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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized |
|
| Placebo | Active Comparator | After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The need for admission to neonatal intensive care unit (NICU) | Number of newborns admitted to NICU for respiratory morbidity | first 24 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| APGAR score below 6 at 5 minute | number of newborns delivered with APGAR score below 6 at 5 minutes | 5 minutes after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal mortality | number of neonates died from respiratory morbidity with one month of delivery | first month after delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M kotb, MD | Contact | 01008681999 | 0020 | ahmedmkotp@hotmail.com |
| ahmed DR kotb, MD | Contact | 1008681999 | 0020 | ahmedmkotp@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams University | Recruiting | Cairo | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| D059245 | Transient Tachypnea of the Newborn |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Placebos | Drug | placebos tablet will be given before elective Cesarean sections |
|
| D012120 | Respiration Disorders |
| D059246 | Tachypnea |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |