Preterm PregnancyNCT06164080
The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes
A study testing participants receiving Corticosteroid in people with Preterm Pregnancy and Antenatal Corticosteroid, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Pregnancy, Antenatal Corticosteroid, Perinatal Problems
- What is being tested?
- participants receiving Corticosteroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Oct 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pregnant women who had normal vaginal delivery, cesarean section or operative delivery between 34-37 weeks
- Singleton pregnancies resulting in a live birth
Who cannot join
- Twin pregnancies
- All births before 34 weeks or after 37 weeks
- Pregnant women with intrauterine ex fetus
- Fetuses with major congenital and chromosomal abnormalities
- Pregnant women who administrated antenatal corticosteroids for any reason before 34 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes In Late Preterm Pregnant Women
In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense.
Read the detailed description
This study is a single-center prospective case-control study investigating the effect of antenatal corticosteroids administered in the late preterm period on early and late perinatal outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October 1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were included. Patient were divided into two groups antenatal corticosteroid administration (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were compared between these two groups.
- Being tested
- participants receiving Corticosteroid
- Keywords
- Antenatal corticosteroids, Late preterm pregnancy, Late perinatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participants receiving CorticosteroidOther
Also called betamethasone, dekort
Pregnant women using antenatal corticosteroids for any reason before 34 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antenatal corticosteroid non-administration | No intervention | Pregnant women who did not use antenatal corticosteroid before 34 weeks |
| Antenatal corticosteroid administration | Active comparator | Pregnant women using antenatal corticosteroids for any reason before 34 weeks Receives: Other: participants receiving Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of antenatal corticosteroid effects
intramuscular 3 mg betamethasone (dekort 8mg/2 ml) corticosteroid injection in perinatal period
Measured: 16 months
Secondary outcomes (1)
Other consequences of antenatal corticosteroid effects in late term pregnant women
Other consequences of antenatal corticosteroid administered in late preterm pregnant women in the neonatal period are the need for neonatal intensive care due to reasons other than respiratory distress, respiratory complications such as pneumonia, other complications such as sepsis, perinatal death, chronic lung disease (even after 28 days of birth, oxygen need) long-term outcomes in postnatal infants ( third month, sixth month, twelfth month, emotional and emotional consequences in the family, and maternal side effects.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm PregnancyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164080
- Sponsor's protocol ID
- 2011-KAEK-25 2021/05-10
- Status last verified
- Dec 2023
- First submitted
- 4 Apr 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes In Late Preterm Pregnant Women
- ClinicalTrials.gov ID
- NCT06164080
- Acronym / sponsor ID
- 2011-KAEK-25 2021/05-10
- Keywords
- Antenatal corticosteroids, Late preterm pregnancy, Late perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Dec 2023 (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.
In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense.
Detailed description
This study is a single-center prospective case-control study investigating the effect of antenatal corticosteroids administered in the late preterm period on early and late perinatal outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October 1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were included. Patient were divided into two groups antenatal corticosteroid administration (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were compared between these two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal corticosteroid non-administration | No intervention | –Pregnant women who did not use antenatal corticosteroid before 34 weeks |
| Antenatal corticosteroid administration | Active comparator | Other: participants receiving CorticosteroidPregnant women using antenatal corticosteroids for any reason before 34 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All pregnant women who had normal vaginal delivery, cesarean section or operative delivery between 34-37 weeks
- Singleton pregnancies resulting in a live birth
Key exclusion criteria (5 listed)
- Twin pregnancies
- All births before 34 weeks or after 37 weeks
- Pregnant women with intrauterine ex fetus
- Fetuses with major congenital and chromosomal abnormalities
- Pregnant women who administrated antenatal corticosteroids for any reason before 34 weeks
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 |
|---|---|---|
| participants receiving CorticosteroidAlso: betamethasone, dekortPregnant women using antenatal corticosteroids for any reason before 34 weeks | Other | Antenatal corticosteroid administration |
Primary outcome
The results of antenatal corticosteroid effects
Time frame: 16 months
intramuscular 3 mg betamethasone (dekort 8mg/2 ml) corticosteroid injection in perinatal period
1 secondary outcome
Other consequences of antenatal corticosteroid effects in late term pregnant women
Time frame: 16 months
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 11 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing participants receiving Corticosteroid in people with Preterm Pregnancy and Antenatal Corticosteroid, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
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 11 Dec 2023. 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 Turkey (Türkiye). 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?
The results of antenatal corticosteroid effects (time frame: 16 months). 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 11 Dec 2023.