Clinical trial NCT01401179: Antibiotics Study in Preterm Premature Rupture of the Membranes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Premature Rupture of the Membranes
Keywords: Preterm Premature Rupture of Fetal Membranes
antibiotic therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 101
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.

Eligibility 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)

Primary outcomes:
measure: Neonatal composite morbidity
timeFrame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
Secondary outcomes:
measure: the incidence of abnormal brain sonography
timeFrame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
measure: infantile neurologic outcome
timeFrame: at 6 months and 1 year of corrected age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical center
Study officials:
affiliation: Samsung Medical Center
name: Soo-Young Oh, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: