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Labor and DeliveryARRIVENCT01990612

A Randomized Trial of Induction Versus Expectant Management

A study testing Elective Induction of Labor in people with Labor and Delivery, run by The George Washington University Biostatistics Center at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Any age, women only
Conditions the study is for
Labor and Delivery
What is being tested?
Elective Induction of Labor
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,106 participants
Where
16 sitesUnited States
Study dates
Mar 2014to Jan 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Nulliparous - no previous pregnancy beyond 20 weeks
  • Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  • 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.

Who cannot join

  • Project gestational age at date of first ultrasound is > 20 weeks 6 days
  • Plan for induction of labor prior to 40 weeks 5 days
  • Plan for cesarean delivery or contraindication to labor
  • Breech presentation
  • Signs of labor (regular painful contractions with cervical change)
  • Fetal demise or known major fetal anomaly
Show all 18Show fewer
  • Heparin or low-molecular weight heparin during the current pregnancy
  • Placenta previa, accreta, vasa previa
  • Active vaginal bleeding greater than bloody show
  • Ruptured membranes
  • Cerclage in current pregnancy
  • Known oligohydramnios, defined as AFI < 5 or MVP < 2
  • Fetal growth restriction, defined as EFW < 10th percentile
  • Known HIV positivity because of modified delivery plan
  • 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)
  • Refusal of blood products
  • Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
  • Delivery planned elsewhere at a non-Network site

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern University-Prentice Hospital

    Chicago, Illinois, 60611

  • Case Western Reserve University

    Cleveland, Ohio, 44109

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • Dept of OB/GYN, Southwestern Medical Center, University of Texas

    Dallas, Texas, 75235-9032

  • University of Colorado

    Denver, Colorado, 80045

  • Duke University

    Durham, North Carolina, 27710

  • University of Texas - Galveston

    Galveston, Texas, 77555

  • University of Texas - Houston

    Houston, Texas, 77030

  • Columbia University-St. Luke's Hospital

    New York, New York, 10032

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Brown University

    Providence, Rhode Island, 02905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Stanford University

    Stanford, California, 94305-5317

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Elective Induction of Labor
Keywords
Induction of labor, Expectant management of labor, 39 weeks gestation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elective Induction of LaborProcedure or surgery

    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.

Study groups in NCT01990612
Study groupRoleWhat they receive
Expectant ManagementNo interventionExpectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Elective Induction of LaborOtherElective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Receives: Procedure: Elective Induction of Labor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Severe Neonatal Morbidity and Perinatal Mortality

    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

    Measured: delivery through 72 hours after birth

  2. Perinatal Death (Component of Primary Outcome)

    Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

    Measured: antepartum pregnancy period through hospital discharge

  3. Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)

    Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation

    Measured: Delivery through discharge

  4. Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)

    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.

    Measured: Delivery through 5 minutes after birth

  5. Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)

    Measured: delivery through discharge

  6. Number of Infants With Neonatal Seizure (Component of Primary Outcome)

    Measured: Delivery through discharge

  7. Number of Infants With Neonatal Infection (Component of Primary Outcome)

    Neonatal infection includes confirmed sepsis and/or confirmed pneumonia

    Measured: delivery through discharge

  8. Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)

    Measured: Delivery through discharge

  9. Number of Infants With Birth Trauma (Component of Primary Outcome)

    Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis

    Measured: During the Delivery process

  10. Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)

    Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

    Measured: delivery through disharge

  11. Hypotension Requiring Vasopressor Support (Component of Primary Outcome)

    Measured: delivery through discharge

Secondary outcomes (26)

  1. Number of Participants With Cesarean Delivery

    Measured: delivery

  2. Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery

    Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas

    Measured: delivery

  3. Participants Who Had Operative Vaginal Delivery

    Measured: delivery

  4. Number of Participants Who Had Chorioamnionitis

    Chorioamnionitis, defined as a clinical diagnosis before delivery

    Measured: at any time from randomization through delivery

  5. Number of Participants With Third or Fourth Degree Perineal Laceration

    Measured: delivery

  6. Number of Maternal Deaths

    Maternal death at anytime between randomization and hospital discharge.

    Measured: from randomization to hospital discharge

  7. Number of Participants Admitted to Intensive Care Unit (ICU)

    Admission of the participant to the intensive care unit (ICU)

    Measured: delivery through hospital discharge

  8. Number of Participants Experiencing Hypertensive Disorder of Pregnancy

    Measured: Randomization to hospital discharge

  9. Number of Participants With Postpartum Hemorrhage

    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

    Measured: delivery through hospital discharge

  10. Labor Agentry Scale Scores

    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.

