Premature BirthPhase 2/3ACSinPROMNCT02469519
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
A Phase 2/3 study testing Betamethasone - ACTIVE in people with Premature Birth, run by Pediatrix at 9 sites in United States.
Trial summary
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Betamethasone - ACTIVE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Mar 2016to 31 Oct 2022
- Phase
- Phase 2/3
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants age 18 years or older
- 24w0d to 32w6d weeks gestation
- Singleton pregnancy
- Received first course of ACS at or prior to 31w6d gestation
- Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
- Expectant management planned
- Premature Ruptured membranes (PROM) before onset of labor
Who cannot join
- Known major fetal anomalies
- Multiple gestation
- Not a candidate for expectant management
- Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
- Already receiving corticosteroids for another condition
- Any contraindications to the maternal use of corticosteroids
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
University of South Alabama Medical Center
Mobile, Alabama, 36617
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Phoenix Perinatal Associates
Phoenix, Arizona, 85014
Good Samaritan Hospital
San Jose, California, 95008
Swedish Medical Center
Seattle, Washington, 98122-4307
Lousiana State University Health Science
Shreveport, Louisiana, 60612
About this study
Official title: A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
Read the detailed description
This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.
- Conditions
- Premature Birth
- Being tested
- Betamethasone - ACTIVE, Normal Saline - PLACEBO
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone - ACTIVEDrug
Also called antenatal corticosteroid, dexamethasone
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
Normal Saline - PLACEBOOther
Also called NS
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone - ACTIVE | Experimental | Booster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses] Receives: Drug: Betamethasone - ACTIVE |
| normal saline - PLACEBO | Placebo comparator | Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm. Receives: Other: Normal Saline - PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Neonatal Morbidity
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
Measured: from birth through the first 28 days of life
Secondary outcomes (11)
Gestational age of baby
gestational age of the baby on the day of it's birth
Measured: measured within the first 24 hours following birth.
Baby's birth weight
weight of the baby taken with in the first hours following birth
Measured: measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)
a measurement done by ultrasound taken at any time during the pregnancy prior to birth
Measured: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Baby's Head Circumference
a measurement of the baby's head taken within the first hours following birth
Measured: measured within the first 24 hours following birth
Newborn Mechanical Ventilatory days
measurement of the total number of days the baby requires mechanical ventilatory support
Measured: measured from birth to 28 days following birth
Newborn Oxygen support days
measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)
Measured: measured from birth to 28 days following birth
Newborn Surfactant therapy
measurement of the need for newborn surfactant therapy within the first 28 day following birth
Measured: measured within the first 24 hours following birth
Newborn Hospital Days
the number of days that newborn remains in the hospital following its birth.
Measured: measured within the first 24 hours following birth
Pneumothorax
diagnosis of a collapsed lung supported by clinical or radiologic evidence.
Measured: measured within the first 24 hours following birth
Maternal Infectious Morbidity
diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
Measured: measured within the first 24 hours following birth
time from first dose of study drug to birth
the number of hours/days from the time of the first dose of study drug until birth
Measured: measured in days/hours from the time of administration of first study drug until birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start3 Mar 2016
- Primary completion15 Aug 2022
- Study completion31 Oct 2022
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 Premature BirthStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Porreco, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469519
- Sponsor's protocol ID
- OBX0034
- Acronym
- ACSinPROM
- Status last verified
- Dec 2022
- First submitted
- 5 Jun 2015
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Porreco R, Garite TJ, Combs CA, Maurel K, Huls CK, Baker S, Fortner KB, Longo SA, Nageotte M, Lewis D, Tran L; Obstetrix Collaborative Research Network. Booster course of antenatal corticosteroids after preterm prelabor rupture of membranes: a double-blind randomized trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100896. doi: 10.1016/j.ajogmf.2023.100896. Epub 2023 Feb 14.
PubMed 36796641
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes
- ClinicalTrials.gov ID
- NCT02469519
- Acronym / sponsor ID
- ACSinPROM / OBX0034
- Conditions
- Premature Birth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 11 Jun 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 trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
Detailed description
This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone - ACTIVE | Experimental | Drug: Betamethasone - ACTIVEBooster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses] |
| normal saline - PLACEBO | Placebo comparator | Other: Normal Saline - PLACEBONormal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants age 18 years or older
- 24w0d to 32w6d weeks gestation
- Singleton pregnancy
- Received first course of ACS at or prior to 31w6d gestation
- Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
Key exclusion criteria (6 listed)
- Known major fetal anomalies
- Multiple gestation
- Not a candidate for expectant management
- Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
- Already receiving corticosteroids for another condition
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 |
|---|---|---|
| Betamethasone - ACTIVEAlso: antenatal corticosteroid, dexamethasoneantenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses. | Drug | Betamethasone - ACTIVE |
| Normal Saline - PLACEBOAlso: NSnormal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses | Other | normal saline - PLACEBO |
Primary outcome
Composite Neonatal Morbidity
Time frame: from birth through the first 28 days of life
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
11 secondary outcomes
Gestational age of baby
Time frame: measured within the first 24 hours following birth.
Baby's birth weight
Time frame: measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)
Time frame: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Baby's Head Circumference
Time frame: measured within the first 24 hours following birth
Newborn Mechanical Ventilatory days
Time frame: measured from birth to 28 days following birth
Newborn Oxygen support days
Time frame: measured from birth to 28 days following birth
Newborn Surfactant therapy
Time frame: measured within the first 24 hours following birth
Newborn Hospital Days
Time frame: measured within the first 24 hours following birth
Pneumothorax
Time frame: measured within the first 24 hours following birth
Maternal Infectious Morbidity
Time frame: measured within the first 24 hours following birth
time from first dose of study drug to birth
Time frame: measured in days/hours from the time of administration of first study drug until birth.
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 15 Dec 2022.
- Derived from this study: PubMed 36796641Porreco R, Garite TJ, Combs CA, Maurel K, Huls CK, Baker S, Fortner KB, Longo SA, Nageotte M, Lewis D, Tran L; Obstetrix Collaborative Research Network. Booster course of antenatal corticosteroids after preterm prelabor rupture of membranes: a double-blind randomized trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100896. doi: 10.1016/j.ajogmf.2023.100896. Epub 2023 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
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
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
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.
Richard Porreco, MD principal investigator
Pediatrix
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Betamethasone - ACTIVE in people with Premature Birth, run by Pediatrix at 9 sites 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 7 inclusion and 6 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Composite Neonatal Morbidity (time frame: from birth through the first 28 days of life). 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 NCT02469519, 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 15 Dec 2022.