Labor and Delivery
Conditions
Keywords
Induction of labor, Expectant management of labor, 39 weeks gestation
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.
Interventions
PROCEDUREElective Induction of Labor
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Perinatal Death (Component of Primary Outcome) | antepartum pregnancy period through hospital discharge | Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death |
| 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 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) | delivery through discharge | Neonatal infection includes confirmed sepsis and/or confirmed pneumonia |
| Number of Infants With Meconium Aspiration Syndrome (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 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 |
| Hypotension Requiring Vasopressor Support (Component of Primary Outcome) | delivery through discharge | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Hypertensive Disorder of Pregnancy | Randomization to 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 |
| 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. |
| 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 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 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 Infants With Cephalohematoma | delivery through hospital discharge | — |
| Number of Infants With Neonatal Hypoglycemia | delivery through discharge | glucose \< 35 mg/dl and requiring IV therapy |
| 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 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 |
| Maternal Postpartum Length of Hospital Stay | delivery through hospital discharge | — |
| Neonatal Length of Hospital Stay | delivery through hospital discharge | — |
| 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 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 |
| Duration of Respiratory Support | delivery through hospital discharge | including ventilator, CPAP, high-flow nasal cannula (HFNC) |
| Shoulder Dystocia | delivery | — |
| Number of Participants With Cesarean Delivery | delivery | — |
| 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 |
| Participants Who Had Operative Vaginal Delivery | delivery | — |
| Number of Infants Who Had Transfusion of Blood Products or Blood | delivery through hospital discharge | — |
| Number of Infants With Hyperbilirubinemia | delivery through discharge | Hyperbilirubinemia requiring phototherapy or exchange transfusion |
| 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 Maternal Deaths | from randomization to hospital discharge | Maternal death at anytime between randomization and hospital discharge. |
| Number of Participants Admitted to Intensive Care Unit (ICU) | delivery through hospital discharge | Admission of the participant to the intensive care unit (ICU) |
Countries
United States
Participant flow
Recruitment details
50,581 low-risk nulliparous women at 34 weeks 0 days gestation to 38 weeks 6 days gestation were screened for eligibility between March 2014 and August 2017 at 41 hospitals participating in the MFMU network. Women who consented were assessed again between 38 weeks 0 days gestation and 38 weeks 6 days gestation for new indications of ineligibility.
Participants by arm
| Arm | Count |
|---|---|
| Expectant Management Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | 3,044 |
| Elective Induction of Labor Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Elective Induction of Labor: 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. | 3,062 |
| Total | 6,106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Expectant Management | Elective Induction of Labor | Total |
|---|---|---|---|
| Age, Continuous | 23 years | 24 years | 24 years |
| Age, Customized ≥35 years | 136 Participants | 114 Participants | 250 Participants |
| BMI ≥30 at randomization | 1575 Participants | 1632 Participants | 3207 Participants |
| BMI at randomization | 30.3 kg/m^2 | 30.5 kg/m^2 | 30.4 kg/m^2 |
| Drank alcohol | 107 Participants | 133 Participants | 240 Participants |
| Employment status Employed full time | 1209 Participants | 1226 Participants | 2435 Participants |
| Employment status Employed part time | 353 Participants | 341 Participants | 694 Participants |
| Employment status Not employed | 1474 Participants | 1486 Participants | 2960 Participants |
| History of pregnancy loss No previous pregnancy loss | 2266 Participants | 2364 Participants | 4630 Participants |
| History of pregnancy loss Previous pregnancy loss | 778 Participants | 698 Participants | 1476 Participants |
| Length of gestation at randomization | 38.3 weeks | 38.3 weeks | 38.3 weeks |
| Married or living with partner | 1798 Participants | 1814 Participants | 3612 Participants |
