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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793153
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Amro M. Hetta, Al-Azhar University

Tracking Information
First Submitted Date  ICMJE December 31, 2018
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE December 19, 2018
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • Intra-operative Blood Loss (ml) [ Time Frame: 20 minutes ]
    Estimating Blood Loss during LSCS immediately after delivery of the fetus and prior to delivery of the placenta till closure of uterine incision.
  • Post-operative Vaginal Blood Loss (ml) [ Time Frame: 6 hours ]
    Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • Change in Pre- versus Post-operative Hemoglobin value. [ Time Frame: 48 hours post operative period ]
    Recording change in Pre- versus Post-operative Hemoglobin (g/dl) value.
  • Change in Pre- versus Post-operative Hematocrit value. [ Time Frame: 48 hours post operative period ]
    Recording change in Pre- versus Post-operative Hematocrit (%) value.
  • Use of extra Oxytocin (more than 5 i.u.). [ Time Frame: 20 minutes ]
    Use of extra Oxytocin (more than 5 i.u.).
  • Use of Methergine. [ Time Frame: 6 hours ]
    Use of Methergine.
  • Use of Misopristole. [ Time Frame: 6 hours ]
    Use of Misopristole.
  • Requirement of blood products. [ Time Frame: 6 hours ]
    Requirement of blood products during Intra- and 6 hours Post-LSCS.
  • Total blood loss greater than 1000 cc. [ Time Frame: 7 hours ]
    Total blood loss (ml) greater than 1000 cc.
  • Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions. [ Time Frame: 7 hours ]
    Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
  • Total time uterus wrapped during hysterotomy repair. [ Time Frame: 30 minutes ]
    Total time (minutes) uterus wrapped during hysterotomy repair.
  • Uterine temperature after wrap removal. [ Time Frame: Less than one minute ]
    Uterine temperature (Fahrenheit) after wrap removal recorded by infrared thermometer.
  • Patient temperature pre, intra, and postoperative. [ Time Frame: 7 hours ]
    Patient temperature (Fahrenheit) pre, intra, and during first 6 hours postoperative.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
Official Title  ICMJE A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
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.
Detailed Description

Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.

The incidence of caesarean delivery is increasing, and the average blood loss during caesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL).

Caesarean section (CS) rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after caesarean section, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Indeed we need to reduce the bleeding during and after caesarean sections aiming for reducing the morbidity and mortality rate due to obstetric hemorrhage, which can be life threatening.

The hematocrit level falls by 10% and blood transfusion is required in 6% of women undergoing caesarean delivery versus 4% of women who have a vaginal birth. Numerous methods for performing caesarean section exist targeting a safe delivery for the infant with minimum maternal morbidity. Operative morbidity includes hemorrhage, anemia, and blood products transfusion may be required associated with many risks and complications.

Women who undergo a caesarean delivery are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent cesarean, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.

The uterus is a smooth muscle whose contraction is modulated most directly by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus and beneath the placenta enlarge to provide adequate perfusion to the placenta. After separation of the placenta the uterine smooth muscle cells contract in a pincer-like action to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately 4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000 cesarean sections require hysterectomy to control bleeding.

Release of calcium ions from sarcoplasmic reticulum stores is the immediateinitiator of contraction, and calcium's diffusion from the muscle filaments andre-uptake by the sarcoplasmic reticulum results in relaxation of contraction. Insome smooth muscles cold enhances contraction; perhaps by slowing the re-uptake of calcium.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cesarean Section Complications
  • Intrapartum Hemorrhage
  • Postpartum Hemorrhage
  • Atony, Uterine
Intervention  ICMJE Procedure: Uterine Cooling Technique
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.
Other Name: Hetta-UCT
Study Arms  ICMJE
  • No Intervention: Control
    Standard Lower Segment Cesarean Section (LSCS) will be done.
  • Active Comparator: Study
    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.
    Intervention: Procedure: Uterine Cooling Technique
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
99
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2019)
100
Actual Study Completion Date  ICMJE March 25, 2019
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793153
Other Study ID Numbers  ICMJE OB1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After publishing
Access Criteria: Full text
Responsible Party Amro M. Hetta, Al-Azhar University
Study Sponsor  ICMJE Al-Azhar University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amro M. Hetta, M. Sc. OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Study Director: Abdallah K. Ahmed, MD OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Study Chair: Mofeed F. Mohamed, MD OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
PRS Account Al-Azhar University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP