OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Cairo, Egypt
NCT Number: NCT03793153
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.
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Notify Me20 year–40 year
Female
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 :
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
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.
Time frame: 6 hours
Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
Time frame: 48 hours post operative period
Recording change in Pre- versus Post-operative Hemoglobin (g/dl) value.
Time frame: 48 hours post operative period
Recording change in Pre- versus Post-operative Hematocrit (%) value.
Time frame: 20 minutes
Use of extra Oxytocin (more than 5 i.u.).
Time frame: 6 hours
Use of Methergine.
Time frame: 6 hours
Use of Misopristole.
Time frame: 6 hours
Requirement of blood products during Intra- and 6 hours Post-LSCS.
Time frame: 7 hours
Total blood loss (ml) greater than 1000 cc.
Time frame: 7 hours
Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
Time frame: 30 minutes
Total time (minutes) uterus wrapped during hysterotomy repair.
Time frame: Less than one minute
Uterine temperature (Fahrenheit) after wrap removal recorded by infrared thermometer.
Time frame: 7 hours
Patient temperature (Fahrenheit) pre, intra, and during first 6 hours postoperative.
Al-Azhar University
Other
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