| Method of conception In vitro fertilization | 47 Participants | 56 Participants | 103 Participants |
| Method of conception Ovulation inducation or artificial insemination | 24 Participants | 30 Participants | 54 Participants |
| Method of conception Spontaneous | 2973 Participants | 2976 Participants | 5949 Participants |
| Modified Bishop score <5 at randomization | 1954 Participants | 1919 Participants | 3873 Participants |
| Modified Bishop Score at randomization | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| Private insurance for prenatal care | 1335 Participants | 1404 Participants | 2739 Participants |
| Race/Ethnicity, Customized Asian | 106 Participants | 87 Participants | 193 Participants |
| Race/Ethnicity, Customized Black | 699 Participants | 707 Participants | 1406 Participants |
| Race/Ethnicity, Customized Hispanic | 808 Participants | 866 Participants | 1674 Participants |
| Race/Ethnicity, Customized Other, unknown or more than one race | 72 Participants | 73 Participants | 145 Participants |
| Race/Ethnicity, Customized White | 1359 Participants | 1329 Participants | 2688 Participants |
| Sex: Female, Male Female | 3044 Participants | 3062 Participants | 6106 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoked cigarettes | 242 Participants | 224 Participants | 466 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 3,059 | 2 / 3,037 |
| other Total, other adverse events | 0 / 3,037 | 0 / 3,059 |
| serious Total, serious adverse events | 3 / 3,037 | 2 / 3,059 |
Outcome results
Primary
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
Population: The analysis was intent to treat.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Composite of Severe Neonatal Morbidity and Perinatal Mortality | 164 Participants |
| Elective Induction of Labor | Composite of Severe Neonatal Morbidity and Perinatal Mortality | 132 Participants |
p-value: 0.04995% CI: [0.64, 1]Chi-squared
Primary
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)
Time frame: delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Hypotension Requiring Vasopressor Support (Component of Primary Outcome) | 5 Participants |
| Elective Induction of Labor | Hypotension Requiring Vasopressor Support (Component of Primary Outcome) | 2 Participants |
95% CI: [0.06, 1.79]
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome) | 18 Participants |
| Elective Induction of Labor | Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome) | 12 Participants |
95% CI: [0.32, 1.37]
Primary
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
Time frame: During the Delivery process
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Birth Trauma (Component of Primary Outcome) | 18 Participants |
| Elective Induction of Labor | Number of Infants With Birth Trauma (Component of Primary Outcome) | 14 Participants |
95% CI: [0.38, 1.55]
Primary
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
Time frame: delivery through disharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome) | 7 Participants |
| Elective Induction of Labor | Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome) | 9 Participants |
95% CI: [0.48, 3.42]
Primary
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
Time frame: Delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) | 26 Participants |
| Elective Induction of Labor | Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) | 17 Participants |
95% CI: [0.35, 1.19]
Primary
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)
Time frame: delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) | 20 Participants |
| Elective Induction of Labor | Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) | 14 Participants |
95% CI: [0.35, 1.37]
Primary
Number of Infants With Neonatal Infection (Component of Primary Outcome)
Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
Time frame: delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Neonatal Infection (Component of Primary Outcome) | 12 Participants |
| Elective Induction of Labor | Number of Infants With Neonatal Infection (Component of Primary Outcome) | 9 Participants |
95% CI: [0.31, 1.76]
Primary
Number of Infants With Neonatal Seizure (Component of Primary Outcome)
Time frame: Delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Neonatal Seizure (Component of Primary Outcome) | 4 Participants |
| Elective Induction of Labor | Number of Infants With Neonatal Seizure (Component of Primary Outcome) | 11 Participants |
95% CI: [0.91, 8.12]
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome) | 127 Participants |
| Elective Induction of Labor | Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome) | 91 Participants |
95% CI: [0.55, 0.93]
Primary
