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

NCT03581721 | Completed

• 2 other identifiers: K170402J2017-A03139-4
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postoperative Hypothermia

Keywords

Postoperative hypothermia; caesarean section; IV fluids warming

Outcome Measures

Primary Outcomes (1)

• Incidence of Maternal postoperative hypothermia

  Obtained by placing a skin sensor on the right temporal region and measured using the 3M™ SpotOn™ Monitoring System on arrival at the PACU Hypothermia is defined as a Temperature \<36°C

  until Hour 12

Secondary Outcomes (16)

• Maternal Shivering

  Until Hour 12

• Maternal shivering

  Until Hour 12

• Maternal Thermal discomfort

  until Hour 12

• Maternal Thermal discomfort

  Until Hour 12

• Need of active maternal warming

  Until Hour 12

Study Arms (2)

The control group

NO INTERVENTION

Control group according to usual practices: no active warming (no fluid warming). The fluid warmer device will be set up but not activated. The control group will receive IV fluid coload at room temperature through the fluid warmer set to "off". The device is hidden

The warming group

EXPERIMENTAL

"IV fluid warming with the enFlow® or Fluido®Compact IV fluid warmer" : Women will receive IV fluid coload warmed to 40°C through the enFlow® or Fluido®Compact device. The box will be also hidden. The fluid warmer will be turned off at the end of surgery, just before transfer to the PACU.

Device: enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer

Interventions

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

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

The warming group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• unability to give written consent
• body mass index\> 40kg / m2
• gravidic hypertensive disease
• uncontrolled diabetes
• cardiovascular disease under treatment
• coagulation disorder

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital, Port-Royal Maternity

Paris, 75014, France

Location

Related Publications (7)

• Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.

  PMID: 11506130 BACKGROUND

• Perlman J, Kjaer K. Neonatal and Maternal Temperature Regulation During and After Delivery. Anesth Analg. 2016 Jul;123(1):168-72. doi: 10.1213/ANE.0000000000001256.

  PMID: 27314693 BACKGROUND

• Butwick AJ, Lipman SS, Carvalho B. Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413-9, table of contents. doi: 10.1213/01.ane.0000286167.96410.27.

  PMID: 17959975 BACKGROUND

• Horn EP, Bein B, Steinfath M, Ramaker K, Buchloh B, Hocker J. The incidence and prevention of hypothermia in newborn bonding after cesarean delivery: a randomized controlled trial. Anesth Analg. 2014 May;118(5):997-1002. doi: 10.1213/ANE.0000000000000160.

  PMID: 24681658 BACKGROUND

• Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.

  PMID: 19502035 BACKGROUND

• Sultan P, Habib AS, Cho Y, Carvalho B. The Effect of patient warming during Caesarean delivery on maternal and neonatal outcomes: a meta-analysis. Br J Anaesth. 2015 Oct;115(4):500-10. doi: 10.1093/bja/aev325.

  PMID: 26385660 BACKGROUND

• Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181.

  PMID: 26895002 BACKGROUND

Study Officials

• Marie Pierre Bonnet, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Pascal Alfonsi

  Saint Joseph Hospital, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: July 10, 2018
• Study Start: July 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: May 30, 2022
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)