CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03581721
NCT03581721N/ACompleted

Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active IV Fluid Warming: a Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris·interventional·Posted Jul 10, 2018·Updated Mar 30, 2026

In Brief

A clinical study evaluating enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer for Postoperative Hypothermia. Completed, enrolled 75 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartJul 1, 2018
Primary CompletionMar 31, 2021
Study CompletionMay 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.0 years ago

Interventions

enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmerdevice

The fluid warmer will be set up by an external co-investigator in every patient included in the study. It will be turned on in patients belonging to the "warming" group, and turned off in the control group