A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

February 19, 2019 updated by: The George Washington University Biostatistics Center

Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama - Birmingham
    • California
      • Stanford, California, United States, 94305-5317
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80045
        • University Of Colorado
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Prentice Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University-St. Luke's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43210
        • Ohio State University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University
    • Texas
      • Dallas, Texas, United States, 75235-9032
        • Dept of OB/GYN, Southwestern Medical Center, University of Texas
      • Galveston, Texas, United States, 77555
        • University of Texas - Galveston
      • Houston, Texas, United States, 77030
        • University of Texas - Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Nulliparous - no previous pregnancy beyond 20 weeks
  2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

  1. Project gestational age at date of first ultrasound is > 20 weeks 6 days
  2. Plan for induction of labor prior to 40 weeks 5 days
  3. Plan for cesarean delivery or contraindication to labor
  4. Breech presentation
  5. Signs of labor (regular painful contractions with cervical change)
  6. Fetal demise or known major fetal anomaly
  7. Heparin or low-molecular weight heparin during the current pregnancy
  8. Placenta previa, accreta, vasa previa
  9. Active vaginal bleeding greater than bloody show
  10. Ruptured membranes
  11. Cerclage in current pregnancy
  12. Known oligohydramnios, defined as AFI < 5 or MVP < 2
  13. Fetal growth restriction, defined as EFW < 10th percentile
  14. Known HIV positivity because of modified delivery plan
  15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
  16. Refusal of blood products
  17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
  18. Delivery planned elsewhere at a non-Network site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
OTHER: Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Procedure: Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of Severe Neonatal Morbidity and Perinatal Mortality
Time Frame: delivery through 72 hours after birth

Includes any one of:

  • Perinatal death
  • Need for respiratory support within 72 hours after birth
  • Apgar score of 3 or less at 5 minutes
  • Hypoxic-ischemic encephalopathy
  • Seizure
  • Infection (confirmed sepsis or pneumonia)
  • Meconium aspiration system
  • Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)
  • Intracranial or subaleal hemorrhage
  • Hypotension requiring vasopressor support
delivery through 72 hours after birth
Perinatal Death (Component of Primary Outcome)
Time Frame: antepartum pregnancy period through hospital discharge
Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death
antepartum pregnancy period through hospital discharge
Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)
Time Frame: Delivery through discharge
Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation
Delivery through discharge
Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)
Time Frame: Delivery through 5 minutes after birth
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Delivery through 5 minutes after birth
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)
Time Frame: delivery through discharge
delivery through discharge
Number of Infants With Neonatal Seizure (Component of Primary Outcome)
Time Frame: Delivery through discharge
Delivery through discharge
Number of Infants With Neonatal Infection (Component of Primary Outcome)
Time Frame: delivery through discharge
Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
delivery through discharge
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
Time Frame: Delivery through discharge
Delivery through discharge
Number of Infants With Birth Trauma (Component of Primary Outcome)
Time Frame: During the Delivery process
Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis
During the Delivery process
Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)
Time Frame: delivery through disharge
Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma
delivery through disharge
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)
Time Frame: delivery through discharge
delivery through discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Cesarean Delivery
Time Frame: delivery
delivery
Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery
Time Frame: delivery
Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas
delivery
Participants Who Had Operative Vaginal Delivery
Time Frame: delivery
delivery
Number of Participants Who Had Chorioamnionitis
Time Frame: at any time from randomization through delivery
Chorioamnionitis, defined as a clinical diagnosis before delivery
at any time from randomization through delivery
Number of Participants With Third or Fourth Degree Perineal Laceration
Time Frame: delivery
delivery
Number of Maternal Deaths
Time Frame: from randomization to hospital discharge
Maternal death at anytime between randomization and hospital discharge.
from randomization to hospital discharge
Number of Participants Admitted to Intensive Care Unit (ICU)
Time Frame: delivery through hospital discharge
Admission of the participant to the intensive care unit (ICU)
delivery through hospital discharge
Number of Participants Experiencing Hypertensive Disorder of Pregnancy
Time Frame: Randomization to hospital discharge
Randomization to hospital discharge
Number of Participants With Postpartum Hemorrhage
Time Frame: delivery through hospital discharge

defined as any of the following:

