Wireless Physiologic Monitoring After Cesarean

NCT06654115 | Active Not Recruiting

• 1 other identifier: LUNDMZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

With over 18.5 million procedures performed worldwide and increasing, Cesarean section (CS) is the commonest surgical procedure. Inpatient monitoring is typically intense due to high risk for hemorrhage and other complications in the immediate post-operative period. Vital signs, including heart rate, blood pressure, saturation and temperature are monitored every 10-15 minutes. Maintaining this level of monitoring requires a significant dedication of human resources which is unattainable in resource-limited settings (RLS). Advancements in wireless physiologic monitoring offer a novel strategy to improve current monitoring levels. Through our project, we will evaluate the clinical use of a wireless physiological monitoring system for immediate postpartum monitoring in women after CS. Our primary aims are: I) To explore the clinical adequacy of wireless physiologic monitoring vs standard of care (SOC) monitoring immediately after uncomplicated Cesarean section in a RLS II) To explore the usability of wireless physiologic monitoring vs SOC monitoring among healthcare staff in a RLS

Conditions

Cesarean Section Complications; Vital Signs Monitoring; Maternal Health Care

Outcome Measures

Primary Outcomes (1)

• Clinical Adequacy Score

  Composite adequacy score (CAS), is a composite of registered measurements of HR, saturation and BP measured during the first 2 hours after birth. Each registered vital sign will give 1 point.

  4 months

Secondary Outcomes (1)

• System Usuability Scale index

  4 months

Study Arms (2)

WIP

ACTIVE COMPARATOR

wireless biosensor arm

Device: Wireless Physiologic Monitoring

SOC

NO INTERVENTION

Standard of care

Interventions

Wireless Physiologic Monitoring DEVICE

YHE® BP Doctor Pro Blood Pressure Smartwatch, which is a commericially available device. The device can monitor heart rate, blood pressure and saturation.

WIP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cesarean sections are an operation performed only on pregnant females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age ≥18 years, 2) undergoing CS for singleton pregnancy, 3) willing to stay in postpartum unit for at least 24 hours, 4) willing to wear sensor during their time at the post-operative monitoring ward, 5) able to provide consent 6) ability to speak Urdu/Punjabi or English

You may not qualify if:

• \) women with complicated CS (e.g. due to excessive perioperative bleeding), 2) women with immediate-emergency CS due to fetal or maternal disease, 3) no informed, written consent 4) unwilling to wear devices or participate in questionnaires, or 5) known infectious disease including but not limited to viral hepatitis, tuberculosis, or HIV.

Sponsors & Collaborators

• Lund University: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Sir Ganga Ram Hospital: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Sir Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 22, 2023
• Primary Completion: January 31, 2024
• Study Completion: August 15, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)