Antibiotics Study in Preterm Premature Rupture of the Membranes (PPROM)
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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 |
- 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 ]
- 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
- 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 |
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
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:
|
Rupture Wounds and Injuries Anti-Bacterial Agents Cefazolin Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate |
Clarithromycin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013