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

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503606
• Other study ID #: 2011-07-005
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: December 2021

Study information

• Verified date: April 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Drug:
• Cefazolin
Cefazolin 1.0gm IVs q 12 hours after randomization for one week
• Clarithromycin
clarithromycin 500mg po bid after randomization for one week
• Cefazolin
Cefazolin 1.0gm IVs q 12 hours after randomization until delivery
• Clarithromycin
clarithromycin 500mg po bid after randomization until delivery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks
Secondary	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	at 6 months and 1 year of corrected age