Preterm Premature Rupture of the MembranesPhase 3PPROMNCT01401179
Antibiotics Study in Preterm Premature Rupture of the Membranes
A Phase 3 study testing cefazolin, erythromycin, clarithromycin in people with Preterm Premature Rupture of the Membranes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Premature Rupture of the Membranes
- What is being tested?
- cefazolin, erythromycin, clarithromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2005to Apr 2010
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PPROM, PA 23+0~33+0wks
- ROM <48 hrs before randomization
- singleton
- Cervical dilatation <3cm
- uterine contraction less than 4 times per 1 hr
Who cannot join
- Major fetal malformation
- Multifetal pregnancy
- Rupture of the membrane >8hrs before randomization
- Prior antibiotics use at local clinic before referral
- Vaginal bleeding
- IIOC (incompetent internal os of cervix)
Show all 12Show fewer
- Placenta previa
- Gestational diabetes or overt diabetes
- Hypertensive disorders in pregnancy
- Liver cirrhosis
- Acute renal failure
- IUGR(Intrauterine growth restriction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Trial of Cefazolin or Combination of Cefazolin and Erythromycin or Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of the Membranes
The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM.
Read the detailed description
Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). The group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). In group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). This study is designed to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality and to review the evidence and provide recommendations on the use of antibiotics, especially by comparing the combination regimen in PPROM.
- Being tested
- cefazolin, erythromycin, clarithromycin
- Keywords
- Preterm Premature Rupture of Fetal Membranes, antibiotic therapy
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefazolin, erythromycin, clarithromycinDrug
Antibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery.
| Study group | Role | What they receive |
|---|---|---|
| cefazolin | Active comparator | Not described Receives: Drug: cefazolin, erythromycin, clarithromycin |
| cefazolin plus erythromycin | Active comparator | cefazolin, erythromycin Receives: Drug: cefazolin, erythromycin, clarithromycin |
| cefazolin plus clarithromycin | Active comparator | Not described Receives: Drug: cefazolin, erythromycin, clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal composite morbidity
- respiratory distress syndrome(RDS)
- bronchopulmonary dysplasia(BPD)
- intraventricular hemorrhage(IVH,≥grade 3)
- retinopathy of prematurity(ROP,≥grade 3)
- necrotizing enterocolitis(NEC,≥stage 2)
- proven neonatal sepsis
Measured: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
Secondary outcomes (2)
the incidence of abnormal brain sonography
Measured: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
infantile neurologic outcome
The outcome was evaluated in five sub-domains (development, neurologic examination, Bayley Scales of Infant Development-II, vision, and hearing). The final outcome scale was divided into normal, mild, moderate, and severe disability.
Measured: at 6 months and 1 year of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startApr 2005
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of the MembranesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Soo-Young Oh, M.D., PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401179
- Sponsor's protocol ID
- 2005-04-003
- Acronym
- PPROM
- Status last verified
- Jul 2011
- First submitted
- 19 Jul 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial of Cefazolin or Combination of Cefazolin and Erythromycin or Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of the Membranes
- ClinicalTrials.gov ID
- NCT01401179
- Acronym / sponsor ID
- PPROM / 2005-04-003
- Keywords
- Preterm Premature Rupture of Fetal Membranes, antibiotic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Jul 2011 (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.
The purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in PPROM.
Detailed description
Despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. Although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. Antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. However the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. The group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). The group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). In group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). This study is designed to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality and to review the evidence and provide recommendations on the use of antibiotics, especially by comparing the combination regimen in PPROM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cefazolin | Active comparator | Drug: cefazolin, erythromycin, clarithromycin |
| cefazolin plus erythromycin | Active comparator | Drug: cefazolin, erythromycin, clarithromycincefazolin, erythromycin |
| cefazolin plus clarithromycin | Active comparator | Drug: cefazolin, erythromycin, clarithromycin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- PPROM, PA 23+0~33+0wks
- ROM <48 hrs before randomization
- singleton
- Cervical dilatation <3cm
- uterine contraction less than 4 times per 1 hr
Key exclusion criteria (12 listed)
- Major fetal malformation
- Multifetal pregnancy
- Rupture of the membrane >8hrs before randomization
- Prior antibiotics use at local clinic before referral
- Vaginal bleeding
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 |
|---|---|---|
| cefazolin, erythromycin, clarithromycinAntibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery. | Drug | cefazolin, cefazolin plus clarithromycin, cefazolin plus erythromycin |
Primary outcome
Neonatal composite morbidity
Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
1. respiratory distress syndrome(RDS) 2. bronchopulmonary dysplasia(BPD) 3. intraventricular hemorrhage(IVH,≥grade 3) 4. retinopathy of prematurity(ROP,≥grade 3) 5. necrotizing enterocolitis(NEC,≥stage 2) 6. proven neonatal sepsis
2 secondary outcomes
the incidence of abnormal brain sonography
Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
infantile neurologic outcome
Time frame: at 6 months and 1 year of corrected age
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 8 Aug 2011.
Related trials for Preterm Premature Rupture of the Membranes
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
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.
Soo-Young Oh, M.D., PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cefazolin, erythromycin, clarithromycin in people with Preterm Premature Rupture of the Membranes, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 12 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 8 Aug 2011. 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 South Korea. 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.
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 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?
Neonatal composite morbidity (time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.). 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 8 Aug 2011.