawaiian or Pacific Islander, more than 1 race, and White, and ethnicity
categories of Hispanic or non-Hispanic were used as defined in the US Natality data.
The pre-ARRIVE period took place from January 2016 until July 2018. The primary exposure was
ARRIVE trial publication in August 2018, and a 3-month dissemination period was chosen a priori.
The post-ARRIVE period took place from November 2018 until March 2020, ending at this time to
avoid potential confounding from the COVID-19 pandemic. The outcomes of interest were rate of
39-week induction and CD among low-risk nulliparous patients at 39 weeks of gestation or longer.
Our impact model allowed for both immediate and ongoing changes in temporal trends. The primary
ITS model was constructed using Poisson regression and adjusted for seasonality. We additionally
controlled for the proportion of individuals 35 years or older and with body mass index (BMI;
calculated as weight in kilograms divided by height in meters squared) of 30 or more, patient-level
factors known to be associated with CD and changing over time.4,5 Checks for model robustness,
including analysis excluding patients with hypertensive disorders of pregnancy, are described in the
eMethods in Supplement 1. Analyses were performed using Stata version 17 (StataCorp), tests were
2-sided, and statistical significance was set at P < .05.
Open Access. This is an open access article distributed under the terms of the CC-BY License.
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JAMA Network Open | Obstetrics and Gynecology Rates of Induction of Labor at 39 Weeks and Cesarean Delivery After ARRIVE
Results
A total of 2 860 942 births were included (1 889 599 births [66%] from the pre-ARRIVE period and
971 343 births [34%] from the post-ARRIVE period). In the pre-ARRIVE period, 146 164 patients
(7.7%) were aged 35 years or older, 367 068 (19.9%) had a BMI of 30 or higher, 1 419 494 patients
(75.1%) self-reported their race as White, and 408 106 (21.8%) self-reported as Hispanic ethnicity. In
the post-ARRIVE period, 81 890 patients (8.4%) were 35 years or older, 205 026 (21.5%) had a BMI
of 30 or higher, 728 337 (75.0%) self-reported their race as White, and 221 007 (23.0%) self-reported
as Hispanic ethnicity (Table). There was an immediate increase in 39-week induction rate after the
dissemination period; with a 39-week induction rate of 15.0% vs an expected 13.8% based on
Table. Population Characteristics Before and After the Pre- and Post-ARRIVE Trial Publication
Patient, No. (%)
Characteristic Pre-ARRIVE Trial (n = 1 889 599)a Post-ARRIVE Trial (n = 971 343)b
Maternal age, y
≤35 1 743 435 (92.3) 889 453 (91.6)
>35 146 164 (7.7) 81 890 (8.4)
BMI
>30 367 068 (19.9) 205 026 (21.5)
>40 58 405 (3.2) 32 824 (3.4)
Race
Asian 147 808 (7.8) 74 144 (7.6)
Black 252 103 (13.3) 130 234 (13.4)
Native American 14 004 (0.7) 7688 (0.8)
Native Hawaiian or Pacific Islander 4466 (0.2) 2782 (0.3)
More than 1 race 51 724 (2.7) 28 158 (2.9)
White 1 419 494 (75.1) 728 337 (75.0)
Maternal ethnicity
Hispanic 408 106 (21.6) 221 007 (22.8)
Non-Hispanic 1 481 493 (78.4) 750 336 (77.2) Abbreviations: ARRIVE, A Randomized Trial of
Induction vs Expectant Management; BMI, body mass
Delivery characteristics
index (calculated as weight in kilograms divided by
39-wk labor induction 237 545 (12.6) 164 857 (17.0)
height in meters squared).
Cesarean delivery 472 262 (25.0) 237 999 (24.5) a
January 2016 to July 2018.
Birth >41 wks 296 602 (15.7) 127 794 (13.2) b
November 2018 to March 2020.
