Pregnancy Related Clinical Trial
— uSI-rangesOfficial title:
Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions
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.
Status | Not yet recruiting |
Enrollment | 51 |
Est. completion date | October 2021 |
Est. primary completion date | October 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
PreTeL, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlating uSI with the optimized dosing actions increase, hold and decrease | uSI clustering with dosing actions will be identified to provide guidance when prospectively dosing oxytocin | 8 months | |
Primary | Human factors in recording multichannel EMG during labor | Difficulties and discomfort of the EMG recording process will be identified and corrected | 8 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A |