    Measured: Between 6 hours after delivery and 8 weeks after delivery

  11. Labor Pain Scores

    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.

    Measured: During labor and delivery

  12. Number of Participants With Maternal Postpartum Infection

    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

    Measured: delivery through discharge

  13. Number of Participants With Venous Thromboembolism

    Maternal deep venous thrombosis or pulmonary embolism

    Measured: delivery through discharge

  14. Number of Participants With Indications for Cesarean Delivery

    Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication

    Measured: Labor and delivery

  15. Duration of Respiratory Support

    including ventilator, CPAP, high-flow nasal cannula (HFNC)

    Measured: delivery through hospital discharge

  16. Number of Infants With Cephalohematoma

    Measured: delivery through hospital discharge

  17. Shoulder Dystocia

    Measured: delivery

  18. Number of Infants Who Had Transfusion of Blood Products or Blood

    Measured: delivery through hospital discharge

  19. Number of Infants With Hyperbilirubinemia

    Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Measured: delivery through discharge

  20. Number of Infants With Neonatal Hypoglycemia

    glucose < 35 mg/dl and requiring IV therapy

    Measured: delivery through discharge

  21. Number Infants Admitted to NICU or Intermediate Care

    Number infants admitted to intensive care unit (NICU) or intermediate care unit

    Measured: delivery through hospital discharge

  22. Number of Hours on the Labor and Delivery Unit

    Median duration of stay in labor and delivery unit

    Measured: Hours from admission to L&D to discharge from L&D

  23. Maternal Postpartum Length of Hospital Stay

    Measured: delivery through hospital discharge

  24. Neonatal Length of Hospital Stay

    Measured: delivery through hospital discharge

  25. Number of Participants With Indications for Operative Vaginal Delivery

    Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications

    Measured: Labor and delivery

  26. Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery

    Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding

    Measured: 4-8 weeks after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionNov 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Masking
None (open label)
Enrolment
6,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990612
Sponsor's protocol ID
HD36801-ARRIVE
Other IDs
UG1HD027869, UG1HD027915, UG1HD034116, UG1HD034208, UG1HD040500, UG1HD040485, UG1HD040544, UG1HD053097
Acronym
ARRIVE
Status last verified
Feb 2019
First submitted
15 Nov 2013
Last updated
21 Feb 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

    PubMed 30089070

  • Mallett G, Hill K, Doherty L, Grobman WA, Reddy UM, Tita ATN, Silver RM, Rice MM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Costantine MM, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN, Macones GA; The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor. Obstet Gynecol. 2023 Jul 1;142(1):117-124. doi: 10.1097/AOG.0000000000005230.

    PubMed 37290106

  • Costantine MM, Sandoval GJ, Grobman WA, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation. Obstet Gynecol. 2022 May 1;139(5):866-876. doi: 10.1097/AOG.0000000000004753. Epub 2022 Apr 5.

    PubMed 35576345

  • Silver RM, Rice MM, Grobman WA, Reddy UM, Tita ATN, Mallett G, Hill K, Thom EA, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation. Obstet Gynecol. 2020 Oct;136(4):698-705. doi: 10.1097/AOG.0000000000004046.

    PubMed 32925634

  • Mallett G, Hill K, de Voest J, Bousleiman SZ, Allard D, Harris S, Salazar A, Clark K, Ortiz F, Bartholomew A, Dalton W, Craig J, Bickus M; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy. Obstet Gynecol. 2020 Oct;136(4):731-737. doi: 10.1097/AOG.0000000000003998.

    PubMed 32925629

  • El-Sayed YY, Rice MM, Grobman WA, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women. Obstet Gynecol. 2020 Oct;136(4):692-697. doi: 10.1097/AOG.0000000000004055.

    PubMed 32925628

  • Dude A, Fette LM, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Iams JD, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal Sense of Control During Childbirth and Infant Feeding Method. Obstet Gynecol. 2020 Mar;135(3):583-590. doi: 10.1097/AOG.0000000000003697.

    PubMed 32028504

Questions about this trial

What is this clinical trial studying?

A study testing Elective Induction of Labor in people with Labor and Delivery, run by The George Washington University Biostatistics Center at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Severe Neonatal Morbidity and Perinatal Mortality (time frame: delivery through 72 hours after birth). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01990612, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.

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