Postpartum Hemorrhage， Cesarean Section
Conditions
Brief summary
One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary catheter insertion preoperatively.
Detailed description
Intrauterine Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu. Rectal Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively Standard Care All participants received standard active management of the third stage of labor including: Intravenous bolus of 5 IU oxytocin after fetal delivery 20 IU oxytocin diluted in 500 mL lactated Ringer's solution infused at 125 mL/hour Surgical Protocol All cesarean deliveries were performed under spinal anesthesia using a standardized surgical technique
Interventions
400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Low risk women with singleton living fetus scheduled for elective cesarean delivery * American Society of Anesthesiologists (ASA) physical status I or II * Age: 20-40 years * Parity: 0-3 * Gestational age: 37-40 completed weeks * Body mass index (BMI): 18-30 kg/m² * Planned spinal anesthesia * Provision of informed consent
Exclusion criteria
* High risk pregnancies (anemia, renal disease, cardiac disease, hepatic disease, coagulopathies) * Increased risk for obstetric hemorrhage (placenta previa, placenta accreta spectrum, polyhydramnios, history of PPH, uterine rupture, uterine fibroids) * Allergy to prostaglandins or prostaglandin contraindications (e.g., asthma) * Complicated cesarean sections (bladder/ureteric injury, intestinal injury, massive intraoperative bleeding) * Known fetal or structural anomalies * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated intraoperative blood loss | at time of surgery | Combined blood from suction and soaked materials |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAhmed Maged
Cairo University
Outcome results
None listed