Transient Tachypnea of the NewbornNCT01772381
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
A study testing Dexamethasone in people with Transient Tachypnea of the Newborn, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care. Read more about this study
- Who is it for?
- Ages 22 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transient Tachypnea of the Newborn
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2010to Jun 2011
- 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 22 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Previous caesarean section
- Complete 37 week calculated from the first day of the last menstrual period.
Who cannot join
- Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
- Hypertensive patients.
- Chronic disease e.g. diabetes mellitus.
- Known renal disease.
- Pre-operative infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean
Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.
Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.
Read more
Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.
The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.
Read the detailed description
Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.
- Conditions
- Transient Tachypnea of the Newborn
- Being tested
- Dexamethasone
- Keywords
- Dexamethasone, term, elective cesarean section
- Medical subject headings
- Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Long acting corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Special care baby unit
Special care baby unit admission for babies with respiratory distress
Measured: 24 hours
Secondary outcomes (1)
Severity of respiratory distress
Severity of respiratory distress and the level of care in response
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transient Tachypnea of the NewbornStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Rabei, Ain Shams Maternity Hospital
- Investigators
- Noha H Rabei, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772381
- Sponsor's protocol ID
- noharabei
- Status last verified
- Jan 2013
- First submitted
- 31 Dec 2012
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.
PubMed 34935127
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean
- ClinicalTrials.gov ID
- NCT01772381
- Acronym / sponsor ID
- noharabei
- Conditions
- Transient Tachypnea of the Newborn
- Keywords
- Dexamethasone, term, elective cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Jan 2013 (estimated)
- 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.
Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.
Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.
Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.
The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.
Detailed description
Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Previous caesarean section
- Complete 37 week calculated from the first day of the last menstrual period.
Key exclusion criteria (5 listed)
- Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
- Hypertensive patients.
- Chronic disease e.g. diabetes mellitus.
- Known renal disease.
- Pre-operative infection.
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 |
|---|---|---|
| DexamethasoneAlso: DecadronLong acting corticosteroid | Drug | Dexamethasone |
Primary outcome
Special care baby unit
Time frame: 24 hours
Special care baby unit admission for babies with respiratory distress
1 secondary outcome
Severity of respiratory distress
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 34935127Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.
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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.
Noha H Rabei, MD principal investigator
Ain Shams Maternity 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 Dexamethasone in people with Transient Tachypnea of the Newborn, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 21 Jan 2013. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Special care baby unit (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772381, which also lists 1 linked publication.
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 21 Jan 2013.