  • Transfusion
  • Non-elective hysterectomy
  • Use of two or more uterotonics other than oxytocin
  • Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade
  • Curettage
delivery through hospital discharge
Labor Agentry Scale Scores
Time Frame: Between 6 hours after delivery and 8 weeks after delivery
Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.
Between 6 hours after delivery and 8 weeks after delivery
Labor Pain Scores
Time Frame: During labor and delivery
Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.
During labor and delivery
Number of Participants With Maternal Postpartum Infection
Time Frame: delivery through discharge

Defined as any of the following:

  • Clinical diagnosis of endometritis
  • Wound reopened for hematoma, seroma, infection or other reasons
  • Cellulitis requiring antibiotics
  • Pneumonia
  • Pyelonephritis
  • Bacteremia - unknown source
  • Septic pelvic thrombosis
delivery through discharge
Number of Participants With Venous Thromboembolism
Time Frame: delivery through discharge
Maternal deep venous thrombosis or pulmonary embolism
delivery through discharge
Number of Participants With Indications for Cesarean Delivery
Time Frame: Labor and delivery
Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication
Labor and delivery
Duration of Respiratory Support
Time Frame: delivery through hospital discharge
including ventilator, CPAP, high-flow nasal cannula (HFNC)
delivery through hospital discharge
Number of Infants With Cephalohematoma
Time Frame: delivery through hospital discharge
delivery through hospital discharge
Shoulder Dystocia
Time Frame: delivery
delivery
Number of Infants Who Had Transfusion of Blood Products or Blood
Time Frame: delivery through hospital discharge
delivery through hospital discharge
Number of Infants With Hyperbilirubinemia
Time Frame: delivery through discharge
Hyperbilirubinemia requiring phototherapy or exchange transfusion
delivery through discharge
Number of Infants With Neonatal Hypoglycemia
Time Frame: delivery through discharge
glucose < 35 mg/dl and requiring IV therapy
delivery through discharge
Number Infants Admitted to NICU or Intermediate Care
Time Frame: delivery through hospital discharge
Number infants admitted to intensive care unit (NICU) or intermediate care unit
delivery through hospital discharge
Number of Hours on the Labor and Delivery Unit
Time Frame: Hours from admission to L&D to discharge from L&D
Median duration of stay in labor and delivery unit
Hours from admission to L&D to discharge from L&D
Maternal Postpartum Length of Hospital Stay
Time Frame: delivery through hospital discharge
delivery through hospital discharge
Neonatal Length of Hospital Stay
Time Frame: delivery through hospital discharge
delivery through hospital discharge
Number of Participants With Indications for Operative Vaginal Delivery
Time Frame: Labor and delivery
Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications
Labor and delivery
Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery
Time Frame: 4-8 weeks after delivery
Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding
4-8 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The George Washington University Biostatistics Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Menachem Miodovnik, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Study Chair: William Grobman, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HD36801-ARRIVE
  • U10HD036801 (U.S. NIH Grant/Contract)
  • UG1HD087230 (U.S. NIH Grant/Contract)
  • UG1HD027869 (U.S. NIH Grant/Contract)
  • UG1HD040500 (U.S. NIH Grant/Contract)
  • UG1HD034208 (U.S. NIH Grant/Contract)
  • UG1HD027915 (U.S. NIH Grant/Contract)
  • UG1HD040485 (U.S. NIH Grant/Contract)
  • UG1HD053097 (U.S. NIH Grant/Contract)
  • UG1HD040544 (U.S. NIH Grant/Contract)
  • UG1HD040545 (U.S. NIH Grant/Contract)
  • UG1HD040560 (U.S. NIH Grant/Contract)
  • UG1HD040512 (U.S. NIH Grant/Contract)
  • UG1HD087192 (U.S. NIH Grant/Contract)
  • UG1HD068282 (U.S. NIH Grant/Contract)
  • UG1HD068258 (U.S. NIH Grant/Contract)
  • UG1HD068268 (U.S. NIH Grant/Contract)
  • UG1HD034116 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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