Oxytocin and Fetal Heart Rate Changes

Conditions

• Fetal Bradycardia Complicating Labor and Delivery
• Fetal Bradycardia During Labor
• Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Half dose Oxytocin — DRUG
  Patients randomized to the half dose oxytocin group will have the oxytocin infusion reduced to 50 % prior to placement of combined spinal epidural for labor analgesia

Study Details

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.

Key Dates

Start date

Feb 20, 2019

Status verified

May 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

730 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard Dose Oxytocin
  Patients randomized to the standard dose oxytocin will have their oxytocin infusion maintained at the standard of care protocol prior to placement of a combined spinal epidural for labor analgesia
• Experimental: Half Dose Oxytocin
  Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.

Primary Outcome Measure

Incidence of non-reassuring fetal heart rate tracings [ Time Frame: 1.5 hours ]

Central Contacts

• Unyime Ituk
  319-356-2633
  [email protected]

Locations (2)

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