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Antibiotics Study in Preterm Premature Rupture of the Membranes (PPROM)

Primary Purpose

Preterm Premature Rupture of the Membranes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cefazolin, erythromycin, clarithromycin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Premature Rupture of the Membranes focused on measuring Preterm Premature Rupture of Fetal Membranes, antibiotic therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Samsung Medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

cefazolin

cefazolin plus erythromycin

cefazolin plus clarithromycin

Arm Description

cefazolin, erythromycin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the incidence of abnormal brain sonography
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.

Full Information

First Posted
July 19, 2011
Last Updated
August 5, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01401179
Brief Title
Antibiotics Study in Preterm Premature Rupture of the Membranes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of the Membranes
Keywords
Preterm Premature Rupture of Fetal Membranes, antibiotic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cefazolin
Arm Type
Active Comparator
Arm Title
cefazolin plus erythromycin
Arm Type
Active Comparator
Arm Description
cefazolin, erythromycin
Arm Title
cefazolin plus clarithromycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
cefazolin, erythromycin, clarithromycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal composite morbidity
Description
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
Time Frame
Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
Secondary Outcome Measure Information:
Title
the incidence of abnormal brain sonography
Time Frame
Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks.
Title
infantile neurologic outcome
Description
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.
Time Frame
at 6 months and 1 year of corrected age

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Young Oh, M.D., PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Antibiotics Study in Preterm Premature Rupture of the Membranes

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