CompletedNot Applicable

Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

Germany40 participantsStarted 2013-02

Plain-language summary

This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest. Therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.

Who can participate

Age range

20 Minutes

Sex

ALL

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: * parturients undergoing planned, elective cesarean section under spinal anaesthesia * mothers classified as American Society of Anaesthesiologists (ASA) status I or II * written informed consent Exclusion Criteria: * mothers younger than 18 years * mothers classified as American Society of Anaesthesiologists (ASA) status III or higher * caesarean section planned under general anaesthesia. * any expected problems with the newborn such as: * gestation date \< 36 or \> 42 week * placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)

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

Body core temperature of the newborn

Timeframe: 20 min after birth

Trial details

NCT IDNCT01793558

SponsorUniversity Hospital Schleswig-Holstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Thermoregulation Impairment trials