Cesarean Section
Conditions
Keywords
cesarean section, Misoprostol, sublingual, uterotonics
Brief summary
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till October 2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.
Interventions
DRUGMisoprostol
mesotac
OTHERPlacebo
Placebo tablet identical to the misoprostol tablet but without the active ingredient
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients booked for elective cesarean section. * Singleton pregnancies. * Full term pregnancies (GA 37- 42 Wks). * Age (18-40 yrs). * body mass index (BMI) (20-30(Kg/m2 .
Exclusion criteria
* Contraindication to spinal anesthesia. * Blood dyscrasias. * Large fibroids. * Multiple pregnancies. * Overdistended uterus eg. Hydramnios. * Pre-eclampsia. * Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl). * Previous history of PPH. * Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. * Placenta previa. * Previous myomectomy. * Extreme of BMI (\<20 or \>30 Kg/m2 ).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for extra uterotonics | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | intraoperative | — |
| postpartum hemorrhage | 24 hours | — |
| neonatal outcome | 5 minutes | measured by APGAR score at 1 and 5 minutes |
Countries
Egypt
Outcome results
None listed