Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothe… (NCT03316716) | Clinical Trial Compass
CompletedNot Applicable
Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia
Ireland150 participantsStarted 2018-01-24
Plain-language summary
Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers on the new-born's temperature and general wellbeing. The two active warming methods recommended by NICE are the use of forced-air warming and fluid warmers.
Women's temperature tends to fall below the normal level (36.0oC to 37.5oC) during caesarean section if they have not been actively warmed during their operation (peri-operative). Peri-operative hypothermia may increase the morbidities experienced by women after caesarean section. While shivering is the most common postoperative incident, hypothermia may delay wound healing or increase the risk of wound infection, and can increase the risk of haemorrhage.
Neonatal hypothermia has a direct effect on the baby's cardiopulmonary, vascular system and central nervous system and increases the risks of mortality and morbidity. Specifically, neonatal hypothermia can lead to respiratory difficulties and apnoea, hypoxemia, carbon dioxide retention, metabolic acidosis, hypoglycaemia and decreased oxygen delivery to the tissues.
The absence of research and evidence on the effects of actively warming women undergoing caesarean section at term gestation on the temperature of new-borns during SSC means that further research is required.
Who can participate
Age range
18 Years – 50 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:
In order for women and their new-borns to be eligible to participate in the study they should be;
* Aged 18 years or over
* Able to provide informed consent for themselves and their babies
* Who have a singleton pregnancy between 37+0 and 41+6 weeks gestation
* Whose foetus/new-born is alive/born alive, and has no risk factors such as congenital or cardiovascular anomalies (see Appendix 2, TSRF)
* Who receive spinal or combined spinal anaesthesia for their caesarean section
* Have an elective CS
* Who are willing and able to perform skin-to-skin contact
Exclusion Criteria:
Women will be excluded from this study if they;
* Have pyrexia (\> 37.5C on admission to ward)
* Have a maternal medical disease (ie. Spinal abnormalities, coagulation abnormalities, maternal serology positive, congestive heart failure, severe renal function impairment)
* Have general anaesthesia
* Have a baby who has a congenital anomaly (ie. Spina bifida, anencephaly, hydrocephaly, cardiovascular anomalies, anomalies of nervous system, defects of anterior abdominal wall)
* Have a baby who has abnormal Doppler artery velocimetry
* Have a stillbirth baby
* Have a recent USS estimating the fetal weight less than 2000g
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
1
Neonatal hypothermia
Timeframe: approximately 50 minutes after delivery