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

Primary Purpose

Preterm Premature Rupture of Membrane

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Cefazolin

Clarithromycin

Cefazolin

Clarithromycin

About this trial

This is an interventional treatment trial for Preterm Premature Rupture of Membrane focused on measuring preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin

Eligibility Criteria

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

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

Sites / Locations

Samsung Medical center, Sungkyunkwan University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

one-week treatment group

until-delivery treatment group

Arm Description

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery

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

infantile neurologic outcome

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

Full Information

NCT ID

NCT01503606

First Posted

December 25, 2011

Last Updated

April 18, 2022

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01503606

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Premature Rupture of Membrane

Keywords

preterm premature rupture of membrane, antibiotics, duration, cefazolin, clarithromycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

one-week treatment group

Arm Type

Active Comparator

Arm Description

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Arm Title

until-delivery treatment group

Arm Type

Active Comparator

Arm Description

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery

Intervention Type

Drug

Intervention Name(s)

Cefazolin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

clarithromycin 500mg po bid after randomization for one week

Intervention Type

Drug

Intervention Name(s)

Cefazolin

Intervention Description

Cefazolin 1.0gm IVs q 12 hours after randomization until delivery

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

clarithromycin 500mg po bid after randomization until delivery

Primary Outcome Measure Information:

Title

Neonatal composite morbidity

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

infantile neurologic outcome

Description

Time Frame

at 6 months and 1 year of corrected age

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soo-young Oh, MD, PhD

Organizational Affiliation

Samsung Medical Center, Sungkyunkwan University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical center, Sungkyunkwan University School of Medicine

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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