Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions

Status unconfirmed · Early Phase 1

Conditions studied: Pregnancy Related, Labor Long, Fetal Distress

In brief

Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.

Key facts

Study ID

NCT04548453

Run by

PreTeL, Inc

People needed

51

Starts

2021-04-01

Expected to finish

2021-10-01

Last updated by the study team

2020-09-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 18 or greater
• At least 37 weeks gestation
• English reading and speaking
• Female gender
• Singleton fetus
• Planned continuous external fetal monitoring: to include fetal heart rate and uterine contraction monitoring
• May have clinical indications for internal monitoring (IUPC and/or FSE) that replaces external monitoring.
• Induction or augmentation of labor with oxytocin (Pitocin)
• Subjects undergoing artificial rupture of membranes (AROM) or who experienced spontaneous rupture of membranes (SROM), with a plan for oxytocin administration, will be included as a special category.
• Subjects may undergo cervical ripening.
• Patients must be able to review and sign informed consent to participate in the study.
• Trial of labor after Cesarean section are eligible for participation
• Women diagnosed with diabetes and/or pre-eclampsia with or without magnesium therapy are eligible for participation
• Women with other complications of pregnancy are eligible for participation if the complication does not interfere with fetal monitoring, EMG monitoring or other recording of data.

You may not qualify if…

• Non-English reading and/or speaking
• Twins, triplets and other multifetal gestations
• Non-vertex presentation
• Planned Cesarean delivery
• Significant uterine anomalies such as didelphys or bicornuate uterus (women with small, clinically insignificant anomalies such as uterine fibroids are not excluded).
• Participants cannot be participating in any other research study or protocol regarding uterine contraction monitoring during the same study period as required for our study.
• Known allergy to ECG pad adhesive
• Non-living fetus
• Major fetal malformation
• Fetal distress, or other indications for emergent delivery
• Other than a Category I fetal heart tracing at the beginning of the recording.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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