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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04407975

Enrollment

400

Registered

2020-05-29

Start date

2020-05-29

Completion date

2021-05-31

Last updated

2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Morbidity

Brief summary

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

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.

Interventions

OTHERPlacebo

A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.

OTHERBetamethasone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

17 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with respiratory morbidity	at birth	Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score

Secondary

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

Countries

Lebanon

Contacts

Primary ContactManal Hubeish, MD

drmanalhubeishhusari@gmail.com+9611636297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026