A Randomized Trial of Induction Versus Expectant Management

N/ACompletedNCT01990612

The George Washington University Biostatistics Center6,106 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

6,106

Conditions

Labor and Delivery

Interventions

Elective Induction of LaborPROCEDURE

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

Sex: FEMALE

Medical Language ↔ Plain English

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. Breech presentation 5. Signs of labor (regular painful contractions with cervical change) 6. Fetal demise or known major fetal anomaly 7. Heparin or low-molecular weight heparin during the current pregnancy 8. Placenta previa, accreta, vasa previa 9. Active vaginal bleeding greater than bloody show 10. Ruptured membranes 11. Cerclage in current pregnancy 12. Known oligohydramnios, defined as AFI \< 5 or MVP \< 2 13. Fetal growth restriction, defined as EFW \< 10th percentile 14. Known HIV positivity because of modified delivery plan 15. 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) 16. Refusal of blood products 17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality 18. Delivery planned elsewhere at a non-Network site

Locations (16)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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

Time frame: delivery through 72 hours after birth

Perinatal Death (Component of Primary Outcome)

Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

Time frame: 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

Time frame: 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.

Time frame: Delivery through 5 minutes after birth

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

Time frame: delivery through discharge

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

Time frame: Delivery through discharge

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

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants With Cesarean Delivery

Time frame: delivery

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

Time frame: delivery

Participants Who Had Operative Vaginal Delivery

Time frame: delivery

Number of Participants Who Had Chorioamnionitis

Chorioamnionitis, defined as a clinical diagnosis before delivery

Time frame: at any time from randomization through delivery

Number of Participants With Third or Fourth Degree Perineal Laceration

Time frame: delivery

Number of Maternal Deaths

Maternal death at anytime between randomization and hospital discharge.

Time frame: from randomization to hospital discharge

Number of Participants Admitted to Intensive Care Unit (ICU)

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

Time frame: delivery through hospital discharge

Number of Participants Experiencing Hypertensive Disorder of Pregnancy

Time frame: Randomization to hospital discharge

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

Time frame: delivery through hospital discharge

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.

Time frame: Between 6 hours after delivery and 8 weeks after delivery

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.

Time frame: During labor and delivery

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

Time frame: delivery through discharge

Number of Participants With Venous Thromboembolism

Maternal deep venous thrombosis or pulmonary embolism

Time frame: delivery through discharge

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

Time frame: Labor and delivery

Duration of Respiratory Support

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

Time frame: delivery through hospital discharge

Number of Infants With Cephalohematoma

Time frame: delivery through hospital discharge

Shoulder Dystocia

Time frame: delivery

Number of Infants Who Had Transfusion of Blood Products or Blood

Time frame: delivery through hospital discharge

Number of Infants With Hyperbilirubinemia

Hyperbilirubinemia requiring phototherapy or exchange transfusion

Time frame: delivery through discharge

Number of Infants With Neonatal Hypoglycemia

glucose \< 35 mg/dl and requiring IV therapy

Time frame: delivery through discharge

Number Infants Admitted to NICU or Intermediate Care

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

Time frame: delivery through hospital discharge

Number of Hours on the Labor and Delivery Unit

Median duration of stay in labor and delivery unit

Time frame: Hours from admission to L&D to discharge from L&D

Maternal Postpartum Length of Hospital Stay

Time frame: delivery through hospital discharge

Neonatal Length of Hospital Stay

Time frame: delivery through hospital discharge

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

Time frame: Labor and delivery

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

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

Time frame: 4-8 weeks after delivery