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Trial · NCT03407625

Registered outcomes24

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Vaginal Deliveryat deliveryvaginal delivery at first induction
SecondaryTime to Deliveryfrom start of induction agent to time of deliveryTime (in hours) from start of induction agent to delivery at first induction
SecondaryIndication for Cesarean Deliveryat deliveryAmong women delivered by cesarean, the indication for cesarean
SecondaryDose of Oxytocin Given (mcg or mg)at deliveryTotal dose of oxytocin given for induction as calculated by volume infused, concentration of solution and rate of infusion
SecondaryTime With Foley Bulb in PlaceFrom time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours.time (in hours) from insertion to removal or expulsion of foley bulb
SecondaryPresence of Chorioamnionitisat deliveryIntrapartum fever (temp equal or greater than 38C) with no other identified cause
SecondaryUse of Intravenous Analgesia During Laborat deliveryIntravenous analgesia used between the start of induction and delivery
SecondaryNumber of Participants Used Neuraxial Analgesia During Laborfrom start of induction to deliveryRegional or neuraxial analgesia (labor epidural or spinal) used between the start of induction and delivery
SecondaryNumber of Participants Used General Anesthesia for Deliveryat deliveryGeneral anesthesia administered for delivery
SecondaryNumber of Participants With Meconium-stained Amniotic FluidAt the time of rupture of membranes and at deliveryIdentification of any meconium (green tinge) in the amniotic fluid before or during delivery by a healthcare provider's assessment of gross fluid color.
SecondaryTerbutaline Useat deliveryAdministration of terbutaline, a tocolytic agent, for tetanic contractions with or without fetal heart rate decelerations
SecondaryNumber of Participants With Tachysystoleat delivery6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer
SecondaryNumber of Participants With Uterine Hyperstimulation Syndromeat deliveryTachysystole accompanied by fetal heart rate decelerations
SecondaryNumber of Participants With Excess Blood Lossat deliveryMaternal excess blood loss is defined as \>500ml for vaginal and \>1000ml for cesarean delivery
SecondaryNumber of Participants With Blood Transfusionat deliveryadministration of blood products related to delivery blood loss
SecondaryNumber of Participants With Uterine Ruptureat deliveryspontaneous separation of myometrium in a previously intact, unscarred uterus
SecondaryNumber of Participants With Unplanned Hysterectomyat discharge from the hospital following deliveryunplanned removal of the uterus following delivery of the fetus
SecondaryNumber of Participants With Postpartum FeverFollowing delivery and prior to dischargeFever recorded in the time after delivery but prior to discharge from the hospital, with clinical assessment of endometritis
SecondaryNumber of Participants With Umbilical Cord Blood pH <7.0at deliveryArterial or venous cord blood pH defined as \<7.0
SecondaryNumber of Participants With an 5-minute Apgar Score Less Than 45 minutes after time of birth
Appearance, Pulse, Grimace, Activity, Respirations - scored from 0 to 2 for each component, added to make a total score and used as an assessment of initial response to newborn resuscitation, lower scores associated with poor outcomes. Here defined as Apgar less than 4 at 5 minutes.

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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