Trial Outcomes & Findings for A Randomized Trial of Induction Versus Expectant Management (NCT NCT01990612)

NCT ID: NCT01990612

Last Updated: 2019-02-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6106 participants
• Primary outcome timeframe: delivery through 72 hours after birth
• Results posted on: 2019-02-21

Participant Flow

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.

Participant milestones

Measure	Expectant Management Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	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.
Overall Study STARTED	3044	3062
Overall Study COMPLETED	3037	3059
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Measure	Expectant Management Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	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.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	5	2

Baseline Characteristics

Data on employment status are missing for a total of 17 women.

Baseline characteristics by cohort

Measure	Expectant Management n=3044 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3062 Participants 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.	Total n=6106 Participants Total of all reporting groups
Age, Continuous	23 years n=3044 Participants	24 years n=3062 Participants	24 years n=6106 Participants
Age, Customized ≥35 years	136 Participants n=3044 Participants	114 Participants n=3062 Participants	250 Participants n=6106 Participants
Sex: Female, Male Female	3044 Participants n=3044 Participants	3062 Participants n=3062 Participants	6106 Participants n=6106 Participants
Sex: Female, Male Male	0 Participants n=3044 Participants	0 Participants n=3062 Participants	0 Participants n=6106 Participants
Race/Ethnicity, Customized White	1359 Participants n=3044 Participants	1329 Participants n=3062 Participants	2688 Participants n=6106 Participants
Race/Ethnicity, Customized Black	699 Participants n=3044 Participants	707 Participants n=3062 Participants	1406 Participants n=6106 Participants
Race/Ethnicity, Customized Asian	106 Participants n=3044 Participants	87 Participants n=3062 Participants	193 Participants n=6106 Participants
Race/Ethnicity, Customized Hispanic	808 Participants n=3044 Participants	866 Participants n=3062 Participants	1674 Participants n=6106 Participants
Race/Ethnicity, Customized Other, unknown or more than one race	72 Participants n=3044 Participants	73 Participants n=3062 Participants	145 Participants n=6106 Participants
Married or living with partner	1798 Participants n=3044 Participants	1814 Participants n=3062 Participants	3612 Participants n=6106 Participants
Employment status Employed full time	1209 Participants n=3036 Participants • Data on employment status are missing for a total of 17 women.	1226 Participants n=3053 Participants • Data on employment status are missing for a total of 17 women.	2435 Participants n=6089 Participants • Data on employment status are missing for a total of 17 women.
Employment status Employed part time	353 Participants n=3036 Participants • Data on employment status are missing for a total of 17 women.	341 Participants n=3053 Participants • Data on employment status are missing for a total of 17 women.	694 Participants n=6089 Participants • Data on employment status are missing for a total of 17 women.
Employment status Not employed	1474 Participants n=3036 Participants • Data on employment status are missing for a total of 17 women.	1486 Participants n=3053 Participants • Data on employment status are missing for a total of 17 women.	2960 Participants n=6089 Participants • Data on employment status are missing for a total of 17 women.
Private insurance for prenatal care	1335 Participants n=3044 Participants • Data is missing for one participant.	1404 Participants n=3061 Participants • Data is missing for one participant.	2739 Participants n=6105 Participants • Data is missing for one participant.
History of pregnancy loss No previous pregnancy loss	2266 Participants n=3044 Participants	2364 Participants n=3062 Participants	4630 Participants n=6106 Participants
History of pregnancy loss Previous pregnancy loss	778 Participants n=3044 Participants	698 Participants n=3062 Participants	1476 Participants n=6106 Participants
Length of gestation at randomization	38.3 weeks n=3044 Participants	38.3 weeks n=3062 Participants	38.3 weeks n=6106 Participants
Method of conception In vitro fertilization	47 Participants n=3044 Participants	56 Participants n=3062 Participants	103 Participants n=6106 Participants
Method of conception Ovulation inducation or artificial insemination	24 Participants n=3044 Participants	30 Participants n=3062 Participants	54 Participants n=6106 Participants
Method of conception Spontaneous	2973 Participants n=3044 Participants	2976 Participants n=3062 Participants	5949 Participants n=6106 Participants
Smoked cigarettes	242 Participants n=3044 Participants	224 Participants n=3062 Participants	466 Participants n=6106 Participants
Drank alcohol	107 Participants n=3043 Participants • Data are missing for 1 participant	133 Participants n=3062 Participants • Data are missing for 1 participant	240 Participants n=6105 Participants • Data are missing for 1 participant
BMI at randomization	30.3 kg/m^2 n=3027 Participants • Data are missing for 30 women	30.5 kg/m^2 n=3049 Participants • Data are missing for 30 women	30.4 kg/m^2 n=6076 Participants • Data are missing for 30 women
BMI ≥30 at randomization	1575 Participants n=3027 Participants • Data are missing for 30 women	1632 Participants n=3049 Participants • Data are missing for 30 women	3207 Participants n=6076 Participants • Data are missing for 30 women
Modified Bishop Score at randomization	4 units on a scale n=3042 Participants • Data is missing for 2 participants.	4 units on a scale n=3062 Participants • Data is missing for 2 participants.	4 units on a scale n=6104 Participants • Data is missing for 2 participants.
Modified Bishop score <5 at randomization	1954 Participants n=3042 Participants • Data is missing for 2 participants	1919 Participants n=3062 Participants • Data is missing for 2 participants	3873 Participants n=6104 Participants • Data is missing for 2 participants

