The Effect of Forced Air Warming During Caseraen Section on Maternal Hypothermia: Randomized Controlled Trial

NCT04667000 | Completed DMC

• 1 other identifier: KA-180051
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

During the cesarean section; Hypothermia can be seen due to reasons such as anesthesia, premedication drugs, cold operating room environment, exposure of tissues and organs, and use of cold intravenous fluids. Hypothermia associated with cesarean may affect maternal and fetal health negatively. As a result of hypothermia, coagulopathy, infection, undesirable cardiac events that cause an increase in oxygen consumption, delay in postoperative recovery and wound healing, postoperative nausea and vomiting, chills and relief may be observed in the mother. Newborns born from hypothermic mothers have lower body temperature, pH and Apgar scores. It is important to evaluate all women in terms of risk factors in the preoperative period in the prevention of hypothermia and complications related to hypothermia. Prevention of hypothermia, which has negative effects on maternal and newborn health, is one of the risks that the nurse can address independently. Therefore, this research; In order to determine the effect of heating different body areas using compressed air heating technique during cesarean section on hypothermia, tremor, thermal comfort, postpartum comfort and maternal satisfaction, a parallel group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Adult Hospital Gynecology and Obstetrics Department delivery room and obstetrics service. Research data, Introductory Information Form (Appendix 1), Obstetric and Postpartum Features Form (Appendix 2), Patient Monitoring Form (Appendix 3), Termal Comfort Perception Scale (Appendix 4), Shivering Level Diagnostic Form (Appendix 5), LATCH Breastfeeding The Diagnostic and Measurement Tool (Appendix 6) will be collected using the Visual Analogue Scale (Appendix 7) and the Thermal Comfort Scale that will be developed by the researchers. Pregnant women who meet the inclusion criteria will be included in the research. Women will be divided into 4 groups as the lower extremities are heated, the upper extremities are heated, the whole body is heated, and the control group. According to the group of women; It will be heated 30 minutes before surgery and 30 minutes after surgery with lower limb, upper limb or whole body. Women in the control group will not be heated.

Conditions

Cesarean Section Complications; Hypothermia

Keywords

hypothermia; nursing care; cesarean section

Outcome Measures

Primary Outcomes (1)

• Maternal Hypothermia

  Maternal hypothermia is defined as body temperature falling below 36 ° C.

  30 minutes before the intervention to 30 minutes after the intervention.

Secondary Outcomes (4)

• Shivering

  30 minutes before the intervention to 30 minutes after the intervention.

• Thermal Comfort

  30 minutes before the intervention to 30 minutes after the intervention.

• Apgar Score

  30 minutes before the intervention to 30 minutes after the intervention.

• Breastfeeding Timing

  30 minutes before the intervention to 30 minutes after the intervention.

Study Arms (4)

lower extremities

EXPERIMENTAL

the women's lower extremities will be heated with Forced Air Warming

Other: Forced Air Warming

upper extremities

EXPERIMENTAL

the women's upper extremities will be heated with Forced Air Warming

Other: Forced Air Warming

whole body

EXPERIMENTAL

the women's whole body will be heated with Forced Air Warming

Other: Forced Air Warming

control group

NO INTERVENTION

there is no intervention for this group

Interventions

Forced Air Warming OTHER

We will use Forced Air Warming for cesarean patient

lower extremities; upper extremities; whole body

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- between the ages of 18-35
• Speak, understand and write Turkish
• weeks and more pregnant
• ASA I (Normal, a disease other than surgical pathology that does not cause a systemic disorder or a healthy person without a systemic problem)
• Spinal anesthesia is planned
• No high-risk pregnancy diagnosis (Oligodydroamniosis, early membrane rupture, gestational diabetes mellitus, preeclampsia, fetal tachycardia, nonreactive NST, intrauterine growth retardation)
• Body mass index\> 19 kg / m2 and \<40 kg / m2,
• Having a single pregnancy and
• Pregnant women who agreed to participate in the study will be included in the sample.

You may not qualify if:

• \- Emergency cesarean section
• Individuals with Forced Air Warming contraindications (Acute infection, Maternal fever before operation, etc.)
• In case of any complication that may develop in the mother or newborn at any stage of the research
• Pregnant women who want to leave the research at any stage of the research will be excluded from the sample.

Sponsors & Collaborators

• Hacettepe University: lead
• Cigdem Yucel: collaborator
• Ozgur Ozyuncu: collaborator

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (46)

• Akhtar Z, Hesler BD, Fiffick AN, Mascha EJ, Sessler DI, Kurz A, Ayad S, Saager L. A randomized trial of prewarming on patient satisfaction and thermal comfort in outpatient surgery. J Clin Anesth. 2016 Sep;33:376-85. doi: 10.1016/j.jclinane.2016.04.041. Epub 2016 Jun 3.

