CompletedNot Applicable

Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming

France75 participantsStarted 2018-07-01

Plain-language summary

Maternal hypothermia is very frequent after caesarean delivery under spinal anaesthesia and should be prevented, as it induces discomfort and increases the risk of postoperative complications. Several modalities of active warming have been explored, with contrasting results. Small IV Fluid warming systems offer effective and safe IV fluid warming without discomfort, and are very easy to use. The investigators hypothesize that such devices can efficiently prevent hypothermia after caesarean section even with high flow rates of infusion. The purpose of this study is to determine whether active fluid warming reduces the occurrence of maternal hypothermia after scheduled caesarean section, as compared with no active warming. The investigators plane to conduce a double-blinded randomized controlled trial. Seventy women undergoing scheduled caesarean section under spinal anaesthesia in 3 different maternity units will be included. The primary outcome is the occurrence of maternal hypothermia (\<36.0°C) on admission to the post anaesthesia care unit. The secondary outcomes are perioperative maternal hypothermia, maternal thermal discomfort, maternal recovery and neonatal well-being

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Pregnant women * without any major co-morbidity (ASA status 1 or 2), * with normal singleton pregnancy, * who will deliver by scheduled caesarean section under spinal anesthesia at gestational age ≥ 37 weeks of amenorrhea, * Aged ≥ 18 years * with health insurance Exclusion Criteria: * Patient refusal to participate in the study * Maternal temperature ≥38.0 ° C or \<36.0 ° C at the time of randomization, * Spinal anaesthesia refused or contraindicated, * unplanned caesarean section * caesarean delivery scheduled since less than 48 hours * caesarean section performed under epidural or general anesthesia * participation of the mother in another interventional research or intervention, or during the exclusion period following a previous search * unability to give written consent * body mass index\> 40kg / m2 * gravidic hypertensive disease * uncontrolled diabetes * cardiovascular disease under treatment * coagulation disorder

What they're measuring

Incidence of Maternal postoperative hypothermia

Timeframe: until Hour 12

Trial details

NCT IDNCT03581721

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31