NCT01990612|CompletedResultsDMC
A Randomized Trial of Induction Versus Expectant Management
ARRIVE
Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
Loading search results
Sponsor study identifier
Secondary identifiers
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
interventional
6,106
1 country
16
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Actual (reported)Study Completion
January 2018
Actual (reported)A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2013
Actual (reported)November 21, 2013
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2017
Actual (reported)January 2018
Actual (reported)January 25, 2019
Actual (reported)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
delivery through 72 hours after birth
Perinatal Death (Component of Primary Outcome)
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)
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)
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 Participants With Cesarean Delivery
delivery
Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery
delivery
Participants Who Had Operative Vaginal Delivery
delivery
Number of Participants Who Had Chorioamnionitis
at any time from randomization through delivery
Number of Participants With Third or Fourth Degree Perineal Laceration
delivery
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama - Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Stanford, California, 94305-5317, United States
University of Colorado
Denver, Colorado, 80045, United States
Northwestern University-Prentice Hospital
Chicago, Illinois, 60611, United States
Columbia University-St. Luke's Hospital
New York, New York, 10032, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
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.
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.
Menachem Miodovnik, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rebecca Clifton, PhD
The George Washington University Biostatistics Center
William Grobman, MD
Northwestern University
6,106 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2013
First Posted
November 21, 2013
Study Start
Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)
delivery through discharge
Number of Infants With Neonatal Seizure (Component of Primary Outcome)
Delivery through discharge
Number of Infants With Neonatal Infection (Component of Primary Outcome)
Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
delivery through discharge
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
Delivery through discharge
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
During the Delivery process
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
delivery through disharge
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)
delivery through discharge
Contact the study team to confirm eligibility.
Case Western Reserve University
Cleveland, Ohio, 44109, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Brown University
Providence, Rhode Island, 02905, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, 75235-9032, United States
University of Texas - Galveston
Galveston, Texas, 77555, United States
University of Texas - Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
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.
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.
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.
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.
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.
March 2014
This date has not been verified as actual or estimated.
Primary Completion
November 2017
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
February 21, 2019
Results First Posted
January 25, 2019
Record last verified: 2019-02
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: