Cooling the Uterus in C-section After Dysfunctional Labor

NCT02910115 | Terminated

• 1 other identifier: 015-028
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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 for dysfunctional labor.

Conditions

Blood Loss; Dysfunctional Labor; Uterine Atony

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss

  up to 24 hours after surgery

Secondary Outcomes (2)

• Change in Hematocrit

  up to 24 hours after surgery

• Need for use of uterotonic medications

  during cesarean section

Study Arms (2)

Control Group

OTHER

Following delivery of the fetus patients in the control group will have Pitocin® administered to them intravenously according to the usual protocol. The uterus may be wrapped lap sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice. At the discretion of the attending obstetrician additional uterotonic medications (Pitocin®, Methergine® Cytotec® and/or Hemabate®) may be given to improve uterine contraction.

Drug: Pitocin

Study Group

EXPERIMENTAL

Following delivery of the fetus, patients in the study group also will have Pitocin® administered to them according to the usual protocol. 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 cold laparotomy sponges saturated in sterile, iced normal saline. The skin of the abdomen will be draped to prevent contact with the cold towels. Additional uterotonic medications may be given at the discretion of the attending obstetrician.

Other: Cold laparotomy sponges; Drug: Pitocin

Interventions

Pitocin DRUG

Pitocin is administered intravenously according to the usual protocol.

Also known as: IV Oxytocin

Control Group; Study Group

Cold laparotomy sponges OTHER

Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline

Also known as: cold lap sponges

Study Group

Eligibility Criteria

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

You may qualify if:

• pregnant women of any age
• gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.

You may not qualify if:

• Women who refuse to be in the study
• women who are unable to consent due to emergent nature of the cesarean section
• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

MeSH Terms

Conditions

Hemorrhage; Dystocia; Uterine Inertia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jack Stecher, MD

  BUMC Labor and Delivery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: September 21, 2016
• Study Start: May 14, 2015
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2018
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share