A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss

NCT03793153 | Completed DMC

• 1 other identifier: OB1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.

Conditions

Cesarean Section Complications; Intrapartum Hemorrhage; Postpartum Hemorrhage; Atony, Uterine

Outcome Measures

Primary Outcomes (2)

• Intra-operative Blood Loss (ml)

  Estimating Blood Loss during LSCS immediately after delivery of the fetus and prior to delivery of the placenta till closure of uterine incision.

  20 minutes

• Post-operative Vaginal Blood Loss (ml)

  Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.

  6 hours

Secondary Outcomes (11)

• Change in Pre- versus Post-operative Hemoglobin value.

  48 hours post operative period

• Change in Pre- versus Post-operative Hematocrit value.

  48 hours post operative period

• Use of extra Oxytocin (more than 5 i.u.).

  20 minutes

• Use of Methergine.

  6 hours

• Use of Misopristole.

  6 hours

Study Arms (2)

Control

NO INTERVENTION

Standard Lower Segment Cesarean Section (LSCS) will be done.

Study

ACTIVE COMPARATOR

Uterine Cooling Technique: Standard LSCS will be done except immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. The skin of the abdomen will be draped to prevent contact with the cold towels. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.

Procedure: Uterine Cooling Technique

Interventions

Uterine Cooling Technique PROCEDURE

Standard LSCS will be done except immediatelyfollowing delivery of the fetus the uterus will beexternalized in the usual fashion and the body of theuterus cephalad to the hysterotomy incision will bewrapped in sterile surgical towels saturated in sterile,iced normal saline. These towels will come from asterile cooling pot set to 30 degrees Fahrenheit. Theskin of the abdomen will be draped to prevent contactwith the cold towels. Iced saline-soaked towels will bekept in place for a minimum of 5 minutes and replacedat the discretion of the attending obstetrician until thehysterotomy is closed and the uterus is replaced intothe patient's abdomen.

Also known as: Hetta-UCT

Study

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy at term between 38±5 days and 40 weeks.
• Elective planned or emergency repeated lower segment cesarean sections(LSCS).
• Pregnant women who will accept to be in the study, and have giveninformed consent.

You may not qualify if:

• Women who refuse to be in the study, and women who are unable to consentdue to emergent nature of the cesarean section will be excluded. Women whoare unable to understand the nature of the study due to mental illness, mentalretardation, medical condition, or other communication barrier will be excluded,or who with severe medical and surgical complications as any of the followingwill be excluded :
• Heart, liver, kidney, or brain diseases, and blood disorders.
• Abruptio placenta, and placental abnormalities or accrete syndromes.
• Polyhydraminos, macrosomia, or preeclampsia.
• History of thromboembolic disorders, or severe anemia.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University

Cairo, Egypt

Location

Related Publications (19)

• Goswami U, Sarangi S, Gupta S, Babbar S. Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial. Saudi J Anaesth. 2013 Oct;7(4):427-31. doi: 10.4103/1658-354X.121077.

  PMID: 24348295 BACKGROUND

• Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.

  PMID: 12709915 BACKGROUND

• Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.

  PMID: 26226243 BACKGROUND

• Maged AM, Helal OM, Elsherbini MM, Eid MM, Elkomy RO, Dahab S, Elsissy MH. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery. Int J Gynaecol Obstet. 2015 Dec;131(3):265-8. doi: 10.1016/j.ijgo.2015.05.027. Epub 2015 Aug 15.

  PMID: 26341174 BACKGROUND

• Ahmed MR, Sayed Ahmed WA, Madny EH, Arafa AM, Said MM. Efficacy of tranexamic acid in decreasing blood loss in elective caesarean delivery. J Matern Fetal Neonatal Med. 2015 Jun;28(9):1014-8. doi: 10.3109/14767058.2014.941283. Epub 2014 Jul 28.

  PMID: 25068947 BACKGROUND

• Movafegh A, Eslamian L, Dorabadi A. Effect of intravenous tranexamic acid administration on blood loss during and after cesarean delivery. Int J Gynaecol Obstet. 2011 Dec;115(3):224-6. doi: 10.1016/j.ijgo.2011.07.015. Epub 2011 Aug 27.

  PMID: 21872857 BACKGROUND

• CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

  PMID: 20554319 BACKGROUND

• Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. doi: 10.1097/01.AOG.0000219750.79480.84.

  PMID: 16738145 BACKGROUND

• Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.

  PMID: 22071057 BACKGROUND

• Cahill AG, Stamilio DM, Odibo AO, Peipert JF, Ratcliffe SJ, Stevens EJ, Sammel MD, Macones GA. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol. 2006 Oct;195(4):1143-7. doi: 10.1016/j.ajog.2006.06.045. Epub 2006 Jul 17.

  PMID: 16846571 BACKGROUND

• Gungorduk K, Yildirim G, Asicioglu O, Gungorduk OC, Sudolmus S, Ark C. Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study. Am J Perinatol. 2011 Mar;28(3):233-40. doi: 10.1055/s-0030-1268238. Epub 2010 Oct 26.

  PMID: 20979013 BACKGROUND

• Magann EF, Evans S, Hutchinson M, Collins R, Lanneau G, Morrison JC. Postpartum hemorrhage after cesarean delivery: an analysis of risk factors. South Med J. 2005 Jul;98(7):681-5. doi: 10.1097/01.SMJ.0000163309.53317.B8.

  PMID: 16108235 BACKGROUND

• Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. (2012): Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care, 16(Suppl 1): P439.

  BACKGROUND

• World Health Organization (2010): World health report (2010) Background Paper, No 30. Available at www.who.int/entity/healthsystems/topics/financing/healthreport/30Csectioncosts.pdf.

  BACKGROUND

• Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.

  PMID: 24974589 BACKGROUND

• World Health Organization (2006): WHO Recommendations on the Prevention of Postpartum Hemorrhage. Available at www.pphprevention.org/files/who_summaryofOct.2006techconsult.pdf.

  BACKGROUND

• Gohel M, Patel P, Gupta A, Desai P. (2007): Efficacy of tranexamic acid in decreasing blood loss during and after cesarean section: A randomized case controlled prospective study. The Journal of Obstetrics and Gynecology of India, 57(3): 227-230.

  BACKGROUND

• Yehia AH, Koleib MH, Abdelazim IA, Atik A. (2014): Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction, 3(1): 53-56.

  BACKGROUND

• Mitchell JL, Stecher J, Crowson J, Rich D. (2015): Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial [79]. Obstetrics & Gynecology.

  BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Study Officials

• Amro M. Hetta, M. Sc.

  OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Abdallah K. Ahmed, MD

  OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University

  STUDY DIRECTOR

• Mofeed F. Mohamed, MD

  OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Degree (MD) Candidate

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 4, 2019
• Study Start: December 19, 2018
• Primary Completion: March 20, 2019
• Study Completion: March 25, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publishing
• Access Criteria: Full text

Locations

EG (1)