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Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active Intravenous Warming (CESAR-RESOL2)

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ClinicalTrials.gov Identifier: NCT03581721
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Postoperative Hypothermia Device: enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Maternal Hypothermia After Scheduled Caesarean Section Using Active IV Fluid Warming: a Randomized Controlled Trial
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: The control group
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
Experimental: The warming group
"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
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




Primary Outcome Measures :
  1. Incidence of Maternal postoperative hypothermia [ Time Frame: until Hour 12 ]
    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


Secondary Outcome Measures :
  1. Maternal Shivering [ Time Frame: Until Hour 12 ]
    Measured on a 4 points scale (0 = no chills, 1 = intermittent, low intensity, 2 = moderate, 3 = continuous) Just before the spinal anesthesia and every 10 minutes in the operative room

  2. Maternal shivering [ Time Frame: Until Hour 12 ]
    Score of 4 points (0 = no chills, 1 = intermittent, low intensity, 2 = moderate, 3 = continuous and intense) On arrival at SSPI, one hour and 2 hours after, and just before leaving the PACU

  3. Maternal Thermal discomfort [ Time Frame: until Hour 12 ]
    Visual analogic scale between 0 and 100 (0: absence of thermal discomfort, 100: extreme thermal discomfort) Just before the spinal anesthesia and every 10 min during the surgery

  4. Maternal Thermal discomfort [ Time Frame: Until Hour 12 ]
    Numerical scale between 0 and 100 (0: absence of thermal discomfort, 100: extreme thermal discomfort) On arrival at SSP, one hour and 2 hours after, and just before leaving the PACU

  5. Need of active maternal warming [ Time Frame: Until Hour 12 ]
    use of a air forced warming blanked, peroperatively and Until H2 after surgery

  6. Neonatal core hypothermia [ Time Frame: Within 30th minutes of life ]
    Measure of Temperature °C with cutaneous thermometer

  7. Apgar score [ Time Frame: minute 1 after birth ]
    Clinically evaluated

  8. Apgar score [ Time Frame: minute 5 after birth ]
    Clinically evaluated

  9. Apgar score [ Time Frame: minute 10 after birth ]
    Clinically evaluated :assessment of the newborn infant well-being

  10. Arterial umbilical pH measurement (physiological parameter) [ Time Frame: Within 30th minutes of life ]
    Blood test

  11. Arterial umbilical base deficit measurement [ Time Frame: Within 30th minutes of life ]
    Blood test

  12. Variation in perioperative hemoglobinemia [ Time Frame: Within 24hours before cesarean and one day after surgery ]
    Blood test

  13. Hemoglobin concentration [ Time Frame: one day after surgery ]
    blood test

  14. Postpartum anemia [ Time Frame: One day after surgery ]
    Maternal hemoglobin concentration

  15. Maternal postoperative recovery [ Time Frame: between day 3 and day 5 after surgery ]
    6-minute walk test (6 MWT)

  16. Estimation of Quality of life [ Time Frame: at the time of the postoperative appointment, around 40 days after surgery ]
    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581721


Contacts
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Contact: Marie Pierre Bonnet, Bonnet : +33 1 48 51 39 21 marie-pierre.bonnet@aphp.fr
Contact: Laurence l, PhD +33 1 58 41 35 45 laurence.lecomte@aphp.fr

Locations
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France
Cochin Hospital, Port-Royal Maternity Recruiting
Paris, France, 75014
Contact: Marie Pierre Bonnet, MD, PhD    +33 1 48 51 39 21    marie-pierre.bonnet@aphp.fr   
Principal Investigator: Pascal Alfonsi, MD, PhD         
Principal Investigator: Karim Bouattour, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marie Pierre Bonnet, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Pascal Alfonsi Saint Joseph Hospital, Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03581721     History of Changes
Other Study ID Numbers: K170402J
2017-A03139-4 ( Registry Identifier: ANSM )
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postoperative hypothermia
caesarean section
IV fluids warming

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms