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

April 8, 2019 updated by: Amro M. Hetta, Al-Azhar University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Hetta-UCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 minutes
Post-operative Vaginal Blood Loss (ml)
Time Frame: 6 hours
Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours post operative period
Change in Pre- versus Post-operative Hematocrit value.
Time Frame: 48 hours post operative period
Recording change in Pre- versus Post-operative Hematocrit (%) value.
48 hours post operative period
Use of extra Oxytocin (more than 5 i.u.).
Time Frame: 20 minutes
Use of extra Oxytocin (more than 5 i.u.).
20 minutes
Use of Methergine.
Time Frame: 6 hours
Use of Methergine.
6 hours
Use of Misopristole.
Time Frame: 6 hours
Use of Misopristole.
6 hours
Requirement of blood products.
Time Frame: 6 hours
Requirement of blood products during Intra- and 6 hours Post-LSCS.
6 hours
Total blood loss greater than 1000 cc.
Time Frame: 7 hours
Total blood loss (ml) greater than 1000 cc.
7 hours
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.
7 hours
Total time uterus wrapped during hysterotomy repair.
Time Frame: 30 minutes
Total time (minutes) uterus wrapped during hysterotomy repair.
30 minutes
Uterine temperature after wrap removal.
Time Frame: Less than one minute
Uterine temperature (Fahrenheit) after wrap removal recorded by infrared thermometer.
Less than one minute
Patient temperature pre, intra, and postoperative.
Time Frame: 7 hours
Patient temperature (Fahrenheit) pre, intra, and during first 6 hours postoperative.
7 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 19, 2018

Primary Completion (ACTUAL)

March 20, 2019

Study Completion (ACTUAL)

March 25, 2019

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (ACTUAL)

January 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

After publishing

IPD Sharing Access Criteria

Full text

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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