Antibiotics Study in Preterm Premature Rupture of the Membranes

Phase 3

Completed

• Conditions: Preterm Premature Rupture of the Membranes
• Interventions: Drug: cefazolin, erythromycin, clarithromycin

• Registration Number: NCT01401179
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
cefazolin plus erythromycin	cefazolin, erythromycin, clarithromycin	cefazolin, erythromycin
cefazolin plus clarithromycin	cefazolin, erythromycin, clarithromycin	-
cefazolin	cefazolin, erythromycin, clarithromycin	-

Primary Outcome Measures

Name	Time	Method
Neonatal composite morbidity	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

Secondary Outcome Measures

Name	Time	Method
the incidence of abnormal brain sonography	Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
infantile neurologic outcome	at 6 months and 1 year of corrected age	The outcome was 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.

Trial Locations

Locations (1)

Samsung Medical center; 🇰🇷 Seoul, Korea, Republic of