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The ARRIVE Trial and Professional Guidance: Elective 39 Week Induction to Reduce the Risk of Cesarean Section

Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the results from the ARRIVE Trial
2. State the current ACOG/SMFM guidance for inducing labor in women at 39 weeks with uncomplicated pregnancies

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from March 4 2018 through 07/15/2022, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

SUMMARY:

The ARRIVE study (A Randomized Trial of Induction Versus Expectant Management), authored by Grobman et al. (NEJM, 2018), was undertaken to determine if elective induction of labor (IOL) of low-risk nulliparous women at 39 weeks reduces adverse perinatal and neonatal morbidity compared to expectant management. SMFM released a statement, endorsed by ACOG, addressing the ARRIVE findings.

SMFM Recommendations

It is reasonable to offer elective IOL to low-risk, nulliparous women at or beyond 39 weeks and 0 days of gestation. We recommend that providers who choose this approach ensure that women meet eligibility criteria of the ARRIVE trial.

We recommend against offering elective IOL to women under circumstances that are inconsistent with the ARRIVE study protocol unless performed as part of research or quality improvement.

We recommend that further research be conducted to measure the impact of this practice in settings other than a clinical trial.

Study Highlights

Methods

- Multicenter, randomized, controlled, parallel-group, unmasked trial
  - - Low-risk nulliparous women between 34w0d-38w6d
  - - Live singleton, vertex fetus
  - - No contraindications to vaginal delivery
  - No planned cesarean deliver

- Low-risk
  - No maternal or fetal condition that would be an indication for delivery <40w5d

- Randomization
  - - Induction group: IOL at 39w0d-39w4d
  - Expectant group: No elective delivery <40w5d and begin delivery no later than 42w2d

- Primary outcome
  - Composite of perinatal death or severe neonatal complications

Secondary outcomes
- Multiple neonatal and maternal outcomes including mode of delivery

Results

- 3,062 women labor induction group | 3,044 expectant management group
- Primary outcome not statistically different
  - 4.3% of neonates in induction group vs 5.4% in the expectant group
  - Relative risk (RR) 0.80; 95% CI, 0.64-1.00 (P=0.049)
    - To account for an interim analysis, a two-tailed P value of <0.046 was used for statistical significance threshold

- Cesarean delivery was less frequent in the induced labor group (19%) vs the expectant management group (22%)
  - RR 0.84; 95% CI 0.76-0.93

- Preeclampsia and gestational hypertension occurred in 9.1% of the induced group vs 14.1% of the expectant management group
  - RR 0.64; 95% CI 0.56-0.74

Among newborns, 3% in the induced group needed respiratory support vs 4.2% in the expectant management group
- RR 0.71; 95% CI 0.55-0.93

Conclusions

There was no difference between groups with respect to composite adverse perinatal outcome, but there was reduced frequency of cesarean section in the induction group
There was increased incidence of maternal hypertension/preeclampsia and newborn respiratory support in the expectant management group
The authors state

Our data suggest that 1 cesarean delivery may be avoided for every 28 deliveries among low-risk nulliparous women who plan to undergo elective induction of labor at 39 weeks.

KEY POINTS:

Induction Protocol Highlights

Patients had a cervical exam between 72 hours prior to randomization and 24 hours after randomization
IOL protocol
- Induction using oxytocin
- Unfavorable cervix (modified Bishop score <5) underwent cervical ripening
  - method left to patient’s physician’s discretion
  - with or followed by oxytocin stimulation
‘Failed’ Labor in latent phase
- At least 12 hours after completion of cervical ripening, rupture of membranes, and use of a uterine stimulant
- Cesarean decision left to patient’s physician’s discretion
Additional SMFM recommendations
- Shared decision making is ‘critical’
- All women in this study had ultrasound dating, early in pregnancy
  - Certain LMP: <21 weeks
  - Uncertain LMP: First trimester ultrasound
ACOG has also released a Practice Advisory related to ARRIVE (see ‘Learn More-Primary Sources’ below) that also highlights the importance of shared decision making as well as taking in to account “resources available (including personnel), and the setting in which the intervention will be implemented”

Learn More – Primary Sources:

Labor Induction versus Expectant Management in Low-Risk Nulliparous Women

SMFM Statement: Elective induction of labor in low-risk nulliparous women at term: The ARRIVE trial

ACOG Practice Advisory: Clinical guidance for integration of the findings of The ARRIVE Trial: Labor Induction versus Expectant Management in Low-Risk Nulliparous Women

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The ARRIVE Trial and Professional Guidance: Elective 39 Week Induction to Reduce the Risk of Cesarean Section