Respiratory MorbidityNCT04407975
Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean
A study testing Betamethasone in people with Respiratory Morbidity, run by Makassed General Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Respiratory Morbidity
- What is being tested?
- Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteLebanon
- Study dates
- 29 May 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women with singleton or multiple gestation,
- between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)
Who cannot join
- any medical problem that could affect fetal well-being;
- evidence of intrauterine infection,
- oligohydramnios,
- fetal congenital malformations,
- preeclampsia,
- maternal hypertension,
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- 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 locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Manal Hubesih, MD, +9611636000 ext. 6297, drmanalhubesihhusari@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Respiratory Morbidity
- Being tested
- Betamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneOther
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
PlaceboOther
A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Experimental | Patients will receive 14 mg (2 ml) intramuscular betamethasone Receives: Other: Betamethasone |
| Placebo | Placebo comparator | Patients will receive an equivalent volume of normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with respiratory morbidity
Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score
Measured: at birth
Secondary outcomes (1)
Admission to Neonatal Intensive Care Unit (NICU)
Reasons for NICU admission and length of stay
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start29 May 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hubeish, Makassed General Hospital
- Investigators
- Manal Hubeish, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407975
- Sponsor's protocol ID
- 642020
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04407975
- Acronym / sponsor ID
- 642020
- Conditions
- Respiratory Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Experimental | Other: BetamethasonePatients will receive 14 mg (2 ml) intramuscular betamethasone |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive an equivalent volume of normal saline |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- women with singleton or multiple gestation,
- between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)
Key exclusion criteria (13 listed)
- any medical problem that could affect fetal well-being;
- evidence of intrauterine infection,
- oligohydramnios,
- fetal congenital malformations,
- preeclampsia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetamethasoneA 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 | Other | Betamethasone |
| PlaceboA single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline. | Other | Placebo |
Primary outcome
Percentage of patients with respiratory morbidity
Time frame: at birth
Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score
1 secondary outcome
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Hubeish, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone in people with Respiratory Morbidity, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Hubeish, MD (+9611636297, drmanalhubeishhusari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with respiratory morbidity (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.