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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01401179
First received: July 19, 2011
Last updated: August 5, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Preterm Premature Rupture of the Membranes
Drug: cefazolin, erythromycin, clarithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Neonatal composite morbidity [ Time Frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
  • infantile neurologic outcome [ Time Frame: at 6 months and 1 year of corrected age ] [ Designated as safety issue: No ]
    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.


Enrollment: 101
Study Start Date: April 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cefazolin 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.
Active Comparator: cefazolin plus erythromycin
cefazolin, erythromycin
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.
Active Comparator: cefazolin plus clarithromycin 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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401179

Locations
Korea, Republic of
Samsung Medical center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Soo-Young Oh, M.D., PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Soo-young Oh, M.D. PhD, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT01401179     History of Changes
Other Study ID Numbers: 2005-04-003
Study First Received: July 19, 2011
Last Updated: August 5, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Preterm Premature Rupture of Fetal Membranes
antibiotic therapy

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Anti-Bacterial Agents
Cefazolin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Clarithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014