Perinatal Death (Component of Primary Outcome)
Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death
Time frame: antepartum pregnancy period through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Perinatal Death (Component of Primary Outcome) | 3 Participants |
| Elective Induction of Labor | Perinatal Death (Component of Primary Outcome) | 2 Participants |
95% CI: [0.12, 3.33]
Secondary
Duration of Respiratory Support
including ventilator, CPAP, high-flow nasal cannula (HFNC)
Time frame: delivery through hospital discharge
Population: One neonate had cardiorespiratory resuscitation and 0 days on mechanical ventilation, continuous positive airway pressure or high flow nasal cannula.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Duration of Respiratory Support | 0 days | 2911 Participants |
| Expectant Management | Duration of Respiratory Support | 1 day | 70 Participants |
| Expectant Management | Duration of Respiratory Support | Greater than 1 day | 56 Participants |
| Elective Induction of Labor | Duration of Respiratory Support | 0 days | 2968 Participants |
| Elective Induction of Labor | Duration of Respiratory Support | 1 day | 55 Participants |
| Elective Induction of Labor | Duration of Respiratory Support | Greater than 1 day | 36 Participants |
p-value: 0.01Cochran-Armitage trend test
Secondary
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
Population: Data for 6 to 96 hours after delivery are missing for 288 women (127 in the induction group and 161 in the expectant-management group); data for 4 to 8 weeks after delivery are missing for 736 women (349 in the induction group and 387 in the expectant-management group).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Expectant Management | Labor Agentry Scale Scores | At 6-96 hr after delivery | 164 score on a scale |
| Expectant Management | Labor Agentry Scale Scores | At 4-8 weeks after delivery | 174 score on a scale |
| Elective Induction of Labor | Labor Agentry Scale Scores | At 6-96 hr after delivery | 168 score on a scale |
| Elective Induction of Labor | Labor Agentry Scale Scores | At 4-8 weeks after delivery | 176 score on a scale |
Comparison: Analysis for 6-96 hours after deliveryp-value: <0.001Chi-squared
Comparison: Analysis for 4-8 weeks after deliveryp-value: 0.01Chi-squared
Secondary
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
Population: Data on worst score are missing for 274 women (110 in the induction group and 164 in the expectant-management group); data on overall score are missing for 275 women (110 in the induction group and 165 in the expectant-management group).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Expectant Management | Labor Pain Scores | Worst score | 9 score on a scale |
| Expectant Management | Labor Pain Scores | Overall score | 7 score on a scale |
| Elective Induction of Labor | Labor Pain Scores | Worst score | 8 score on a scale |
| Elective Induction of Labor | Labor Pain Scores | Overall score | 7 score on a scale |
Comparison: Analysis for Worst labor pain scorep-value: <0.001Chi-squared
Comparison: Analysis for Overall labor pain scorep-value: <0.001Chi-squared
Secondary
Maternal Postpartum Length of Hospital Stay
Time frame: delivery through hospital discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Maternal Postpartum Length of Hospital Stay | 2 days | 2084 Participants |
| Expectant Management | Maternal Postpartum Length of Hospital Stay | 4 days | 166 Participants |
| Expectant Management | Maternal Postpartum Length of Hospital Stay | 3 days | 452 Participants |
| Expectant Management | Maternal Postpartum Length of Hospital Stay | >4 days | 18 Participants |
| Expectant Management | Maternal Postpartum Length of Hospital Stay | <2 days | 317 Participants |
| Elective Induction of Labor | Maternal Postpartum Length of Hospital Stay | >4 days | 17 Participants |
| Elective Induction of Labor | Maternal Postpartum Length of Hospital Stay | <2 days | 322 Participants |
| Elective Induction of Labor | Maternal Postpartum Length of Hospital Stay | 2 days | 2191 Participants |
| Elective Induction of Labor | Maternal Postpartum Length of Hospital Stay | 3 days | 399 Participants |
| Elective Induction of Labor | Maternal Postpartum Length of Hospital Stay | 4 days | 130 Participants |
p-value: 0.01Cochran-Armitage trend test
Secondary
Neonatal Length of Hospital Stay
Time frame: delivery through hospital discharge
Population: Data is missing for 5 participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Neonatal Length of Hospital Stay | 2 days | 1904 Participants |
| Expectant Management | Neonatal Length of Hospital Stay | 4 days | 189 Participants |
| Expectant Management | Neonatal Length of Hospital Stay | 3 days | 498 Participants |
