Neonatal Outcome
Conditions
Brief summary
This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol. 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
Cytotec
OTHERPlacebo
Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
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
1. Patients candidate for cesarean section. 2. Full term pregnancies (GA 37- 42 Wks). 3. Age (18-40 yrs). 4. body mass index (BMI) (20-30(Kg/m2 . Exclusion Criteia: 1. Contraindication to spinal anesthesia. 2. Blood dyscrasias. 3. Large fibroids. 4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. 5. Emergency CS such as fetal distress 6. Extreme of BMI (\<20 or \>30 Kg/m2 ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal outcome | 5 minutes | measured by APGAR score at 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NICU admission | 24 hours | Number of neonates admitted to NICU within 24 hours. |
| amount of blood loss | 24 hours | — |
| Postpartum hemorrhage | 24 hours | — |
| Need for extra uterotonics | 24 hours | — |
Other
| Measure | Time frame |
|---|---|
| APGAR score at 1 minute | 1 minute |
Countries
Egypt
Outcome results
None listed