Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor and Delivery
- Sponsor
- The George Washington University Biostatistics Center
- Enrollment
- 6106
- Locations
- 16
- Primary Endpoint
- Number of Infants With Neonatal Seizure (Component of Primary Outcome)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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)
Time Frame: delivery through discharge
Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
Perinatal Death (Component of Primary Outcome)
Time Frame: 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)
Time Frame: delivery through discharge
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
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
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.
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
Time Frame: Delivery through discharge
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)
Time Frame: delivery through discharge
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
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
Secondary Outcomes
- 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)
- Number of Participants With Maternal Postpartum Infection(delivery through discharge)
- Number of Participants With Venous Thromboembolism(delivery through discharge)
- Number of Infants With Hyperbilirubinemia(delivery through discharge)
- Number of Infants With Neonatal Hypoglycemia(delivery through discharge)
- Maternal Postpartum Length of Hospital Stay(delivery through hospital discharge)
- Number of Maternal Deaths(from randomization to hospital discharge)
- Number of Participants With Postpartum Hemorrhage(delivery through hospital discharge)
- Duration of Respiratory Support(delivery through hospital discharge)
- Number of Participants Who Had Uterine Incisional Extension at Cesarean 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)
- Number of Participants With Indications for Cesarean Delivery(Labor and delivery)
- Number of Hours on the Labor and Delivery Unit(Hours from admission to L&D to discharge from L&D)
- Number of Participants With Indications for Operative Vaginal Delivery(Labor and delivery)
- Number of Participants Admitted to Intensive Care Unit (ICU)(delivery through hospital discharge)
- Labor Pain Scores(During labor and delivery)
- Number Infants Admitted to NICU or Intermediate Care(delivery through hospital discharge)
- Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery(4-8 weeks after delivery)
- Number of Infants With Cephalohematoma(delivery through hospital discharge)
- Shoulder Dystocia(delivery)
- Number of Infants Who Had Transfusion of Blood Products or Blood(delivery through hospital discharge)
- Neonatal Length of Hospital Stay(delivery through hospital discharge)