C08.381.840.500.475Phase 4NCT04816097
Dexamethasone Before Elective Cesarean Section at Term in Reducing Neonatal Respiratory Distress Syndrome
A Phase 4 study testing Dexamethasone phosphate in people with C08.381.840.500.475 and C08.381.840.500.737, run by Ain Shams University.
Trial summary
Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births. assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- C08.381.840.500.475, C08.381.840.500.737
- What is being tested?
- Dexamethasone phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestational age (37-39wks).
- Singleton pregnancy.
- Didn't receive any steroid treatment during pregnancy.
Who cannot join
- Undetermined gestational age
- Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
- Congenital fetal malformations
- Emergency CS
- Pregnant refusing to participate in the study or unable to consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial)
Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.
assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result
Read the detailed description
Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration
- Conditions
- C08.381.840.500.475, C08.381.840.500.737
- Being tested
- Dexamethasone phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone phosphateDrug
4 doses of dexamethasone 6mg IM 48h before elective CS.
| Study group | Role | What they receive |
|---|---|---|
| Steroid Group | Active comparator | Participants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS. Receives: Drug: Dexamethasone phosphate |
| No Steroid Group | No intervention | Participants will receive No treatment before elective CS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of neonatal respiratory distress syndrome (RDS)
Measured: 1st 6 hours after delivery
Secondary outcomes (3)
APGAR score
A: Activity/muscle tone
0 points: limp or floppy
- point: limbs flexed
- points: active movement P: Pulse/heart rate
0 points: absent
- point: less than 100 beats per minute
- points: greater than 100 beats per minute G: Grimace (response to stimulation, such as suctioning the baby's nose)
0 points: absent
- point: facial movement/grimace with stimulation
- points: cough or sneeze, cry and withdrawal of foot with stimulation A: Appearance (color)
0 points: blue, bluish-gray, or pale all over
- point: body pink but extremities blue
- points: pink all over R: Respiration/breathing
0 points: absent
- point: irregular, weak crying
- points: good, strong cry
Measured: 1 min after delivery
APGAR score
A: Activity/muscle tone
0 points: limp or floppy
- point: limbs flexed
- points: active movement P: Pulse/heart rate
0 points: absent
- point: less than 100 beats per minute
- points: greater than 100 beats per minute G: Grimace (response to stimulation, such as suctioning the baby's nose)
0 points: absent
- point: facial movement/grimace with stimulation
- points: cough or sneeze, cry and withdrawal of foot with stimulation A: Appearance (color)
0 points: blue, bluish-gray, or pale all over
- point: body pink but extremities blue
- points: pink all over R: Respiration/breathing
0 points: absent
- point: irregular, weak crying
- points: good, strong cry
Measured: 5 min after delivery
Rate of Neonatal intraventricular hemorrhage (IVH)
Measured: within 1st 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C08.381.840.500.475Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
- Investigators
- Hassan Awad, Professor, Study chair, AinSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816097
- Sponsor's protocol ID
- Steroids for lung maturity
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Dexamethasone Administration Before Elective Cesarean Section at Term in Reducing the Incidence of Neonatal Respiratory Distress Syndrome (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04816097
- Acronym / sponsor ID
- Steroids for lung maturity
- Conditions
- C08.381.840.500.475, C08.381.840.500.737
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
Prophylactic antenatal administration of corticosteroid enhance fetal lung maturity and reduce the probability of respiratory morbidity in preterm births.
assessment of administration of four doses intramuscular dexamethasone 48h before elective cesarean section at term in reducing the incidence of neonatal respiratory distress syndrome and NICU admission as a result
Detailed description
Term neonates born between (37-39 wks) by elective cesarean section are likely to develop respiratory distress syndrome more than neonates born by vaginal delivery, and this risk increases for the subgroup of neonates born after elective caeserean section , i.e. before onset of labour , , with potentially severe implications The risk is decreasing with advanced gestational age and neonates born in 37 weeks are at 1.7 times more than those born at 38 weeks , which in turn are at 2.4 times more than those born at 39 weeks If the pregnant female is given four intramuscular injections of 6 mg of dexamethasone , 48 hrs before elective caesarean section decreases the neonatal respiratory morbidity. Five studies lasting between 3 to 20 years with more than 1500 patients have shown no adverse effect of single course of antenatal corticosteroid , neither through infection of the fetus or mother nor in long term neurological or cognitive effect According to Cochrane Database of Systematic Reviews 2018 , prophylactic administration of antenatal corticosteroids appeared to reduce the rate of RDS by approximately 52%. It also reduced the need for NICU admission, both due to respiratory morbidity (by approximately 58%) and for any indication. The reduction of NICU admissions due to respiratory reasons is consistent with the reduction of respiratory morbidity after corticosteroid administration
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid Group | Active comparator | Drug: Dexamethasone phosphateParticipants will receive 4 doses of dexamethasone 6mg IM 48h before elective CS. |
| No Steroid Group | No intervention | –Participants will receive No treatment before elective CS. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age (37-39wks).
- Singleton pregnancy.
- Didn't receive any steroid treatment during pregnancy.
Key exclusion criteria (5 listed)
- Undetermined gestational age
- Maternal chronic diseases (e.g: hypertension, DM-2) to avoid any side effects of steroid use and to keep the pregnant 's case from getting worse.
- Congenital fetal malformations
- Emergency CS
- Pregnant refusing to participate in the study or unable to consent
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 |
|---|---|---|
| Dexamethasone phosphate4 doses of dexamethasone 6mg IM 48h before elective CS. | Drug | Steroid Group |
Primary outcome
incidence of neonatal respiratory distress syndrome (RDS)
Time frame: 1st 6 hours after delivery
3 secondary outcomes
APGAR score
Time frame: 1 min after delivery
APGAR score
Time frame: 5 min after delivery
Rate of Neonatal intraventricular hemorrhage (IVH)
Time frame: within 1st 48 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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.
Hassan Awad, Professor study chair
AinSU
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone phosphate in people with C08.381.840.500.475 and C08.381.840.500.737, run by Ain Shams University.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed M Abass, MD (02 01066903903, ahmedmams@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of neonatal respiratory distress syndrome (RDS) (time frame: 1st 6 hours after delivery). 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 26 Mar 2021.