Neonatal Respiratory Distress, Transient Tachypnea of the Newborn
Conditions
Brief summary
Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn. It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.
Interventions
DRUGMisoprostol
Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
DRUGPlacebo
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 years or more. * Early term singleton pregnancy. * Elective caesarian section at (37 - 38+6) weeks of gestation. * Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction). * Informed written consent signed by the participating pregnant woman.
Exclusion criteria
* Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma. * Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study. * Pregnancies of known fetal diseases or chromosomal abnormalities. * Non-singleton pregnancies. * Emergency caesarian section as in ruptured membrane and women in labor pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of neonatal respiratory morbidity (NRM) | up to 24 hours after birth | The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal intensive care unit (NICU) admission | up to 24 hours after birth | The incidence of the need for neonatal intensive care unit admission during the first ten days after delivery in early term neonates born to elective caesarian section. |
Countries
Egypt
Outcome results
None listed