Pregnancy; Habitual Aborter Clinical Trial
Official title:
Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
| Verified date | March 2013 |
| Source | Monica Healthcare Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Pregnant, age 15-40 - Term gestation (>36 completed weeks) - Singleton fetus - Active labor - Vertex presentation - Requiring internal monitoring Exclusion Criteria: - Clinical contraindication for Intra Uterine Pressure Catheter - Major fetal malformation |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Queens Hospital Center | New York | New York |
| United States | Temple University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Monica Healthcare Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement. | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour | No |
| Primary | The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM | During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement. | during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour | No |
| Secondary | The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM | During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement | between 35 mins & 15hrs during first & second stage labor | No |