Antenatal CorticosteroidsNCT03133104
Repeat Antenatal Corticosteroids
An observational study of Antenatal Corticosteroids, run by St. Louis University at 1 site in United States.
Trial summary
This study will review records of women who broke their water early who received a repeat course of antenatal steroids. Read more about this study
- Who is it for?
- Ages 13 to 55 years, women only
- Conditions the study is for
- Antenatal Corticosteroids
- What is being tested?
- Antenatal corticosteroids
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to Aug 2017
- Phase
- Observational
- 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 13 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: pregnant women preterm premature rupture of membranes All ethnic backgrounds
Who may be able to join
- pregnant women with preterm premature rupture of membranes
Who cannot join
- Women who did not have preterm premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes
This study will review records of women who broke their water early who received a repeat course of antenatal steroids.
Read the detailed description
Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight.
Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.
One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.
The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.
- Conditions
- Antenatal Corticosteroids
- Being tested
- Antenatal corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal corticosteroidsOther
Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods
| Study group | Role | What they receive |
|---|---|---|
| antenatal corticosteroids | Women who received a rescue dose of steroids Receives: Other: Antenatal corticosteroids | |
| No antenatal corticosteroids | Women who did not received a rescue dose of steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant outcomes
infant birth weight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start5 Jan 2017
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal CorticosteroidsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Buskmiller, MD, St. Louis University
- Investigators
- Cara Buskmiller, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133104
- Sponsor's protocol ID
- 27833
- Status last verified
- Nov 2017
- First submitted
- 17 Jan 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT03133104
- Acronym / sponsor ID
- 27833
- Conditions
- Antenatal Corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 5 Jan 2017
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Apr 2017 (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.
This study will review records of women who broke their water early who received a repeat course of antenatal steroids.
Detailed description
Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight.
Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.
One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.
The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antenatal corticosteroids | – | Other: Antenatal corticosteroidsWomen who received a rescue dose of steroids |
| No antenatal corticosteroids | – | –Women who did not received a rescue dose of steroids |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pregnant women preterm premature rupture of membranes All ethnic backgrounds
Key inclusion criteria (1 listed)
- pregnant women with preterm premature rupture of membranes
Key exclusion criteria (1 listed)
- Women who did not have preterm premature rupture of membranes
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 |
|---|---|---|
| Antenatal corticosteroidsWomen and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods | Other | antenatal corticosteroids |
Primary outcome
Infant outcomes
Time frame: 1 year
infant birth weight
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 29 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Antenatal Corticosteroids
Active, not recruitingPhase 2
Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes
Diabetes Mellitus, Type 2, Preterm Birth
RecruitingPhase 4
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Preterm Birth, Premature Birth
Recruiting
Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS
Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Acute
RecruitingObservational study
Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
Preterm Birth, Hyperglycemia
Recruiting
Low Dose Antenatal Corticosteroids for Late Preterm Delivery
Respiratory Morbidity, Preterm Labor
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.
Cara Buskmiller, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antenatal Corticosteroids, run by St. Louis University at 1 site in United States.
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 1 inclusion and 1 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 29 Nov 2017. 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 United States. 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?
Infant outcomes (time frame: 1 year). 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 29 Nov 2017.