  PMID: 27555196 BACKGROUND

• Apfelbaum JL, Silverstein JH, Chung FF, Connis RT, Fillmore RB, Hunt SE, Nickinovich DG, Schreiner MS, Silverstein JH, Apfelbaum JL, Barlow JC, Chung FF, Connis RT, Fillmore RB, Hunt SE, Joas TA, Nickinovich DG, Schreiner MS; American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2013 Feb;118(2):291-307. doi: 10.1097/ALN.0b013e31827773e9. No abstract available.

  PMID: 23364567 BACKGROUND

• Arkilic CF, Akca O, Taguchi A, Sessler DI, Kurz A. Temperature monitoring and management during neuraxial anesthesia: an observational study. Anesth Analg. 2000 Sep;91(3):662-6. doi: 10.1097/00000539-200009000-00031.

  PMID: 10960396 BACKGROUND

• Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.

  PMID: 18927450 BACKGROUND

• Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005.

  PMID: 26227528 BACKGROUND

• Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

  PMID: 26849801 BACKGROUND

• Carpenter L, Baysinger CL. Maintaining perioperative normothermia in the patient undergoing cesarean delivery. Obstet Gynecol Surv. 2012 Jul;67(7):436-46. doi: 10.1097/OGX.0b013e3182605ccd.

  PMID: 22926250 BACKGROUND

• Chakladar A, Dixon MJ, Crook D, Harper CM. The effects of a resistive warming mattress during caesarean section: a randomised, controlled trial. Int J Obstet Anesth. 2014 Nov;23(4):309-16. doi: 10.1016/j.ijoa.2014.06.003. Epub 2014 Jun 13.

  PMID: 25266313 BACKGROUND

• Chebbout R, Newton RS, Walters M, Wrench IJ, Woolnough M. Does the addition of active body warming to in-line intravenous fluid warming prevent maternal hypothermia during elective caesarean section? A randomised controlled trial. Int J Obstet Anesth. 2017 May;31:37-44. doi: 10.1016/j.ijoa.2017.04.008. Epub 2017 Apr 27.

  PMID: 28576354 BACKGROUND

• Chung SH, Lee BS, Yang HJ, Kweon KS, Kim HH, Song J, Shin DW. Effect of preoperative warming during cesarean section under spinal anesthesia. Korean J Anesthesiol. 2012 May;62(5):454-60. doi: 10.4097/kjae.2012.62.5.454. Epub 2012 May 24.

  PMID: 22679543 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

• Duff J, Di Staso R, Cobbe KA, Draper N, Tan S, Halliday E, Middleton S, Lam L, Walker K. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial. BMC Surg. 2012 Jul 20;12:14. doi: 10.1186/1471-2482-12-14.

  PMID: 22817672 BACKGROUND

• Fallis WM, Hamelin K, Symonds J, Wang X. Maternal and newborn outcomes related to maternal warming during cesarean delivery. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):324-31. doi: 10.1111/j.1552-6909.2006.00052.x.

  PMID: 16700681 BACKGROUND

• Geller EJ, Wu JM, Jannelli ML, Nguyen TV, Visco AG. Maternal outcomes associated with planned vaginal versus planned primary cesarean delivery. Am J Perinatol. 2010 Oct;27(9):675-83. doi: 10.1055/s-0030-1249765. Epub 2010 Mar 16.

  PMID: 20235001 BACKGROUND

• Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.

  PMID: 30016540 BACKGROUND

• Harper CM, Andrzejowski JC, Alexander R. NICE and warm. Br J Anaesth. 2008 Sep;101(3):293-5. doi: 10.1093/bja/aen233. No abstract available.

  PMID: 18710834 BACKGROUND

• Hess PE, Snowman CE, Wang J. Hypothermia after cesarean delivery and its reversal with lorazepam. Int J Obstet Anesth. 2005 Oct;14(4):279-83. doi: 10.1016/j.ijoa.2005.02.004.

  PMID: 16143507 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

• Horn EP, Schroeder F, Gottschalk A, Sessler DI, Hiltmeyer N, Standl T, Schulte am Esch J. Active warming during cesarean delivery. Anesth Analg. 2002 Feb;94(2):409-14, table of contents. doi: 10.1097/00000539-200202000-00034.

  PMID: 11812709 BACKGROUND

• Jaiyeoba O. Postoperative infections in obstetrics and gynecology. Clin Obstet Gynecol. 2012 Dec;55(4):904-13. doi: 10.1097/GRF.0b013e3182714734.

  PMID: 23090459 BACKGROUND

• Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.

  PMID: 8176525 BACKGROUND

• John M, Ford J, Harper M. Peri-operative warming devices: performance and clinical application. Anaesthesia. 2014 Jun;69(6):623-38. doi: 10.1111/anae.12626. Epub 2014 Apr 10.

