Trial record 7 of 16 for:    Pulmonary Embolism | Open Studies | NIH, U.S. Fed

A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01990612
First received: November 15, 2013
Last updated: May 15, 2014
Last verified: April 2014
  Purpose

Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal morbidity and perinatal mortality.


Condition Intervention
Labor and Delivery
Procedure: Elective Induction of Labor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • composite of severe neonatal morbidity and perinatal mortality [ Time Frame: delivery ] [ Designated as safety issue: No ]

    The composite includes any one of the following:

    • Antepartum, intrapartum, or neonatal death
    • Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiorespiratory support within first 72 hours
    • Apgar ≤ 3 at 5 minutes
    • Neonatal encephalopathy as defined by Shankaran et al.48
    • Seizures
    • Sepsis. The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, CSF, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.
    • Pneumonia confirmed by X-ray or positive blood culture.
    • Meconium aspiration syndrome
    • Birth trauma (bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury)
    • Intracranial hemorrhage or subgaleal hemorrhage
    • Hypotension requiring pressor support


Secondary Outcome Measures:
  • Cesarean delivery and indication [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Operative vaginal delivery and indication [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Chorioamnionitis, defined as a clinical diagnosis before delivery [ Time Frame: before delivery ] [ Designated as safety issue: No ]
  • Third or fourth degree perineal laceration [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Maternal death [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Admission to intensive care unit (ICU) [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Preeclampsia/gestational hypertension [ Time Frame: before delivery ] [ Designated as safety issue: No ]
  • Postpartum hemorrhage [ Time Frame: delivery ] [ Designated as safety issue: No ]

    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

  • Maternal venous thromboembolism (deep venous thrombosis or pulmonary embolism) [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Birth weight, macrosomia > 4500 g, large for gestational age (LGA) defined as > 90th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Duration of respiratory support including ventilator, CPAP, high-flow nasal cannula (HFNC) [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Small for gestational age defined as < 5th and < 10th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Cephalohematoma [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Shoulder dystocia [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Transfusion of blood products or blood [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Hyperbilirubinemia requiring phototherapy or exchange transfusion [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Hypoglycemia (glucose < 40 mg%) requiring IV therapy [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Admission to neonatal intensive care unit (NICU) or intermediate care unit [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Number of clinic visits post randomization to admission for delivery [ Time Frame: randomization until delivery ] [ Designated as safety issue: No ]
  • ER/urgent care/triage visits post randomization to delivery [ Time Frame: randomization until delivery ] [ Designated as safety issue: No ]
  • Non-stress tests, biophysical profiles (BPPs), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress tests [ Time Frame: randomization until delivery ] [ Designated as safety issue: No ]
  • Epidural use [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Use of induction and ripening agents, maximum dose of oxytocin [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Antepartum hospital admission [ Time Frame: antepartum ] [ Designated as safety issue: No ]
  • Number of hours on the labor and delivery unit [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Maternal postpartum length of hospital stay [ Time Frame: after delivery ] [ Designated as safety issue: No ]
  • Neonatal length of hospital stay [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Length of neonatal intensive care unit or intermediate care stay [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Post discharge resource utilization including inpatient and outpatient visits for mother or baby [ Time Frame: discharge to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: March 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Expectnant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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. Signs of labor (regular painful contractions with cervical change) 5. Fetal demise or known major fetal anomaly 6. Heparin or low-molecular weight heparin during the current pregnancy 7. Placenta previa, accreta, vasa previa 8. Active vaginal bleeding greater than bloody show 9. Ruptured membranes 10. Cerclage in current pregnancy 11. Known oligohydramnios, defined as AFI < 5 or MVP < 2 12. Fetal growth restriction, defined as EFW < 10th percentile 13. Known HIV positivity because of modified delivery plan 14. 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) 15. Refusal of blood products 16. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality 17. Delivery planned elsewhere at a non-Network site

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990612

Contacts
Contact: Uma Reddy, MD, MPH 301-496-1074 uma.reddy@nih.gov

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262    stacylharris@uabmc.edu   
Principal Investigator: Alan TN Tita, MD         
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305-5317
Contact: Cynthia Willson, RN, BSN    650-724-6372    cwillson@stanford.edu   
Principal Investigator: Yasser El-Sayed, MD         
United States, Colorado
University of Colorado Not yet recruiting
Denver, Colorado, United States, 80045
Contact: Kathy Hale, RN BSN    303-724-6685    kathy.a.hale@ucdenver.edu   
Principal Investigator: Ronald Gibbs, MD         
United States, Illinois
Northwestern University-Prentice Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett       g-mallett@northwestern.edu   
Principal Investigator: William Grobman, MD         
United States, New York
Columbia University-St. Luke's Hospital Recruiting
New York City, New York, United States, 10032
Contact: Sabine Bousleiman, MSN    212-305-4348    sb1080@columbia.edu   
Contact: Ronald J Wapner, MD    212-305-6293    RW2191@columbia.edu   
Principal Investigator: Ronald Wapner, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M Thorp, Jr., MD         
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Tammy S Bishop, RNC MSN    919-668-7475    sincl008@mc.duke.edu   
Principal Investigator: Geeta K Swamy, MD         
United States, Ohio
Case Western Reserve University Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533    wdalton@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Hospital Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Francee Johnson, RN    614-293-5632    johnson.126@osu.edu   
Principal Investigator: Jay D Iams, MD         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RNC    401-274-1122    dallard@wihri.org   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas Not yet recruiting
Dallas, Texas, United States, 75235-9032
Contact: Lisa Moseley, RN    214-590-1835    lisa.moseley@utsouthwestern.edu   
Principal Investigator: Kenneth J Leveno, MD         
University of Texas - Southwest Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Lisa Moseley, RN       lisa.moseley@utsouthwestern.edu   
Contact    214-648-2591      
Principal Investigator: Brian Casey, MD         
University of Texas - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN BSN    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Baha Sibai, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN    801-585-7645    Kim.Hill@hsc.utah.edu   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
Investigators
Study Director: Uma Reddy, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth Thom, PhD The George Washington University Biostatistics Center
Study Chair: William Grobman, MD Northwestern University
  More Information

No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01990612     History of Changes
Other Study ID Numbers: HD36801-ARRIVE
Study First Received: November 15, 2013
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 28, 2014