PRIMARY outcome

Timeframe: delivery through 72 hours after birth

Population: The analysis was intent to treat.

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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Composite of Severe Neonatal Morbidity and Perinatal Mortality	164 Participants	132 Participants

PRIMARY outcome

Timeframe: antepartum pregnancy period through hospital discharge

Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Perinatal Death (Component of Primary Outcome)	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Delivery through discharge

Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)	127 Participants	91 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)	18 Participants	12 Participants

PRIMARY outcome

Timeframe: delivery through discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)	20 Participants	14 Participants

PRIMARY outcome

Timeframe: Delivery through discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Neonatal Seizure (Component of Primary Outcome)	4 Participants	11 Participants

PRIMARY outcome

Timeframe: delivery through discharge

Neonatal infection includes confirmed sepsis and/or confirmed pneumonia

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Neonatal Infection (Component of Primary Outcome)	12 Participants	9 Participants

PRIMARY outcome

Timeframe: Delivery through discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)	26 Participants	17 Participants

PRIMARY outcome

Timeframe: During the Delivery process

Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Birth Trauma (Component of Primary Outcome)	18 Participants	14 Participants

PRIMARY outcome

Timeframe: delivery through disharge

Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)	7 Participants	9 Participants

PRIMARY outcome

Timeframe: delivery through discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)	5 Participants	2 Participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Cesarean Delivery	674 Participants	569 Participants

SECONDARY outcome

Timeframe: 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).

Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery	48 Participants	28 Participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Participants Who Had Operative Vaginal Delivery	258 Participants	222 Participants

SECONDARY outcome

Timeframe: at any time from randomization through delivery

Chorioamnionitis, defined as a clinical diagnosis before delivery

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants Who Had Chorioamnionitis	429 Participants	407 Participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Third or Fourth Degree Perineal Laceration	89 Participants	103 Participants

SECONDARY outcome

Timeframe: from randomization to hospital discharge

Maternal death at anytime between randomization and hospital discharge.

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Maternal Deaths	0 Participants	0 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge

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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants Admitted to Intensive Care Unit (ICU)	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Randomization to hospital discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants Experiencing Hypertensive Disorder of Pregnancy	427 Participants	277 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Postpartum Hemorrhage	137 Participants	142 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Labor Agentry Scale Scores At 6-96 hr after delivery	164 score on a scale Interval 143.0 to 181.0	168 score on a scale Interval 148.0 to 183.0
Labor Agentry Scale Scores At 4-8 weeks after delivery	174 score on a scale Interval 154.0 to 188.0	176 score on a scale Interval 157.0 to 189.0

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Labor Pain Scores Worst score	9 score on a scale Interval 8.0 to 10.0	8 score on a scale Interval 7.0 to 10.0
Labor Pain Scores Overall score	7 score on a scale Interval 5.0 to 9.0	7 score on a scale Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Maternal Postpartum Infection	65 Participants	50 Participants

SECONDARY outcome

Timeframe: delivery through discharge

Maternal deep venous thrombosis or pulmonary embolism

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Venous Thromboembolism	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Labor and delivery

Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Indications for Cesarean Delivery Dystocia	289 Participants	259 Participants
Number of Participants With Indications for Cesarean Delivery Non-reassuring fetal status	332 Participants	275 Participants
Number of Participants With Indications for Cesarean Delivery Other c-section indication	53 Participants	35 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Duration of Respiratory Support 0 days	2911 Participants	2968 Participants
Duration of Respiratory Support 1 day	70 Participants	55 Participants
Duration of Respiratory Support Greater than 1 day	56 Participants	36 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Cephalohematoma	90 Participants	83 Participants

SECONDARY outcome

Timeframe: delivery

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Shoulder Dystocia	65 Participants	59 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants Who Had Transfusion of Blood Products or Blood	5 Participants	4 Participants

SECONDARY outcome

Timeframe: delivery through discharge

Population: Data were missing for 4 participants.

Hyperbilirubinemia requiring phototherapy or exchange transfusion

Outcome measures

Measure	Expectant Management n=3034 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3058 Participants 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.
Number of Infants With Hyperbilirubinemia	142 Participants	145 Participants

SECONDARY outcome

Timeframe: delivery through discharge

glucose < 35 mg/dl and requiring IV therapy

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Infants With Neonatal Hypoglycemia	35 Participants	37 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge

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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number Infants Admitted to NICU or Intermediate Care	394 Participants	358 Participants

SECONDARY outcome

Timeframe: 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.

Median duration of stay in labor and delivery unit

Outcome measures

Measure	Expectant Management n=3036 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3058 Participants 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.
Number of Hours on the Labor and Delivery Unit	14 hours Interval 9.0 to 20.0	20 hours Interval 13.0 to 28.0

SECONDARY outcome

Timeframe: delivery through hospital discharge

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Maternal Postpartum Length of Hospital Stay 2 days	2084 Participants	2191 Participants
Maternal Postpartum Length of Hospital Stay <2 days	317 Participants	322 Participants
Maternal Postpartum Length of Hospital Stay 3 days	452 Participants	399 Participants
Maternal Postpartum Length of Hospital Stay 4 days	166 Participants	130 Participants
Maternal Postpartum Length of Hospital Stay >4 days	18 Participants	17 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge

Population: Data is missing for 5 participants

Outcome measures

Measure	Expectant Management n=3034 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3057 Participants 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.
Neonatal Length of Hospital Stay <2 days	315 Participants	321 Participants
Neonatal Length of Hospital Stay 2 days	1904 Participants	2030 Participants
Neonatal Length of Hospital Stay 3 days	498 Participants	457 Participants
Neonatal Length of Hospital Stay 4 days	189 Participants	142 Participants
Neonatal Length of Hospital Stay >4 days	128 Participants	107 Participants

SECONDARY outcome

Timeframe: Labor and delivery

Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants With Indications for Operative Vaginal Delivery Dystocia	94 Participants	101 Participants
Number of Participants With Indications for Operative Vaginal Delivery Non-reassuring fetal status	156 Participants	119 Participants
Number of Participants With Indications for Operative Vaginal Delivery Other indication	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 4-8 weeks after delivery

Population: breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM)

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

Outcome measures

Measure	Expectant Management n=3037 Participants Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 Participants 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.
Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery Breastfeeding	891 Participants	916 Participants
Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery Breast Feeding and Formula Feeding	831 Participants	863 Participants
Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery Formula Feeding	972 Participants	981 Participants

Adverse Events

Expectant Management

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Elective Induction of Labor

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Expectant Management n=3037 participants at risk Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.	Elective Induction of Labor n=3059 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Perinatal Death	0.10% 3/3037 • Number of events 3037 • Adverse event data were collected and evaluated from the date of randomization (between 38 weeks, 0 days gestation and 38 weeks, 6 days gestation) through approximately 8 weeks postpartum. This time frame encompasses between 9 and 12 weeks. The primary and secondary outcomes comprise all the adverse events that occurred. We expect this is different than, for example, a medication trial in which adverse events other than those related to the outcomes may occur.	0.07% 2/3059 • Number of events 3059 • Adverse event data were collected and evaluated from the date of randomization (between 38 weeks, 0 days gestation and 38 weeks, 6 days gestation) through approximately 8 weeks postpartum. This time frame encompasses between 9 and 12 weeks. The primary and secondary outcomes comprise all the adverse events that occurred. We expect this is different than, for example, a medication trial in which adverse events other than those related to the outcomes may occur.

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Grobman

Northwestern University

Phone: 312-472-4661

Email: w-grobman@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER