Preterm Premature Rupture of MembranePhase 3NCT01503606
Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane
A Phase 3 study testing Cefazolin and Clarithromycin in people with Preterm Premature Rupture of Membrane, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- Cefazolin and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2021
- 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
- preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
- ROM <72 hrs before randomization
- cervical dilatation <3cm
- uterine contraction less than 4 times per 1 hr
Who cannot join
- Major fetal malformation
- Rupture of the membrane >72hrs before randomization
- Vaginal bleeding
- IIOC (incompetent internal os of cervix)
- Placenta previa
- Gestational diabetes or overt diabetes
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- Hypertensive disorders in pregnancy
- Liver cirrhosis
- Acute renal failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Official title: Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- Cefazolin, Clarithromycin
- Keywords
- preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Cefazolin 1.0gm IVs q 12 hours after randomization for one week
ClarithromycinDrug
clarithromycin 500mg po bid after randomization for one week
CefazolinDrug
Cefazolin 1.0gm IVs q 12 hours after randomization until delivery
ClarithromycinDrug
clarithromycin 500mg po bid after randomization until delivery
| Study group | Role | What they receive |
|---|---|---|
| one-week treatment group | Active comparator | Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week Receives: Drug: Cefazolin; Drug: Clarithromycin |
| until-delivery treatment group | Active comparator | Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery Receives: Drug: Cefazolin; Drug: 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 (1)
infantile neurologic outcome
The outcome will be 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 posted4 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2020
- Study completionDec 2021
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 Preterm Premature Rupture of MembraneStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oh Soo Young, Samsung Medical Center
- Investigators
- Soo-young Oh, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503606
- Sponsor's protocol ID
- 2011-07-005
- Status last verified
- Apr 2022
- First submitted
- 25 Dec 2011
- Last updated
- 20 Apr 2022
- Results posted
- No
Publications
Sung JH, Kim JH, Kim Y, Choi YS, Hong S, Choi SJ, Kim JS, Roh CR, Oh SY. A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100886. doi: 10.1016/j.ajogmf.2023.100886. Epub 2023 Feb 4.
PubMed 36746334
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
- ClinicalTrials.gov ID
- NCT01503606
- Acronym / sponsor ID
- 2011-07-005
- Conditions
- Preterm Premature Rupture of Membrane
- Keywords
- preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 4 Jan 2012 (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 neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-week treatment group | Active comparator | Drug: Cefazolin, Drug: ClarithromycinCefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week |
| until-delivery treatment group | Active comparator | Drug: Cefazolin, Drug: ClarithromycinCefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
- ROM <72 hrs before randomization
- cervical dilatation <3cm
- uterine contraction less than 4 times per 1 hr
Key exclusion criteria (9 listed)
- Major fetal malformation
- Rupture of the membrane >72hrs before randomization
- Vaginal bleeding
- IIOC (incompetent internal os of cervix)
- Placenta previa
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 |
|---|---|---|
| CefazolinCefazolin 1.0gm IVs q 12 hours after randomization for one week | Drug | one-week treatment group |
| Clarithromycinclarithromycin 500mg po bid after randomization for one week | Drug | one-week treatment group |
| CefazolinCefazolin 1.0gm IVs q 12 hours after randomization until delivery | Drug | until-delivery treatment group |
| Clarithromycinclarithromycin 500mg po bid after randomization until delivery | Drug | until-delivery treatment group |
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
1 secondary outcome
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 20 Apr 2022.
- Derived from this study: PubMed 36746334Sung JH, Kim JH, Kim Y, Choi YS, Hong S, Choi SJ, Kim JS, Roh CR, Oh SY. A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100886. doi: 10.1016/j.ajogmf.2023.100886. Epub 2023 Feb 4.
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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.
Soo-young Oh, MD, 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 and Clarithromycin in people with Preterm Premature Rupture of Membrane, 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 4 inclusion and 9 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 20 Apr 2022. 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?
On the ClinicalTrials.gov record for NCT01503606, 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 20 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.