| Expectant Management | Neonatal Length of Hospital Stay | >4 days | 128 Participants |
| Expectant Management | Neonatal Length of Hospital Stay | <2 days | 315 Participants |
| Elective Induction of Labor | Neonatal Length of Hospital Stay | >4 days | 107 Participants |
| Elective Induction of Labor | Neonatal Length of Hospital Stay | <2 days | 321 Participants |
| Elective Induction of Labor | Neonatal Length of Hospital Stay | 2 days | 2030 Participants |
| Elective Induction of Labor | Neonatal Length of Hospital Stay | 3 days | 457 Participants |
| Elective Induction of Labor | Neonatal Length of Hospital Stay | 4 days | 142 Participants |
p-value: 0.002Cochran-Armitage trend test
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number Infants Admitted to NICU or Intermediate Care | 394 Participants |
| Elective Induction of Labor | Number Infants Admitted to NICU or Intermediate Care | 358 Participants |
p-value: 0.1395% CI: [0.79, 1.03]Chi-squared
Secondary
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
Population: Excludes 7 women who delivered before admission to the labor and delivery unit. Data are missing for 2 women.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Expectant Management | Number of Hours on the Labor and Delivery Unit | 14 hours |
| Elective Induction of Labor | Number of Hours on the Labor and Delivery Unit | 20 hours |
p-value: <0.001Wilcoxon Rank-Sum
Secondary
Number of Infants Who Had Transfusion of Blood Products or Blood
Time frame: delivery through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants Who Had Transfusion of Blood Products or Blood | 5 Participants |
| Elective Induction of Labor | Number of Infants Who Had Transfusion of Blood Products or Blood | 4 Participants |
p-value: 0.7595% CI: [0.2, 2.74]Chi-squared
Secondary
Number of Infants With Cephalohematoma
Time frame: delivery through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Cephalohematoma | 90 Participants |
| Elective Induction of Labor | Number of Infants With Cephalohematoma | 83 Participants |
p-value: 0.5695% CI: [0.68, 1.23]Chi-squared
Secondary
Number of Infants With Hyperbilirubinemia
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Time frame: delivery through discharge
Population: Data were missing for 4 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Hyperbilirubinemia | 142 Participants |
| Elective Induction of Labor | Number of Infants With Hyperbilirubinemia | 145 Participants |
p-value: 0.9195% CI: [0.81, 1.27]Chi-squared
Secondary
Number of Infants With Neonatal Hypoglycemia
glucose \< 35 mg/dl and requiring IV therapy
Time frame: delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Infants With Neonatal Hypoglycemia | 35 Participants |
| Elective Induction of Labor | Number of Infants With Neonatal Hypoglycemia | 37 Participants |
p-value: 0.8495% CI: [0.66, 1.66]Chi-squared
Secondary
Number of Maternal Deaths
Maternal death at anytime between randomization and hospital discharge.
Time frame: from randomization to hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Maternal Deaths | 0 Participants |
| Elective Induction of Labor | Number of Maternal Deaths | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants Admitted to Intensive Care Unit (ICU) | 8 Participants |
| Elective Induction of Labor | Number of Participants Admitted to Intensive Care Unit (ICU) | 4 Participants |
p-value: 0.2695% CI: [0.13, 1.55]Chi-squared
Secondary
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
Population: breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Breastfeeding | 891 Participants |
| Expectant Management | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Breast Feeding and Formula Feeding | 831 Participants |
| Expectant Management | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Formula Feeding | 972 Participants |
| Elective Induction of Labor | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Breastfeeding | 916 Participants |
| Elective Induction of Labor | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Breast Feeding and Formula Feeding | 863 Participants |
| Elective Induction of Labor | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Formula Feeding | 981 Participants |
Comparison: Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.p-value: 0.8895% CI: [0.89, 1.15]Regression, Logistic
Comparison: Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.p-value: 0.7895% CI: [0.86, 1.12]Regression, Logistic
Secondary
Number of Participants Experiencing Hypertensive Disorder of Pregnancy
Time frame: Randomization to hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants Experiencing Hypertensive Disorder of Pregnancy | 427 Participants |
| Elective Induction of Labor | Number of Participants Experiencing Hypertensive Disorder of Pregnancy | 277 Participants |
