Antibiotics Study in Preterm Premature Rupture of the Membranes
Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Premature Rupture of the Membranes
Intervention: cefazolin, erythromycin, clarithromycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s): Soo-Young Oh, M.D., PhD, Principal Investigator, Affiliation: Samsung Medical Center
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Neonatal composite morbidity
Secondary outcome: the incidence of abnormal brain sonographyinfantile neurologic outcome
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Locations and Contacts
Samsung Medical center, Seoul 135-710, Korea, Republic of
Additional Information
Starting date: April 2005
Last updated: August 5, 2011
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