Wireless Physiologic Monitoring After Cesarean (NCT06654115) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Wireless Physiologic Monitoring After Cesarean
Pakistan100 participantsStarted 2023-10-22
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1\) 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
Exclusion Criteria:
1\) 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.