Clinical trial

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

Name
Martina Asaad
Description
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%
Trial arms
Trial start
2023-08-31
Estimated PCD
2023-11-20
Trial end
2023-11-30
Status
Recruiting
Treatment
Misoprostol
All participants will be assigned for giving misoprostol rectally either preoperative or postoperative
Arms:
Post-operative rectal misoprostol, Pre-operative and post-operative rectal misoprostol
Other names:
Syntocinon
Size
128
Primary endpoint
Intraoperative blood loss (defined as blood loss ≥500 cc)
First 2 hours from the starting of the operation
Intraoperative blood loss (defined as blood loss ≥500 cc)
First 2 hours from the starting of the operation
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}
Updated at
2023-10-17

1 organization

1 product

3 indications

Organization
Egymedicalpedia
Indication
Hemorrhage
Indication
Surgery
Indication
Postoperative