Figure. Expected and Observed Trends in 39-Week Labor Induction and Cesarean
Delivery type
Cesarean Induction
Before publication Before publication
Observed after publication Observed after publication
Expected after publication Expected after publication
30
25
Deliveries, %
20
15
10
Jan Aug Oct Mar
2016 2018 2020 Dots indicate the monthly estimate and the shaded
Monthly estimates, date area is the dissemination period.
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JAMA Network Open | Obstetrics and Gynecology Rates of Induction of Labor at 39 Weeks and Cesarean Delivery After ARRIVE
pre-ARRIVE trends (adjusted incident rate ratio [aIRR], 1.10; 95% CI, 1.08-1.13; P < .001) and CD rates
were significantly lower than expected (24.7% vs 25.1%; aIRR, 0.988; 95% CI, 0.978-0.997; P = .01)
(Figure). Significant ongoing temporal changes were also noted—an increase of 0.009 (95% CI,
0.007-0.011) 39-week inductions per month (P < .001) and a decrease of 0.0014 (95% CI, 0.0008-
0.0022) CDs per month (P < .001) (Figure). Induction results were robust to all diagnostic checks
while CD results were robust to only some of these checks (eMethods in Supplement 1).
Discussion
These findings suggest that the publication of the ARRIVE trial was associated with an increase in
39-week induction rates and a reduction in CD rates for low-risk nulliparous patients across the US.
Strengths of our study include its large sample size and that it builds upon prior reports6 by using a
robust quasi-experimental method which can overcome many limitations of traditional prestudy and
poststudy design as it accounts for underlying trends already occurring in the population.
This study has limitations. Birth certificate data are limited in clinical granularity, and we were
unable to replicate the exact cohort included in the ARRIVE trial. Our CD rate was slightly higher than
what was seen in the ARRIVE trial, which may reflect individual-level risk factors not captured in birth
certificate data. Additionally, ITS can be difficult to interpret in settings with multiple ongoing
interventions that may affect outcomes, which may be why the change in CD is less robust. Future
work is needed to understand whether the findings of the ARRIVE trial are being implemented
similarly in different subgroups and if trends are similar in all practice settings.
ARTICLE INFORMATION
Accepted for Publication: June 29, 2023.
Published: August 10, 2023. doi:10.1001/jamanetworkopen.2023.28274
Correction: This article was corrected on September 18, 2023, to fix an error in the byline.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2023 Wood R
et al. JAMA Network Open.
Corresponding Author: Rachel Wood, MD, Division of Maternal Fetal Medicine, Department of Obstetrics and
Gynecology, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115 (rachel.wood@duke.edu).
Author Affiliations: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Brigham and
Women’s Hospital, Boston, Massachusetts (Wood, Little); Division of Maternal Fetal Medicine, Department of
Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts (Freret, Clapp).
Author Contributions: Drs Wood and Little had full access to all of the data in the study and take responsibility for
the integrity of the data and the accuracy of the data analysis. Drs Wood and Freret are cofirst authors.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: Wood, Freret, Little.
Drafting of the manuscript: Wood, Clapp, Little.
Critical review of the manuscript for important intellectual content: All authors.
Statistical analysis: Wood, Clapp, Little.
Administrative, technical, or material support: Wood, Little.
Supervision: Clapp, Little.
Conflict of Interest Disclosures: Dr Wood reported receiving grants from Medicem outside the submitted work.
Dr Clapp reported receiving private equity from Delfina Care outside the submitted work. Dr Little reported
receiving grants from Medicem, Hologic, and Pulsenmore outside the submitted work. No other disclosures were
reported.
Data Sharing Statement: See Supplement 2.
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JAMA Network Open | Obstetrics and Gynecology Rates of Induction of Labor at 39 Weeks and Cesarean Delivery After ARRIVE
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SUPPLEMENT 1.
eMethods.
eReferences.
SUPPLEMENT 2.
Data Sharing Statement
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