Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosin… (NCT04548453) | Clinical Trial Compass
UnknownEarly Phase 1
Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions
United States51 participantsStarted 2021-04
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 …
What they're measuring
1
Correlating uSI with the optimized dosing actions increase, hold and decrease
Timeframe: 8 months
2
Human factors in recording multichannel EMG during labor