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

Study of agreement between Paxxy fetal heart rate and maternal heart rate monitoring with CTG and pulse oximetry.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2024/026

Enrollment

Registered

2024-08-11

Start date

2024-08-12

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal heart rate and maternal heart rate

Interventions

Study setting is the professorial obstetric unit of de Soysa Hospital for Women Recruitment: The patients will be recruited by the research assistant and house officers in the ward who will explain t

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Agreement between Paxxy FHR with CTG and Paxxy MHR with pulse oximetry MHR will be analysed. The correlation and mean difference (95% confidence interval [CI]) between Paxxy and CTG measures of FHR and between PXXY and pulse oximeter measured MHR will be calculated. Bland Altman plots will be generated to show the agreement between the two monitoring methods. This will be done by plotting the difference in measurement between the two methods vs the average in measurement of the two methods [Initial monitoring for 20 minutes with a standard CTG will be done after admission to ward. After about 5 minutes of mobilisation of the mother Paxxy monitoring and pulse oxymeter monitoring will be done for further 20 minutes. ]	—

Measure

Time frame

Agreement between Paxxy FHR with CTG and Paxxy MHR with pulse oximetry MHR will be analysed. The correlation and mean difference (95% confidence interval [CI]) between Paxxy and CTG measures of FHR and between PXXY and pulse oximeter measured MHR will be calculated. Bland Altman plots will be generated to show the agreement between the two monitoring methods. This will be done by plotting the difference in measurement between the two methods vs the average in measurement of the two methods [Initial monitoring for 20 minutes with a standard CTG will be done after admission to ward. After about 5 minutes of mobilisation of the mother Paxxy monitoring and pulse oxymeter monitoring will be done for further 20 minutes. ]

—

Secondary

Measure	Time frame
None []	—

Countries

Sri Lanka

Contacts

Public ContactIndunil Piyadigama

Senior lecturer, Department of Obstetrics and Gynaecology,Faculty of Medicine,University of Colombo

indunil@obg.cmb.ac.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026