Status:
COMPLETED
Antibiotics Study in Preterm Premature Rupture of the Membranes
Lead Sponsor:
Samsung Medical Center
Conditions:
Preterm Premature Rupture of the Membranes
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- PPROM, PA 23+0\~33+0wks
- ROM \<48 hrs before randomization
- singleton
- Cervical dilatation \<3cm
- uterine contraction less than 4 times per 1 hr
Exclusion
- 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)
- Placenta previa
- Gestational diabetes or overt diabetes
- Hypertensive disorders in pregnancy
- Liver cirrhosis
- Acute renal failure
- IUGR(Intrauterine growth restriction)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01401179
Start Date
April 1 2005
End Date
April 1 2010
Last Update
August 8 2011
Active Locations (1)
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1
Samsung Medical center
Seoul, South Korea, 135-710