Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Single Dose Antenatal Betamethasone on the Incidence of Neonatal Respiratory Morbidity After Elective Cesarean Section at Term: A Prospective Double Blinded Placebo Controlled Trial

Conditions
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Respiratory Morbidity

Intervention / Treatment
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* Other: Betamethasone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with singleton or multiple gestation, between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period) Exclusion Criteria: any medical problem that could affect fetal well-being; evidence of intrauterine infection, oligohydramnios, fetal congenital malformations, preeclampsia, maternal hypertension, severe fetal rhesus sensitization, antepartum hemorrhage, Intrauterine growth restriction preterm rupture of membranes preterm delivery previously received antenatal steroids less than one month ago those who decline to participate in the study.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betamethasone<br>Patients will receive 14 mg (2 ml) intramuscular betamethasone | Other: Betamethasone<br>* 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<br>|
| Placebo Comparator: Placebo<br>Patients will receive an equivalent volume of normal saline | Other: Placebo<br>* A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to Neonatal Intensive Care Unit (NICU) | Reasons for NICU admission and length of stay | up to 2 weeks |