A Randomized Trial of Induction Versus Expectant Management

Not Applicable

Completed

Conditions: Labor and Delivery

Interventions: Procedure: Elective Induction of Labor

Registration Number: NCT01990612

Lead Sponsor: The George Washington University Biostatistics Center

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 6106

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elective Induction of Labor	Elective Induction of Labor	Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days

Primary Outcome Measures

Name	Time	Method
Number of Infants With Neonatal Seizure (Component of Primary Outcome)	Delivery through discharge
Number of Infants With Neonatal Infection (Component of Primary Outcome)	delivery through discharge	Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
Perinatal Death (Component of Primary Outcome)	antepartum pregnancy period through hospital discharge	Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)	delivery through discharge
Number of Infants With Birth Trauma (Component of Primary Outcome)	During the Delivery process	Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis
Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)	Delivery through discharge	Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation
Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)	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.
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)	Delivery through discharge
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)	delivery through discharge
Composite of Severe Neonatal Morbidity and Perinatal Mortality	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
Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)	delivery through disharge	Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cesarean Delivery	delivery
Number of Participants Experiencing Hypertensive Disorder of Pregnancy	Randomization to hospital discharge
Participants Who Had Operative Vaginal Delivery	delivery
Labor Agentry Scale Scores	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.
Number of Participants With Maternal Postpartum Infection	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
Number of Participants With Venous Thromboembolism	delivery through discharge	Maternal deep venous thrombosis or pulmonary embolism
Number of Infants With Hyperbilirubinemia	delivery through discharge	Hyperbilirubinemia requiring phototherapy or exchange transfusion
Number of Infants With Neonatal Hypoglycemia	delivery through discharge	glucose \< 35 mg/dl and requiring IV therapy
Maternal Postpartum Length of Hospital Stay	delivery through hospital discharge
Number of Maternal Deaths	from randomization to hospital discharge	Maternal death at anytime between randomization and hospital discharge.
Number of Participants With Postpartum Hemorrhage	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
Duration of Respiratory Support	delivery through hospital discharge	including ventilator, CPAP, high-flow nasal cannula (HFNC)
Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery	delivery	Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas
Number of Participants Who Had Chorioamnionitis	at any time from randomization through delivery	Chorioamnionitis, defined as a clinical diagnosis before delivery
Number of Participants With Third or Fourth Degree Perineal Laceration	delivery
Number of Participants With Indications for Cesarean Delivery	Labor and delivery	Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication
Number of Hours on the Labor and Delivery Unit	Hours from admission to L&D to discharge from L&D	Median duration of stay in labor and delivery unit
Number of Participants With Indications for Operative Vaginal Delivery	Labor and delivery	Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications
Number of Participants Admitted to Intensive Care Unit (ICU)	delivery through hospital discharge	Admission of the participant to the intensive care unit (ICU)
Labor Pain Scores	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.
Number Infants Admitted to NICU or Intermediate Care	delivery through hospital discharge	Number infants admitted to intensive care unit (NICU) or intermediate care unit
Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery	4-8 weeks after delivery	Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding
Number of Infants With Cephalohematoma	delivery through hospital discharge
Number of Infants Who Had Transfusion of Blood Products or Blood	delivery through hospital discharge
Neonatal Length of Hospital Stay	delivery through hospital discharge
Shoulder Dystocia	delivery

Trial Locations

Locations (16): Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
Northwestern University-Prentice Hospital
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Chicago, Illinois, United States
Duke University
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Durham, North Carolina, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
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Dallas, Texas, United States
University of Texas - Galveston
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Galveston, Texas, United States
University of Texas - Houston
🇺🇸
Houston, Texas, United States
University of Utah
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Salt Lake City, Utah, United States
University of Alabama - Birmingham
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Birmingham, Alabama, United States
Columbia University-St. Luke's Hospital
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New York, New York, United States
Stanford University
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Stanford, California, United States
University of Colorado
🇺🇸
Denver, Colorado, United States
University of North Carolina - Chapel Hill
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Chapel Hill, North Carolina, United States
Ohio State University Hospital
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Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC
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Pittsburgh, Pennsylvania, United States
Brown University
🇺🇸
Providence, Rhode Island, United States