| 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
| The analysis was intent to treat. | Posted | | Count of Participants | | Participants | | delivery through 72 hours after birth | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value <0.46 considered stat sig | 0.049 | | Risk Ratio (RR) | 0.80 | | | 2-Sided | 95 | 0.64 | 1.00 | | | One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk. | | Superiority | | |
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| Primary | Perinatal Death (Component of Primary Outcome) | Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death | | Posted | | Count of Participants | | Participants | | antepartum pregnancy period through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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 | | Posted | | Count of Participants | | Participants | | Delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | Delivery through 5 minutes after birth | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Primary | Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) | | | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Primary | Number of Infants With Neonatal Seizure (Component of Primary Outcome) | | | Posted | | Count of Participants | | Participants | | Delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Primary | Number of Infants With Neonatal Infection (Component of Primary Outcome) | Neonatal infection includes confirmed sepsis and/or confirmed pneumonia | | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Primary | Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) | | | Posted | | Count of Participants | | Participants | | Delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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 | | Posted | | Count of Participants | | Participants | | During the Delivery process | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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 | | Posted | | Count of Participants | | Participants | | delivery through disharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Primary | Hypotension Requiring Vasopressor Support (Component of Primary Outcome) | | | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Secondary | Number of Participants With Cesarean Delivery | | | Posted | | Count of Participants | | Participants | | delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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 | 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). | Posted | | Count of Participants | | Participants | | delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Participants Who Had Operative Vaginal Delivery | | | Posted | | Count of Participants | | Participants | | delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Secondary | Number of Participants Who Had Chorioamnionitis | Chorioamnionitis, defined as a clinical diagnosis before delivery | | Posted | | Count of Participants | | Participants | | at any time from randomization through delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Secondary | Number of Participants With Third or Fourth Degree Perineal Laceration | | | Posted | | Count of Participants | | Participants | | delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Secondary | Number of Maternal Deaths | Maternal death at anytime between randomization and hospital discharge. | | Posted | | Count of Participants | | Participants | | from randomization to hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Participants Admitted to Intensive Care Unit (ICU) | Admission of the participant to the intensive care unit (ICU) | | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| Secondary | Number of Participants Experiencing Hypertensive Disorder of Pregnancy | | | Posted | | Count of Participants | | Participants | | Randomization to hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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
| | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| 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. | 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). | Posted | | Median | Inter-Quartile Range | score on a scale | | Between 6 hours after delivery and 8 weeks after delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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. | 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). | Posted | | Median | Inter-Quartile Range | score on a scale | | During labor and delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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| 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
| | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Participants With Venous Thromboembolism | Maternal deep venous thrombosis or pulmonary embolism | | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | Labor and delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Duration of Respiratory Support | including ventilator, CPAP, high-flow nasal cannula (HFNC) | One neonate had cardiorespiratory resuscitation and 0 days on mechanical ventilation, continuous positive airway pressure or high flow nasal cannula. | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Infants With Cephalohematoma | | | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Shoulder Dystocia | | | Posted | | Count of Participants | | Participants | | delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Infants Who Had Transfusion of Blood Products or Blood | | | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Infants With Hyperbilirubinemia | Hyperbilirubinemia requiring phototherapy or exchange transfusion | Data were missing for 4 participants. | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Infants With Neonatal Hypoglycemia | glucose < 35 mg/dl and requiring IV therapy | | Posted | | Count of Participants | | Participants | | delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number Infants Admitted to NICU or Intermediate Care | Number infants admitted to intensive care unit (NICU) or intermediate care unit | | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Hours on the Labor and Delivery Unit | Median duration of stay in labor and delivery unit | Excludes 7 women who delivered before admission to the labor and delivery unit. Data are missing for 2 women. | Posted | | Median | Inter-Quartile Range | hours | | Hours from admission to L&D to discharge from L&D | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Maternal Postpartum Length of Hospital Stay | | | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Neonatal Length of Hospital Stay | | Data is missing for 5 participants | Posted | | Count of Participants | | Participants | | delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | Labor and delivery | | | | ID | Title | Description |
|---|
| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
| |
| Secondary | Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery | Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding | breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM) | Posted | | Count of Participants | | Participants | | 4-8 weeks after delivery | | | | ID | Title | Description |
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| OG000 | Expectant Management | Expectant management (unless a medical indication arises) until at least 40 weeks 5 days. | | OG001 | 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. |
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