Antibiotics Study in Preterm Premature Rupture of the Membranes

Preterm Premature Rupture of the Membranes Clinical Trial

— PPROM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401179
• Other study ID #: 2005-04-003
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2011
• Last updated: August 5, 2011
• Start date: April 2005
• Est. completion date: April 2010

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of the Membranes
• Rupture

Intervention

Drug:
• cefazolin, erythromycin, clarithromycin
Antibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal composite morbidity	respiratory distress syndrome(RDS); bronchopulmonary dysplasia(BPD); intraventricular hemorrhage(IVH,=grade 3); retinopathy of prematurity(ROP,=grade 3); necrotizing enterocolitis(NEC,=stage 2); proven neonatal sepsis	Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.	No
Secondary	the incidence of abnormal brain sonography		Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.	No
Secondary	infantile neurologic outcome	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.	at 6 months and 1 year of corrected age	No