Clinical trial NCT03793153: A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
Official title: A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Intrapartum Hemorrhage
Postpartum Hemorrhage
Atony, Uterine
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-operative Blood Loss (ml)
timeFrame: 20 minutes
measure: Post-operative Vaginal Blood Loss (ml)
timeFrame: 6 hours
Secondary outcomes:
measure: Change in Pre- versus Post-operative Hemoglobin value.
timeFrame: 48 hours post operative period
measure: Change in Pre- versus Post-operative Hematocrit value.
timeFrame: 48 hours post operative period
measure: Use of extra Oxytocin (more than 5 i.u.).
timeFrame: 20 minutes
measure: Use of Methergine.
timeFrame: 6 hours
measure: Use of Misopristole.
timeFrame: 6 hours
measure: Requirement of blood products.
timeFrame: 6 hours
measure: Total blood loss greater than 1000 cc.
timeFrame: 7 hours
measure: Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.
timeFrame: 7 hours
measure: Total time uterus wrapped during hysterotomy repair.
timeFrame: 30 minutes
measure: Uterine temperature after wrap removal.
timeFrame: Less than one minute
measure: Patient temperature pre, intra, and postoperative.
timeFrame: 7 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
Study officials:
affiliation: OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
name: Amro M. Hetta, M. Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
name: Abdallah K. Ahmed, MD
role: STUDY_DIRECTOR
affiliation: OB/GYN Departments, Al-Hussein University Hospital, Al-Azhar University
name: Mofeed F. Mohamed, MD
role: STUDY_CHAIR
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