Blood Loss Clinical Trial
Official title:
Can Cooling the Uterus During Cesarean Delivery Reduce Blood Loss, Reduce Drug Use, and Decrease the Risk for Hysterectomy in Women With Dysfunctional Labor?
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.
Two hundred patients will be drawn from all pregnant women who require a cesarean delivery
for dysfunctional labor. Dysfunctional labor will be defined as cervical dilation of 3 or
more centimeters, in active labor without cervical change for 2 or more hours. Patients will
be randomly assigned to the study group or the control group, and each group will have 100
patients.
Following the delivery of the fetus, patients in the control group will have IV Pitocin
administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in
room-temperature saline while the uterine incision is closed per the attending
obstetrician's usual practice. Additional utero-tonic medications may be given to improve
uterine contraction.
In the study group, following the delivery of the fetus, the uterus will be externalized in
the usual fashion, except the uterus will be wrapped with lap sponges saturated in sterile,
iced normal saline. Additional utero-tonic medications may also be given in the study group
to improve uterine contraction.
Immediately after the delivery of the fetus and prior to the delivery of the placenta, the
amniotic fluid and blood on the surgical field will be aspirated into the suction canister.
This amount of fluid in the suction canister will be noted and subtracted from the amount of
fluid in the canister at the conclusion of the surgery.
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. Post surgical vaginal
bleeding will be monitored and calculated until the patient is discharged from the labor and
delivery unit. Use of utero-tonic medications will be recorded.
At the conclusion of the study, the amount of blood loss and utero-tonic drugs between the
control and study groups will be compared. The need for additional surgeries, such as a
hysterectomy or D&C, will be compared between the two groups.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
| Completed |
NCT05426564 -
Exploratory Assessment of the Quantra® System in Adult ECMO Patients
|
||
| Active, not recruiting |
NCT05492214 -
The Effect of Time Window for Umbilical Cord Clamping During Cesareans on Offspring Hemoglobin and Maternal Blood Loss
|
N/A | |
| Withdrawn |
NCT05518279 -
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
|
Phase 3 | |
| Completed |
NCT02569658 -
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
|
N/A | |
| Completed |
NCT01048658 -
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
|
Phase 4 | |
| Terminated |
NCT02908516 -
Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures
|
Phase 4 | |
| Completed |
NCT04089865 -
Oral Versus Intravenous Tranexamic Acid
|
Phase 4 | |
| Recruiting |
NCT06403163 -
Transfusion Surveillance in Anaesthesia
|
||
| Recruiting |
NCT02265562 -
Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy
|
Phase 3 | |
| Completed |
NCT02312440 -
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
|
Phase 3 | |
| Completed |
NCT02083809 -
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
|
N/A | |
| Completed |
NCT01895101 -
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
|
Phase 4 | |
| Completed |
NCT01099475 -
Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery
|
N/A | |
| Completed |
NCT00990288 -
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
|
Phase 4 | |
| Completed |
NCT03365999 -
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement.
|
Phase 2 | |
| Recruiting |
NCT05550623 -
Pneumatic Tourniquet Versus no Tourniquet in Transfemoral Amputation
|
N/A | |
| Completed |
NCT05012202 -
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
|
||
| Completed |
NCT02311309 -
Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
|
N/A | |
| Withdrawn |
NCT01712971 -
Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery
|
N/A |