Preterm LaborPhase 3NCT02351310
Effectiveness of ACS in Extreme Preemies
A Phase 3 study testing Betamethasone in people with Preterm Labor and Premature Birth, run by Pediatrix.
Trial summary
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Premature Birth
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2015
- Phase
- Phase 3
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age at time of study entry
- Gestational age between 22 0/7 to 23 6/7 weeks, inclusive at time of randomization regardless of whether the provider and patient decide to consider the fetus viable and provide obstetric interventions and cesarean section if needed.
- Singleton pregnancy
- Threatening to deliver by the best estimate of the clinician within the ensuing week
- Thought by the clinician to be able to delay delivery at least 3 hours from the time of randomization.
- Desired Pregnancy
Show all 14Show fewer
- All clinical complications related to or leading to delivery except those listed as exclusion criteria are eligible. All of the following clinical complications are eligible including but not limited to:
- premature labor,
- incompetent cervix with or without prolapsing membranes,
- Preterm Premature Rupture of the membranes (PPROM),
- chorioamnionitis,
- all hypertensive disorders of pregnancy,
- vaginal bleeding due to placenta previa, abruption or unknown etiology,
- being delivered for medical complication of pregnancy, and others.
Who cannot join
- Maternal history of insulin dependent diabetes
- Known congenital fetal anomaly
- Known Hydrops fetalis with this current pregnancy
- Severe intrauterine growth restriction < 10% percentile
- Patient receiving corticosteroids for other maternal indications other than for fetal lung maturity
- Patient with h/o HIV or active Tuberculosis.
- Any other known contraindication to corticosteroids
About this study
Official title: Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.
Read the detailed description
The purpose of this study to evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 0/7 and 23 6/7 weeks at the time of admission. If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration, the patient is eligible to be randomized. Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age: those at 22 0/7 to 22 6/7 weeks and those at 23 0/7 weeks to 23 6/7 weeks. Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below:
- 2 doses of Betamethasone, 12 mg intramuscularly (IM), 24 hours apart, or if as in some hospitals occasionally occurs and betamethasone is unavailable -
- 4 doses of Dexamethasone IM 6 mg, 12 hours apart.
Remainder of care will be at the discretion of the clinician.
Randomized 22 0/7 - 22 6/7:
For patients randomized between 22 0/7 and 22 6/7 weeks and who are undelivered > 24 0/7 weeks, the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician.
Randomized 23 0/7 to 23 6/7:
For those patients randomized at 23 0/7 to 23 6/7 weeks and who remain undelivered > 24 0/7 weeks and < 1 week after study medication was administered, a second blinded set of medications/placebos will be provided. For patients who received Betamethasone (or dexamethasone) placebo will be provided and for those who received placebo Betamethasone will be provided.(for both at the doses described in 3.4.3). In this group, at any time > 24 0/7 weeks and less than one week of the previous dose, if the clinician feels the patient is still at risk for delivering, this second blinded set of study drugs will be administered. This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d. In this group, if the patient remains undelivered at > 25 weeks, administration of an open label course of ACS will be at the discretion of the MD.
Primary Outcome of this study is composite morbidity and mortality. The N on this study is 68 (34 in each group)
- Conditions
- Preterm Labor, Premature Birth
- Being tested
- Betamethasone, Placebo
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called ACS
Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)
PlaceboGenetic
Also called Normal Saline
Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone | Active comparator | Betamethasone: 12 mg given intramuscularly (IM), 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable - • 4 doses of Dexamethasone IM 6 mg, 12 hours apart Receives: Drug: Betamethasone |
| Normal Saline | Placebo comparator | Quantity Sufficient (QS) of Normal Saline (NS) given intramuscularly (IM), 24 hours apart or if hospital is using Dexamethasone in place of Betamethasone then administer NS x 4 doses 12 hours apart Receives: Genetic: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Neonatal Morbidity
Defined as one or more of the following: fetal death, neonatal death within 30 days of delivery, respiratory distress syndrome (oxygen requirement, clinical diagnosis and consistent chest x-ray), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia, blood culture proven sepsis, necrotizing enterocolitis (NEC).
Measured: First 30 days after birth
Secondary outcomes (5)
Preterm Birth prior to 34weeks gestational age.
Preterm birth that occurs between the time of enrollment into the study (22w0d-23w6d) until 34w6d.
Measured: From entry into the study until 34 weeks gestational age.
Respiratory Distress Syndrome (RDS)
RDS is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or  with respiratory insufficiency of prematurity requiring ventilator support are present.
Measured: First 30 days after birth
Birth Weight
newborns birth weight
Measured: Measured at time of birth
Newborn Head Circumference measurement
Measurement of newborn head circumference done at time of birth.
