Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia

NCT03316716 | Completed DMC

• 1 other identifier: RotundaH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-operative warming is well established for general operations, but there is limited literature on the active warming of pregnant women undergoing caesarean section (CS). Specifically, there is a lack of evidence on the effect, if any, of actively warming mothers on the new-born's temperature and general wellbeing. The two active warming methods recommended by NICE are the use of forced-air warming and fluid warmers. Women's temperature tends to fall below the normal level (36.0oC to 37.5oC) during caesarean section if they have not been actively warmed during their operation (peri-operative). Peri-operative hypothermia may increase the morbidities experienced by women after caesarean section. While shivering is the most common postoperative incident, hypothermia may delay wound healing or increase the risk of wound infection, and can increase the risk of haemorrhage. Neonatal hypothermia has a direct effect on the baby's cardiopulmonary, vascular system and central nervous system and increases the risks of mortality and morbidity. Specifically, neonatal hypothermia can lead to respiratory difficulties and apnoea, hypoxemia, carbon dioxide retention, metabolic acidosis, hypoglycaemia and decreased oxygen delivery to the tissues. The absence of research and evidence on the effects of actively warming women undergoing caesarean section at term gestation on the temperature of new-borns during SSC means that further research is required.

Conditions

Neonatal Hypothermia

Keywords

caesarean section; neonatal hypothermia; maternal hypothermia; active warming; skin-to-skin contact

Outcome Measures

Primary Outcomes (1)

• Neonatal hypothermia

  Neonatal hypothermia is defined as temperature \< 36.5C

  approximately 50 minutes after delivery

Secondary Outcomes (13)

• Maternal Hypothermia

  approximately 10 minutes before delivery

• Maternal Hypothermia

  approximately 30 minutes after delivery

• Maternal Hypothermia

  approximately 50 minutes after delivery

• Maternal core temperatures

  approximately 10 minutes before delivery

• Maternal core temperatures

  approximately 30 minutes after delivery

Study Arms (2)

Control Group

NO INTERVENTION

Women randomised to the control group will receive the hospital's current standard of care which is the peri-operative administration of room-temperature (25°C) IV fluids (Hartman's solution) started before the insertion of regional anaesthesia and continued until the transfer of the woman to the postnatal ward.

active warming group

EXPERIMENTAL

Women randomised in the intervention group will recieve warm IV fluids. The IV fluids (Hartman's solution) will be warmed to 39°C with the use of Hotline™ device.

Procedure: active warming

Interventions

active warming PROCEDURE

Women randomised to the intervention group will be administrated warm IV fluids (39°C) consisting of Hartman's solution with the use of the theatre's Hotline™ device. The Hotline™ device is set to 39°C in which the Hartman's solution bags will be infused to the women peri-operatively.

active warming group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In order for women and their new-borns to be eligible to participate in the study they should be;
• Aged 18 years or over
• Able to provide informed consent for themselves and their babies
• Who have a singleton pregnancy between 37+0 and 41+6 weeks gestation
• Whose foetus/new-born is alive/born alive, and has no risk factors such as congenital or cardiovascular anomalies (see Appendix 2, TSRF)
• Who receive spinal or combined spinal anaesthesia for their caesarean section
• Have an elective CS
• Who are willing and able to perform skin-to-skin contact

You may not qualify if:

• Women will be excluded from this study if they;
• Have pyrexia (\> 37.5C on admission to ward)
• Have a maternal medical disease (ie. Spinal abnormalities, coagulation abnormalities, maternal serology positive, congestive heart failure, severe renal function impairment)
• Have general anaesthesia
• Have a baby who has a congenital anomaly (ie. Spina bifida, anencephaly, hydrocephaly, cardiovascular anomalies, anomalies of nervous system, defects of anterior abdominal wall)
• Have a baby who has abnormal Doppler artery velocimetry
• Have a stillbirth baby
• Have a recent USS estimating the fetal weight less than 2000g

Sponsors & Collaborators

• Aliona Vilinsky-Redmond: lead

Study Sites (1)

Rotunda Hospital

Dublin, Dublin 1, Ireland

Location

Related Publications (9)

• Munday J, Hines S, Wallace K, Chang AM, Gibbons K, Yates P. A systematic review of the effectiveness of warming interventions for women undergoing cesarean section. Worldviews Evid Based Nurs. 2014 Dec;11(6):383-93. doi: 10.1111/wvn.12067. Epub 2014 Sep 30.

  PMID: 25269994 BACKGROUND

• NICE (2008) The Management of Inadvertent Perioperative Hypothermia in Adults. Retrieved from http://www.ncbi.nlm.nih.gov/books/NBK53797/ on 18/8/2016.

  BACKGROUND

• Vilinsky A., Sheridan A. & Nugent L.E. (2016) Preventing peri-operative maternal and neonatal hypothermia after skin-to-skin contact. Journal of Neonatal Nursing 22(4), 163-170.

  BACKGROUND

• WHO (1997) Thermal protection of the newborn: a practical guide. , Maternal and Newborn Health/Safe Motherhood Unit, Division of Reproductive Health

  BACKGROUND

• Knobel R, Holditch-Davis D. Thermoregulation and heat loss prevention after birth and during neonatal intensive-care unit stabilization of extremely low-birthweight infants. Adv Neonatal Care. 2010 Oct;10(5 Suppl):S7-14. doi: 10.1097/ANC.0b013e3181ef7de2.

  PMID: 20838082 BACKGROUND

• Kumar V, Shearer JC, Kumar A, Darmstadt GL. Neonatal hypothermia in low resource settings: a review. J Perinatol. 2009 Jun;29(6):401-12. doi: 10.1038/jp.2008.233. Epub 2009 Jan 22.

  PMID: 19158799 BACKGROUND

• Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.

  PMID: 23369256 BACKGROUND

• Smith J. (2014) Methods and Devices of Temperature Measurement in the Neonate: A Narrative Review and Practice Recommendations. Newborn and Infant Nursing Reviews 14(2), 64-71.

  BACKGROUND

• Vilinsky A. & Sheridan A. (2014) Hypothermia in the newborn: An exploration of its cause, effect and prevention. British Journal of Midwifery 22(8), 557-562 556p.

  BACKGROUND

Study Officials

• Conan McCaul, MD

  Head of Anaesthesia Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 20, 2017
• Study Start: January 24, 2018
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)