Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage

NCT02229513 | Completed Results

• 1 other identifier: 013-035
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section. The investigators suspect that it may.

Conditions

Postpartum Hemorrhage; Uterine Atony

Keywords

postpartum hemorrhage; uterine atony; cesarean section; cesarean hysterectomy; acute blood loss anemia; uterotonics; obstetric hemorrhage; severe hemorrhage; blood transfusion; obstetric emergencies; obstetrics; massive hemorrhage; hemorrhage; uterine cooling

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.

  During surgery and in the PACU (approximately 3 total hours)

Secondary Outcomes (11)

• Change in Pre- vs Post-operative Hematocrit

  48 hours post operative period

• Use of Uterotonic Medications

  During surgery and in the PACU (approximately 3 total hours)

• Use of Extra Oxytocin

  Intraoperatively

• Use of Methergine

  Intraoperatively

• Use of Hemabate

  Intraoperatively

Other Outcomes (3)

• Patient Temperature

  Pre-op, Intra-op, Post-Op

• Total Time Uterus Wrapped

  During hysterotomy repair

• Uterine Temperature After Wrap Removed

  Immediately following hysterotomy repair

Study Arms (2)

Control

NO INTERVENTION

Normal cesarean technique.

Uterine Cooling

EXPERIMENTAL

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. 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

Interventions

Uterine Cooling PROCEDURE

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. 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.

Also known as: Hush Slush Machine

Uterine Cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant adult women of any gravidity, and gestational duration who present for cesarean section at Baylor University Medical Center in Dallas and who have given informed consent to be in the study.

You may not qualify if:

• Women who refuse to be in the study, and women who are unable to consent due to emergent nature of the cesarean section will be excluded. Women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.
• Inability to exteriorize the uterus during c-section.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia; Hemorrhage

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Janice Mitchell, PI
• Organization: Baylor University Medical Center

janicemitchellmd@gmail.com

713-705-6240

Study Officials

• Janice L Mitchell, MD

  Baylor University Medical Center Resident

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: September 1, 2014
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 19, 2018
• Results First Posted: January 13, 2016

Record last verified: 2015-12

Locations

US (1)