Measured: Measured at time of birth
Need for Newborn Surfactant Therapy
administration of newborn surfactant therapy within the first 30day of life.
Measured: First 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Company decided not to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas J Garite, MD, Study director, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351310
- Sponsor's protocol ID
- OBX0031
- Status last verified
- Mar 2016
- First submitted
- 27 Jan 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth
- ClinicalTrials.gov ID
- NCT02351310
- Acronym / sponsor ID
- OBX0031
- Conditions
- Preterm Labor, Premature Birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decided not to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jan 2015 (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.
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.
Detailed description
The purpose of this study to evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 0/7 and 23 6/7 weeks at the time of admission. If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration, the patient is eligible to be randomized. Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age: those at 22 0/7 to 22 6/7 weeks and those at 23 0/7 weeks to 23 6/7 weeks. Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below:
- 2 doses of Betamethasone, 12 mg intramuscularly (IM), 24 hours apart, or if as in some hospitals occasionally occurs and betamethasone is unavailable -
- 4 doses of Dexamethasone IM 6 mg, 12 hours apart.
Remainder of care will be at the discretion of the clinician.
Randomized 22 0/7 - 22 6/7:
For patients randomized between 22 0/7 and 22 6/7 weeks and who are undelivered > 24 0/7 weeks, the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician.
Randomized 23 0/7 to 23 6/7:
For those patients randomized at 23 0/7 to 23 6/7 weeks and who remain undelivered > 24 0/7 weeks and < 1 week after study medication was administered, a second blinded set of medications/placebos will be provided. For patients who received Betamethasone (or dexamethasone) placebo will be provided and for those who received placebo Betamethasone will be provided.(for both at the doses described in 3.4.3). In this group, at any time > 24 0/7 weeks and less than one week of the previous dose, if the clinician feels the patient is still at risk for delivering, this second blinded set of study drugs will be administered. This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d. In this group, if the patient remains undelivered at > 25 weeks, administration of an open label course of ACS will be at the discretion of the MD.
Primary Outcome of this study is composite morbidity and mortality. The N on this study is 68 (34 in each group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone | Active comparator | Drug: BetamethasoneBetamethasone: 12 mg given intramuscularly (IM), 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable - • 4 doses of Dexamethasone IM 6 mg, 12 hours apart |
| Normal Saline | Placebo comparator | Genetic: PlaceboQuantity Sufficient (QS) of Normal Saline (NS) given intramuscularly (IM), 24 hours apart or if hospital is using Dexamethasone in place of Betamethasone then administer NS x 4 doses 12 hours apart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 18 years of age at time of study entry
- Gestational age between 22 0/7 to 23 6/7 weeks, inclusive at time of randomization regardless of whether the provider and patient decide to consider the fetus viable and provide obstetric interventions and cesarean section if needed.
- Singleton pregnancy
- Threatening to deliver by the best estimate of the clinician within the ensuing week
- Thought by the clinician to be able to delay delivery at least 3 hours from the time of randomization.
Key exclusion criteria (7 listed)
- Maternal history of insulin dependent diabetes
- Known congenital fetal anomaly
- Known Hydrops fetalis with this current pregnancy
- Severe intrauterine growth restriction < 10% percentile
- Patient receiving corticosteroids for other maternal indications other than for fetal lung maturity
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 |
|---|---|---|
| BetamethasoneAlso: ACSCourse of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart) | Drug | Betamethasone |
| PlaceboAlso: Normal SalineCourse of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart). | Genetic | Normal Saline |
Primary outcome
Composite Neonatal Morbidity
Time frame: First 30 days after birth
Defined as one or more of the following: fetal death, neonatal death within 30 days of delivery, respiratory distress syndrome (oxygen requirement, clinical diagnosis and consistent chest x-ray), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia, blood culture proven sepsis, necrotizing enterocolitis (NEC).
5 secondary outcomes
Preterm Birth prior to 34weeks gestational age.
Time frame: From entry into the study until 34 weeks gestational age.
Respiratory Distress Syndrome (RDS)
Time frame: First 30 days after birth
Birth Weight
Time frame: Measured at time of birth
Newborn Head Circumference measurement
Time frame: Measured at time of birth
Need for Newborn Surfactant Therapy
Time frame: First 30 days after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Preterm Labor
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Thomas J Garite, MD study director
Pediatrix
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Betamethasone in people with Preterm Labor and Premature Birth, run by Pediatrix.
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 14 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Mar 2016. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite Neonatal Morbidity (time frame: First 30 days after 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 14 Mar 2016.