Blood Loss, Surgical Clinical Trial
Official title:
A Comparative Study Between Preoperative and Postoperative Rectal Misoprostol in the Reduction of Blood Loss During and After Elective Cesarean Section : A Double Blinded Randomized Controlled Trial
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%
Status | Recruiting |
Enrollment | 128 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 20, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Gestational age ( 37 to 41 weeks). 2. Singleton healthy fetus. 3. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia. 4. Body mass index of (25-30 Kg/m2). 5. Normal coagulation profile. 6. Normal amniotic fluid volume assessed by amniotic fluid index. Exclusion Criteria: 1. Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders. 2. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients. 3. Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium. 4. Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids. 5. Antepartum hemorrhage ( placenta previa and placental abruption). 6. Women who will undergo caesarean section because of failure of induction of labor. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Egymedicalpedia |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative blood loss (defined as blood loss =500 cc) | Outcome of the study will be measured in terms of assessment of Hemoglobin level | First 2 hours from the starting of the operation | |
Primary | Intraoperative blood loss (defined as blood loss =500 cc) | Outcome of the study will be measured in terms of assessment of Hematocrit level | First 2 hours from the starting of the operation | |
Secondary | Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours) | Outcome of the study will be measured in terms of assessment of Hemoglobin level post operatively. | first 24 hours after C-Section] | |
Secondary | Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours) | Outcome of the study will be measured in terms of assessment of Hematocrit level post operatively. | first 24 hours after C-Section] |
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