RECRUITING
I'm interested ...!!
Oxytocin and Fetal Heart Rate Changes
The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fetal heart rate changes.
Conditions:
🦠 Fetal Bradycardia Complicating Labor and Delivery 🦠 Fetal Bradycardia During Labor 🦠 Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
🗓️ Study Start (Actual) 20 February 2019
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 730
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Iowa City, Iowa, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Healthy nulliparous or multiparous women at term (37 \> weeks' gestation)
    • * Singleton pregnancy
    • * Request for neuraxial analgesia
    • * Oxytocin used for induction of labor or augmentation of labor per institutional protocols

    Exclusion Criteria:

    • * Use of chronic analgesic medications
    • * Prior administration of systemic opioid labor analgesia
    • * Non-vertex presentation
    • * Contraindication to neuraxial analgesia
    • * Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 July 2017
  • First Submitted that Met QC Criteria 25 July 2017
  • First Posted 28 July 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024
I'm interested ...!!