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Trial · NCT01973036

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime From Induction of Labor Until DeliveryTime from induction to delivery (average 14.2 hours)Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries
SecondaryNumber of Participants With ChorioamnionitisDuration of Labor (average 4.8 hours)
Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3). Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.
SecondaryNumber of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of OxytocinDuration of Labor (average 4.8 hours)
SecondaryNumber of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of OxytocinDuration of Labor (average 4.8 hours)
SecondaryDuration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal DeliveriesDuration of Labor (average 4.8 hours)
SecondaryRate of Failed Induction of Labor as the Indication for CesareanDuration of Labor (average 4.8 hours)
This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction. One patient was missing information for failed induction.
SecondaryRate of EndomyometritisDuration of hospital stay (average 3.4 days)Endomyometritis defined as: Temperature ≥100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever
SecondaryMaternal Length of Stay, From Admission to Discharge (Days)Duration of hospital stay (average 3.4 days)
SecondaryRate of Five Minute Apgar Score < 5Duration of hospital stay (average 3.4 days)
Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10.
SecondaryArterial Cord Blood Gas (pH), When ObtainedWithin 1 hour of delivery
SecondaryRate of Neonatal SepsisDuration of hospital stay (average 3.4 days)Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]
SecondaryNeonatal Intensive Care Unit (NICU) Admission RateDuration of hospital stay (average 3.4 days)
SecondaryNeonatal Length of StayDuration of hospital stay (average 3.4 days)
SecondaryNumber of Participants With Confirmed Histologic Chorioamnionitis/FunisitisDuration of hospital stay (average 3.4 days)Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
SecondaryTime From Induction to Delivery (Hours)Time from induction to delivery (average 14.2 hours)Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
SecondaryOverall Cesarean DeliveryDuration of hospital stay (average 3.4 days)
SecondaryRate of ChorioamnionitisDuration of hospital stay (average 3.4 days)
Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)
SecondaryMaternal Length of Stay From Delivery to Discharge (Hours)Duration of hospital stay (average 3.4 days)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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