New England Journal of Medicine August 09, 2018

Labor Induction versus Expectant Management in Low-Risk Nulliparous Women

William A. Grobman, Madeline M. Rice, Uma M. Reddy, et al.

Bottom Line

Among low-risk nulliparous women, elective labor induction at 39 weeks did not significantly improve a composite of adverse perinatal outcomes but did significantly reduce the rate of cesarean delivery and hypertensive disorders of pregnancy compared to expectant management.

Key Findings

1. The primary composite outcome of perinatal death or severe neonatal complications occurred in 4.3% of the induction group compared to 5.4% of the expectant-management group, a difference that was not statistically significant (RR 0.80; 95% CI, 0.64 to 1.00) [1.5].
2. Cesarean delivery rates were significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; RR 0.84; 95% CI, 0.76 to 0.93; P<0.001).
3. Women assigned to elective induction had a significantly lower risk of developing hypertensive disorders of pregnancy compared to those managed expectantly (9.1% vs. 14.1%; RR 0.64; 95% CI, 0.56 to 0.74; P<0.001).
4. Neonates in the induction group required respiratory support significantly less frequently than those in the expectant management group (3.0% vs. 4.2%).

Study Design

Design
Randomized Controlled Trial
Open-Label
Sample
6,106
Patients
Duration
Hospital discharge
Median
Setting
Multicenter, US
Population Low-risk nulliparous women with a live, singleton fetus in vertex presentation at 38 weeks 0 days to 38 weeks 6 days of gestation.
Intervention Elective induction of labor at 39 weeks 0 days to 39 weeks 4 days of gestation.
Comparator Expectant management, avoiding elective delivery before 40 weeks 5 days and mandating delivery initiation no later than 42 weeks 2 days.
Outcome A composite of perinatal death or severe neonatal complications (including respiratory support, Apgar score <3 at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection, meconium aspiration syndrome, birth trauma, or intracranial or subgaleal hemorrhage).

Study Limitations

Only 27% (6,106 of 22,533) of eligible women consented to randomization, introducing potential selection bias and raising concerns about the broad generalizability of the findings [1.5].
The trial utilized an open-label design; the lack of blinding of patients and providers could have subconsciously influenced clinical decisions regarding the threshold for performing a cesarean delivery.
The study population was restricted strictly to low-risk nulliparous women, limiting the applicability of the findings to multiparous women or those with pre-existing risk factors.
Despite the robust sample size, the study was underpowered to detect differences in individual, rare catastrophic outcomes such as perinatal death or stillbirth.

Clinical Significance

The ARRIVE trial was a paradigm-shifting study that reversed the long-held obstetric dogma that elective induction inherently increases the risk of cesarean section in nulliparous women. Its robust findings prompted major professional societies, including ACOG and SMFM, to endorse offering elective induction at 39 weeks as a safe and reasonable clinical option through shared decision-making.

Historical Context

Historically, elective induction in nulliparous women was highly discouraged based on older observational data that associated it with increased rates of cesarean delivery. However, these earlier studies were heavily flawed by comparing elective induction at 39 weeks to spontaneous labor at 39 weeks, rather than the true clinical alternative of expectant management (which carries the real-world risks of post-term complications, macrosomia, and later indicated inductions). The ARRIVE trial was definitively designed to correct this methodological flaw by utilizing a properly randomized expectant management control group.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

In the ARRIVE trial, elective induction at 39 weeks was associated with a lower rate of hypertensive disorders of pregnancy. Based on the pathophysiology of preeclampsia and gestational hypertension, why is delivery at 39 weeks protective compared to expectant management?

Key Response

Preeclampsia and gestational hypertension are driven by placental dysfunction and the release of anti-angiogenic factors that accumulate over time. The placenta is the source of the disease; therefore, delivering the placenta at 39 weeks halts the progressive endothelial damage, preventing the clinical onset of hypertensive disorders that would otherwise develop during the expectant management period.

Resident
Resident

When counseling a low-risk nulliparous patient at 38 weeks about elective induction versus expectant management, how do you explain the impact on the risk of cesarean delivery based on the ARRIVE trial, and what Bishop score considerations should be factored into the decision?

Key Response

The ARRIVE trial showed a statistically significant decrease in the cesarean delivery rate for the induction group (18.6% vs 22.2%) regardless of the initial Bishop score. Residents must translate this to patients by explaining that induction at 39 weeks actually decreases the risk of needing a C-section compared to waiting, challenging the old dogma that inducing an unripe cervix increases C-section risk.

