Cesarean Delivery Affecting Fetus, Transient Tachypnea Newborn
Conditions
Brief summary
Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising. Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.
Interventions
DRUGMisoprostol
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
DRUGPlacebos
placebos tablet will be given before elective Cesarean sections
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 35 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 years or more. * Term singleton pregnancy (38 - 38+6 weeks gestation). * Planned for elective transverse lower segment caesarean section with an indication.
Exclusion criteria
* Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease. * Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol. * Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study. * Pregnancies with known foetal malformation/s or chromosomal aberration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The need for admission to neonatal intensive care unit (NICU) | first 24 hours after delivery | Number of newborns admitted to NICU for respiratory morbidity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| APGAR score below 6 at 5 minute | 5 minutes after delivery | number of newborns delivered with APGAR score below 6 at 5 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| neonatal mortality | first month after delivery | number of neonates died from respiratory morbidity with one month of delivery |
Countries
Egypt
Contacts
Primary ContactAhmed M kotb, MD
Backup Contactahmed DR kotb, MD
Outcome results
None listed