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Completed

NCT Number: NCT01990612

A Randomized Trial of Induction Versus Expectant Management

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

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Key information

Conditions

Labor and Delivery

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Elective Induction of Labor

Procedure

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.

Primary outcomes

  1. 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

  2. Perinatal Death (Component of Primary Outcome)

    Time frame: antepartum pregnancy period through hospital discharge

    Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

  3. 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

  4. 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.

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

    Time frame: delivery through discharge

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

    Time frame: Delivery through discharge

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

    Time frame: delivery through discharge

    Neonatal infection includes confirmed sepsis and/or confirmed pneumonia

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

    Time frame: Delivery through discharge

  9. 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

  10. 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

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

    Time frame: delivery through discharge

Secondary outcomes

  1. Number of Participants With Cesarean Delivery

    Time frame: delivery

  2. 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

  3. Participants Who Had Operative Vaginal Delivery

    Time frame: delivery

  4. Number of Participants Who Had Chorioamnionitis

    Time frame: at any time from randomization through delivery

    Chorioamnionitis, defined as a clinical diagnosis before delivery

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

    Time frame: delivery

  6. Number of Maternal Deaths

    Time frame: from randomization to hospital discharge

    Maternal death at anytime between randomization and hospital discharge.

  7. 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)

  8. Number of Participants Experiencing Hypertensive Disorder of Pregnancy

    Time frame: Randomization to hospital discharge

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. Number of Participants With Venous Thromboembolism

    Time frame: delivery through discharge

    Maternal deep venous thrombosis or pulmonary embolism

  14. 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

  15. Duration of Respiratory Support

    Time frame: delivery through hospital discharge

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

  16. Number of Infants With Cephalohematoma

    Time frame: delivery through hospital discharge

  17. Shoulder Dystocia

    Time frame: delivery

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

    Time frame: delivery through hospital discharge

  19. Number of Infants With Hyperbilirubinemia

    Time frame: delivery through discharge

    Hyperbilirubinemia requiring phototherapy or exchange transfusion

  20. Number of Infants With Neonatal Hypoglycemia

    Time frame: delivery through discharge

    glucose < 35 mg/dl and requiring IV therapy

  21. 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

  22. 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

  23. Maternal Postpartum Length of Hospital Stay

    Time frame: delivery through hospital discharge

  24. Neonatal Length of Hospital Stay

    Time frame: delivery through hospital discharge

  25. 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

  26. 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

Sponsors and collaborators

Lead sponsor

The George Washington University Biostatistics Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: ARRIVE

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 21, 2013
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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