Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJune 1, 2020
May 1, 2020
11 months
May 18, 2020
May 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with respiratory morbidity
Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score
at birth
Secondary Outcomes (1)
Admission to Neonatal Intensive Care Unit (NICU)
up to 2 weeks
Study Arms (2)
Betamethasone
EXPERIMENTALPatients will receive 14 mg (2 ml) intramuscular betamethasone
Placebo
PLACEBO COMPARATORPatients will receive an equivalent volume of normal saline
Interventions
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
A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.
Eligibility Criteria
You may qualify if:
- women with singleton or multiple gestation,
- between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Makassed General Hospital
Beirut, Lebanon
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manal Hubeish, MD
Makassed General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 29, 2020
Study Start
May 29, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
June 1, 2020
Record last verified: 2020-05