Skip to main content
OpenTrials
Completed

NCT Number: NCT01503606

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Premature Rupture of Membrane Preterm Premature Rupture of the Membranes

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
  • ROM <72 hrs before randomization
  • cervical dilatation <3cm
  • uterine contraction less than 4 times per 1 hr

Exclusion criteria

  • Major fetal malformation
  • Rupture of the membrane >72hrs before randomization
  • Vaginal bleeding
  • IIOC (incompetent internal os of cervix)
  • Placenta previa
  • Gestational diabetes or overt diabetes
  • Hypertensive disorders in pregnancy
  • Liver cirrhosis
  • Acute renal failure

Treatment and study plan

Cefazolin

Drug

Cefazolin 1.0gm IVs q 12 hours after randomization for one week

Clarithromycin

Drug

clarithromycin 500mg po bid after randomization for one week

Primary outcomes

  1. Neonatal composite morbidity

    Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks

    • 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 outcomes

  1. infantile neurologic outcome

    Time frame: at 6 months and 1 year of corrected age

    The outcome will be 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Jan 4, 2012
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.