p-value: <0.00195% CI: [0.56, 0.74]Chi-squared
Secondary
Number of Participants Who Had Chorioamnionitis
Chorioamnionitis, defined as a clinical diagnosis before delivery
Time frame: at any time from randomization through delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants Who Had Chorioamnionitis | 429 Participants |
| Elective Induction of Labor | Number of Participants Who Had Chorioamnionitis | 407 Participants |
p-value: 0.3595% CI: [0.83, 1.07]Chi-squared
Secondary
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
Population: Neonatal length of hospital stay missing in 5 (2 induction group (IOL); 3 expectant-management group (EM)); incisional extensions at cesarean section missing in 9 (5 IOL; 4 EM); breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery | 48 Participants |
| Elective Induction of Labor | Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery | 28 Participants |
p-value: 0.0295% CI: [0.36, 0.92]Chi-squared
Secondary
Number of Participants With Cesarean Delivery
Time frame: delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants With Cesarean Delivery | 674 Participants |
| Elective Induction of Labor | Number of Participants With Cesarean Delivery | 569 Participants |
p-value: <0.00195% CI: [0.76, 0.93]Chi-squared
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Number of Participants With Indications for Cesarean Delivery | Dystocia | 289 Participants |
| Expectant Management | Number of Participants With Indications for Cesarean Delivery | Non-reassuring fetal status | 332 Participants |
| Expectant Management | Number of Participants With Indications for Cesarean Delivery | Other c-section indication | 53 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Cesarean Delivery | Dystocia | 259 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Cesarean Delivery | Non-reassuring fetal status | 275 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Cesarean Delivery | Other c-section indication | 35 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Expectant Management | Number of Participants With Indications for Operative Vaginal Delivery | Dystocia | 94 Participants |
| Expectant Management | Number of Participants With Indications for Operative Vaginal Delivery | Non-reassuring fetal status | 156 Participants |
| Expectant Management | Number of Participants With Indications for Operative Vaginal Delivery | Other indication | 6 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Operative Vaginal Delivery | Dystocia | 101 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Operative Vaginal Delivery | Non-reassuring fetal status | 119 Participants |
| Elective Induction of Labor | Number of Participants With Indications for Operative Vaginal Delivery | Other indication | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants With Maternal Postpartum Infection | 65 Participants |
| Elective Induction of Labor | Number of Participants With Maternal Postpartum Infection | 50 Participants |
p-value: 0.1595% CI: [0.53, 1.1]Chi-squared
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants With Postpartum Hemorrhage | 137 Participants |
| Elective Induction of Labor | Number of Participants With Postpartum Hemorrhage | 142 Participants |
p-value: 0.8195% CI: [0.82, 1.29]Chi-squared
Secondary
Number of Participants With Third or Fourth Degree Perineal Laceration
Time frame: delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants With Third or Fourth Degree Perineal Laceration | 89 Participants |
| Elective Induction of Labor | Number of Participants With Third or Fourth Degree Perineal Laceration | 103 Participants |
p-value: 0.3395% CI: [0.87, 1.52]Chi-squared
Secondary
Number of Participants With Venous Thromboembolism
Maternal deep venous thrombosis or pulmonary embolism
Time frame: delivery through discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Number of Participants With Venous Thromboembolism | 1 Participants |
| Elective Induction of Labor | Number of Participants With Venous Thromboembolism | 2 Participants |
p-value: 195% CI: [0.26, 26.8]Chi-squared
Secondary
Participants Who Had Operative Vaginal Delivery
Time frame: delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Participants Who Had Operative Vaginal Delivery | 258 Participants |
| Elective Induction of Labor | Participants Who Had Operative Vaginal Delivery | 222 Participants |
p-value: 0.0795% CI: [0.72, 1.01]Chi-squared
Secondary
Shoulder Dystocia
Time frame: delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Expectant Management | Shoulder Dystocia | 65 Participants |
| Elective Induction of Labor | Shoulder Dystocia | 59 Participants |
p-value: 0.5695% CI: [0.64, 1.28]Chi-squared