Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
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Purpose
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.
| Condition |
|---|
|
Pre Term Labor Multiple Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples |
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study population is women of >= 24 weeks of singleton pregnancy or women of >=24 weeks of multiple pregnancy, that have been admitted to the Labor and delivery suite
Inclusion Criteria:
- She is >=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or >=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit
- She is in the latent phase of spontaneous labor, or has been admitted for induction of labor
- She has given her informed consent to participate as a subject
- She has none of the exclusion criteria
Exclusion Criteria:
- Known major fetal malformation or chromosome abnormality
- Involvement in another clinical trial currently or previously in this pregnancy
- Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives)
- Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Sabine Z Bousleiman, RN MSN 212-305-2862 sb1080@mail.cumc.columbia.edu | |
| Principal Investigator: | Fadi Mizra, Dr | New York Presbytarian Hospital |
More Information
No publications provided
| Responsible Party: | Monica Healthcare Ltd |
| ClinicalTrials.gov Identifier: | NCT01360905 History of Changes |
| Other Study ID Numbers: | 100_CT-045 |
| Study First Received: | May 24, 2011 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Monica Healthcare Ltd:
|
PTL Multiples |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 23, 2013