  PMID: 24720346 BACKGROUND

• Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.

  PMID: 18494388 BACKGROUND

• Kurz A. Physiology of thermoregulation. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):627-44. doi: 10.1016/j.bpa.2008.06.004.

  PMID: 19137807 BACKGROUND

• Leeth D, Mamaril M, Oman KS, Krumbach B. Normothermia and patient comfort: a comparative study in an outpatient surgery setting. J Perianesth Nurs. 2010 Jun;25(3):146-51. doi: 10.1016/j.jopan.2010.03.010.

  PMID: 20511085 BACKGROUND

• Letko MD. Understanding the Apgar score. J Obstet Gynecol Neonatal Nurs. 1996 May;25(4):299-303. doi: 10.1111/j.1552-6909.1996.tb02575.x.

  PMID: 8708830 BACKGROUND

• May T, Seder DB, Fraser GL, Tu C, McCrum B, Lucas L, Riker RR. Association of the Bedside Shivering Assessment Scale and derived EMG power during therapeutic hypothermia in survivors of cardiac arrest. Resuscitation. 2011 Aug;82(8):1100-3. doi: 10.1016/j.resuscitation.2011.03.037. Epub 2011 Apr 16.

  PMID: 21592643 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25.

  PMID: 20346624 BACKGROUND

• Mpogoro FJ, Mshana SE, Mirambo MM, Kidenya BR, Gumodoka B, Imirzalioglu C. Incidence and predictors of surgical site infections following caesarean sections at Bugando Medical Centre, Mwanza, Tanzania. Antimicrob Resist Infect Control. 2014 Aug 11;3:25. doi: 10.1186/2047-2994-3-25. eCollection 2014.

  PMID: 25126415 BACKGROUND

• Mylonas I, Friese K. Indications for and Risks of Elective Cesarean Section. Dtsch Arztebl Int. 2015 Jul 20;112(29-30):489-95. doi: 10.3238/arztebl.2015.0489.

  PMID: 26249251 BACKGROUND

• Ng SF, Oo CS, Loh KH, Lim PY, Chan YH, Ong BC. A comparative study of three warming interventions to determine the most effective in maintaining perioperative normothermia. Anesth Analg. 2003 Jan;96(1):171-6, table of contents. doi: 10.1097/00000539-200301000-00036.

  PMID: 12505947 BACKGROUND

• Paris LG, Seitz M, McElroy KG, Regan M. A randomized controlled trial to improve outcomes utilizing various warming techniques during cesarean birth. J Obstet Gynecol Neonatal Nurs. 2014 Nov-Dec;43(6):719-28. doi: 10.1111/1552-6909.12510. Epub 2014 Oct 14.

  PMID: 25316112 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

  PMID: 18156884 BACKGROUND

• Scott EM, Buckland R. A systematic review of intraoperative warming to prevent postoperative complications. AORN J. 2006 May;83(5):1090-104, 1107-13. doi: 10.1016/s0001-2092(06)60120-8.

  PMID: 16722286 BACKGROUND

• 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

• Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.

  PMID: 10691247 BACKGROUND

• Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.

  PMID: 25350672 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

• Sahin A, Aypar U. Effect of amino acid solutions on intraoperative hypothermia and postoperative shivering. Comparison of two anesthetic regimens. Acta Anaesthesiol Scand. 2002 Jan;46(1):64-7.

  PMID: 11903074 BACKGROUND

• Torloni MR, Betran AP, Souza JP, Widmer M, Allen T, Gulmezoglu M, Merialdi M. Classifications for cesarean section: a systematic review. PLoS One. 2011 Jan 20;6(1):e14566. doi: 10.1371/journal.pone.0014566.

  PMID: 21283801 BACKGROUND

• Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3.

  PMID: 17004666 BACKGROUND

• Warttig S, Alderson P, Campbell G, Smith AF. Interventions for treating inadvertent postoperative hypothermia. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD009892. doi: 10.1002/14651858.CD009892.pub2.

  PMID: 25411963 BACKGROUND

• Woolnough M, Allam J, Hemingway C, Cox M, Yentis SM. Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial. Int J Obstet Anesth. 2009 Oct;18(4):346-51. doi: 10.1016/j.ijoa.2009.02.009. Epub 2009 Aug 7.

  PMID: 19665366 BACKGROUND

• Wu X. The safe and efficient use of forced-air warming systems. AORN J. 2013 Mar;97(3):302-8. doi: 10.1016/j.aorn.2012.12.008.

  PMID: 23452695 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

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ozgur Ozyuncu, PhD

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Model Details: parallel group randomized controlled study

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: December 14, 2020
• Study Start: May 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 1, 2022
• Last Updated: September 22, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)