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

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Premature Rupture of Membrane

Intervention: Cefazolin (Drug); Clarithromycin (Drug); Cefazolin (Drug); Clarithromycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Soo-young Oh, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine

Overall contact:
Soo-Young Oh, M.D., PhD, Phone: 82-2-3410-3517, Email: ohsymd@skku.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Neonatal composite morbidity

Secondary outcome: infantile neurologic outcome

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Soo-Young Oh, M.D., PhD, Phone: 82-2-3410-3517, Email: ohsymd@skku.edu

Samsung Medical center, Sungkyunkwan University School of Medicine, Seoul 135-710, Korea, Republic of; Recruiting
Soo-young Oh, MD, PhD, Phone: 82-2-3410-3519, Email: ohsymd@skku.edu
Soo-young Oh, MD,PhD, Principal Investigator
Additional Information

Starting date: October 2011
Last updated: January 1, 2012

Page last updated: August 23, 2015

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