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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 sonography

infantile 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

Page last updated: August 23, 2015

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