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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section Complications, Intrapartum Hemorrhage, Postpartum Hemorrhage, Atony, Uterine

Intervention / Treatment
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* Procedure: Uterine Cooling Technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard Lower Segment Cesarean Section (LSCS) will be done. | |
| Active Comparator: Study<br>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<br>* 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.<br>* Other names: Hetta-UCT;|

What is the study measuring?
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Primary Outcome Measures

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