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Patients undergoing elective C-section will be randomized into two groups. The first group will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The second group will receive placebo.
This is a prospective double blinded randomized clinical trial. Patients will be randomized into two groups. Group A will receive one dose of Betamethasone at least 24 hours before scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be studied in order to assess the effect of Betamethasone on respiratory morbidity of the newborn infant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone | Experimental | Patients will receive 14 mg (2 ml) intramuscular betamethasone |
|
| Placebo | Placebo Comparator | Patients will receive an equivalent volume of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Other | A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with respiratory morbidity | Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score | at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Admission to Neonatal Intensive Care Unit (NICU) | Reasons for NICU admission and length of stay | up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manal Hubeish, MD | Contact | +9611636297 | drmanalhubeishhusari@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Manal Hubeish, MD | Makassed General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Other | A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline. |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |