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

Makassed General Hospital

Status: Unknown

Conditions: Respiratory Morbidity

Treatments: Other: Placebo; Other: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04407975

642020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 17 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Betamethasone

Experimental group

Description:

Patients will receive 14 mg (2 ml) intramuscular betamethasone

Treatment:

Other: Betamethasone

Placebo

Placebo Comparator group

Description:

Patients will receive an equivalent volume of normal saline

Treatment:

Other: Placebo