Fellow
Fellow

The primary outcome of the ARRIVE trial was a composite of perinatal mortality and severe neonatal morbidity. Despite a reduction in the relative risk, it did not reach statistical significance (p=0.08). As an MFM fellow, how do you interpret the composition of this primary outcome, its statistical power given the baseline event rate, and the implications for neonatal safety?

Key Response

The primary composite outcome had a lower than expected baseline event rate in this low-risk population, meaning the trial was ultimately underpowered to detect a statistically significant difference. However, the point estimate favored induction, and fellows should recognize that the data strongly supports that 39-week induction does not cause neonatal harm (like increased respiratory distress) compared to expectant management.

Attending
Attending

Adopting the ARRIVE trial findings broadly means offering 39-week induction to all low-risk nulliparous women. From a labor and delivery unit leadership perspective, what are the logistical, resource, and throughput implications of shifting to this practice model?

Key Response

While medically beneficial in reducing C-sections, 39-week inductions, particularly with unfavorable cervices, significantly increase the time patients spend occupying L&D beds compared to spontaneous labor. Attendings must weigh the clinical benefits against operational strain on nursing staff, bed availability, and hospital costs, making unit throughput a critical barrier to universal implementation.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

Only about 27% of eligible women consented to participate in the ARRIVE trial. How does this low participation rate introduce volunteer bias, and what methodological concerns does this raise regarding the external validity and generalizability of the absolute risk reductions observed for cesarean delivery?

Key Response

A low consent rate suggests the study population may not perfectly represent the general population of low-risk nulliparous women. Women who agree to participate in a randomized trial about labor induction might differ in unmeasured ways (e.g., pain tolerance, birth preferences, socioeconomic status) from those who decline, potentially skewing the baseline cesarean rate or the effectiveness of the intervention in a broader, unselected population.

Journal Editor
Journal Editor

Due to the nature of the intervention, the ARRIVE trial could not be blinded for patients or providers. As a reviewer evaluating this trial, how might the lack of provider blinding have influenced the secondary outcome of cesarean delivery rates, particularly regarding the threshold for diagnosing failure to progress?

Key Response

Providers knew which arm the patients were in. For a patient in the expectant management group, providers might have had different thresholds for patience before calling a C-section compared to an elective 39-week induction where strict, standardized protocols for cervical ripening and oxytocin administration were emphasized, potentially introducing an ascertainment bias that favored the induction group.

Guideline Committee
Guideline Committee

Following the ARRIVE trial, ACOG released a Practice Advisory stating that it is 'reasonable to offer' elective induction of labor at 39 weeks to low-risk nulliparous women. Why did ACOG choose this wording rather than making it a universal recommendation, and what shared decision-making elements must be documented according to these guidelines?

Key Response

ACOG recognized the clinical benefits (reduced C-sections and hypertensive disorders) but stopped short of a universal mandate due to patient autonomy, varying birth preferences, and systemic resource limitations. The 'reasonable to offer' language requires shared decision-making where the clinician discusses the modest absolute risk reduction in C-section, lack of significant neonatal benefit, longer duration of labor, and ensures firm gestational age dating before proceeding.

Clinical Landscape

Noteworthy Related Trials

1992

Hannah Post-term Trial

n = 3,407 · NEJM

Tested

Induction of labor at 41 weeks

Population

Women with uncomplicated pregnancies at 41 or more weeks of gestation

Comparator

Expectant management with serial fetal monitoring

Endpoint

Perinatal mortality and neonatal morbidity

Key result: Induction of labor at 41 weeks resulted in a lower rate of cesarean section compared to expectant management, with no increase in adverse perinatal outcomes.
2009

HYPITAT Trial

n = 756 · Lancet

Tested

Induction of labor

Population

Women with gestational hypertension or mild pre-eclampsia at 36-41 weeks

Comparator

Expectant management

Endpoint

Composite of poor maternal outcome

Key result: Induction of labor significantly reduced the risk of poor maternal outcomes without increasing the rate of cesarean delivery.
2019

SWEPIS Trial

n = 2,760 · BMJ

Tested

Induction of labor at 41 weeks

Population

Low-risk women with uncomplicated pregnancies at 41 weeks

Comparator

Expectant management until 42 weeks

Endpoint

Composite perinatal morbidity and mortality

Key result: The trial was stopped early due to significantly higher perinatal mortality in the expectant management group compared to the induction group.

Tailored to your role

Want this tailored to you?

Add your specialty or training stage to get role-specific takeaways and more questions.

Personalize this analysis