CompletedNot Applicable

Prevention of Hypothermia During Caesarean Section: Continuous Core Temperature Monitoring With Zero-heat-flux

Germany111 participantsStarted 2019-10-15

Plain-language summary

Nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. Over 30% of the patients undergoing a caesarean section experience a fall of the body core temperature under 36°C during the procedure. Following a retrospective cohort design, this study aims to examine the magnitude of hypothermia in the parturient and newborn population as well as the impact and efficiency of forced-air warming on preventing it. The researchers plan to conduct a retrospective analysis of the caesarean section treatment protocol at our institution over a period of 5 months including approximately 300 patients who underwent both elective and emergency caesarean sections.

Who can participate

Age range

18 Years – 45 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: Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019 Exclusion Criteria: * different anaesthesia procedure (e.g. intubation anaesthesia, peridural anaesthesia etc.), * American Society of Anesthesiologists (ASA) Classification III or higher, * BMI( Body mass index) \>45 kg·m-2, * patients with incomplete documentation, * estimated perioperative blood loss \> 500ml, * other perioperative complications (ex. insufficient analgesia and change of anaesthesia procedure).

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.

What they're measuring

Hypothermia rate OR

Timeframe: Through completion of the surgical procedure, an average of 1 hour

Hypothermia rate RR

Timeframe: Through completion of the postoperative recovery, an average of 2 hours

Trial details

NCT IDNCT04132154

SponsorSt. Marien-Hospital Düren

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-06-23

View on ClinicalTrials.gov More Inadvertent Perioperative Hypothermia trials