A study to determine the comparability between the Paxxy monitor compared to CTG and pulse oximetry in monitoring fetal and maternal heart rates among term mothers with uncomplicated singleton pregnancy – single arm study
Not Applicable
- Conditions
- Fetal heart rate and maternal heart rate
- Registration Number
- SLCTR/2024/026
- Lead Sponsor
- Paxxy FMS LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
•All term mothers (37+0 - 41+7) presenting to the professorial unit of De Soysa Hospital for Women.
•Have clinical indications for fetal monitoring.
•Age 18-45 years.
Exclusion Criteria
1. Multiple pregnancy
2. Fetal growth restriction
3. Hypertension and diabetes in pregnancy
4. BMI>30
5. Significant uterine anomalies such as didelphys or bicornuate uterus (Women with small ,clinically insignificant anomalies such as uterine fibroids are not excluded)
6. Inability to fit both Paxxy and CTG due to fetal position.
7. Known allergy to ECG pad adhesive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method